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

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

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.

Study Overview

• Status: Completed
• Conditions: STEMI
• Intervention / Treatment: Procedure: angioplasty

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Romania
  • Bihor
    • Oradea, Bihor, Romania
      • Spitalul Clinic Judetean de Urgenta Oradea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

multivessel patients with STEMI uncomplicated by cardiogenic shock

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; patients who received complete revascularization by angioplasty during the PPCI	Procedure: angioplasty; angioplasty of all non-culprit lesions
Group B; patients who underwent complete revascularization by angioplasty in a staged procedure	Procedure: angioplasty; angioplasty of all non-culprit lesions

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oradea
• Investigators: Principal Investigator: Mihnea-Traian T Nichita-Brendea, MD, Spitalul Clinic Judetean de Urgenta Oradea

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 5, 2020

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: PPCI, multivessel coronary artery disease, STEMI
• Other Study ID Numbers: Uoradea

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No