Gasior Pawel, Gierlotka Marek, Szczurek-Katanski Krzysztof, Osuch Marcin, Gnot Roman, Hawranek Michał, Gasior Mariusz, Polonski Lech
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Centre for Heart Diseases, Zabrze, Poland.
Catheter Cardiovasc Interv. 2019 Jun 1;93(7):E362-E368. doi: 10.1002/ccd.27919. Epub 2018 Oct 8.
We sought to determine the 1-year clinical follow-up in patients treated with the thin strut (71 μm) bioabsorbable polymer-coated sirolimus-eluting stent (BP-SES) vs durable coating everolimus eluting stent (DP-EES) in daily clinical routine.
Presence of durable polymers may be associated with late/very late stent thrombosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety.
Interventional Cardiology Network Registry is a prospective, multicenter, observational registry of 21,400 consecutive patients treated with PCI since 2010. We analyzed 4,670 patients treated with either a BP-SES (ALEX, Balton, Poland) or DP-EES (XIENCE, Abbott, USA) with available 1-year clinical follow-up using propensity-score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all cause death, myocardial infarction (MI), and definite/probable stent thrombosis as safety outcomes.
After propensity score matching, 1,649 patients treated with BP-SES and 1,649 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. There was no significant difference between tested groups in in-hospital mortality. One-year follow-up demonstrated comparable efficacy outcome, TVR (BP-SES 5.9% vs DP-EES 4.6% P = 0.45), as well as comparable safety outcomes, all cause death, MI and definite/probable stent thrombosis.
In this multicenter registry, the BP-SES thin strut biodegradable polymer-coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to the DP-EES. These data support the relative safety and efficacy of DP-SES in a broad range of patients undergoing percutaneous coronary intervention.
我们试图确定在日常临床实践中,接受薄支柱(71μm)生物可吸收聚合物涂层西罗莫司洗脱支架(BP-SES)治疗的患者与耐用涂层依维莫司洗脱支架(DP-EES)治疗的患者的1年临床随访情况。
耐用聚合物的存在可能与晚期/极晚期支架血栓形成的发生以及延长双联抗血小板治疗的需求有关。生物可吸收聚合物可能有助于支架愈合,从而提高临床安全性。
介入心脏病学网络注册研究是一项前瞻性、多中心、观察性注册研究,自2010年以来连续纳入21400例接受PCI治疗的患者。我们使用倾向评分匹配分析了4670例接受BP-SES(ALEX,Balton,波兰)或DP-EES(XIENCE,雅培,美国)治疗且有1年临床随访数据的患者。结局包括作为疗效指标的靶血管血运重建(TVR)以及作为安全性指标的全因死亡、心肌梗死(MI)和明确/可能的支架血栓形成。
经过倾向评分匹配后,选择了1649例接受BP-SES治疗的患者和1649例接受DP-EES治疗的患者。两组的手术和临床特征相似。两组在院内死亡率方面无显著差异。1年随访显示疗效指标TVR相当(BP-SES为5.9%,DP-EES为4.6%,P = 0.45),安全性指标全因死亡、MI和明确/可能的支架血栓形成也相当。
在这项多中心注册研究中,BP-SES薄支柱可生物降解聚合物涂层西罗莫司洗脱支架在植入后1年的临床结局与DP-EES相当。这些数据支持DP-SES在广泛接受经皮冠状动脉介入治疗的患者中的相对安全性和有效性。