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Prior percutaneous coronary intervention (PCI) studies have shown the risk of perforation, dissection, access-site complications, and restenosis is higher in women than in men. Females tend to have narrower, more tortuous vessels and more comorbidities at the time of revascularization. As women are often under-represented in PCI trials, gender sub-analyses are warranted. Potential gender differences in terms of 3-year outcomes were assessed in this post-hoc analysis of the ORBIT II study.
The ORBIT II study evaluated the safety and efficacy of the Coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions prior to stent placement and enrolled 443 subjects (286 males and 157 females) in the U.S. The OAS utilizes an eccentrically mounted diamond-coated crown which expands radially via centrifugal force, resulting in the differential sanding of calcified plaque. The major adverse cardiac event (MACE) rate was defined as cardiac death, target vessel revascularization, and myocardial infarction (CK-MB > 3X ULN).
Females were significantly older than males and female population had lower mean eGFR, lower rate of prior coronary artery bypass grafting, and fewer current or former smokers. Procedural success was similar irrespective of gender; however the severe dissection rate was higher in females (6.4% vs 1.7%, p=0.01). The cumulative event rates though 3 years are shown in Figure.
The 3-year MACE rate was similar in males and females in the ORBIT II study. Further studies are needed to better understand the impact of gender on calcific coronary artery disease treatment.