Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.
Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.
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DOI：
10.1161/jaha.116.003255
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发表时间：
2016-03-15
影响因子：
5.4
通讯作者：
Pilgrim T
中科院分区：
文献类型：
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作者：
Zbinden R;Piccolo R;Heg D;Roffi M;Kurz DJ;Muller O;Vuilliomenet A;Cook S;Weilenmann D;Kaiser C;Jamshidi P;Franzone A;Eberli F;Jüni P;Windecker S;Pilgrim T
目前还没有关于超薄支架生物降解聚合物西罗莫司洗脱支架(BP-SES)长期性能的数据。我们报道了Bioscience(超薄Strut生物可降解聚合物西罗莫司洗脱支架与耐用聚合物伊波利莫斯洗脱支架用于经皮冠状动脉血管重建术)试验的两年临床结果，该试验比较了BP-SES和耐用聚合物伊波利莫斯洗脱支架(DP-EES)在接受经皮冠状动脉介入治疗的患者中的疗效。共有2119名符合最小排除标准的患者被分配到BP-SES(n=1063)或DP-EES(n=1056)治疗中。2048例(97%)获得2年随访。主要终点是靶病变失败，包括心源性死亡、靶血管心肌梗死或临床显示的靶病变血运重建。2年后，BP-SES组和DP-EES组分别有107例(10.5%)和107例(10.4%)发生靶病变失败(风险比[RR]1.00，95%可信区间0.77~1.31，P=0.979)。在心源性死亡(RR1.01，95%CI0.62~1.63，P=0.984)、靶血管心肌梗死(RR0.91，95%CI0.60~1.39，P=0.669)、靶病变血管重建(RR1.17，95%CI0.81~1.71，P=0.403)、明确支架内血栓形成(RR1.38，95%CI0.56~3.44，P=0.485)方面，BP-SES与DP-EES无显著差异。BP-SES组2例(0.2%)，DP-EES组4例(0.4%)(P=0.423)。在ST段抬高心肌梗死患者中，BP-SES与DP-EES相比靶病变失败的风险较低(RR0.48，95%CI0.23~0.99，P=0.043，P交互作用=0.026)。在两年的随访中，BP-SES和DP-EES保持了可比的安全性和有效性。网址：https://www.clinicaltrials.gov.唯一标识：NCT01443104。
No data are available on the long‐term performance of ultrathin strut biodegradable polymer sirolimus‐eluting stents (BP‐SES). We reported 2‐year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP‐SES with durable‐polymer everolimus‐eluting stents (DP‐EES) in patients undergoing percutaneous coronary intervention. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP‐SES (n=1063) or DP‐EES (n=1056). Follow‐up at 2 years was available for 2048 patients (97%). The primary end point was target‐lesion failure, a composite of cardiac death, target‐vessel myocardial infarction, or clinically indicated target‐lesion revascularization. At 2 years, target‐lesion failure occurred in 107 patients (10.5%) in the BP‐SES arm and 107 patients (10.4%) in the DP‐EES arm (risk ratio [RR] 1.00, 95% CI 0.77–1.31, P=0.979). There were no significant differences between BP‐SES and DP‐EES with respect to cardiac death (RR 1.01, 95% CI 0.62–1.63, P=0.984), target‐vessel myocardial infarction (RR 0.91, 95% CI 0.60–1.39, P=0.669), target‐lesion revascularization (RR 1.17, 95% CI 0.81–1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56–3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP‐SES arm and 4 cases (0.4%) in the DP‐EES arm (P=0.423). In the prespecified subgroup of patients with ST‐segment elevation myocardial infarction, BP‐SES was associated with a lower risk of target‐lesion failure compared with DP‐EES (RR 0.48, 95% CI 0.23–0.99, P=0.043, P interaction=0.026). Comparable safety and efficacy profiles of BP‐SES and DP‐EES were maintained throughout 2 years of follow‐up. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.