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Clinical Trials/NCT04582175
NCT04582175
Completed
Not Applicable

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

University of Oradea1 site in 1 country100 target enrollmentJuly 1, 2020
ConditionsSTEMI

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
STEMI
Sponsor
University of Oradea
Enrollment
100
Locations
1
Primary Endpoint
one year all-cause mortality
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
September 5, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Oradea
Responsible Party
Principal Investigator
Principal Investigator

Nichita-Brendea Mihnea-Traian

MD

University of Oradea

Eligibility Criteria

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

Outcomes

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

Study Sites (1)

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