Context: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy(VBT) affording the best results....Context: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy(VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established. Objective: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries. Design, Setting, and Patients: Prospective, multicenter, randomized trial conducted between June 6, 2003, and July 16, 2004, at 37 North American academic and community-based institutions in 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent(vessel diameter, 2.5-3.75 mm; lesion length, ≤ 46 mm). Interventions: Patients were randomly assigned to undergo angioplasty followed by VBT with a β source(n=201) or paclitaxel-eluting stent implantation(n=195). Clinical and angiographic follow-up at 9 months was scheduled in all patients. Main Outcome Measure: Ischemia-driven target vessel revascularization at 9 months. Results: Diabetes mellitus was present in 139 patients(35.1% ). Median reference vessel diameter was 2.65 mm and median lesion length was 15.3 mm. In the VBT group, new stents were implanted in 22 patients(10.9% )and in the paclitaxel-eluting stent group, multiple stents were required in 57 patients(29.2% ), with median stent length of 24 mm. Follow-up at 9 months was complete in 194 patients in the VBT group and 191 patients in the paclitaxel-eluting stent group(96.5% and 97.9% , respectively). For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target lesion revascularization were 27(13.9% ) vs 12(6.3% )(relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P=.01); for ischemic target vessel revascularization, 34(17.5% ) vs 20(10.5% )(RR, 0.60; 95% CI, 0.36-1.00; P=.046); and for overall major adverse cardiac events, 39(20.1% ) vs 22(11.5% )(RR, 0.57; 95% CI, 0.35-0.93; P=.02), with similar rates of cardiac death or myocardial infarction(10 [5.2% ] vs 7 [3.7% ]; RR, 0.71; 95% CI, 0.28-1.83; P=.48) and target vessel thrombosis(5 [2.6% ] vs 3 [1.6% ]; RR, 0.61; 95% CI, 0.15-2.50; P=.72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxel-eluting stents(RR, 0.47; 95% CI, 0.30-0.71; P< .001). Conclusion: Treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than angioplasty followed by VBT reduces clinical and angiographic restenosis at 9 months and improves event-free survival. Trial Registration: ClinicalTrials. gov Identifier: NCT00287573.展开更多
Context: Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited. Ob...Context: Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited. Objective: To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare metal stent. Design, Setting, and Patients: Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005. Interventions: Vascular brachytherapy(n=125) or the sirolimus-eluting stent(n=259). Main Outcome Measure: Target vessel failure(cardiac death, myocardial infarction, or target vessel revascularization)at 9 months postprocedure. Results: Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients(mean [SD], 16.76 [8.55] mm vs 17.22 [7.97] mm, respectively; P=.61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group(P=.28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent(relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P=.02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group(RR, 2.3 [95% CI, 1.3-3.9]; P=.004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group(RR, 1.5 [95% CI, 1.0-2.2]; P=.07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up(mean [SD], 1.52 [0.63] mm vs 1.80 [0.63] mm; P< .001), reflecting greater net lumen gain in the analysis segment(0.68 [0.60] vs 1.0 [0.61] mm; P< .001) due to stenting and no edge restenosis. Conclusion: Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent. Trial Registration: ClinicalTrials.gov Identifier: NCT00231257.展开更多
