Monjur Mohammad Riashad, Said Christian F, Bamford Paul, Parkinson Michael, Szirt Richard, Ford Thomas
Department of Cardiology, Central Coast Local Health District, Gosford, New South Wales, Australia.
Faculty of Health and Medicine, The University of Newcastle, Callaghan, New South Wales, Australia.
Open Heart. 2020 Oct;7(2). doi: 10.1136/openhrt-2020-001394.
Determine whether an ultrathin biodegradable polymer sirolimus-eluting stent ('Orsiro'-BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).
We conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.
Nine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.
The Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.
确定超薄可生物降解聚合物西罗莫司洗脱支架（“Orsiro”生物可降解聚合物西罗莫司洗脱支架）是否比第二代耐用聚合物药物洗脱支架具有临床优势。
我们对比较Orsiro生物可降解聚合物西罗莫司洗脱支架与耐用聚合物药物洗脱支架的随机临床试验进行了前瞻性系统评价和荟萃分析（国际前瞻性系统评价注册库登记号：CRD42019147136）。主要结局是靶病变失败（心脏死亡、靶血管心肌梗死和临床指征的靶病变血运重建的复合终点），在最长可及随访时进行评估。
9项试验将11302例患者随机分为Orsiro生物可降解聚合物西罗莫司洗脱支架组或耐用聚合物药物洗脱支架组。在平均加权随访2.8年时，6089例接受生物可降解聚合物西罗莫司洗脱支架的参与者中有501例（8.2%）发生主要结局（靶病变失败），而5213例接受耐用聚合物药物洗脱支架的参与者中有495例（9.5%）发生。这相当于靶病变失败的绝对风险降低1.3%，有利于Orsiro生物可降解聚合物西罗莫司洗脱支架（比值比0.82；95%置信区间0.69至0.98；p=0.03）。这是由靶血管心肌梗死的减少所驱动的（比值比0.80；95%置信区间0.65至0.98；p=0.03）。其他临床终点（心脏死亡、靶病变血运重建和支架血栓形成）无显著差异。
在短期至中期随访中，与当代第二代药物洗脱支架相比，Orsiro生物可降解聚合物西罗莫司洗脱支架在接受经皮冠状动脉介入治疗的患者中显示出有前景的临床结局。需要更多研究来评估更长随访期以及不同临床和病变亚组中的性能。
