Three-Year Results of Safety and Efficacy of the Everolimus-Eluting Coronary Stent in Women (from the SPIRIT III Randomized Clinical Trial)
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文摘
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.

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