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

• ClinicalTrials.gov Identifier: NCT01478984
• Recruitment Status: Unknown
• First Posted: November 24, 2011
• Last Update Posted: November 24, 2011
• Sponsor: Gennaro Sardella
• Information provided by (Responsible Party): Gennaro Sardella, University of Roma La Sapienza

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non ST Segment Elevation MI and Unstable Angina	Procedure: One-Stage group; Procedure: Multi-Staged group	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 247 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial
• Study Start Date: October 2011
• Actual Primary Completion Date: October 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Major Adverese Cardiac and cerebral Events (MACCE) [ Time Frame: 12 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.
2. Major Adverese Cardiac and cerebral Events (MACCE) [ Time Frame: 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.
3. MACCE [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Gennaro Sardella, MD; +390649979035; rino.sardella@uniroma1.it

Locations

Italy

Dept.of Cardiovascular Sciences,Policlinico Umberto I; Recruiting

Rome, Italy, 00161

Contact: Luigi Lucisano, MD +390649979044 luigilucisano@yahoo.it

Contact: Massimo Mancone, MD, PhD +390649979044 massimomancone@gmail.com

Sponsors and Collaborators

Gennaro Sardella

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT01478984
• Other Study ID Numbers: SMILE
• First Posted: November 24, 2011
• Last Update Posted: November 24, 2011
• Last Verified: November 2011

Keywords provided by Gennaro Sardella, University of Roma La Sapienza:

NSTEMI; PCI; onestage; multistaged

Additional relevant MeSH terms:

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations