Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI) (SMILE)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non ST Segment Elevation MI and Unstable Angina |
Procedure: One-Stage group Procedure: Multi-Staged group |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Major Adverese Cardiac and cerebral Events (MACCE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
- Major Adverese Cardiac and cerebral Events (MACCE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 247 |
| Study Start Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Gennaro Sardella, MD | +390649979035 | rino.sardella@uniroma1.it |
| 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 | |
More Information
No publications provided
| Responsible Party: | Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01478984 History of Changes |
| Other Study ID Numbers: | SMILE |
| Study First Received: | November 11, 2011 |
| Last Updated: | November 21, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
NSTEMI PCI onestage multistaged |
Additional relevant MeSH terms:
|
Angina, Unstable Myocardial Infarction Angina Pectoris Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013