Menown Ian B A, Mamas Mamas A, Cotton James M, Hildick-Smith David, Eberli Franz R, Leibundgut Gregor, Tresukosol Damras, Macaya Carlos, Copt Samuel, Sadozai Slama Sara, Stoll Hans-Peter
Craigavon Cardiac Centre & Queens University Belfast, UK.
University Hospital of North Midlands NHS Trust, Keele Cardiovascular Research Group, Keele University, UK.
Int J Cardiol Heart Vasc. 2020 Jan 27;26:100472. doi: 10.1016/j.ijcha.2020.100472. eCollection 2020 Feb.
The biolimus-eluting stent (BES) was the first to elute anti-proliferative drug from a biodegradable polymer. In the randomized LEADERS trial, a stainless steel BES showed non-inferior efficacy compared to a sirolimus-eluting stent and a long-term safety advantage. We report the first clinical efficacy and safety outcomes of a new thin-strut cobalt chromium biolimus-eluting stent (CoCr-BES) from an international multi-centre registry.
We studied 400 all-comer patients with coronary disease receiving CoCr-BES at 12 centres, with follow-up at 9 months and 2 years. The primary endpoint was incidence of major adverse cardiac events (MACE) at 9 months comprising cardiac death, myocardial infarction (MI), and clinically indicated target vessel revascularization (ci-TVR). Key protocol elements were the same as the randomized LEADERS trial to enable a historical control for propensity-matched comparison.
Mean patient age was 65 ± 11 years, 19% had diabetes, and 55% presented with unstable angina or MI. On discharge, 96% of patients were on dual antiplatelet therapy (DAPT) and 69% were on DAPT at 9 months. MACE at 9 months occurred in 3.9% of patients, cardiac death in 0.8%, MI in 1.1% and ci-TVR in 2.7%. One patient (0.25%) experienced definite or probable stent thrombosis (ST). A propensity-adjusted comparison showed similar clinical outcomes to the BES arm in the LEADERS trial for the primary endpoint MACE.
The new CoCr-BES showed low rates of MACE, MI, ci-TVR and ST at 9 months, similar to the BES arm in LEADERS.
生物雷帕霉素洗脱支架（BES）是首个从可生物降解聚合物中洗脱抗增殖药物的支架。在随机对照的LEADERS试验中，一款不锈钢BES与西罗莫司洗脱支架相比显示出非劣效性疗效以及长期安全性优势。我们报告了一项来自国际多中心注册研究的新型薄支架钴铬生物雷帕霉素洗脱支架（CoCr-BES）的首批临床疗效和安全性结果。
我们研究了在12个中心接受CoCr-BES治疗的400例冠心病患者，随访时间为9个月和2年。主要终点是9个月时主要不良心脏事件（MACE）的发生率，包括心源性死亡、心肌梗死（MI）和临床指征的靶血管血运重建（ci-TVR）。关键方案要素与随机对照的LEADERS试验相同，以便进行倾向匹配比较的历史对照。
患者平均年龄为65±11岁，19%患有糖尿病，55%表现为不稳定型心绞痛或心肌梗死。出院时，96%的患者接受双联抗血小板治疗（DAPT），9个月时69%的患者仍在接受DAPT。9个月时，3.9%的患者发生MACE，0.8%的心源性死亡，1.1%的心肌梗死，2.7%的ci-TVR。1例患者（0.25%）发生明确或可能的支架血栓形成（ST）。倾向调整后的比较显示，在主要终点MACE方面，临床结果与LEADERS试验中BES组相似。
新型CoCr-BES在9个月时MACE、MI、ci-TVR和ST的发生率较低，与LEADERS试验中的BES组相似。
