Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions.

Objectives: The aim of this analysis is to evaluate potential differences according to gender in terms of acute and 30-day clinical outcomes in patients enrolled in the ORBIT II trial with de novo, severely calcified coronary lesions treated with orbital atherectomy to facilitate stent delivery.

Background: Previous studies have shown an increased risk of safety events in females compared to males undergoing percutaneous coronary intervention.

Methods: ORBIT II, a prospective, nonrandomized, multicenter, single arm study conducted in the US evaluated the safety and efficacy of the coronary OAS to facilitate stent placement in de novo, severely calcified coronary lesions in 443 subjects (286 males and 157 females).