Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)

Study Overview
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Brief Summary
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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.

Official Title
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Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial

Conditions
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Non ST Segment Elevation MI and Unstable Angina

Intervention / Treatment
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* Procedure: One-Stage group
* Procedure: Multi-Staged group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: one staged PCI<br>the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions. | Procedure: One-Stage group<br>* Patients randomized to One-Stage group were completely revascularizated in one time PCI,<br>|
| Active Comparator: multistaged PCI<br>the patients randomized to this arms in the first stage the investigators treat only the culprit lesion and in second stage the investigators treat the other vessels | Procedure: Multi-Staged group<br>* patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverese Cardiac and cerebral Events (MACCE) | 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. | 12 months | 
| Major Adverese Cardiac and cerebral Events (MACCE) | 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. | 30 days | 
| MACCE | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI, PCI, onestage, multistaged