News | May 07, 2010

SPIRIT IV Trial Results Confirm Everolimus Stent’s Superior Safety, Efficacy

May 7, 2010 – Findings from the SPIRIT IV trial, one of the largest randomized clinical trials comparing two drug eluting stents with 3,690 U.S.-based patients, were published this week in The New England Journal of Medicine. The results show that one year after a stenting procedure, patients treated with the Xience V everolimus-eluting coronary stent were significantly less likely to have a major adverse event such as a heart attack, repeat procedure or cardiac death, compared to patients treated with a Taxus Express2 paclitaxel-eluting coronary stent.

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. These results were originally presented during the September 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference.

The trial’s primary endpoint of target lesion failure (TLF), Xience V demonstrated a statistically superior 38 percent reduction compared to Taxus at one year (4.2 percent for Xience vs. 6.8 percent for Taxus). TLF is defined as a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR). The SPIRIT IV trial also found that the one-year rate of blood clots (stent thrombosis) with Xience V is among the lowest reported to date with any drug-eluting stent (0.29 percent per Academic Research Consortium definition of definite/probable stent thrombosis).

Data from Diabetics
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 (6.4 percent for Xience V vs. 6.9 percent for Taxus). In the critical safety endpoint of stent thrombosis as presented during TCT 2009, Xience V demonstrated a 40 percent reduction compared to TAXUS in patients with diabetes (per ARC definition of definite/probable stent thrombosis, 0.80 percent for Xience V vs. 1.33 percent for Taxus).

The Largest Stent Trial
"With more than 3 million stent procedures being performed annually worldwide, determining the safety and efficacy differences between various drug eluting stents has important implications for societal health," said Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center. He is the immediate past chairman of the Cardiovascular Research Foundation in New York and is the principal investigator of the SPIRIT IV trial. "With nearly 4,000 patients studied, SPIRIT IV represents the largest randomized trial of two drug eluting stents completed to date, and found that the everolimus-eluting stent significantly reduces a patient's risk of experiencing a heart attack, stent thrombosis, or the need for a repeat procedure within one year, compared to the paclitaxel-eluting stent. Based on these results, and results from the 1,800-patient COMPARE study conducted in the Netherlands, the everolimus-eluting stent has set a new standard for patient safety and efficacy."

Cost Analysis
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.

The SPIRIT IV cost-effectiveness analysis was presented by David Cohen, M.D., MSc, of St. Luke's Mid America Heart Institute in Kansas City, Mo., in March 2010 at the Optimizing PCI Outcomes symposium sponsored by the Cardiovascular Research Foundation. The analysis found that one-year total medical costs (initial hospitalization plus follow-up) were approximately $150 lower for patients treated with XIENCE V than those treated with Taxus. When costs not related to the original treated vessel (nontarget-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.

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

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