INFINITY-SWEDEHEART 的原理和设计:一项基于登记的随机临床试验,比较了西罗莫司洗脱的 DynamX 生物适配器和佐他罗莫司洗脱的 Resolute Onyx 支架的临床疗效。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-08-02 DOI:10.1016/j.ahj.2024.07.016
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引用次数: 0

摘要

背景:现代药物洗脱支架已取得重大改进,但仍会在冠状动脉内形成一个僵硬的笼。一年后靶病变失败(TLF)的年发生率为 2-4%,五年后半数患者出现心绞痛。DynamX 生物适配器是一种西罗莫司洗脱的薄型(71 微米)钴铬平台,其螺旋股可在生物可吸收聚合物涂层在体内降解后解锁和分离。这能使血管恢复正常的生理功能和运动,同时进行代偿性适应性重塑,从而减少再次介入的需要,缓解经皮冠状动脉介入治疗(PCI)后的心绞痛:INFINITY-SWEDEHEART试验是一项基于登记的单盲随机临床试验(R-RCT),旨在评估DynamX生物适配器与Resolute Onyx支架相比,在治疗新发原发性冠状动脉病变的缺血性心脏病患者中的安全性和有效性。R-RCT框架允许利用与试验数据库集成的现有国家临床登记处进行招募、随机化和基线人口统计学、药物和临床结果的务实数据收集。主要目标是证明在 1 年内免于 TLF(心血管死亡、靶血管心肌梗死或缺血导致的靶病变血管再通)的非劣效性。从 6 个月到随访结束(5 年),将依次测试下列次要终点的优越性:1)所有受试者的 TLF;2)所有受试者的靶血管失败;3)急性冠状动脉综合征(ACS)受试者的 TLF。随后的优越性测试将根据事件数量确定时间,以确保足够的统计能力。心绞痛相关症状、功能和生活质量的变化将使用西雅图心绞痛问卷-简易版进行评估。将对预先确定的亚组进行分析。在瑞典的 20 个地点,共有 2400 名患者接受了随机治疗。摘要:INFINITY-SWEDEHEART研究旨在评估DynamX生物适配器与Resolute Onyx支架在普通PCI患者群体中的长期安全性和有效性。
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Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent

Background

Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI).

Methods

The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients.

Summary

The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.

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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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