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

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.

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Key information

Conditions

STEMI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spitalul Clinic Judetean de Urgenta Oradea

Oradea, Bihor County, Romania

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
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
Age between 18 and 90 years
Written informed consent could be obtained from all the patients

Exclusion criteria

Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis
Cardiogenic shock
Non-cardiovascular known co-morbidity reducing life expectancy to < 2 years
Any factor precluding 1year follow-up
Prior Coronary Artery Bypass Graft (CABG) Surgery
A different operator from the previously designated
Unable to provide consent for any other reason

Treatment and study plan

Angioplasty

Procedure

angioplasty of all non-culprit lesions

Primary outcomes

one year all-cause mortality

Time frame: one year

death at one year
MACCE at one year

Time frame: one year

major adverse cardiac and cerebrovascular events including cardiac death, stroke, symptom-driven revascularization, myocardial infarction

Sponsors and collaborators

Lead sponsor

University of Oradea

Other

Registry information

Official study title

A Retrospective, One Center Comparison of Outcomes Between Complete Revascularization by PCI at the Time of PPCI or During the Index Hospital Admission in One Hundred MVD Patients With ST-elevation MI Uncomplicated by Cardiogenic Shock

Acronym: Promise

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Oct 9, 2020
Registry last updated: Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed