Division of Cardiology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea - Cardiocentro, Napoli, Italy.
Am J Cardiol. 2019 Jul 15;124(2):195-204. doi: 10.1016/j.amjcard.2019.04.015. Epub 2019 Apr 23.
We aim to compare Polymer-Free Biolimus-Eluting Stent (PF-BES) with Durable Polymer Everolimus-Eluting stent (DP-EES) in unselected patients. PF-BES showed a favorable profile in high-bleeding risk patients who underwent percutaneous coronary intervention. Limited data are available on PF-BES compared with second-generation durable polymer-coated drug-eluting stents in patients eligible for standard dual antiplatelet therapy. A total of 848 consecutive patients were enrolled: 306 patients were treated with PF-BES and 542 with DP-EES. Stent performance was tested in a propensity score-matched population and in a Complex Higher-Risk and Indicated Patients (CHIP) subpopulation. A per-lesion analysis on 1,204 lesions (PF-BES = 424 vs DP-EES = 780) was also performed. At a medium follow-up of 18.5 ± 5.0 months, no differences in the matched population were found in terms of major adverse cardiac events (PF-BES 9.0% vs DP-EES 4.5%; p 0.091), myocardial infarction (PF-BES 6.2% vs DP-EES 2.3%; p 0.111), stent restenosis (PF-BES 2.3% vs DP-EES 0.0%; p 0.123), definite or probable stent thrombosis (PF-BES 2.8% vs DP-EES 1.1%; p 0.448). A significant inferior rate of restenosis was observed in the DP-EES arm in the whole (PF-BES 2.3% vs DP-EES 0.6%; p 0.041) and CHIP populations (PF-BES 4.3% vs DP-EES 0.5%; p 0.023), as well as in the per-lesion analysis (DP-EES 0.4% vs PF-BES 1.7%; p 0.039). In conclusion, in a real-world cohort PF-BES performed similarly to DP-EES in terms of restenosis and stent thrombosis in the matched population. Nonetheless, in the whole and CHIP populations, as well as in the per-lesion analysis, restenosis occurrence resulted higher in the PF-BES group.
我们旨在比较无聚合物载药生物可降解洗脱支架(PF-BES)与持久性聚合物依维莫司洗脱支架(DP-EES)在未经选择的患者中的疗效。PF-BES 在接受经皮冠状动脉介入治疗的高出血风险患者中显示出良好的效果。在适合标准双联抗血小板治疗的患者中,与第二代持久性聚合物涂层药物洗脱支架相比,PF-BES 的数据有限。共纳入 848 例连续患者:306 例患者接受 PF-BES 治疗,542 例患者接受 DP-EES 治疗。在倾向评分匹配人群和复杂高危和适应证患者(CHIP)亚组中测试了支架性能。还对 1204 个病变进行了病变水平分析(PF-BES=424 例 vs DP-EES=780 例)。在 18.5±5.0 个月的中位随访中,在匹配人群中,主要不良心脏事件(PF-BES9.0% vs DP-EES4.5%;p=0.091)、心肌梗死(PF-BES6.2% vs DP-EES2.3%;p=0.111)、支架内再狭窄(PF-BES2.3% vs DP-EES0.0%;p=0.123)、明确或可能的支架血栓形成(PF-BES2.8% vs DP-EES1.1%;p=0.448)无差异。在整个 DP-EES 组(PF-BES2.3% vs DP-EES0.6%;p=0.041)和 CHIP 人群(PF-BES4.3% vs DP-EES0.5%;p=0.023)中,以及在病变水平分析中(DP-EES0.4% vs PF-BES1.7%;p=0.039),DP-EES 组的再狭窄率明显较低。总之,在真实世界队列中,PF-BES 在匹配人群中的再狭窄和支架血栓形成方面与 DP-EES 表现相似。然而,在整个人群和 CHIP 人群以及病变水平分析中,PF-BES 组的再狭窄发生率更高。