Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent

Seoul National University Hospital250 enrolled

Overview

Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

250

Conditions

Coronary Angiography Drug-eluting Stents Fractional Flow Reserve, Myocardial

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Elective PCI * Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion) * Reference diameter \> 2.5mm, lesion length \< 60mm (cover by 2 stents) * No documented evidence of ischemia by noninvasive tests Exclusion Criteria: * Acute ST elevation MI * Left main disease * Chronic renal failure (cr \>2 mg/dL) * Expected survival \< 2yrs * \> 1degree AV block

Outcomes

Primary Outcomes

Clinical event: Cardiac death, myocardial infarction, target lesion revascularization

Time frame: 9 months

Secondary Outcomes

IVUS

IVUS minimum lumen area

Time frame: at the time of procedure