We sought to demonstrate that brachytherapy reduces coronary spasm in refracto ry and highly symptomatic variant angina. In some patients with variant angina d ue to extensive vasoconstriction, intensive drug therapy ...We sought to demonstrate that brachytherapy reduces coronary spasm in refracto ry and highly symptomatic variant angina. In some patients with variant angina d ue to extensive vasoconstriction, intensive drug therapy fails to sufficiently r elieve symptoms. In 18 patients with frequent angina episodes despite triple ant i anginal therapy, coronary spasm was induced by intracoronary acetylcholine (A Ch) infusion. Five patients had spasm in a second vessel. Intracoronary radiatio n(20 Gy) was applied to vasospastic segments using a beta emitting (32P) wire s ource centered within a Galileo balloon. Parameters of vessel function before an d after brachytherapy were investigated. Before brachytherapy, artery diameters decreased(p< 0.0001) from 2.8±0.4 mm to 1.0±0.4 mm for the first vessels and f rom 3.1±0.3 mm to 1.0±0.2 mm for the second vessels. After brachytherapy (143 ±106 and 80±52 days for first and second vessels, respectively), ACh induced vasoconstriction was significantly reduced. The ACh induced changes in artery d iameter before and after brachytherapy were -1.5±0.5 mm and -0.5±0.3mm(p< 0. 0001) for the first vessels and -1.4±0.3 mm and -0.4±0.2 mm (p< 0.01) for th e second vessels, respectively. In non irradiated spastic vessels, ACh induced vasoconstriction remained unchanged (e.g., -1.7±0.6 mm, -1.6±0.3 mm, and - 1.5±0.5 mm for second vessels, at first investigation, first follow up, and im mediately before brachytherapy, respectively). Angina frequency decreased from 1 5.6±6.0 to 2.2±2.4 angina episodes/week(p< 0.001) in treated patients. Brachyt herapy is a potential therapy in patients with highly symptomatic variant angina .展开更多
目的：探讨并总结在局限性低/中危前列腺癌患者中采用低剂量率近距离前列腺内放射粒子植入术治疗的有效性及安全性。方法：将133例局限性前列腺癌患者分为低危组和中危组,采用近距离放射性粒子植入术治疗。术后定期进行前列腺特异性抗原...目的：探讨并总结在局限性低/中危前列腺癌患者中采用低剂量率近距离前列腺内放射粒子植入术治疗的有效性及安全性。方法：将133例局限性前列腺癌患者分为低危组和中危组,采用近距离放射性粒子植入术治疗。术后定期进行前列腺特异性抗原（prostatic specific antigen,PSA）及影像学监测,观察术后近、远期并发症并进行分析。结果：本组患者平均术前PSA（13.45±7.1）μg/L,前列腺体积（44.37±21.43）m L,处方放射剂量（152.0±17.3）Gy。24例初始前列腺体积〉60 m L者术前接受3~6个月新辅助内分泌治疗,低危组与中危组平均年龄、前列腺体积、90%的靶区体积接受的最低剂量（D90）等方面差异均无统计学意义;两组患者国际前列腺症状评分（international prostatic symptomatic score,IPSS）术后第2个月达峰值,术后第4个月后恢复至术前水平;PSA术后第3个月开始回落。研究期间未出现影像学肿瘤进展者,低危组1例、中危组3例随访期间出现生化复发。结论：单纯以近距离内放射粒子植入术治疗早期前列腺癌术后最常见的并发症为下尿路症状,在低危及中危前列腺癌组均可获得较为满意的肿瘤无进展生存。展开更多
文摘Context: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy(VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established. Objective: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries. Design, Setting, and Patients: Prospective, multicenter, randomized trial conducted between June 6, 2003, and July 16, 2004, at 37 North American academic and community-based institutions in 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent(vessel diameter, 2.5-3.75 mm; lesion length, ≤ 46 mm). Interventions: Patients were randomly assigned to undergo angioplasty followed by VBT with a β source(n=201) or paclitaxel-eluting stent implantation(n=195). Clinical and angiographic follow-up at 9 months was scheduled in all patients. Main Outcome Measure: Ischemia-driven target vessel revascularization at 9 months. Results: Diabetes mellitus was present in 139 patients(35.1% ). Median reference vessel diameter was 2.65 mm and median lesion length was 15.3 mm. In the VBT group, new stents were implanted in 22 patients(10.9% )and in the paclitaxel-eluting stent group, multiple stents were required in 57 patients(29.2% ), with median stent length of 24 mm. Follow-up at 9 months was complete in 194 patients in the VBT group and 191 patients in the paclitaxel-eluting stent group(96.5% and 97.9% , respectively). For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target lesion revascularization were 27(13.9% ) vs 12(6.3% )(relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P=.01); for ischemic target vessel revascularization, 34(17.5% ) vs 20(10.5% )(RR, 0.60; 95% CI, 0.36-1.00; P=.046); and for overall major adverse cardiac events, 39(20.1% ) vs 22(11.5% )(RR, 0.57; 95% CI, 0.35-0.93; P=.02), with similar rates of cardiac death or myocardial infarction(10 [5.2% ] vs 7 [3.7% ]; RR, 0.71; 95% CI, 0.28-1.83; P=.48) and target vessel thrombosis(5 [2.6% ] vs 3 [1.6% ]; RR, 0.61; 95% CI, 0.15-2.50; P=.72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxel-eluting stents(RR, 0.47; 95% CI, 0.30-0.71; P< .001). Conclusion: Treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than angioplasty followed by VBT reduces clinical and angiographic restenosis at 9 months and improves event-free survival. Trial Registration: ClinicalTrials. gov Identifier: NCT00287573.
