Background Durable polymer drug eluting stent （DES） is confronted with many issues, especially the inci- dence of late stent thrombosis （ST） which is mainly due to delayed healing and re-endothelization by the dur...Background Durable polymer drug eluting stent （DES） is confronted with many issues, especially the inci- dence of late stent thrombosis （ST） which is mainly due to delayed healing and re-endothelization by the durable polymer coating. Newer polymer-free DES might have a reduction in late stent thrombosis. Therefore, the aim of this study was to evaluate the efficacy and safety of two different drug eluting stents in patients with acute coro- nary syndromes （ACS） by one year follow-up. Methods This study assessed the results of the Nano polymer- free SES （Lepu Medical Technology, Beijing, China） and Endeavor durable-polymer ZES （Medtronic, Minneapo- lis, MN, USA） in ACS patients by clinical follow-up and coronary angiography analysis. The primary endpoint was the onset of any major adverse cardiac events （MACE） such as cardiac death, myocardial infarction （MI） and target vessel revascularization （TVR）. The secondary endpoints were target lesion revascularization （TLR） and stent thrombosis （ST） at the end of one year follow-up. Results Between April 2014 and June 2015, a total of 513 consecutive patients were enrolled in this trial. There were 259 patients enrolled in Nano group and 253 pa- tients in Endeavor group. Mean age was 62.8 ＋10.3 years old （range： 28 to 87 years of age）, and 65.3% of pa- tients were male. Compared Nano-SES to Endeavor-ZES, the incidence of MACE was 5.4% vs. 7.1%. The hazard ratio （HR） was 1.32 with 95% confidence interval （CI） as 0.64-2.72 （P = 0.45）. Secondary end points showed TLR （1.9% vs. 3.2%; HR, 1.42; 95% CI, 0.45-4.55; P = 0.55） and ST （0.4% vs. 0.8%; HR, 2.03; 95% CI, 0.18- 5.37; P = 0.99）, in the one-year period of follow-up. Conclusion Within one-year, the Nano polymer-free SES has similar safety and efficacy compared with the Endeavor durable-polymer ZES in the treatment of patients with ACS.展开更多
Background Radiofrequency catheter ablation （RFCA） and cryoballoon ablation （CBA） are the two common ablation technologies used for the treatment of paroxysmal atrial fibrillation （PAF）. However, there is no con...Background Radiofrequency catheter ablation （RFCA） and cryoballoon ablation （CBA） are the two common ablation technologies used for the treatment of paroxysmal atrial fibrillation （PAF）. However, there is no consensus on which ablation method is the optimal choice. Methods We searched PubMed, EMBASE, Cochrane Library, Web of Knowledge and clinical trials.gov for clinically controlled trials （published up to January 11, 2017）. All included studies included fulfilled our previously defined criteria. The primary clinical outcome was the proportion of participants free from atrial fibrillation at 12-months follow-up. ; The secondary clinical outcomes were as the procedure time, fluoroscopy time, and total complications. Results We identified 573 studies, seven randomized controlled trials （RCTs） and 11 non-RCTs were included in this analysis （n=4982 participants）. Compared with RFCA, CBA had similar proportion of participants free from PAF at 12-months follow-up （70.8% vs. 69%; relative risk [RR] ： 1.01; 95% CI： 0.97 to 1.05）. Additionally, procedure time （149.61 vs. 174.73min; weighted mean difference WMD： 25.55; 95% CI： 44.69 to 6.41） was shorter in the CBA group, but the fluoroscopy time （34.52 vs. 38.59 min; WMD： 2.08; 95% CI： 5.86 to 1.71） did not have any significant difference. Total complication was not significantly different in both groups （RR： 1.22; 95% CI： 0.74 to 2.02 ）. Conclusions CBA is similar to RFCA with respect to clinical efficacy for PAF during the follow-up period of 12 months, and with no increased overall safety risk in the cryoballoon group CBA.展开更多
