Fractional Flow Reserve Versus Instantaneous Wave-Free Ratio in Assessment of Lesion Hemodynamic Significance and Explanation of their Discrepancies. International, Multicenter and Prospective Trial: The FiGARO Study.

Background The FiGARO (FFR versus iFR in Assessment of Hemodynamic Lesion Significance, and an Explanation of Their Discrepancies) trial is a prospective registry searching for predictors of fractional flow reserve/instantaneous wave-free ratio (FFR/iFR) discrepancy. Methods and Results FFR/iFR were analyzed using a Verrata wire, and coronary flow reserve was analyzed using a Combomap machine (both Philips-Volcano). The risk polymorphisms for endothelial nitric oxide synthase and for heme oxygenase-1 were analyzed. In total, 1884 FFR/iFR measurements from 1564 patients were included. The FFR/iFR discrepancy occurred in 393 measurements (20.9%): FFRp (positive)/iFRn (negative) type (264 lesions, 14.0%) and FFRn/iFRp (129 lesions, 6.8%) type. Coronary flow reserve was measured in 343 lesions, correlating better with iFR (R=0.56, P<0.0001) than FFR (R=0.36, P<0.0001). The coronary flow reserve value in FFRp/iFRn lesions (2.24±0.7) was significantly higher compared with both FFRp/iFRp (1.39±0.36), and FFRn/iFRn lesions (1.8±0.64, P<0.0001). Multivariable logistic regression analysis confirmed (1) sex, age, and lesion location in the right coronary artery as predictors for FFRp/iFRn discrepancy; and (2) hemoglobin level, smoking, and renal insufficiency as predictors for FFRn/iFRp discrepancy. The FFRn/iFRp type of discrepancy was significantly more frequent in patients with both risk types of polymorphisms (endothelial nitric oxide synthaser+heme oxygenase-1r): 8 patients (24.2%) compared with FFRp/iFRn type of discrepancy: 2 patients (5.9%), P=0.03. Conclusions Predictors for FFRp/iFRn discrepancy were sex, age, and location in the right coronary artery. Predictors for FFRn/iFRp were hemoglobin level, smoking, and renal insufficiency. The risk type of polymorphism in endothelial nitric oxide synthase and heme oxygenase-1 genes was more frequently found in patients with FFRn/iFRp type of discrepancy. Registration URL: https://clinicaltrials.gov; Unique identifier: NCT03033810.

Safety of early discharge in low risk patients after acute ST-segment elevation myocardial infarction, treated with primary percutaneous coronary intervention. Open label, randomized trial.

BACKGROUND: The length of hospital stay in patients with acute myocardial infarction and ST-segment elevation (STEMI) has been shortened in recent years with corresponding savings in costs, but there is limited available data on its implementation in clinical practice. The aim of this trial was to determine whether early discharge in selected patients after STEMI is feasible and safe. METHODS: 151 patients with STEMI successfully treated with primary percutaneous coronary intervention (PCI) who fulfilled the inclusion criteria of low risk were randomly assigned to two groups on a 1:1 ratio: early (within 48-72 h of admission) and standard (after 72 h) discharge. The primary end point was the composite of death, myocardial infarction (MI), unstable angina, stroke, unplanned rehospitalization, repeated target vessel revascularization and stent thrombosis at 90 days after discharge. The study is registered with ClinicalTrials.gov (identifier NCT02023983). RESULTS: The primary end point occurred in 5 patients in the early group and 6 in the standard group (6.6% vs. 8.0%, P=0.765). There were no significant differences in the incidence of individual components of the primary end point at 90 days. The length of hospital stay was significantly shorter in the intervention group (60.8 ± 8.5 vs. 92.1 ± 12.1 h, P<0.0001). CONCLUSION: This study confirms that early discharge within 48-72 h in selected low risk patients after STEMI treated with successful primary PCI is feasible and safe, with outcomes comparable to the later discharge. This strategy applies to more than a quarter of all STEMI patients.