Power David A, Camaj Anton, Kereiakes Dean J, Ellis Stephen G, Gao Runlin, Kimura Takeshi, Ali Ziad A, Stockelman Kelly A, Dressler Ovidiu, Onuma Yoshinobu, Serruys Patrick W, Stone Gregg W
Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio.
JACC Cardiovasc Interv. 2025 Jan 13;18(1):1-11. doi: 10.1016/j.jcin.2024.08.050.
The risk-benefit ratio of the Absorb bioresorbable vascular scaffold (BVS) may vary before and after 3 years, the time point of complete bioresorption of the poly-L-lactic acid scaffold.
The aim of this study was to determine the time-varying outcomes of the Absorb BVS compared with cobalt-chromium everolimus-eluting stents (EES) from a large individual-patient-data pooled analysis of randomized trials.
The individual patient data from 5 trials that randomized 5,988 patients undergoing percutaneous coronary intervention to the Absorb BVS vs EES with 5-year follow-up were pooled. The primary effectiveness and safety endpoints were target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis (DT).
Between 0 and 5 years, TLF occurred in 15.9% BVS patients vs 13.1% EES patients (HR: 1.25; 95% CI: 1.08-1.43; P = 0.002), and DT occurred in 2.2% vs 1.0%, respectively (HR: 2.38; 95% CI: 1.49-3.79; P = 0.0002). Between 0 and 3 years, TLF occurred in 12.4% BVS patients vs 9.3% EES patients (HR: 1.35; 95% CI: 1.15-1.59; P = 0.0002), and DT occurred in 2.0% vs 0.6%, respectively (HR: 3.58; 95% CI: 2.01-6.36; P < 0.0001). Between 3 and 5 years, TLF occurred in 4.5% BVS patients vs 4.7% EES patients (HR: 0.99; 95% CI: 0.76-1.27; P = 0.91), and DT occurred in 0.2% vs 0.4%, respectively (HR: 0.49; 95% CI: 0.18-1.38; P = 0.17). By spline analysis, the TLF hazard by 5 years was lower with BVS than EES.
Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS. (ABSORB II Randomized Controlled Trial, NCT01425281; A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold [Absorb™ BVS] System in Chinese Population - ABSORB CHINA Randomized Controlled Trial [ABSORB CHINA], NCT01923740; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN], NCT01844284; ABSORB III Randomized Controlled Trial [ABSORB III], NCT01751906; Absorb IV Randomized Controlled Trial, NCT02173379).
在聚左旋乳酸支架完全生物吸收的时间点即3年后，Absorb生物可吸收血管支架（BVS）的风险效益比可能会有所不同。
本研究旨在通过对随机试验的大型个体患者数据汇总分析，确定与钴铬依维莫司洗脱支架（EES）相比，Absorb BVS随时间变化的结果。
汇总了5项试验的个体患者数据，这些试验将5988例接受经皮冠状动脉介入治疗的患者随机分为Absorb BVS组和EES组，并进行了5年的随访。主要有效性和安全性终点为靶病变失败（TLF）（心源性死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建）和器械血栓形成（DT）。
在0至5年之间，TLF在BVS组患者中的发生率为15.9%，在EES组患者中的发生率为13.1%（HR：1.25；95%CI：1.08 - 1.43；P = 0.002），DT的发生率分别为2.2%和1.0%（HR：2.38；95%CI：1.49 - 3.79；P = 0.0002）。在0至3年之间，TLF在BVS组患者中的发生率为12.4%，在EES组患者中的发生率为9.3%（HR：1.35；95%CI：1.15 - 1.59；P = 0.0002），DT的发生率分别为2.0%和0.6%（HR：3.58；95%CI：2.01 - 6.36；P < 0.0001）。在3至5年之间，TLF在BVS组患者中的发生率为4.5%，在EES组患者中的发生率为4.7%（HR：0.99；95%CI：0.76 - 1.27；P = 0.91），DT的发生率分别为0.2%和0.4%（HR：0.49；95%CI：0.18 - 1.38；P = 0.17）。通过样条分析，5年时BVS的TLF风险低于EES。
与EES治疗相比，BVS在5年随访期间增加了TLF和DT发生率。然而，第一代Absorb BVS的额外风险期在3年时结束，此时聚左旋乳酸生物吸收完成。此后，BVS的事件发生率相当或更低。（ABSORB II随机对照试验，NCT01425281；Absorb™生物可吸收血管支架[Absorb™ BVS]系统在中国人群中的临床评价 - ABSORB中国随机对照试验[ABSORB CHINA]，NCT01923740；AVJ - 301临床试验：AVJ - 301[Absorb™ BVS]在日本人群中的临床评价[ABSORB JAPAN]，NCT01844284；ABSORB III随机对照试验[ABSORB III]，NCT01751906；Absorb IV随机对照试验，NCT02173379）
