Mid-Term Procedural Related Complications
Procedural related complications occurred in 8 and 2 patients in the single procedure group and in the combined strategy group respectively (5% and 12%, HR=3.5 [0.7-17], p=0.1). One patient in each group presented with a major hemorrhage due to recurrent gastrointestinal bleeding on Aspirin (at 2 years in the single group and 7 months in the combined strategy (1 and 6%, HR=12.0 [0.8-201], p=0.07)). Cardiovascular death occurred in 3 patients in the single procedure group due to hemorrhagic stroke in 2 (2%) and end-stage heart failure in 1. There was no systemic embolization over the follow-up period for the whole cohort (Table 4).