Sirolimus Eluting Stenting in Acute Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-03-31

Brief Summary

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The incidence of stent restenosis in the setting of primary angioplasty is particularly high, reaching a rate of 27% In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. Whether drug-eluting stenting might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a randomized trial in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.

Detailed Description

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The treatment of acute myocardial infarction has evolved dramatically in the last decade. Coronary angioplasty with stent implantation in conjunction with an optimal antitrombotic therapy as abciximab is now considered current standard therapy However, the incidence of stent restenosis in the setting of primary angioplasty remains particularly high, reaching a rate of 27%. A high restenosis rate causes a high re-hospitalization rate for target vessel revascularization and an ensuing increase in cost.In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. This reduced incidence of restenosis occurs without an increase in adverse clinical events over conventional stents and has a very low rate of stent subacute thrombosis. Whether this combination of drug-eluting stents and abciximab might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a one year coronary angiographic study in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Primary angioplasty in acute myocardial infarction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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Exclusion Criteria

Patients were excluded if they were in cardiogenic shock (defined as systolic blood pressure of less than 80 mm Hg for more than 30 minutes or the need for intravenous pressors or intraaortic-balloon counterpulsation); had a history of bleeding diathesis; had a history of leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; had a noncardiac illness associated with a life expectancy of less than one year; were participating in another study; or were unable to give informed consent owing to prolonged cardiopulmonary resuscitation.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roberto Violini, MD

Role: STUDY_CHAIR

Cardiologia Interventistica Ospedale San Camillo Roma

Maurizio Menichelli, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiologia Interventistica Ospedale San Camillo Roma

Locations

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Cardiologia Interventistica Ospedale San Camillo

Roma, Roma, Italy

Site Status

Countries

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Italy

References

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Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, Giulivi A, Alborino D, Azzellino A, Violini R. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol. 2007 May 15;49(19):1924-30. doi: 10.1016/j.jacc.2007.01.081. Epub 2007 Apr 30.

Reference Type DERIVED

PMID: 17498576 (View on PubMed)

Other Identifiers

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183/2003

Identifier Type: -

Identifier Source: org_study_id