Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal, Research Center, Montréal, Québec, Canada.
Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Institut de Cardiologie de Montréal, Montréal, Québec, Canada.
Can J Cardiol. 2018 Jun;34(6):752-758. doi: 10.1016/j.cjca.2018.02.030. Epub 2018 Mar 12.
Real-world long-term safety and efficacy of the ABSORB (Abbott Vascular, Santa Clara, CA) bioresorbable vascular scaffold has not been well characterized in the literature, particularly in the setting of acute coronary syndromes (ACS). Herein, we report outcomes up to 4 years in such a high-risk cohort, with identification of parameters associated with better outcomes.
ReABSORB is a Canadian dual-centre, prospective, nonrandomized, all-comers registry consisting of 125 consecutively enrolled nontrial patients between October 2012 and December 2016. Angiographic and clinical follow-up is now available up to 4 years.
Average age was 59 ± 11 years and 69% were male. Most (70.4%) presented with ACS and the median available follow-up was 1330 days (interquartile range, 1035-1483). Treated lesions (n = 163) were type A in 23%, type B (1 or 2) in 64%, and type C in 13%. Procedural success and device success were 98.2% and 98.8%, respectively. Using Kaplan-Meier methods, major adverse cardiac event-free survival (EFS) up to 4 years of clinical follow-up was 90.7% overall. However, use of a predilation-sizing-postdilation (PSP) technique was associated with an EFS rate of 95.8% vs 74.0% without PSP (P = 0.001). No significant differences in major adverse cardiac EFS rates were found between patients with or without ACS (92.7% vs 86.0%, respectively, P = 0.239). Use of PSP as well as inflation time ≥ 60 seconds were independent predictors of EFS at 2 years.
In this prospective, real-world registry with mostly ACS patients, use of the recommended PSP implantation technique and longer inflations times were associated with significantly higher EFS.
在文献中，尚未很好地描述 ABSORB（雅培血管，加利福尼亚州圣克拉拉）生物可吸收血管支架的真实世界长期安全性和疗效，特别是在急性冠脉综合征（ACS）的情况下。在此，我们报告了此类高危患者队列中长达 4 年的结果，并确定了与更好结果相关的参数。
ReABSORB 是一项加拿大的双中心、前瞻性、非随机、所有患者注册研究，纳入了 2012 年 10 月至 2016 年 12 月期间连续入组的 125 例非试验患者。现可获得长达 4 年的血管造影和临床随访。
平均年龄为 59±11 岁，69%为男性。大多数（70.4%）患者患有 ACS，中位随访时间为 1330 天（四分位距，1035-1483）。治疗病变（n=163）的类型 A 占 23%，类型 B（1 或 2）占 64%，类型 C 占 13%。手术成功率和器械成功率分别为 98.2%和 98.8%。采用 Kaplan-Meier 方法，4 年临床随访时主要不良心脏事件无事件生存率（EFS）总体为 90.7%。然而，使用预扩张-测量-后扩张（PSP）技术的 EFS 率为 95.8%，而无 PSP 的 EFS 率为 74.0%（P=0.001）。ACS 患者和非 ACS 患者的主要不良心脏事件 EFS 率无显著差异（分别为 92.7%和 86.0%，P=0.239）。使用 PSP 以及充气时间≥60 秒是 2 年时 EFS 的独立预测因素。
在这项具有代表性的真实世界注册研究中，大多数患者为 ACS，使用推荐的 PSP 植入技术和更长的充气时间与 EFS 显著提高相关。
