Background and Aim: Newer generation coronary stent systems with low profile metallic frame, biodegradable polymer coating and potent but safe anti-restenosis drug from “limus family” are emerging as safe and effect...Background and Aim: Newer generation coronary stent systems with low profile metallic frame, biodegradable polymer coating and potent but safe anti-restenosis drug from “limus family” are emerging as safe and effective stents. To evaluate the safety and performance of Metafor SES (Meril life Sciences Pvt. Ltd., Vapi, India) in consecutive patients in a real-world population. Methods: The study was a retrospective, non-randomized, single-center study which evaluated the data of 127 patients who underwent percutaneous coronary intervention (PCI) treated with Metafor SES from February 2012 to February 2015 and mean follow-up period of those patients was 3.6 ± 0.6 years. The primary endpoint was a major adverse cardiac event (MACE) including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). In addition, Stent thrombosis (ST) was analyzed at respective follow-up period. Results: A total of 127 patients (mean age: 53.70 ± 8.41 years and 99 males) were included. Among those 80 (63%) patients had hypertension and 58 (45.7%) patients with diabetes mellitus.At follow-up, MACE in form of TLR was observed in 2 (1.6%) patients only. No cardiac death or stent thrombosis was reported in any patient. A total of 169 lesions were treated with the Metafor SES (1.3 stents per lesion). The 38.4% of patients treated with the Metafor SES with lesion length ≥24 mm, and the procedural success was 100%. Conclusions: The lower incidence of MACE in uncontrolled and real world population at long term follow-up clearly depicts the prolonged safety and performance of the Metafor SES.展开更多
Although the occurrence of coronary stent fracture is rare,recent reports showed that stent fracture after sirolimus-eluting stent(SES)implantation may be associated with neointimal hyperplasia and restenosis.We r... Although the occurrence of coronary stent fracture is rare,recent reports showed that stent fracture after sirolimus-eluting stent(SES)implantation may be associated with neointimal hyperplasia and restenosis.We report two cases of stent fracture that occurred late after elective SES implantation into the right coronary artery(RCA)that were related to the aneurysm,restenosis,thrombosis,and vessel occlusion.……展开更多
Aim: The purpose of this registry was to establish long-term safety and efficacy through implantation of Supralimus-Core sirolimus-eluting stents (SES) in real-world patients with coronary artery disease (CAD). Method...Aim: The purpose of this registry was to establish long-term safety and efficacy through implantation of Supralimus-Core sirolimus-eluting stents (SES) in real-world patients with coronary artery disease (CAD). Methods:The present registry was a retrospective, singe-arm, single-centre, investigator-initiated registry. A total of 372 consecutive patients were implanted with Supralimus-Core SES between January 2015 and November 2016. The primary endpoints were major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR) at 24 months. The secondary endpoints were all-cause death and all separate components of the primary endpoint. Additional endpoints included events of stent thrombosis classified as definite, probable, and possible stent thrombosis. Follow-ups were conducted at 30-days, 6-months, 12-months and 24-months after the index procedure. Results: The mean age of the registry population was 56.3 ± 11.1 years. Males constituted 276 (74.2%) patients. Hypertensives, diabetics, alcoholics, tobacco chewers and smokers comprised 198 (53.2%), 160 (43.0%), 93 (25.0%), 91 (24.5%) and 88 (23.7%) of the registry population, respectively. The mean length and diameter of stents implanted was 19.3 ± 8.8 mm and 2.9 ± 0.3 mm, respectively. At the 24-month follow-up, MACE was reported in 14 (3.8%) patients. Cardiac death, MI, TLR and TVR was reported in 7 (1.9%), 4 (1.1%), 3 (0.8%) and 4 (1.1%) patients, respectively. Overall stent thrombosis occurred in 4 (1.1%) patients. Conclusions: The low MACE rate of 3.8% at the 24-month follow-up indicates favorable long-term results after implantation of the ultra-thin strut Supralimus-Core SES in all-comer, real-world patients.展开更多
OBJECTIVE: The primary objective of the S-CORE registry was to assess the safety and efficacy of the Supralimus-Core? sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free surv...OBJECTIVE: The primary objective of the S-CORE registry was to assess the safety and efficacy of the Supralimus-Core? sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: S-CORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in which 562 patients undergoing single or multi-vessel percutaneous coronary intervention were enrolled. The pre-specified primary outcome was the rate of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) at 12-month post-procedure. Stent thrombosis (ST) served as the safety endpoint. RESULTS: A total of 640 lesions were treated in 562 enrolled patients (mean age 57.4 ± 10.7 years) with average stent length of 25.0 ± 9.0 mm. Stent delivery was successful in 99% cases. A total of 554 (98.6%) patients have been followed up to 12 months. The incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%) respectively. The composite rate of MACE at a 12-month clinical follow-up was 19 (3.4%), consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. The long-term follow-up of this registry is going on to confirm safety and efficacy profiles. CONCLUSIONS: This multicenter registry demonstrated satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events up to 12 months, for the cobalt-chromium biodegradable polymer-based sirolimus-eluting Supralimus-Core? stent in a “real-world” setting.展开更多
