Staged interventional strategies for acute ST-segment elevation myocardial infarction patient with multivessel
Xiang Chen1, Suiji Li1, Bin Wang1
1Department of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen 361000, China.
Insights
The STAGED trial investigates optimal timing for staged complete revascularization (SCR) in acute ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD). This study will determine the best strategy for reducing adverse cardiovascular events after primary PCI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Complete revascularization (CR) reduces adverse cardiovascular events in acute ST-segment elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD) compared to culprit-only revascularization (COR).
- The optimal timing for staged complete revascularization (SCR) after primary percutaneous coronary intervention (PCI) in these patients remains unclear.
- The STAGED trial (NCT04918030) addresses this knowledge gap.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of different timing strategies for staged complete revascularization (SCR).
- To compare early-staged PCI versus delayed-staged PCI in acute STEMI patients with MVD.
Main Methods:
- The STAGED trial is a multicenter, randomized study involving 1,586 acute STEMI patients with MVD undergoing primary PCI.
- Patients are randomized to either early-staged PCI or delayed-staged PCI for SCR.
- The primary endpoint is major adverse cardiac event (MACE) at 12 months, including cardiovascular death, myocardial infarction, or ischemia-driven revascularization.
Main Results:
- This section is not yet available as the trial is ongoing.
- The primary endpoint is major adverse cardiac event (MACE) at 12 months.
- Secondary endpoints include components of MACE, all-cause death, heart failure hospitalization, stroke, contrast-induced nephropathy, and radiation exposure.
Conclusions:
- The STAGED trial is the first randomized controlled study to specifically assess the timing of SCR in acute STEMI patients with MVD.
- Findings will guide optimal treatment strategies for complete revascularization in this high-risk population.
Background:
Complete revascularization (CR) has been shown to reduce the risk of adverse cardiovascular events compared with culprit-only revascularization (COR) in acute ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease (MVD). However, the optimal timing of staged complete revascularization (SCR) after primary percutaneous coronary intervention (PCI) remains unclear.
Trial Design:
The STAGED trial is an investigator-initiated, multicenter, randomized study involving 37 sites, aiming to include 1,586 acute STEMI patients with MVD undergoing successful primary PCI of the culprit lesion followed by SCR. Eligible patients will be assigned to two groups based on the timing of SCR: early-staged PCI and delayed-staged PCI. The primary endpoint is major adverse cardiac event (MACE), including cardiovascular death, myocardial infarction, or ischemia-driven revascularization for both culprit and nonculprit vessels at 12 months since the randomization. The secondary endpoint is individual components of primary endpoint, all-cause death, heart failure-related rehospitalization, stroke, contrast-induced nephropathy, and radiation exposure dose. Follow-up will be conducted through clinic visits or telephone interviews at 1, 3, and 12 months after the index procedure.
Conclusion:
The STAGED trial is the first randomized controlled study specifically designed to evaluate the clinical efficacy and safety of different timing strategies for SCR in acute STEMI patients with MVD.
Trial Registration:
clinicaltrials.gov, NCT04918030.
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