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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01478984
Acronym
SMILE
Enrollment
247
Registered
2011-11-24
Start date
2011-10-31
Completion date
Unknown
Last updated
2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non ST Segment Elevation MI and Unstable Angina

Keywords

NSTEMI, PCI, onestage, multistaged

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.

Interventions

PROCEDUREOne-Stage group

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

PROCEDUREMulti-Staged group

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

Sponsors

Gennaro Sardella
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Major Adverese Cardiac and cerebral Events (MACCE)12 monthsIncidence 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.
MACCE6 monthsIncidence 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.

Countries

Italy

Contacts

Primary ContactGennaro Sardella, MD
rino.sardella@uniroma1.it+390649979035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026