Current new generation stent technology has made remarkable progress in stent design, structure, and component material to improve its performance in reducing stent thrombosis, and restenosis compared to earlier DES a...Current new generation stent technology has made remarkable progress in stent design, structure, and component material to improve its performance in reducing stent thrombosis, and restenosis compared to earlier DES and BMS. Orsiro-Sirolimus eluting stent is new generation ultra-thin strut stent with biodegradable abluminal coating that leaves a polymer free stent after drug release enhances coverage of stent struts and prevents excess neo intimal proliferation. A retrospective data analysis was done to see safety and efficacy of Orsiro in patients treated with ultra-thin DES with Orsiro stents at Sunshine Hospitals, Hyderabad. A total of 331 patients with 525 lesions were treated with 506 Orsiro stents and the major adverse cardiac events (MACE) rate and stent thrombosis (ST) at 2 years’ follow-up were analysed. MACE rate was 1.6% for an average follow-up at 2 years. Out of 2 patients who developed ST, one presented with definite acute stent thrombosis and one with possible, late stent thrombosis and 1.8% non-cardiac death reported during the follow-up. Despite many patients with complex PCI in the ACS subset, Orsiro reduced significant reduction in MACE rate in all spectrum of coronary artery disease patients with excellent acute and long-term results similar to other established FDA-approved current generations stents.展开更多
Objectives To assess long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent(BSES) in vivo by using virtual histology intravascular ultrasound(VH-IVUS).Methods 41 patients were enr...Objectives To assess long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent(BSES) in vivo by using virtual histology intravascular ultrasound(VH-IVUS).Methods 41 patients were enrolled in this study and VH-IVUS was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES(DSES) during long-term follow-up(median =8 months).The presence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss(0.15[0.06,0.30]vs 0.19[0.03, 0.30]mm,P=0.772),the overall incidence of necrotic core abutting to the lumen was significantly less in BSES than DSES group(44%vs.63%,P=0.019)(proximal 18%,stented site 14%and distal 12%in BSES group,proximal 19%, stented site 28%and distal 16%in DSES group).Compared with stented segments each other,the DSES -treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts(73%vs.36%, P=0.005).In addition,more multiple necrotic core abutting to the lumen was observed in DSES group(overall:63%vs. 36%,P=0.015).Furthermore,among the total number of stented segments with necrotic core abutting to the lumen, DSES -treated lesions had more multiple necrotic core abutting to the lumen through the stent struts than BSES -treated lesions in evidence(74%vs.33%,P=0.027).Conclusions By VH-IVUS analysis at follow-up,a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs.The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on drug-eluting stent(DES) surface biodegraded as time went by.展开更多
Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world settin...Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective,multicenter,cohort study conducted at 38 centers across China between November 2018 and December 2019.A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria.The primary endpoint was target lesion failure(TLF),defined as a composite of cardiac death,non-fatal target vessel myocardial infarction(MI),and clinically indicated target lesion revascularization(TLR)at 1-year follow-up.Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998(98.0%)patients completed the 1-year follow-up.The 1-year incidence of TLF was 3.10%(94/2998,95%closed interval:2.54-3.78%).The rates of cardiac death,non-fatal target vessel MI and clinically indicated TLR were 2.33%(70/2998),0.20%(6/2998),and 0.70%(21/2998),respectively.The rate of stent thrombosis was 0.33%(10/2998).Age≥60 years,diabetes mellitus,family history of coronary artery disease,acute myocardial infarction at admission,and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10%and 0.33%,respectively,in patients treated with HELIOS stents.Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov,NCT03916432.展开更多
Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenT...Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.展开更多
