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

Completed

• Conditions: STEMI
• Interventions: Procedure: angioplasty

• Registration Number: NCT04582175
• Lead Sponsor: University of Oradea

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-05
• Status Verified: 2020-10
• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Study First Posted: 2020-10-09
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group A	angioplasty	patients who received complete revascularization by angioplasty during the PPCI
Group B	angioplasty	patients who underwent complete revascularization by angioplasty in a staged procedure

Primary Outcome Measures

Name	Time	Method
one year all-cause mortality	one year	death at one year
MACCE at one year	one year	major adverse cardiac and cerebrovascular events including cardiac death, stroke, symptom-driven revascularization, myocardial infarction

Trial Locations

Locations (1)

Spitalul Clinic Judetean de Urgenta Oradea; 🇷🇴 Oradea, Bihor, Romania