Department of Cardiology Thoraxcentrum Twente, Medisch Spectrum Twente Enschede The Netherlands.
Department of Health Technology and Services Research, Faculty BMS Technical Medical Centre, University of Twente Enschede The Netherlands.
J Am Heart Assoc. 2022 Nov 15;11(22):e026041. doi: 10.1161/JAHA.122.026041. Epub 2022 Nov 8.
Background In a previous trial, higher 5-year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus-eluting stents (SES). We assessed 5-year safety and efficacy of all-comers as well as patients with diabetes treated with SES or Synergy everolimus-eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). Methods and Results The randomized BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) trial enrolled 3514 all-comer patients at 4 Dutch cardiac centers. Patients aged ≥18 years who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Five-year follow-up was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71-1.12], =0.31; and HR, 0.82 [95% CI, 0.65-1.04], =0.10, respectively). Individual components of target vessel failure showed no significant between-stent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stent-groups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [=0.69 and =0.63]). Conclusions Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5-year outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5-year clinical outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803.
在之前的一项试验中，使用可生物降解聚合物 Orsiro 西罗莫司洗脱支架（SES）治疗后，5 年死亡率更高。我们评估了所有患者以及患有糖尿病的患者使用 SES 或 Synergy 依维莫司洗脱支架（EES）与持久聚合物 Resolute Integrity 佐他莫司洗脱支架（ZES）的 5 年安全性和疗效。
这项随机 BIO-RESORT（所有患者中生物可降解聚合物和持久聚合物药物洗脱支架的比较）试验在荷兰 4 家心脏中心纳入了 3514 名所有患者。年龄≥18 岁需要经皮冠状动脉介入治疗的患者符合入组条件。根据糖尿病情况对患者进行分层，并随机分配至 SES、EES 或 ZES 治疗组（1:1:1）。主要终点是靶血管失败（心源性死亡、靶血管心肌梗死或靶血管血运重建）。3514 名患者中，3183 名（90.6%）患者获得 5 年随访。SES 组 1169 例患者中有 142 例（12.7%）、EES 组 1172 例患者中有 130 例（11.6%）、ZES 组 1173 例患者中有 157 例（14.1%）发生主要终点靶血管失败（风险比[HR]，0.89[95%CI，0.71-1.12]，=0.31；HR，0.82[95%CI，0.65-1.04]，=0.10）。支架之间各组成部分的靶血管失败无显著差异。非常晚期明确的支架血栓形成发生率低且相似（SES，1.1%；EES，0.6%；ZES，0.9%）。在糖尿病患者中，支架组之间的靶血管失败无显著差异（SES，19.8%；EES，19.2%；ZES，21.1%[=0.69 和 =0.63]）。
Orsiro SES、Synergy EES 和 Resolute Integrity ZES 显示出相似的 5 年安全性和疗效结果，包括死亡率。在糖尿病患者中进行的预设支架比较也显示，5 年临床结局无显著差异。
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