Background Renal insufficiency is associated with an excess risk of vascular complications and bleeding events in patients who undergo PCI. Heparin is still used commonly for PCI, but the bleeding complications is hig...Background Renal insufficiency is associated with an excess risk of vascular complications and bleeding events in patients who undergo PCI. Heparin is still used commonly for PCI, but the bleeding complications is high. However, Bivalirudin is similar to heparin in ischemic complications and superior to the bleeding complica- tions. Methods A total of 181 patients with coronary artery disease and renal insufficiency were randomly as- signed two treatment groups： Bivalirudin （n = 90）, unfractionated heparin （n = 91）. Activated clotting time （ACT） was determined in patients at 5 min after undergoing PCI at the end of operation immediately （stopping drug im- mediately） , and 30 min,1 h, 2 h after stopping drug. Activated partial thromboplastin time （APTT）, thrombin time （TT）, proth rombin time （PT）, fibrinogen （FIB） index were measured before treatment, 6 h, 24 h and 72 h af- ter the treatment through an automated coagulation analyzer. Platelet count was monitored before treatment and 24 h after treatment. The end points were the proportion of net adverse clinical events （NACE） and stent throm- bosis at 30 days. Results The use of bivalirudin was associated with a statistically significant higher at 5 min af- ter treatment, end of operation immediately （P 〈 0.05）, with statistically significant lower at lh after stopping drug , 2h after stopping drug （P 〈 0.05）. There were no differences between patients at blood coagulation and platelet after operation （P 〉 0.05）, no differences in the 30-day rates of stent thrombosis （0% vs. 0%, P = 1）. Elev- en patients（12.22%） treated with bivalirudin vs. 24 （26.38%） treated with heparin experienced an adverse clinical events at 30 days （relative risk[RR], 0.46; 95%CI, 0.36-0.56; P 〈 0.025）. There were no differences in the major adverse cardiac or cerebral event at the 30-day end point（1.11% vs. 2.20%, P 〉 0.05）. The bleeding at 30 days was abated by using bivalirudin compared with unfracfionated heparin （11.11% vs. 24.18%, P 〈 0.05）. Conclu- sions Compared with the unfractionated heparin, bivalirudin is more quickly in taking effect and recovering and more efficient for PCI in patients with coronary artery disease and renal insufficiency.展开更多
文摘Background Durable polymer drug eluting stent （DES） is confronted with many issues, especially the inci- dence of late stent thrombosis （ST） which is mainly due to delayed healing and re-endothelization by the durable polymer coating. Newer polymer-free DES might have a reduction in late stent thrombosis. Therefore, the aim of this study was to evaluate the efficacy and safety of two different drug eluting stents in patients with acute coro- nary syndromes （ACS） by one year follow-up. Methods This study assessed the results of the Nano polymer- free SES （Lepu Medical Technology, Beijing, China） and Endeavor durable-polymer ZES （Medtronic, Minneapo- lis, MN, USA） in ACS patients by clinical follow-up and coronary angiography analysis. The primary endpoint was the onset of any major adverse cardiac events （MACE） such as cardiac death, myocardial infarction （MI） and target vessel revascularization （TVR）. The secondary endpoints were target lesion revascularization （TLR） and stent thrombosis （ST） at the end of one year follow-up. Results Between April 2014 and June 2015, a total of 513 consecutive patients were enrolled in this trial. There were 259 patients enrolled in Nano group and 253 pa- tients in Endeavor group. Mean age was 62.8 ＋10.3 years old （range： 28 to 87 years of age）, and 65.3% of pa- tients were male. Compared Nano-SES to Endeavor-ZES, the incidence of MACE was 5.4% vs. 7.1%. The hazard ratio （HR） was 1.32 with 95% confidence interval （CI） as 0.64-2.72 （P = 0.45）. Secondary end points showed TLR （1.9% vs. 3.2%; HR, 1.42; 95% CI, 0.45-4.55; P = 0.55） and ST （0.4% vs. 0.8%; HR, 2.03; 95% CI, 0.18- 5.37; P = 0.99）, in the one-year period of follow-up. Conclusion Within one-year, the Nano polymer-free SES has similar safety and efficacy compared with the Endeavor durable-polymer ZES in the treatment of patients with ACS.