Objective The sirolimus-eluting stent （SES） has dramatically reduced the rate ofrestenosis in comparison to that with the baremetal stent （BMS）.This study aimed to evaluate the short-term efficacy and safety of Fi...Objective The sirolimus-eluting stent （SES） has dramatically reduced the rate ofrestenosis in comparison to that with the baremetal stent （BMS）.This study aimed to evaluate the short-term efficacy and safety of Firebird stent implantation for patients with coronary heart disease （CHD）. Methods From Apri12006 through July 2007, 155 patients （mean age 58.93±10.27 years ） with CHD were implanted with Firebird stent or Cypher select stent at Daxing Hospital. Patients were followed up for one year. All-cause mortality, major adverse cardiac events （MACE, including cardiac death, myocardial infarction, recurrence of angina pectoris, heart failure, revascularization, and adverse arrhythmia） and stent thrombosis were compared between the 2 groups. Results Of the 155 consecutive patients, 147 patients were revascularized completely. Of these patients, 48 （with 59 lesions） were treated with Firebird stent, 59 patients （with 75 lesions） with Cypher select stent. The demographic characteristics were similar in the 2 groups. All the angiographic and procedural results were not significantly different between the 2 groups. All-cause mortality, myocardial infarction, recurrence of angina pectoris, MACE and stent thrombosis were almost identical between the 2 groups before discharge, at 6 months and at one year .Conclusion The short-term efficacy and safety of Firebird stent are similar to that of the cypher select stent for the treatment of patients with CHD （J Geriatr Cardlo12009; 6：157-161）.展开更多
In-stent thrombosis after cessation of antiplatelet medications in patients with drug-eluting stents （DES） is a significant problem in medical practice, particularly in the perioperative period. We report a case of ...In-stent thrombosis after cessation of antiplatelet medications in patients with drug-eluting stents （DES） is a significant problem in medical practice, particularly in the perioperative period. We report a case of an 87-year-old man with a medical history of hypertension, coronary artery disease and chronic atrophic gastritis. Very late thrombosis of a sirolimus-eluting stent occurred 1207 days after implantation, seven months after discontinuation of clopidogrel, and the interruption of aspirin 13 days in preparation of an elective endoscopic gastroin-testinal procedure presented with acute myocardial infarction. The patient was treated with thrombectomy and successfully revascularized with superimposition of two sirolimus-eluting stents. Medications administered in the catheterization laboratory included low molecular weight heparin and nitroglycerin. Flow was defined as grade 2 according to the thrombolysis in myocardial infarction scale. Electrocardio-gram after the procedure revealed persistent, but decreased, ST-segment elevation in the anterolateral leads. The patient recovered and was discharged on aspirin and clopidogrel indefinitely. There was no cardiac event during the two year follow-up period. This case underlines the importance of maintaining the balance of thrombosis and bleeding during perioperation of non-cardiac procedure and the possible need for continuation of aspirin therapy during periendoscopic procedures among patients with low bleeding risks who received DES.展开更多
Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This st...Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.展开更多
Background Off-label application of drug-eluting stents （DES） during percutaneous coronary intervention （PCI） was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset...Background Off-label application of drug-eluting stents （DES） during percutaneous coronary intervention （PCI） was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent （SES） in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.Methods The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.Results Long lesions （59.2%）, multi-vessel disease （50.4%）, and small vessel disease （31.6%） were mostly found in angiography. Major adverse cardiac events （MACE） occurred in 51 （5.1%） patients at 1 year clinical follow-up,including cardiac mortality in 6 （0.6%）, non-fatal myocardial infarction in 11 （1.1%）, and target lesion revascularization in 36 （3.5%） of the patients. Definite and probable stent thrombosis （ST） by Academic Research Consortium （ARC） definition occurred in 12 （1.36%） patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was （0.21±0.40） mm in-segment and （0.23±0.36） mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.Conclusions The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. （NCT00552656）展开更多
Optical coherence tomography （OCT） is a new imaging modality with resolution of approximately 10 pm and can be employed to visualize intracoronary characteristics. Sirolimus-eluting stents （SES） are susceptible to...Optical coherence tomography （OCT） is a new imaging modality with resolution of approximately 10 pm and can be employed to visualize intracoronary characteristics. Sirolimus-eluting stents （SES） are susceptible to late thrombosis due to delayed reendothelialization over the stent struts, which may result in acute myocardial infarction or death. This study was designed to evaluate the re-endothelialization and neointimal coverage of SES with OCT 6 months and 12 months after implantation.Methods A total of 36 patients enrolled in the study underwent OCT examination 6 months （17 patients） and 12 months （19 patients） after SES implantation, The strut apposition to the vessel wall and neointimal coverage on SES struts were evaluated by OCT, Results Forty-six SES and 6561 struts were analyzed, At 6 months, 3041 struts （98.7%） were well-apposed and 39 struts （1,3%） were malapposed, At 12 months, 3434 struts （98,6%） were well-apposed and 47 struts （1,4%） were malapposed, Furthermore, only 4 SES at 6 months （18,2%） and 10 SES at 12 months （41,7%） were fully covered by neointimal growth, The average neointimal thicknesses covering the analyzed struts at 6 months and 12 months were （42±28） μm and （88±32） μm, respectively, There were 1989 struts at 6 months （72,1%） and 1461 struts at 12 months （45,6%） with neointimal thickness 〈100 μm, Conclusions OCT was able to visualize the strut apposition to the vessel wall and neointimal coverage on SES struts, At 6-month and 12-month follow-up examinations most struts were covered with thin neointima, but few of the entire SES showed full coverage. To prevent late-stent thrombosis in the presence of uncovered stent struts, longer dual antiplatelet drugs therapy should be recommended,展开更多
Background The Firebird 2TM sirolimus-eluting stent （Firebird 2 stent） is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers o...Background The Firebird 2TM sirolimus-eluting stent （Firebird 2 stent） is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2TM cObalt-Chromium alloy sirolimus-elUting Stent registry （FOCUS registry） aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.Methods The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry.Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.Results Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events （MACE） was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction （MI）, and 6 target vessel revascularization （TVR）. At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis （ST） occurred in 0.43% （22/5058） of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.Conclusion The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.展开更多
Background Insulin resistance（IR）is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of ...Background Insulin resistance（IR）is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention（PCI）with sirolimus-eluting stent（SES）implantation.Methods A total of 467 consecutive patients undergoing SES-based PCI were divided into lR group（n=104）and non-IR group（n=363）.The patients were followed up for one year.The rate of major adverse cardiac events（MACEs） including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test,and the independent risk factors were identified by the Cox regression analysis.Results MACEs occurred more frequently,and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up （all P〈0.05）.IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction（OR=2176,95% CI=1.35-5.47,P=0.034）.Old age,diabetes,and multi-vessel disease were determinants for recurrent angina pectoris after PCI（P〈0.05）.Subgroup analysis revealed that IR（OR=3.35,95% CI=1.07-13.59,P=0.013）and multi-vessel disease（OR=2.19,95%CI=1.01-5.14,P=0.044）were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.Conclusions IR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.展开更多
Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely use...Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.展开更多
Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary...Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention （PCI） with sirolimus-eluting stents （SES） by means of three-dimensional volumetric intravascular ultrasound （IVUS） analyses. Methods One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure. Results In overall 219 treated lesions （137 patients）, late ISA was identified in 25 lesions （16 patients）. Clinical diagnosis of acute coronary syndrome （ACS） and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane （EEM） area in stented segment （（15.34±5.44） vs （13.83±4.51） mm^2, P=0.026）, stented-to-reference segment EEM area ratio （1.13±0.22 vs 1.02±0.18, P 〈0.001）, and plaque and media area （（8.43±3.93） vs （7.01±2.93） mm^2, P =0.002） than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA （OR 6.477, 95%CI 2.297-18.263, P 〈0.001; OR 3.680, 95%Cl 1.181-11.469, P =0.025; respectively）. During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA （18.7% vs 3.3%, P =0.051）. Conclusions The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.展开更多
Background The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial i...Background The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial infarction. Methods This was a prospective, randomized, controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction, treated with zotarolimus-eluting stents or sirolimus-eluting stents. From March 2007 to February 2009, 122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1：1 fashion. The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography, and secondary endpoints were percent diameter stenosis, binary restenosis rate, major adverse cardiac events （a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization）, and late-acquired incomplete stent apposition. Results Angiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group （（0.49±0.65） mm vs. （0.10±0.46） mm, P=0.001）. Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group （（30.0±17.9）% vs. （17.6±14.0）%, P 〈0.001）. In-segment analysis showed similar findings. There were no significant differences in binary restenosis rate, major adverse cardiac events, and late-acquired incomplete stent apposition. Conclusions Compared to sirolimus-eluting stents, the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction. Although there was no significant difference in 1-year clinical outcomes, the clinical implication of increased late lumen loss should be further studied.展开更多
Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES ...Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.展开更多
Background As a kind of sirolimus-eluting stent （SES） made in China, Firebird SES is more effective than bare metal stent （BMS） and not inferior to Cypher SES for short coronary lesions in terms of reduction of re...Background As a kind of sirolimus-eluting stent （SES） made in China, Firebird SES is more effective than bare metal stent （BMS） and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion （VLCL）. The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion （≥ 30 mm） between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event （MACE） that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 （41 lesions） were treated with Firebird SES, 37 （39 lesions） with Cypher SES, and 37 （37 lesions） with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group （in-segment： 14.6% vs 12.8%, relative risk （RR）1.14, P=0.81; in-stent： 9.8% vs 10.3%, RR 0.95, P=0.94）, and significantly lower than those in the BMS group （in-segment： vs 36.1%, RR 0.41 or 0.36, P=-0.04 or 0.03, respectively; in-stent： vs 30.6%, RR 0.32 or 0.34, P=0.03 or 0.04, respectively）. The total MACE rate up to 12 months was also similar in both SES groups （7.7% vs 5.4%, P=1.000）, and significantly lower than that in the BMS group （27.0%, P=0.034 or 0.024, respectively）. The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups （2.7% and 2.7%, respectively, P=1.000）. Conclusions In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.展开更多
文摘Background and Aim: Newer generation coronary stent systems with low profile metallic frame, biodegradable polymer coating and potent but safe anti-restenosis drug from “limus family” are emerging as safe and effective stents. To evaluate the safety and performance of Metafor SES (Meril life Sciences Pvt. Ltd., Vapi, India) in consecutive patients in a real-world population. Methods: The study was a retrospective, non-randomized, single-center study which evaluated the data of 127 patients who underwent percutaneous coronary intervention (PCI) treated with Metafor SES from February 2012 to February 2015 and mean follow-up period of those patients was 3.6 ± 0.6 years. The primary endpoint was a major adverse cardiac event (MACE) including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). In addition, Stent thrombosis (ST) was analyzed at respective follow-up period. Results: A total of 127 patients (mean age: 53.70 ± 8.41 years and 99 males) were included. Among those 80 (63%) patients had hypertension and 58 (45.7%) patients with diabetes mellitus.At follow-up, MACE in form of TLR was observed in 2 (1.6%) patients only. No cardiac death or stent thrombosis was reported in any patient. A total of 169 lesions were treated with the Metafor SES (1.3 stents per lesion). The 38.4% of patients treated with the Metafor SES with lesion length ≥24 mm, and the procedural success was 100%. Conclusions: The lower incidence of MACE in uncontrolled and real world population at long term follow-up clearly depicts the prolonged safety and performance of the Metafor SES.
文摘 Although the occurrence of coronary stent fracture is rare,recent reports showed that stent fracture after sirolimus-eluting stent(SES)implantation may be associated with neointimal hyperplasia and restenosis.We report two cases of stent fracture that occurred late after elective SES implantation into the right coronary artery(RCA)that were related to the aneurysm,restenosis,thrombosis,and vessel occlusion.……
文摘Aim: The purpose of this registry was to establish long-term safety and efficacy through implantation of Supralimus-Core sirolimus-eluting stents (SES) in real-world patients with coronary artery disease (CAD). Methods:The present registry was a retrospective, singe-arm, single-centre, investigator-initiated registry. A total of 372 consecutive patients were implanted with Supralimus-Core SES between January 2015 and November 2016. The primary endpoints were major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR) at 24 months. The secondary endpoints were all-cause death and all separate components of the primary endpoint. Additional endpoints included events of stent thrombosis classified as definite, probable, and possible stent thrombosis. Follow-ups were conducted at 30-days, 6-months, 12-months and 24-months after the index procedure. Results: The mean age of the registry population was 56.3 ± 11.1 years. Males constituted 276 (74.2%) patients. Hypertensives, diabetics, alcoholics, tobacco chewers and smokers comprised 198 (53.2%), 160 (43.0%), 93 (25.0%), 91 (24.5%) and 88 (23.7%) of the registry population, respectively. The mean length and diameter of stents implanted was 19.3 ± 8.8 mm and 2.9 ± 0.3 mm, respectively. At the 24-month follow-up, MACE was reported in 14 (3.8%) patients. Cardiac death, MI, TLR and TVR was reported in 7 (1.9%), 4 (1.1%), 3 (0.8%) and 4 (1.1%) patients, respectively. Overall stent thrombosis occurred in 4 (1.1%) patients. Conclusions: The low MACE rate of 3.8% at the 24-month follow-up indicates favorable long-term results after implantation of the ultra-thin strut Supralimus-Core SES in all-comer, real-world patients.
