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

Phase 3

• Conditions: Non ST Segment Elevation MI and Unstable Angina
• Interventions: Procedure: One-Stage group; Procedure: Multi-Staged group

• Registration Number: NCT01478984
• Lead Sponsor: Gennaro Sardella

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-11-21
• Last Update Submitted: 2011-11-21
• Study First Posted: 2011-11-24
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one staged PCI	One-Stage group	the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.
multistaged PCI	Multi-Staged group	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

Primary Outcome Measures

Name	Time	Method
Major Adverese Cardiac and cerebral Events (MACCE)	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	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.

Trial Locations

Locations (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I; 🇮🇹 Rome, Italy