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). 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.

Carotid ultrasound identifies high risk subclinical atherosclerosis in adults with low framingham risk scores.

BACKGROUND: Worldwide, cardiovascular (CV) disease remains the most common cause of morbidity and mortality. Although effective in predicting CV risk in select populations, the Framingham risk score (FRS) fails to identify many young individuals who experience premature CV events. Accordingly, the aim of this study was to determine the prevalence of high-risk carotid intima-media thickness (CIMT) or plaque, a marker of atherosclerosis and predictor of CV events, in young asymptomatic individuals with low and intermediate FRS (<2% annualized event rate) using the carotid ultrasound protocol recommended by the American Society of Echocardiography and the Society of Vascular Medicine. METHODS: Individuals aged < or = 65 years not taking statins and without diabetes mellitus or histories of coronary artery disease underwent CIMT and plaque examination for primary prevention. Clinical variables including lipid values, family history of premature coronary artery disease, and FRS and subsequent pharmacotherapy recommendations were retrospectively collected for statistical analysis. RESULTS: Of 441 subjects (mean age, 49.7 + or - 7.9 years), 184 (42%; 95% confidence interval, 37.3%-46.5%) had high-risk carotid ultrasound findings (CIMT > or = 75th percentile adjusted for age, gender, and race or presence of plaque). Of those with the lowest FRS of < or =5% (n = 336) (mean age, 48.0 + or - 7.6 years; mean FRS, 2.5 + or - 1.5%), 127 (38%; 95% confidence interval, 32.6%-43.0%) had high-risk carotid ultrasound findings. For individuals with FRS < or = 5% and high-risk carotid ultrasound findings (n = 127; mean age, 47.3 + or - 8.1 years; mean FRS, 2.5 + or - 1.5%), lipid-lowering therapy was recommended by their treating physicians in 77 (61%). CONCLUSIONS: Thirty-eight percent of asymptomatic young to middle-aged individuals with FRS < or = 5% have abnormal carotid ultrasound findings associated with increased risk for CV events. Pharmacologic therapy for CV prevention was recommended in the majority of these individuals. The lack of radiation exposure, relatively low cost, and ability to detect early-stage atherosclerosis suggest that carotid ultrasound for CIMT and plaque detection should continue to be explored as a primary tool for CV risk stratification in young to middle-aged adults with low FRS.