Manual Thrombus Aspiration During PCI in STEMI With Angiographically Evident Thrombus

Overview

The goal of this clinical trial is to determine whether manually removing a visible blood clot before percutaneous coronary intervention (PCI) improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). About 3500 patients who present within 24 hours of symptom onset and have angiographically evident thrombus in the culprit coronary artery (TIMI thrombus grade 2 or higher) will be randomly assigned in a 1:1 ratio to manual thrombus aspiration followed by PCI or PCI alone. The main question is whether adding manual thrombus aspiration reduces the first major adverse cardiac or cerebrovascular event within 30 days. This composite includes death from any cause, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. Researchers will also compare coronary and myocardial reperfusion after PCI, individual clinical events, stroke and other safety outcomes, and major adverse cardiac or cerebrovascular events through 6 and 12 months. Participants will receive their assigned PCI strategy and will be followed during the index hospitalization and at 30 days, 6 months, and 12 months.

TAPSET is an investigator-initiated, prospective, multicenter, randomized, open-label, parallel-group superiority trial with blinded endpoint assessment. Consecutive patients with STEMI presenting within 24 hours of symptom onset undergo preliminary screening and provide written informed consent before randomization. Final eligibility is confirmed after diagnostic coronary angiography demonstrates TIMI thrombus grade 2 or higher in the culprit vessel before guidewire crossing or another intervention that could alter thrombus burden. Eligible participants are randomized through a central web-based system, stratified by six coordinating-center networks, to manual aspiration with the Sniffer II thrombus aspiration catheter followed by PCI or PCI alone. Bailout aspiration with Sniffer II is permitted in the PCI-alone group when clinically necessary. Other thrombectomy devices are not permitted. Concomitant PCI techniques and pharmacological rescue treatment are determined by the operator according to contemporary care. The primary endpoint is the first MACCE through day 30. Clinical events are independently adjudicated, and angiographic and electrocardiographic reperfusion outcomes are centrally assessed by reviewers blinded to treatment allocation. Follow-up occurs at 30 days, 6 months, and 12 months.