Chen Yun-Lin, Fan Jinqi, Chen Guozhu, Cao Li, Lu Li, Xu Yanping, Yin Yuehui
Department of Cardiology, The 2nd Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Medicine (Baltimore). 2019 Apr;98(15):e15217. doi: 10.1097/MD.0000000000015217.
Polymer-free drug-eluting stents (PF-DES) have been demonstrated comparable to permanent polymer drug-eluting stents (PP-DES) during long-term follow-up. As a critical component of drug-eluting stents, antiproliferative drugs may be a confounding factor for the results. Thus, we sought to compare the outcomes of these stents during long-term follow-up, especially in consideration of different stent platforms with the same drugs.
A systemic search was performed to identify the related randomized controlled trials comparing PF-DES with PP-DES. Primary outcomes included short (≤1 year) and long-term (>1 year) target lesion revascularization (TLR), short-term in-stent late luminal loss (LLL) and diameter stenosis (DS). Subgroup analyses stratified by the different platforms with the same proliferative drugs were conducted in TLR, LLL, and DS. Standardized mean differences (SMDs) and risk ratios (RRs) were estimated using fixed /random effects models RESULTS:: A total of 6927 patients extracted from 12 RCTs were enrolled in the meta-analysis. No differences were observed in clinical outcomes of short-term and long-term overall mortality, myocardial infarction and stent thrombosis and angiographic outcomes of short-term in-stent LLL and DS between PF-DES and PP-DES for patients with coronary artery lesions. Nevertheless, compared with PP-DES coated with the same proliferative drugs, PF-DES had significantly increased risks of in-stent LLL (SMD, 0.49; 95% confidence interval [CI], 0.25-0.72) and DS (SMD, 0.67; 95% CI, 0.27-1.07), and long-term TLR (RR, 1.64; 95% CI 1.13-2.39). There were no significant differences in other outcomes.
Under the condition of using same antiproliferative drugs (paclitaxel or sirolimus) in different stent systems, PF-DES are associated with the increased risk of restenosis compared to PP-DES.
无聚合物药物洗脱支架(PF-DES)在长期随访中已被证明与永久性聚合物药物洗脱支架(PP-DES)相当。作为药物洗脱支架的关键组成部分,抗增殖药物可能是结果的一个混杂因素。因此,我们试图比较这些支架在长期随访中的结果,特别是考虑使用相同药物的不同支架平台。
进行系统检索以识别比较PF-DES与PP-DES的相关随机对照试验。主要结局包括短期(≤1年)和长期(>1年)靶病变血运重建(TLR)、短期支架内晚期管腔丢失(LLL)和直径狭窄(DS)。在TLR、LLL和DS中,按使用相同增殖药物的不同平台进行亚组分析。使用固定/随机效应模型估计标准化均数差(SMD)和风险比(RR)。结果:从12项随机对照试验中提取的6927例患者纳入荟萃分析。对于冠状动脉病变患者,PF-DES和PP-DES在短期和长期总体死亡率、心肌梗死和支架血栓形成的临床结局以及短期支架内LLL和DS的血管造影结局方面未观察到差异。然而,与涂覆相同增殖药物的PP-DES相比,PF-DES的支架内LLL(SMD,0.49;95%置信区间[CI],0.25-0.72)和DS(SMD,0.67;95%CI,0.27-1.07)以及长期TLR(RR,1.64;95%CI 1.13-2.39)风险显著增加。其他结局无显著差异。
在不同支架系统中使用相同抗增殖药物(紫杉醇或西罗莫司)的情况下,与PP-DES相比,PF-DES再狭窄风险增加。