文摘Context: Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited. Objective: To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare metal stent. Design, Setting, and Patients: Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005. Interventions: Vascular brachytherapy(n=125) or the sirolimus-eluting stent(n=259). Main Outcome Measure: Target vessel failure(cardiac death, myocardial infarction, or target vessel revascularization)at 9 months postprocedure. Results: Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients(mean [SD], 16.76 [8.55] mm vs 17.22 [7.97] mm, respectively; P=.61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group(P=.28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent(relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P=.02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group(RR, 2.3 [95% CI, 1.3-3.9]; P=.004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group(RR, 1.5 [95% CI, 1.0-2.2]; P=.07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up(mean [SD], 1.52 [0.63] mm vs 1.80 [0.63] mm; P< .001), reflecting greater net lumen gain in the analysis segment(0.68 [0.60] vs 1.0 [0.61] mm; P< .001) due to stenting and no edge restenosis. Conclusion: Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent. Trial Registration: ClinicalTrials.gov Identifier: NCT00231257.
文摘We sought to demonstrate that brachytherapy reduces coronary spasm in refracto ry and highly symptomatic variant angina. In some patients with variant angina d ue to extensive vasoconstriction, intensive drug therapy fails to sufficiently r elieve symptoms. In 18 patients with frequent angina episodes despite triple ant i anginal therapy, coronary spasm was induced by intracoronary acetylcholine (A Ch) infusion. Five patients had spasm in a second vessel. Intracoronary radiatio n(20 Gy) was applied to vasospastic segments using a beta emitting (32P) wire s ource centered within a Galileo balloon. Parameters of vessel function before an d after brachytherapy were investigated. Before brachytherapy, artery diameters decreased(p< 0.0001) from 2.8±0.4 mm to 1.0±0.4 mm for the first vessels and f rom 3.1±0.3 mm to 1.0±0.2 mm for the second vessels. After brachytherapy (143 ±106 and 80±52 days for first and second vessels, respectively), ACh induced vasoconstriction was significantly reduced. The ACh induced changes in artery d iameter before and after brachytherapy were -1.5±0.5 mm and -0.5±0.3mm(p< 0. 0001) for the first vessels and -1.4±0.3 mm and -0.4±0.2 mm (p< 0.01) for th e second vessels, respectively. In non irradiated spastic vessels, ACh induced vasoconstriction remained unchanged (e.g., -1.7±0.6 mm, -1.6±0.3 mm, and - 1.5±0.5 mm for second vessels, at first investigation, first follow up, and im mediately before brachytherapy, respectively). Angina frequency decreased from 1 5.6±6.0 to 2.2±2.4 angina episodes/week(p< 0.001) in treated patients. Brachyt herapy is a potential therapy in patients with highly symptomatic variant angina .
文摘目的：探讨并总结在局限性低/中危前列腺癌患者中采用低剂量率近距离前列腺内放射粒子植入术治疗的有效性及安全性。方法：将133例局限性前列腺癌患者分为低危组和中危组,采用近距离放射性粒子植入术治疗。术后定期进行前列腺特异性抗原（prostatic specific antigen,PSA）及影像学监测,观察术后近、远期并发症并进行分析。结果：本组患者平均术前PSA（13.45±7.1）μg/L,前列腺体积（44.37±21.43）m L,处方放射剂量（152.0±17.3）Gy。24例初始前列腺体积〉60 m L者术前接受3~6个月新辅助内分泌治疗,低危组与中危组平均年龄、前列腺体积、90%的靶区体积接受的最低剂量（D90）等方面差异均无统计学意义;两组患者国际前列腺症状评分（international prostatic symptomatic score,IPSS）术后第2个月达峰值,术后第4个月后恢复至术前水平;PSA术后第3个月开始回落。研究期间未出现影像学肿瘤进展者,低危组1例、中危组3例随访期间出现生化复发。结论：单纯以近距离内放射粒子植入术治疗早期前列腺癌术后最常见的并发症为下尿路症状,在低危及中危前列腺癌组均可获得较为满意的肿瘤无进展生存。
