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

NCT01478984 | Unknown Phase 3 DMC

• 1 other identifier: SMILE
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Non ST Segment Elevation MI and Unstable Angina

Keywords

NSTEMI; PCI; onestage; multistaged

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

one staged PCI

ACTIVE COMPARATOR

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

Procedure: One-Stage group

multistaged PCI

ACTIVE COMPARATOR

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

Interventions

One-Stage group PROCEDURE

Patients randomized to One-Stage group were completely revascularizated in one time PCI,

one staged PCI

Multi-Staged group PROCEDURE

patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

multistaged PCI

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of NSTEMI
• presenting with multivessel disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Gennaro Sardella: lead

Study Sites (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, Rome, 00161, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 26796390 DERIVED

MeSH Terms

Conditions

Angina, Unstable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Central Study Contacts

Gennaro Sardella, MD

CONTACT

+390649979035; rino.sardella@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Cardiology

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 24, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

IT (1)