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New England Journal of Medicine Publishes Abott Spirit IV Trial Results

The New England Journal of Medicine had published findings from Abbott's Spirit IV trial, one of the randomized clinical trials comparing two drug eluting stents, with 3,690 US based patients.

Reportedly, the published study results show that one year after a stenting procedure, patients treated with Abott’s Xience V Everolimus Eluting Coronary Stent System were less likely to have adverse events such as a heart attack, repeat procedure or cardiac death, compared to patients treated with a Taxus Express2 Paclitaxel-Eluting Coronary Stent System (Taxus).

Abott said that the Spirit IV trial also showed that patients treated with Xience V were considerably less likely to experience a blood clot (stent thrombosis) compared to patients treated with Taxus. The results were presented during the September 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference.

In the Spirit IV trial’s primary endpoint of target lesion failure (TLF), Xience V demonstrated a statistically superior 38% reduction compared to Taxus at one year. The trial also found that the one-year rate of blood clots with Xience V is among the lowest among any drug eluting stent.

According to the study, in a subgroup analysis of more than 1,100 patients with diabetes, who typically are sicker and have more challenging artery disease, Xience V demonstrated a numerically lower TLF rate compared to Taxus at one year. In the critical safety endpoint of stent thrombosis as presented during TCT 2009, Xience V demonstrated a 40% reduction compared to Taxus in patients with diabetes.

Separately, in a recent retrospective cost-effectiveness analysis of Spirit IV data, researchers found that the clinical benefits offered by Xience V translated into lower overall medical costs at one year after the stenting procedure.

According to the company, when costs not related to the original treated vessel (non-target-vessel-revascularization) were excluded, the one-year medical costs were approximately $450 lower with Xience V than Taxus. The Xience V and Taxus stents are competitively priced.

Dr Cohen, lead investigator of the Spirit IV cost-effectiveness analysis, said: “The cost-effectiveness analysis of Spirit IV shows that a stent designed to deliver outstanding clinical benefits can deliver economic benefits as well. Since the findings were derived from a multicenter, comparative trial with only clinical follow-up, these results may be generalizable to most US practice settings.”