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Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease

Phase 3
Conditions
Myocardial Infarction
Angioplasty, Transluminal, Percutaneous Coronary
Echocardiography, Stress
Interventions
Procedure: complete multivessel revascularization
Procedure: stress echocardiography and revascularization if required
Registration Number
NCT01179126
Lead Sponsor
Complexo Hospitalario Universitario de A Coruña
Brief Summary

Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. On the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice.

To date, very few observational studies have focused in the multivessel revascularization with disparity of results. Whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results.

Stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. However, this technique has also limitations like the high operator-dependence.

Therefore, the investigators sought to study if the complete multivessel revascularization of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
400
Inclusion Criteria
  • Typical chest pain lasting >30 minutes with ST-segment elevation >=1mm in >=2 contiguous ECG leads or left bundle branch block and presentation < 48 hours since symptom onset.
  • Patients undergoing rescue PCI
  • Patients with effective lysis and coronary angiography in less than 24 hours
  • Presence of other lesion >=70% in a non-culprit artery.
  • Informed consent
Exclusion Criteria
  • Significant left main disease
  • Lesions in vessels < 2 mm
  • Lesions in branches of a main epicardial coronary artery and short irrigation territory
  • Previous coronary artery bypass graft (CABG)
  • Any coronary intervention in the previous month
  • Cardiogenic shock
  • Anatomic features no suitable for coronary intervention
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
complete multivessel revascularizationcomplete multivessel revascularization-
stress echo guided revascularizationstress echocardiography and revascularization if required-
Primary Outcome Measures
NameTimeMethod
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failureone year
Secondary Outcome Measures
NameTimeMethod
Deathone year

cardiovascular death

re-myocardial infarctionone year
revascularization of any vesselone year
admission due to heart failureone year
Cost analysis of both strategies1 year
Incidence of acute renal failure (contrast induced nephropathy)Admission

Trial Locations

Locations (1)

Complejo Hospitalario Universitario A Coruna

🇪🇸

A Coruna, Spain

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