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

Complexo Hospitalario Universitario de A Coruña

Status and phase: Unknown; Phase 3

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Echocardiography, Stress; Myocardial Infarction

Treatments: Procedure: complete multivessel revascularization; Procedure: stress echocardiography and revascularization if required

Study type: Interventional

Funder types: Other

Identifiers

NCT01179126

CROSS-AMI

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

complete multivessel revascularization

Experimental group

Treatment:

Procedure: complete multivessel revascularization

stress echo guided revascularization

Active Comparator group

Treatment:

Procedure: stress echocardiography and revascularization if required