Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction

Nanjing Medical University

Status: Unknown

Conditions: Percutaneous Coronary Intervention; ST-segment Elevation Myocardial Infarction; Fractional Flow Reserve

Study type: Observational

Funder types: Other

Identifiers

NCT02670005

20160010

Details and patient eligibility

About

To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).

Full description

The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age>18 years
• documented acute ST-segment elevation myocardial infarction
• onset of symptom >6 days before percutaneous coronary intervention
• eligible for PCI

Exclusion criteria

• cardiogenic shock or hemodynamic instability
• highly tortuous or calcified arteries
• infarct related artery with a diameter < 2.5mm
• a life expectancy< 2 years
• intolerance to anti-platelet drugs
• left main disease (≥ 50% stenosis)
• contraindication to adenosine
• hypertrophic cardiomyopathy

Trial design

600 participants in 2 patient groups

FFR-PCI group

Description:

patients with ST-segment elevation myocardial infarction (STEMI) who received fractional flow reserve (FFR)-guided selective percutaneous coronary intervention (PCI)

angiography-PCI group

Description:

patients with STEMI who received angiography-guided selective PCI