Comparison Between Two Revascularization Strategies in MVD Patients With Uncomplicated ST-elevation MI

NCT ID: NCT04582175

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-09-05

Brief Summary

The study aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(MVD) patients presenting with ST-elevation myocardial infarction(STEMI) uncomplicated by cardiogenic shock.

Detailed Description

Complete revascularisation in MVD patients with STEMI uncomplicated by cardiogenic shock has been shown to improve outcomes, however the optimal timing of treatment of the non-culprit lesions is not known. The 2018 ESC/EACTS Guidelines on myocardial revascularization states that "routine revascularization of non-IRA (infarct related artery) lesions should be considered in patients with multivessel disease before hospital discharge". Our trial showed that among the fore mentioned patients there was no difference regarding outcomes when using a strategy of complete revascularization with non-culprit lesions PCI during PPCI or during the same hospital admission.

Conditions

STEMI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

group A

patients who received complete revascularization by angioplasty during the PPCI

angioplasty

Intervention Type: PROCEDURE

angioplasty of all non-culprit lesions

Group B

patients who underwent complete revascularization by angioplasty in a staged procedure

angioplasty

Intervention Type: PROCEDURE

angioplasty of all non-culprit lesions

Interventions

angioplasty

angioplasty of all non-culprit lesions

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Men and women with successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI ( PCI for STEMI should be primary PCI in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index PPCI procedure or during a different procedure performed before index hospital discharge.

2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:

• At least 75% diameter stenosis (visual estimation) or
• At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80

3. Age between 18 and 90 years

4. Written informed consent could be obtained from all the patients

Exclusion Criteria

1. Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis

2. Cardiogenic shock

3. Non-cardiovascular known co-morbidity reducing life expectancy to < 2 years

4. Any factor precluding 1year follow-up

5. Prior Coronary Artery Bypass Graft (CABG) Surgery

6. A different operator from the previously designated

7. Unable to provide consent for any other reason

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oradea

OTHER

Sponsor Role: lead

Responsible Party

Nichita-Brendea Mihnea-Traian

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mihnea-Traian T Nichita-Brendea, MD

Role: PRINCIPAL_INVESTIGATOR

Spitalul Clinic Judetean de Urgenta Oradea

Locations

Spitalul Clinic Judetean de Urgenta Oradea

Oradea, Bihor County, Romania

Countries

Romania

Other Identifiers

Uoradea

Identifier Type: -

Identifier Source: org_study_id