INFLUENCE OF GENDER ON IN-HOSPITAL CLINICAL AND ANGIOGRAPHIC OUTCOMESAND ON ONE-YEAR FOLLOW-UP IN THE NEW-APPROACHES-TO-CORONARY-INTERVENTION (NACI) REGISTRY

Higher complication rates and lower success rates for treatment of wom en compared with men have been reported in prior studies of coronary a ngioplasty and in most early reports of outcome with new coronary inte rventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. T hese results are reflected in the current guidelines for coronary angi oplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these diffe rences on the outcome of new-device interventions have not been adequa tely evaluated. This article evaluates the influence of gender on clin ical and angiographic characteristics, interventional procedure and co mplications, angiographic success, and clinical outcomes at hospital d ischarge and 1-year follow-vp, as observed in the New Approaches to Co ronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focu ses on the 90% of patients-975 women and 1,880 men-who had planned pro cedures with a single new device and also had angiographic core labora tory readings. Women compared with men were older, had more recent ons et of coronary ischemic pain that was more severe and unstable, and ha d more frequent histories of other adverse clinical conditions. The di stributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new- device intervention, with or without balloon angioplasty, was signific antly less in women (1.38 mm) than in men (1.53 mm; p < 0.001); this 0 .15 mm difference is consistent with the 0.16-mm smaller reference ves sel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Amon g procedural complications, only treatment for hypotension, blood tran sfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to e mergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on l eaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emerg ent CABG (1.5% vs 1.0%, for women and men, respectively) were not sign ificantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p <0.05) and length of hospital stay after device interventi on was longer (4.4 days vs 3.8 days in men; p <0.01). In both univaria te and multivariate analyses gender did not emerge as a significant va riable in relation to the combined endpoint, death, Q-wave MI, or emer gent CABG at hospital discharge. At 1-year follow-vp more women than m en reported improvement In angina (70% vs 62%) and fewer women than me n had had repeat revascularization (32% vs 36%). Similar proportions w ere alive and free of angina, Q-wave MI and repeat revascularization ( 46% of women vs 45% of men). Although several procedure-related compli cations were more frequent in women than men after coronary interventi ons with new devices, no important disadvantages were observed for wom en in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate t he complex interplay of clinical, vessel, and lesion characteristics o n success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gend er specific interventional strategies may be beneficial. (C) 1997 by E xcerpta Medico, Inc.