Abbott Vascular's Xience V Shows Sustained Benefit in Women at 3 Years in SPIRIT III

February 8, 2011—Vivian G. Ng, MD, et al published 3-year follow-up data from the SPIRIT III trial online ahead of print in the American Journal of Cardiology. The investigators found that the Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) demonstrated improved clinical outcomes compared to the Taxus Express² paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA). Gregg W. Stone, MD, is principal investigator of SPIRIT III, which is sponsored by Abbott Vascular.

In SPIRIT III, 1,002 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 Express² stents. A post hoc gender subset analysis was performed. One-year clinical outcomes have shown that women treated with the Xience V had improved outcomes compared to women treated with Taxus Express², and these follow-up data would determine if this benefit was sustained at a longer term.

The investigators reported that 669 patients (30% women) received Xience V and 332 patients (34% women) received Taxus Express². In the overall population, women had higher 3-year rates of major adverse cardiac events (16% vs 10%; P = .01) and target lesion revascularization (10.2% vs 5.3%; P = .008) compared to men. Women treated with Xience V continued to have lower major adverse cardiac event rates than women treated with Taxus Express² at 2 years (9.5% vs 18.3%; P = .03) and 3 years (12.2% vs 22.6%; P = .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 Express² (12.7% vs 22%; P = .05; 16% vs 26.4%; P = .03, respectively). Stent thrombosis and bleeding complication rates were similar between treatment arms in the gender subgroups through 3 years.

The investigators concluded that women in the SPIRIT III trial have sustained clinical benefits from Xience V implantation compared to Taxus Express² without increases in long-term complications.