Gender and Devices

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No gender-based comparisons were made in the earlier randomized clinical trials comparing bare metal stent (BMS) with balloon angioplasty. Restenosis and revascularization rates were not well defined for women after BMS because of the small sample of women in prospective trials with systematic angio-graphic follow-up. Even though women tend to have smaller vessel size and higher prevalence of diabetes, initially there were intriguing studies reporting that women had similar or lower rates of target vessel revascularization (TVR) than their male counterparts after PCI.22,23 However, with systematic angiographic and clinical follow-up, these reports have not been validated.

In the era of drug-eluting stents (DES), both siroli-mus- and taxus-eluting stents have shown favorable outcomes in women. Both the SIRIUS trial and the TAXUS IV trial demonstrated DES superiority, with reduction in restenosis, TVR, and major adverse cardiac events at 1 year follow-up in women and men.24,25 In TAXUS IV, 1314 patients with severe coronary artery stenosis were randomized to pacli-taxel stent versus BMS. Women comprised 27.9% of the study population. Restenosis rates were similar in women and men treated with TAXUS stent (7.6% vs. 8.6%; P = .80), as was late loss (0.23 vs. 0.22 mm; P = .90).25 Compared to women receiving BMS stents, those receiving TAXUS stents had a significant reduction in 9-month restenosis (29.2% vs. 8.6%; P < .001) and 1-year target lesion revascularization (TLR; 14.9% vs. 7.6%; P = .02).25 Of note, women had a higher unadjusted TLR rate than men at 1 year; however, female gender was not an independent predictor of TLR (odds ratio [OR] = 1.72; 95% CI: 0.68 to 4.37; P = .25).25 In the SIRIUS study, 1058 patients with severe coronary artery stenosis were randomized to sirolimus stent versus BMS. A total of 305 women were enrolled in the trial. The rate of TLR in women randomized to DES was 3.4%, compared with 16.5% in BMS group (P < .001).24 In men, the rate of TLR was 4.4% in the sirolimus group and 16.6% in the BMS group (P < .001).24 In summary, restenosis and revascularization rates are similar between women and men and appear to be directly related to smaller vessel size, body surface area, and incidence of diabetes.

Few gender-based studies exist on the efficacy of directional coronary atherectomy (DCA). However, DCA appears to be associated with lower procedural success and more bleeding complications in women.26 Likewise, large devices such as Excimer laser angio-plasty also appear to be associated with a higher morbidity rate in women, with higher coronary perforation rates.26 No gender-specific data exist on rotational atherectomy, cutting balloon angioplasty, extraction atherectomy, or gamma brachytherapy.

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