文摘OBJECTIVE: The primary objective of the S-CORE registry was to assess the safety and efficacy of the Supralimus-Core? sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: S-CORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in which 562 patients undergoing single or multi-vessel percutaneous coronary intervention were enrolled. The pre-specified primary outcome was the rate of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) at 12-month post-procedure. Stent thrombosis (ST) served as the safety endpoint. RESULTS: A total of 640 lesions were treated in 562 enrolled patients (mean age 57.4 ± 10.7 years) with average stent length of 25.0 ± 9.0 mm. Stent delivery was successful in 99% cases. A total of 554 (98.6%) patients have been followed up to 12 months. The incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%) respectively. The composite rate of MACE at a 12-month clinical follow-up was 19 (3.4%), consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. The long-term follow-up of this registry is going on to confirm safety and efficacy profiles. CONCLUSIONS: This multicenter registry demonstrated satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events up to 12 months, for the cobalt-chromium biodegradable polymer-based sirolimus-eluting Supralimus-Core? stent in a “real-world” setting.
文摘Current new generation stent technology has made remarkable progress in stent design, structure, and component material to improve its performance in reducing stent thrombosis, and restenosis compared to earlier DES and BMS. Orsiro-Sirolimus eluting stent is new generation ultra-thin strut stent with biodegradable abluminal coating that leaves a polymer free stent after drug release enhances coverage of stent struts and prevents excess neo intimal proliferation. A retrospective data analysis was done to see safety and efficacy of Orsiro in patients treated with ultra-thin DES with Orsiro stents at Sunshine Hospitals, Hyderabad. A total of 331 patients with 525 lesions were treated with 506 Orsiro stents and the major adverse cardiac events (MACE) rate and stent thrombosis (ST) at 2 years’ follow-up were analysed. MACE rate was 1.6% for an average follow-up at 2 years. Out of 2 patients who developed ST, one presented with definite acute stent thrombosis and one with possible, late stent thrombosis and 1.8% non-cardiac death reported during the follow-up. Despite many patients with complex PCI in the ACS subset, Orsiro reduced significant reduction in MACE rate in all spectrum of coronary artery disease patients with excellent acute and long-term results similar to other established FDA-approved current generations stents.
文摘Objectives To assess long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent(BSES) in vivo by using virtual histology intravascular ultrasound(VH-IVUS).Methods 41 patients were enrolled in this study and VH-IVUS was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES(DSES) during long-term follow-up(median =8 months).The presence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss(0.15[0.06,0.30]vs 0.19[0.03, 0.30]mm,P=0.772),the overall incidence of necrotic core abutting to the lumen was significantly less in BSES than DSES group(44%vs.63%,P=0.019)(proximal 18%,stented site 14%and distal 12%in BSES group,proximal 19%, stented site 28%and distal 16%in DSES group).Compared with stented segments each other,the DSES -treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts(73%vs.36%, P=0.005).In addition,more multiple necrotic core abutting to the lumen was observed in DSES group(overall:63%vs. 36%,P=0.015).Furthermore,among the total number of stented segments with necrotic core abutting to the lumen, DSES -treated lesions had more multiple necrotic core abutting to the lumen through the stent struts than BSES -treated lesions in evidence(74%vs.33%,P=0.027).Conclusions By VH-IVUS analysis at follow-up,a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs.The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on drug-eluting stent(DES) surface biodegraded as time went by.
文摘Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective,multicenter,cohort study conducted at 38 centers across China between November 2018 and December 2019.A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria.The primary endpoint was target lesion failure(TLF),defined as a composite of cardiac death,non-fatal target vessel myocardial infarction(MI),and clinically indicated target lesion revascularization(TLR)at 1-year follow-up.Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998(98.0%)patients completed the 1-year follow-up.The 1-year incidence of TLF was 3.10%(94/2998,95%closed interval:2.54-3.78%).The rates of cardiac death,non-fatal target vessel MI and clinically indicated TLR were 2.33%(70/2998),0.20%(6/2998),and 0.70%(21/2998),respectively.The rate of stent thrombosis was 0.33%(10/2998).Age≥60 years,diabetes mellitus,family history of coronary artery disease,acute myocardial infarction at admission,and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10%and 0.33%,respectively,in patients treated with HELIOS stents.Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov,NCT03916432.
文摘Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.
