ST-segment Elevation Myocardial Infarction
Conditions
Keywords
ST-segment elevation myocardial infarction, Thrombus aspiration, Percutaneous coronary intervention, Randomized controlled trial, Angiographically evident thrombus, Coronary thrombus, Myocardial reperfusion, TAPSET
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREManual thrombus aspiration
Manual aspiration is performed after guidewire passage and before balloon dilatation or stent implantation in the culprit coronary artery. A large-lumen aspiration catheter is connected to a syringe to generate negative pressure and remove visible thrombotic material. The operator selects the catheter configuration and determines the number of aspiration passes and when to discontinue aspiration according to coronary anatomy, residual thrombus, technical feasibility, and participant safety. Operators receive standardized device-specific training before participating in the trial. No other thrombectomy device is permitted.
PROCEDUREPercutaneous Coronary Intervention
PCI is performed according to contemporary guideline-directed care and local practice. Balloon dilatation, stent implantation, vascular access, antiplatelet treatment, procedural anticoagulation, intracoronary medication, and other procedural details are determined by the operator.
Sponsors
Shenghua Zhou
Second Xiangya Hospital of Central South University
The General Hospital of Northern Theater Command
Second Hospital of Jilin University
First Affiliated Hospital Xi'an Jiaotong University
The First Affiliated Hospital of Dalian Medical University
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants, treating operators, and clinical care teams are aware of treatment allocation. The Clinical Event Committee, central angiographic and electrocardiographic assessors, and statistical analysts remain blinded to randomized allocation.
Intervention model description
Investigator-initiated, multicenter, randomized, open-label, two-group parallel superiority trial with blinded endpoint assessment.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Confirmed ST-segment elevation myocardial infarction with symptom onset-to-hospital arrival of 24 hours or less. * Angiographically evident thrombus in the culprit vessel, defined as TIMI thrombus grade 2 or higher before guidewire crossing or any intervention that could alter thrombus burden. * Written informed consent obtained from the participant or a legally authorized representative before randomization.
Exclusion criteria
* Cardiogenic shock, defined as persistent systolic blood pressure below 90 mmHg for at least 30 minutes or a need for vasopressor support to maintain systolic blood pressure of at least 90 mmHg, together with evidence of end-organ hypoperfusion. * Requirement for emergency coronary artery bypass grafting. * A serious noncardiovascular condition associated with an expected survival of less than 6 months. * Inability to obtain written informed consent from the participant or a legally authorized representative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 30 Days | From randomization through 30 days | The proportion of participants experiencing at least one of the following events: all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. Each component will also be reported separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Death | From randomization through 6 months and through 12 months | Time to death from any cause, reported at both 6 months and 12 months after randomization. |
| Final TIMI Flow Grade 3 | At the end of the index PCI procedure | The proportion of participants with final Thrombolysis in Myocardial Infarction (TIMI) epicardial coronary flow grade 3, assessed by the blinded central angiographic assessment team. |
| Myocardial Blush Grade 3 | At the end of the index PCI procedure | The proportion of participants with myocardial blush grade 3, assessed by the blinded central angiographic assessment team. The full myocardial blush grade 0-3 distribution will also be reported. |
| Complete ST-Segment Resolution | After PCI during the index hospitalization | The proportion of participants with at least 70% ST-segment resolution from the pre-PCI to the post-PCI electrocardiogram, assessed by the blinded central electrocardiographic assessment team. |
| Any Stroke Through 30 Days | From randomization through 30 days | The proportion of participants experiencing any adjudicated stroke. |
| Major Adverse Cardiac or Cerebrovascular Events Through 6 Months | From randomization through 6 months | Time to the first occurrence of all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. |
| Cardiovascular Death | From randomization through 6 months and through 12 months | Time to death adjudicated as cardiovascular in cause, reported at both 6 months and 12 months after randomization. |
| Major Adverse Cardiac or Cerebrovascular Events Through 12 Months | From randomization through 12 months | Time to the first occurrence of all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. |
Countries
China
Contacts
CONTACTShenghua Zhou
Outcome results
None listed