文摘Background Radiofrequency catheter ablation （RFCA） and cryoballoon ablation （CBA） are the two common ablation technologies used for the treatment of paroxysmal atrial fibrillation （PAF）. However, there is no consensus on which ablation method is the optimal choice. Methods We searched PubMed, EMBASE, Cochrane Library, Web of Knowledge and clinical trials.gov for clinically controlled trials （published up to January 11, 2017）. All included studies included fulfilled our previously defined criteria. The primary clinical outcome was the proportion of participants free from atrial fibrillation at 12-months follow-up. ; The secondary clinical outcomes were as the procedure time, fluoroscopy time, and total complications. Results We identified 573 studies, seven randomized controlled trials （RCTs） and 11 non-RCTs were included in this analysis （n=4982 participants）. Compared with RFCA, CBA had similar proportion of participants free from PAF at 12-months follow-up （70.8% vs. 69%; relative risk [RR] ： 1.01; 95% CI： 0.97 to 1.05）. Additionally, procedure time （149.61 vs. 174.73min; weighted mean difference WMD： 25.55; 95% CI： 44.69 to 6.41） was shorter in the CBA group, but the fluoroscopy time （34.52 vs. 38.59 min; WMD： 2.08; 95% CI： 5.86 to 1.71） did not have any significant difference. Total complication was not significantly different in both groups （RR： 1.22; 95% CI： 0.74 to 2.02 ）. Conclusions CBA is similar to RFCA with respect to clinical efficacy for PAF during the follow-up period of 12 months, and with no increased overall safety risk in the cryoballoon group CBA.
文摘Background Renal insufficiency is associated with an excess risk of vascular complications and bleeding events in patients who undergo PCI. Heparin is still used commonly for PCI, but the bleeding complications is high. However, Bivalirudin is similar to heparin in ischemic complications and superior to the bleeding complica- tions. Methods A total of 181 patients with coronary artery disease and renal insufficiency were randomly as- signed two treatment groups： Bivalirudin （n = 90）, unfractionated heparin （n = 91）. Activated clotting time （ACT） was determined in patients at 5 min after undergoing PCI at the end of operation immediately （stopping drug im- mediately） , and 30 min,1 h, 2 h after stopping drug. Activated partial thromboplastin time （APTT）, thrombin time （TT）, proth rombin time （PT）, fibrinogen （FIB） index were measured before treatment, 6 h, 24 h and 72 h af- ter the treatment through an automated coagulation analyzer. Platelet count was monitored before treatment and 24 h after treatment. The end points were the proportion of net adverse clinical events （NACE） and stent throm- bosis at 30 days. Results The use of bivalirudin was associated with a statistically significant higher at 5 min af- ter treatment, end of operation immediately （P 〈 0.05）, with statistically significant lower at lh after stopping drug , 2h after stopping drug （P 〈 0.05）. There were no differences between patients at blood coagulation and platelet after operation （P 〉 0.05）, no differences in the 30-day rates of stent thrombosis （0% vs. 0%, P = 1）. Elev- en patients（12.22%） treated with bivalirudin vs. 24 （26.38%） treated with heparin experienced an adverse clinical events at 30 days （relative risk[RR], 0.46; 95%CI, 0.36-0.56; P 〈 0.025）. There were no differences in the major adverse cardiac or cerebral event at the 30-day end point（1.11% vs. 2.20%, P 〉 0.05）. The bleeding at 30 days was abated by using bivalirudin compared with unfracfionated heparin （11.11% vs. 24.18%, P 〈 0.05）. Conclu- sions Compared with the unfractionated heparin, bivalirudin is more quickly in taking effect and recovering and more efficient for PCI in patients with coronary artery disease and renal insufficiency.