文摘Objective The sirolimus-eluting stent （SES） has dramatically reduced the rate ofrestenosis in comparison to that with the baremetal stent （BMS）.This study aimed to evaluate the short-term efficacy and safety of Firebird stent implantation for patients with coronary heart disease （CHD）. Methods From Apri12006 through July 2007, 155 patients （mean age 58.93±10.27 years ） with CHD were implanted with Firebird stent or Cypher select stent at Daxing Hospital. Patients were followed up for one year. All-cause mortality, major adverse cardiac events （MACE, including cardiac death, myocardial infarction, recurrence of angina pectoris, heart failure, revascularization, and adverse arrhythmia） and stent thrombosis were compared between the 2 groups. Results Of the 155 consecutive patients, 147 patients were revascularized completely. Of these patients, 48 （with 59 lesions） were treated with Firebird stent, 59 patients （with 75 lesions） with Cypher select stent. The demographic characteristics were similar in the 2 groups. All the angiographic and procedural results were not significantly different between the 2 groups. All-cause mortality, myocardial infarction, recurrence of angina pectoris, MACE and stent thrombosis were almost identical between the 2 groups before discharge, at 6 months and at one year .Conclusion The short-term efficacy and safety of Firebird stent are similar to that of the cypher select stent for the treatment of patients with CHD （J Geriatr Cardlo12009; 6：157-161）.
文摘In-stent thrombosis after cessation of antiplatelet medications in patients with drug-eluting stents （DES） is a significant problem in medical practice, particularly in the perioperative period. We report a case of an 87-year-old man with a medical history of hypertension, coronary artery disease and chronic atrophic gastritis. Very late thrombosis of a sirolimus-eluting stent occurred 1207 days after implantation, seven months after discontinuation of clopidogrel, and the interruption of aspirin 13 days in preparation of an elective endoscopic gastroin-testinal procedure presented with acute myocardial infarction. The patient was treated with thrombectomy and successfully revascularized with superimposition of two sirolimus-eluting stents. Medications administered in the catheterization laboratory included low molecular weight heparin and nitroglycerin. Flow was defined as grade 2 according to the thrombolysis in myocardial infarction scale. Electrocardio-gram after the procedure revealed persistent, but decreased, ST-segment elevation in the anterolateral leads. The patient recovered and was discharged on aspirin and clopidogrel indefinitely. There was no cardiac event during the two year follow-up period. This case underlines the importance of maintaining the balance of thrombosis and bleeding during perioperation of non-cardiac procedure and the possible need for continuation of aspirin therapy during periendoscopic procedures among patients with low bleeding risks who received DES.
文摘Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.
基金National Natural Science Foundation of China，Beijing Natural Science Foundation，Specilized Research Fund for the Doctoral Program of High Education of China
文摘Background Off-label application of drug-eluting stents （DES） during percutaneous coronary intervention （PCI） was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent （SES） in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.Methods The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.Results Long lesions （59.2%）, multi-vessel disease （50.4%）, and small vessel disease （31.6%） were mostly found in angiography. Major adverse cardiac events （MACE） occurred in 51 （5.1%） patients at 1 year clinical follow-up,including cardiac mortality in 6 （0.6%）, non-fatal myocardial infarction in 11 （1.1%）, and target lesion revascularization in 36 （3.5%） of the patients. Definite and probable stent thrombosis （ST） by Academic Research Consortium （ARC） definition occurred in 12 （1.36%） patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was （0.21±0.40） mm in-segment and （0.23±0.36） mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.Conclusions The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. （NCT00552656）
文摘Optical coherence tomography （OCT） is a new imaging modality with resolution of approximately 10 pm and can be employed to visualize intracoronary characteristics. Sirolimus-eluting stents （SES） are susceptible to late thrombosis due to delayed reendothelialization over the stent struts, which may result in acute myocardial infarction or death. This study was designed to evaluate the re-endothelialization and neointimal coverage of SES with OCT 6 months and 12 months after implantation.Methods A total of 36 patients enrolled in the study underwent OCT examination 6 months （17 patients） and 12 months （19 patients） after SES implantation, The strut apposition to the vessel wall and neointimal coverage on SES struts were evaluated by OCT, Results Forty-six SES and 6561 struts were analyzed, At 6 months, 3041 struts （98.7%） were well-apposed and 39 struts （1,3%） were malapposed, At 12 months, 3434 struts （98,6%） were well-apposed and 47 struts （1,4%） were malapposed, Furthermore, only 4 SES at 6 months （18,2%） and 10 SES at 12 months （41,7%） were fully covered by neointimal growth, The average neointimal thicknesses covering the analyzed struts at 6 months and 12 months were （42±28） μm and （88±32） μm, respectively, There were 1989 struts at 6 months （72,1%） and 1461 struts at 12 months （45,6%） with neointimal thickness 〈100 μm, Conclusions OCT was able to visualize the strut apposition to the vessel wall and neointimal coverage on SES struts, At 6-month and 12-month follow-up examinations most struts were covered with thin neointima, but few of the entire SES showed full coverage. To prevent late-stent thrombosis in the presence of uncovered stent struts, longer dual antiplatelet drugs therapy should be recommended,
文摘Background The Firebird 2TM sirolimus-eluting stent （Firebird 2 stent） is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2TM cObalt-Chromium alloy sirolimus-elUting Stent registry （FOCUS registry） aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.Methods The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry.Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.Results Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events （MACE） was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction （MI）, and 6 target vessel revascularization （TVR）. At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis （ST） occurred in 0.43% （22/5058） of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.Conclusion The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.
