New-Device Angioplasty in Women: Clinical Outcome and Predictors in a 7,372-Patient Registry

BACKGROUND: Female gender has been identified as an independent predictor of early complications and mortality after conventional balloon angioplasty. To gain insight into the outcome of women after new-device angioplasty, we reviewed the early and late clinical outcome of 7,372 patients undergoing new-device angioplasty between 1991 and 1996 at the Washington Hospital Center. METHODS: Patients (2,077 women and 5,295 men) with native coronary artery (82.5%) or saphenous vein graft lesions undergoing new-device angioplasty were included in the study. In-hospital and 1-year major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization (TLR), were recorded and compared on the basis of gender. Multivariable logistic regression analysis was performed to identify predictors of in-hospital and late mortality, follow-up MACE, and TLR. RESULTS: Women had more baseline comorbid risk factors and smaller reference vessel size compared with men. Women had a higher in-hospital cardiac mortality (1.39% vs 0.66%, P = 0.002), TLR (2.78% vs 1.81%, P = 0.008), and congestive heart failure (4.18% vs 2.29%, P < 0.001) compared with men. Overall in-hospital MACE tended to be higher among women (4.2% vs 3.3%, P = 0.074). Women had a higher 1-year mortality rate (4.39% vs 3.26%, P = 0.018), but a lower follow-up TLR (15.0% vs 18.1%, P = 0.001) and a lower overall MACE rate (29.2% vs 32.7%, P = 0.007) compared with men. Female gender was an independent predictor of in-hospital mortality (odds ratio 2.28, P = 0.02), but not late mortality. CONCLUSIONS: Although female gender appears to carry an inherent risk of in-hospital mortality after new-device angioplasty, the procedural success and mortality rates are favorable compared with those associated with balloon angioplasty series. The long-term clinical outcome of women after new-device angioplasty is excellent. The use of new devices is a safe and effective alternative strategy for the treatment of women with ischemic coronary artery disease. Device-specific outcomes, including stents, will require further evaluation.