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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non ST Segment Elevation MI and Unstable Angina
• Intervention / Treatment: Procedure: One-Stage group; Procedure: Multi-Staged group

• Study Type: Interventional
• Enrollment (Anticipated): 247
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • Dept.of Cardiovascular Sciences,Policlinico Umberto I
    • Contact: Luigi Lucisano, MD; Phone Number: +390649979044; Email: luigilucisano@yahoo.it
    • Contact: Massimo Mancone, MD, PhD; Phone Number: +390649979044; Email: massimomancone@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: one staged PCI; the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.	Procedure: One-Stage group; Patients randomized to One-Stage group were completely revascularizated in one time PCI,
Active Comparator: multistaged PCI; 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; patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gennaro Sardella

Publications and helpful links

General Publications

• Sardella G, Lucisano L, Garbo R, Pennacchi M, Cavallo E, Stio RE, Calcagno S, Ugo F, Boccuzzi G, Fedele F, Mancone M. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):264-72. doi: 10.1016/j.jacc.2015.10.082.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 11, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2011
• Last Update Submitted That Met QC Criteria: November 21, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: PCI; NSTEMI; onestage; multistaged
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Unstable
• Other Study ID Numbers: SMILE