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). The rate of major adverse cardiac events (MACE) defined as a composite of myocardial infarction, target vessel revascularization, and cardiac death was evaluated in-hospital and 30-days postprocedure. For this analysis, the ORBIT II safety and efficacy results were stratified by gender.
Results: At baseline, females were significantly older than males and had a lower mean estimated glomerular filtration rate. Males had a higher rate of previous coronary artery bypass grafting and history of smoking. The rates of successful stent delivery and <50% residual stenosis were similar in males and females. In-hospital and 30-day MACE rates did not differ by gender.
Conclusions: Despite females being older, having smaller arteries, and more renal dysfunction, preparation of severely calcified coronary lesions with orbital atherectomy to facilitate stent deployment results in similar rates of in-hospital and 30-day MACE, irrespective of gender.
Keywords: clinical study; coronary artery disease; female; percutaneous coronary intervention; vascular calcification.
© 2015 Wiley Periodicals, Inc.