Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Non ST Segment Elevation MI and Unstable Angina
- Sponsor
- Gennaro Sardella
- Enrollment
- 247
- Locations
- 1
- Primary Endpoint
- Major Adverese Cardiac and cerebral Events (MACCE)
- Last Updated
- 14 years ago
Overview
Brief Summary
Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI according to current guidelines presenting with multivessel disease. We will exclude patients with cardiogenic shock at presentation (systolic blood pressure <90 mmHg despite drug therapy), left main coronary disease (>50% diameter stenosis), previous coronary artery bypass grafting (CABG) surgery, patients with Syntax Score >32 and candidated to by-pass surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success was defined as the achievement of an angiographic residual stenosis of less than 30% and a thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.
Patients randomized to One-Stage group were completely revascularizated in one time PCI, whereas patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of 600 mg before the PCI (for loading dose administered more than 6 h prior to procedure). Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and clopidogrel 75 mg/day for at least one month.
Investigators
Gennaro Sardella
Associate Professor in Cardiology
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •diagnosis of NSTEMI
- •presenting with multivessel disease
Exclusion Criteria
- •patients with cardiogenic shock at presentation
- •left main coronary disease (\>50% diameter stenosis)
- •previous coronary artery bypass grafting (CABG) surgery
- •patients with Syntax Score \>32
- •candidated to by-pass surgery
- •severe valvular heart disease
- •unsuccessful procedures
Outcomes
Primary Outcomes
Major Adverese Cardiac and cerebral Events (MACCE)
Time Frame: 30 days
Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.
MACCE
Time Frame: 6 months
Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.