Abbott Laboratories and its shareholders must be all giddy with excitement now that the results of the SPIRIT IV trial were just published in the latest New England Journal of Medicine. The study compared the performance of Abbott’s XIENCE V drug eluting stent to that of the TAXUS Express2 stent by Boston Scientific, and found that the XIENCE V resulted in lower risk of post-implantation complications over the TAXUS stent. Additionally, the study found that the XIENCE V resulted in overall lower medical costs at one year after surgery.
From the abstract:
Methods We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization).
Results Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80).
Conclusions Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different.
Abstract in NEJM: Everolimus-Eluting versus Paclitaxel-Eluting Stents in Coronary Artery Disease
Press release: The New England Journal of Medicine Publication of SPIRIT IV Trial Results Confirm Superior Safety and Efficacy of Abbott’s XIENCE V® Drug Eluting Stent Compared to TAXUS…
Product page: XIENCE V…
Flashback: FDA Approves Abbott’s Everolimus Eluting Stent