Long-Term Clinical Outcomes of Fractional Flow Reserve-Guided Versus Routine Drug-Eluting Stent Implantation in Patients With Intermediate Coronary Stenosis: Five-Year Clinical Outcomes of DEFER-DES Trial.

BACKGROUND We aimed to compare the long-term clinical outcomes between fractional flow reserve (FFR)-guided and routine drug-eluting stent (DES) implantation in patients with an intermediate coronary stenosis. METHODS AND RESULTS A total of 229 patients with an angiographically intermediate coronary stenosis were randomly assigned to FFR-guided or Routine-DES implantation group. For FFR-guided group (n=114), treatment strategy was determined according to the target vessel FFR (FFR<0.75: DES implantation [FFR-DES group]; FFR≥0.75: deferral of stenting [FFR-Defer group]). Routine-DES group underwent DES implantation without FFR measurement (n=115). The primary end point was the incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and target lesion revascularization. Of lesions assigned to FFR-guided strategy, only one quarter had functional significance (FFR<0.75). At 2-year follow-up, the cumulative incidence of major adverse cardiac events was 7.9±2.5% in the FFR-guided group and 8.8±2.7% in Routine-DES group (P=0.80). At 5-year follow-up, the cumulative incidence of major adverse cardiac events was 11.6±3.0% and 14.2±3.3% for the FFR-guided group and the Routine-DES group (P=0.55). There was no difference in major adverse cardiac events rates between the 2 groups ≤5-year follow-up (hazard ratio, 1.25; 95% confidence interval, 0.60-2.60). CONCLUSIONS In lesions with angiographically intermediate stenosis, FFR guidance provides a tailored approach, which is at least as good as an angiography-guided routine-DES implantation strategy and avoids unnecessary DES-stenting in a considerable part of the patients. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00592228.