Scholarlink

Background <p>The AAMS open-label clinical study demonstrated the safety and feasibility of epicardial transplantation of autologous right atrial appendage micrografts (AAMs) during coronary artery bypass grafting (CABG) surgery. The study also provided the first indications of therapeutic efficacy of the AAMs, as delivered within an extracellular matrix patch, to reduce ischemic scar and increase viable ventricular wall thickness. To further evaluate the initial beneficial effects observed in the AAMS study, we designed the randomized, double-blinded, and placebo-controlled AAMS2 trial. Focusing on patients with ischemic heart disease (IHD) and myocardial scar, the AAMS2 trial aims to generate state-of-the-art structural and functional imaging data of the myocardium treated with an AAMs-patch during CABG.</p> Methods <p>The AAMS2 trial recruits IHD patients who are set to undergo non-urgent CABG and present with an ischemic myocardial scar in preoperative cardiac magnetic resonance imaging (CMRI) with late gadolinium enhancement. Patients are randomized (1:1) to receive a collagen-based matrix patch (Hemopatch®), with or without AAMs, epicardially onto the scar border. The primary endpoint, assessed by CMRI preoperatively and at 6&#xa0;months post-operative follow-up, focuses on the left ventricle scar mass. The secondary endpoints center on the change in scar mass by the AAMs-patch site and evaluation of therapy safety and feasibility as well as its effects on myocardial structure and function by echocardiography. Change in blood N-terminal-pro-BNP levels in the timeframe is the co-primary endpoint.</p> Discussion <p>Data from the AAMS2 trial provides the first randomized, blinded, and placebo-controlled evaluation of efficacy on epicardial AAMs transplantation for ischemic myocardial scar. This data&#xa0;will pave&#xa0;the road towards rational design of larger AAMs therapeutic efficacy-addressing trial(s).</p> Trial registration <p>ClinicalTrials.gov, NCT05632432, registered 30 November 2022, <a href="https://clinicaltrials.gov/study/NCT05632432">https://clinicaltrials.gov/study/NCT05632432</a>.</p> Graphical Abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Autologous atrial appendage micrografts transplanted during coronary artery bypass surgery: design of the AAMS2 randomized, double-blinded, and placebo-controlled trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月2日

查看全文
  • Vilbert Sikorski,
  • Annu Nummi,
  • Aleksi Kuuva,
  • Erika Wilkman,
  • Helena Rajala,
  • Juhani Stewart,
  • Juhani Junttila,
  • Kai Lindgren,
  • Kari Kervinen,
  • Kari Teittinen,
  • Katja Kohonen,
  • Kati Oksaharju,
  • Marjo Okkonen,
  • Miia Holmström,
  • Miia Lehtinen,
  • Severi Mulari,
  • Panu Taskinen,
  • Piia Simonen,
  • Päivi Karvonen,
  • Päivi Kastell,
  • Päivi Kärjä-Koskenkari,
  • Riina Kandolin,
  • Risto Kesävuori,
  • Sari Kaarlenkaski,
  • Satu Vaara,
  • Sebastian Dahlbacka,
  • Simo Syrjälä,
  • Suvi Syväranta,
  • Tatu Juvonen,
  • Tiina Erkinaro,
  • Tuomas Mäkelä,
  • Pasi Karjalainen,
  • Esko Kankuri,
  • Antti Vento,
  • Antti Nykänen

摘要

Background

The AAMS open-label clinical study demonstrated the safety and feasibility of epicardial transplantation of autologous right atrial appendage micrografts (AAMs) during coronary artery bypass grafting (CABG) surgery. The study also provided the first indications of therapeutic efficacy of the AAMs, as delivered within an extracellular matrix patch, to reduce ischemic scar and increase viable ventricular wall thickness. To further evaluate the initial beneficial effects observed in the AAMS study, we designed the randomized, double-blinded, and placebo-controlled AAMS2 trial. Focusing on patients with ischemic heart disease (IHD) and myocardial scar, the AAMS2 trial aims to generate state-of-the-art structural and functional imaging data of the myocardium treated with an AAMs-patch during CABG.

Methods

The AAMS2 trial recruits IHD patients who are set to undergo non-urgent CABG and present with an ischemic myocardial scar in preoperative cardiac magnetic resonance imaging (CMRI) with late gadolinium enhancement. Patients are randomized (1:1) to receive a collagen-based matrix patch (Hemopatch®), with or without AAMs, epicardially onto the scar border. The primary endpoint, assessed by CMRI preoperatively and at 6 months post-operative follow-up, focuses on the left ventricle scar mass. The secondary endpoints center on the change in scar mass by the AAMs-patch site and evaluation of therapy safety and feasibility as well as its effects on myocardial structure and function by echocardiography. Change in blood N-terminal-pro-BNP levels in the timeframe is the co-primary endpoint.

Discussion

Data from the AAMS2 trial provides the first randomized, blinded, and placebo-controlled evaluation of efficacy on epicardial AAMs transplantation for ischemic myocardial scar. This data will pave the road towards rational design of larger AAMs therapeutic efficacy-addressing trial(s).

Trial registration

ClinicalTrials.gov, NCT05632432, registered 30 November 2022, https://clinicaltrials.gov/study/NCT05632432.

Graphical Abstract