Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy.
Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy.
Cardiovasc Revasc Med. 2022 Feb;35:66-73. doi: 10.1016/j.carrev.2021.04.005. Epub 2021 Apr 8.
A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed.
All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up.
1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES.
In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.
一种无聚合物的依维莫司洗脱支架（PF-BES）和一种佐他莫司洗脱支架（ZES）最近显示出相似的临床特征，并且在接受经皮冠状动脉介入治疗（PCI）的患者的特定临床环境中似乎是竞争选择。它们在冠状动脉分叉病变等复杂手术环境中表现是否相同仍未得到解决。
所有连续接受冠状动脉分叉 PCI 的患者，使用 PF-BES 或来自三个大型多中心真实世界登记处的新迭代 ZES，均被纳入研究。主要终点是主要不良心血管事件（MACE），包括全因死亡、心肌梗死（MI）、靶病变血运重建（TLR）和支架血栓形成（ST）的复合事件。进行了多种分析来调整基线差异，包括倾向评分匹配、倾向评分分层和逆概率加权。根据 Cox 比例风险模型报告结果，该模型在 400 天随访时进行了删失。
1169 例接受冠状动脉分叉病变主支治疗的患者（PF-BES 组 n = 440，ZES 组 n = 729），平均年龄 69 ± 11 岁，75.4%为男性，就诊时 53.8%为急性冠状动脉综合征，26.6%为左主干分叉病变，中位数双联抗血小板治疗时间为 12 个月[范围 12-12]。与 ZES 相比，PF-BES 组的 MACE、全因死亡、TLR 和 ST 发生率趋于更高，但无统计学差异。PF-BES 组的 MI 和靶血管血运重建发生率更高。
在这项大型当代接受冠状动脉分叉 PCI 的患者队列中，使用 PF-BES 和 ZES 装置的 MACE 发生率无统计学差异。然而，观察到倾向于 ZES 装置的差异，这些差异可能具有临床相关性。需要进一步的研究来证实这些发现，并探讨当采用短疗程双联抗血小板治疗时，这些发现是否仍然有效。
