Clinical trial NCT01179126: Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease
Official title: Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Infarction
Angioplasty, Transluminal, Percutaneous Coronary
Echocardiography, Stress
Keywords: myocardial infarction
primary angioplasty
multivessel disease
stress echocardiography
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure
timeFrame: one year
Secondary outcomes:
measure: Incidence of acute renal failure (contrast induced nephropathy)
timeFrame: Admission
measure: Cost analysis of both strategies
timeFrame: 1 year
measure: Death
timeFrame: one year
measure: re-myocardial infarction
timeFrame: one year
measure: revascularization of any vessel
timeFrame: one year
measure: admission due to heart failure
timeFrame: one year
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
Study officials:
affiliation: Interventional Cardiology. Complejo Hospitalario Universitario A Couna
name: Rodrigo Estevez-Loureiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Interventional Cardiology. Complejo Hospitalario A Couna
name: Ramon Calvino-Santos, MD
role: STUDY_CHAIR
affiliation: Interventional Cardiology. Complejo Hospitalario A Couna
name: Nicolas Vazquez-Gonzalez, MD
role: STUDY_CHAIR
affiliation: Interventional Cardiology. Complejo Hospitalario A Couna
name: Jorge Salgado-Fernandez, MD
role: STUDY_CHAIR
affiliation: Interventional Cardiology. Complejo Hospitalario A Couna
name: Pablo Pinon-Esteban, MD
role: STUDY_CHAIR
affiliation: Interventional Cardiology. Complejo Hospitalario A Couna
name: Guillermo Aldama-Lopez, MD
role: STUDY_CHAIR
affiliation: Interventional Cardiology. Complejo Hospitalario A Couna
name: Xacobe Flores-Rios, MD
role: STUDY_CHAIR
affiliation: Stress Echo Unit. Complejo Hospitalario A Couna
name: Jesus Peteiro, MD, PhD
role: STUDY_CHAIR
affiliation: Stress Echo Unit. Complejo Hospitalario A Couna
name: Alberto Bouzas-Mosquera, MD
role: STUDY_CHAIR
affiliation: Coronary Care Unit. Complejo Hospitalario A Couna
name: Jose Angel Rodriguez-Fernandez, MD
role: STUDY_CHAIR
References:
citation: Flores-Rios X, Calvino-Santos RA, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Marzoa-Rivas R, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Vazquez-Gonzalez N, Muniz-Garcia J, Vazquez-Rodriguez JM. Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease. Rev Esp Cardiol (Engl Ed). 2021 Dec;74(12):1054-1061. doi: 10.1016/j.rec.2020.09.028. Epub 2020 Nov 27. English, Spanish.
citation: Calvino-Santos R, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Mesias-Prego A, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Flores-Rios X, Soler-Martin R, Seoane-Pillado T, Vazquez-Gonzalez N, Muniz J, Vazquez-Rodriguez JM. Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial. Circ Cardiovasc Interv. 2019 Oct;12(10):e007924. doi: 10.1161/CIRCINTERVENTIONS.119.007924. Epub 2019 Sep 26.