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

Gennaro Sardella

Status and phase: Unknown; Phase 3

Conditions: Non ST Segment Elevation MI and Unstable Angina

Treatments: Procedure: Multi-Staged group; Procedure: One-Stage group

Study type: Interventional

Funder types: Other

Identifiers

NCT01478984

SMILE

Details and patient eligibility

About

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.

Enrollment: 247 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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247 participants in 2 patient groups

one staged PCI

Active Comparator group

Description:

the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.

Treatment:

Procedure: One-Stage group

multistaged PCI

Active Comparator group

Description:

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

Treatment:

Procedure: Multi-Staged group