Three-year results of safety and efficacy of the everolimus-eluting coronary stent in women (from the SPIRIT III randomized clinical trial).

Women treated with the XIENCE V have improved 1-year clinical outcomes compared to women treated with TAXUS; whether benefits in women are sustained at 3 years is unknown. Three-year follow-up of the SPIRIT III trial revealed improved clinical outcomes of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent. One thousand two patients with coronary artery lesions ≤28 mm in length in 2.5- to 3.75-mm diameter vessels were prospectively randomized to receive XIENCE V or TAXUS stents. A post hoc gender subset analysis was performed. Six hundred sixty-nine patients (30% women) received XIENCE V and 332 patients (34% women) received TAXUS. In the overall population, women had higher 3-year rates of major adverse cardiac events (16.0% vs 10.0%, p = 0.01) and target lesion revascularization (10.2% vs 5.3%, p = 0.008) compared to men. In women, those with XIENCE V continued to have lower major adverse cardiac event rates than those with TAXUS at 2 years (9.5% vs 18.3%, p = 0.03) and 3 years (12.2% vs 22.6%, p = 0.03). Although 1-year target vessel failure rates were similar, at 2- and 3-year follow-up women treated with XIENCE V had approximately 40% relative decreases in target vessel failure rates compared to those treated with TAXUS (12.7% vs 22.0%, p = 0.05; 16.0% vs 26.4%, p = 0.03, respectively). Stent thrombosis and bleeding complication rates were similar between treatment arms in the gender subgroups through 3 years. In conclusion, women in the SPIRIT III trial have sustained clinical benefits from XIENCE V implantation compared to TAXUS without increases in long-term complications.

RCT Entities:   Population Interventions Outcomes