Gender differences in outcomes after primary angioplasty versus primary stenting with and without abciximab for acute myocardial infarction - Results of the controlled abciximab and device investigation to lower late angioplasty complications (CADILLAC) trial

Background - Women with acute myocardial infarction ( AMI) undergoing primary angioplasty have higher rates of morbidity and mortality than do men. Whether contemporary interventional treatment strategies have improved outcomes for women compared with men is unknown. Methods and Results - In the CADILLAC trial, 2082 patients (27% women) with AMI within 12 hours of symptom onset were randomized to balloon angioplasty ( PTCA; n = 518), PTCA + abciximab ( n = 528), stenting ( n = 512), and stenting + abciximab ( n = 524). As compared with men, women had a lower body surface area; had a greater prevalence of diabetes, hypertension, and hyperlipidemia; experienced significant delays to treatment; and had better baseline and final TIMI grade 3 flows. Unadjusted 1-year event rates were higher for women, including death (7.6% versus 3.0%, P < 0.001), ischemic target-vessel revascularization (TVR; 16.7% versus 12.1%, P = 0.006), and major adverse cardiac events ( MACE; 23.9% versus 15.3%, P < 0.001). Female gender was an independent predictor of MACE and bleeding complications, although comorbid risk factors and body surface area but not gender predicted 1-year death. For women, primary stenting resulted in a reduction in 1-year MACE from 28.1% to 19.1% ( P = 0.01) and in ischemic TVR from 20.4% to 10.8% ( P = 0.002) compared with PTCA. The addition of abciximab to primary stenting significantly reduced the 30-day ischemic TVR without increasing bleeding or stroke rates. Conclusions - The higher mortality rate in women compared with men after interventional treatment for AMI may be explained by differences in body size and clinical risk factors, although female gender remains an important independent determinant of overall adverse outcomes. For women in the CADILLAC trial, the addition of abciximab reduced 30-day TVR without increasing bleeding risk, and primary stenting reduced 1-year TVR and MACE rates compared with PTCA.