Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264. doi: 10.1016/j.jcin.2016.11.007. Epub 2017 Jan 18.
The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients.
Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking.
The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months.
From March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33).
At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.
作者旨在比较生物相容的持久聚合物佐他莫司洗脱支架与生物可降解聚合物依维莫司洗脱支架在未经选择的冠状动脉患者中的安全性和疗效。
生物可降解聚合物依维莫司洗脱支架在长期随机全患者试验中优于第一代持久聚合物药物洗脱支架。缺乏比较它们与第二代持久聚合物药物洗脱支架的长期数据。
这是一项随机、多中心、全患者、非劣效性试验，纳入患有慢性稳定型冠状动脉疾病或急性冠状动脉综合征且至少有 1 处需要药物洗脱支架治疗的冠状动脉病变的患者。主要终点包括主要不良心脏事件（MACE），包括安全性（心脏死亡和不能明确归因于非靶病变的心肌梗死）和疗效（靶病变血运重建）的复合终点；MACE 的单个终点；全因死亡率；任何心肌梗死；靶血管血运重建；以及 36 个月时确定或可能的支架血栓形成。
2011 年 3 月至 2012 年 8 月，共 2999 例患者随机（1:1）接受佐他莫司洗脱支架（1502 例）或依维莫司洗脱支架（1497 例）治疗。在 3 年随访时，持久聚合物佐他莫司洗脱支架组有 128 例（8.6%）患者发生 MACE，生物可降解聚合物依维莫司洗脱支架组有 144 例（9.6%）患者发生 MACE（p=0.36）。两组之间心脏死亡（2.7% vs. 3.4%）、不能明确归因于非靶病变的心肌梗死（2.7% vs. 2.5%）和靶病变血运重建（5.4% vs. 5.5%）的发生率无显著差异。持久聚合物佐他莫司洗脱支架组有 6 例（0.4%）患者发生确定的极晚期支架血栓形成，生物可降解聚合物依维莫司洗脱支架组有 10 例（0.7%）患者发生确定的极晚期支架血栓形成（p=0.33）。
在 3 年随访时，持久聚合物佐他莫司洗脱支架与生物可降解聚合物依维莫司洗脱支架在临床结局方面相似，在安全性和疗效结局方面，包括支架血栓形成，无显著差异。