文摘Background Insulin resistance（IR）is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention（PCI）with sirolimus-eluting stent（SES）implantation.Methods A total of 467 consecutive patients undergoing SES-based PCI were divided into lR group（n=104）and non-IR group（n=363）.The patients were followed up for one year.The rate of major adverse cardiac events（MACEs） including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test,and the independent risk factors were identified by the Cox regression analysis.Results MACEs occurred more frequently,and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up （all P〈0.05）.IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction（OR=2176,95% CI=1.35-5.47,P=0.034）.Old age,diabetes,and multi-vessel disease were determinants for recurrent angina pectoris after PCI（P〈0.05）.Subgroup analysis revealed that IR（OR=3.35,95% CI=1.07-13.59,P=0.013）and multi-vessel disease（OR=2.19,95%CI=1.01-5.14,P=0.044）were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.Conclusions IR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.
文摘Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.
文摘Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention （PCI） with sirolimus-eluting stents （SES） by means of three-dimensional volumetric intravascular ultrasound （IVUS） analyses. Methods One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure. Results In overall 219 treated lesions （137 patients）, late ISA was identified in 25 lesions （16 patients）. Clinical diagnosis of acute coronary syndrome （ACS） and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane （EEM） area in stented segment （（15.34±5.44） vs （13.83±4.51） mm^2, P=0.026）, stented-to-reference segment EEM area ratio （1.13±0.22 vs 1.02±0.18, P 〈0.001）, and plaque and media area （（8.43±3.93） vs （7.01±2.93） mm^2, P =0.002） than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA （OR 6.477, 95%CI 2.297-18.263, P 〈0.001; OR 3.680, 95%Cl 1.181-11.469, P =0.025; respectively）. During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA （18.7% vs 3.3%, P =0.051）. Conclusions The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.
文摘Background The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial infarction. Methods This was a prospective, randomized, controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction, treated with zotarolimus-eluting stents or sirolimus-eluting stents. From March 2007 to February 2009, 122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1：1 fashion. The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography, and secondary endpoints were percent diameter stenosis, binary restenosis rate, major adverse cardiac events （a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization）, and late-acquired incomplete stent apposition. Results Angiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group （（0.49±0.65） mm vs. （0.10±0.46） mm, P=0.001）. Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group （（30.0±17.9）% vs. （17.6±14.0）%, P 〈0.001）. In-segment analysis showed similar findings. There were no significant differences in binary restenosis rate, major adverse cardiac events, and late-acquired incomplete stent apposition. Conclusions Compared to sirolimus-eluting stents, the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction. Although there was no significant difference in 1-year clinical outcomes, the clinical implication of increased late lumen loss should be further studied.
文摘Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.
文摘Background As a kind of sirolimus-eluting stent （SES） made in China, Firebird SES is more effective than bare metal stent （BMS） and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion （VLCL）. The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion （≥ 30 mm） between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event （MACE） that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 （41 lesions） were treated with Firebird SES, 37 （39 lesions） with Cypher SES, and 37 （37 lesions） with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group （in-segment： 14.6% vs 12.8%, relative risk （RR）1.14, P=0.81; in-stent： 9.8% vs 10.3%, RR 0.95, P=0.94）, and significantly lower than those in the BMS group （in-segment： vs 36.1%, RR 0.41 or 0.36, P=-0.04 or 0.03, respectively; in-stent： vs 30.6%, RR 0.32 or 0.34, P=0.03 or 0.04, respectively）. The total MACE rate up to 12 months was also similar in both SES groups （7.7% vs 5.4%, P=1.000）, and significantly lower than that in the BMS group （27.0%, P=0.034 or 0.024, respectively）. The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups （2.7% and 2.7%, respectively, P=1.000）. Conclusions In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.
