Abbott's SPIRIT IV trial results published in The New England Journal of Medicine

Findings from Abbott's SPIRIT IV trial, one of the largest randomized clinical trials comparing two drug eluting stents, with 3,690 U.S.-based patients, were published today in The New England Journal of Medicine. The published study results show that one year after a stenting procedure, patients treated with Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System 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 System (TAXUS). 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.

In the SPIRIT IV 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 V vs. 6.8 percent for TAXUS,>

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,>

"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; immediate past chairman of the Cardiovascular Research Foundation in New York; and 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."

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, 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, 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 (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.

"The cost-effectiveness analysis of SPIRIT IV shows that a stent designed to deliver outstanding clinical benefits can deliver economic benefits as well," said Dr. 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."

"The SPIRIT IV data, published today in The New England Journal of Medicine, have changed clinical practice as more and more physicians around the world have embraced the XIENCE V drug eluting stent. With the additional SPIRIT IV cost-effectiveness analysis, we have observed favorable economic data based upon the strong clinical results. These findings should prove valuable as hospitals evaluate different treatment options for coronary artery disease patients," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.