Results from the SPIRIT IV clinical trial, which were first presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium, were published today in the New England Journal of Medicine.
Data from the trial, a large-scale multi-center study of nearly 4,000 patients in the U.S., showed that everolimus-eluting stents demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to paclitaxel-eluting stents. The trial, which was powered for superiority for clinical endpoints without angiographic follow up, also examined the differences in performance of the two stents in patients with diabetes.
"The data published in today's New England Journal of Medicine, and first reported at TCT, demonstrate enhanced safety and efficacy of the everolimus-eluting stent compared to the paclitaxel-eluting stent in this large-scale study without routine angiographic follow-up. The study results also suggest that minimal late loss may be achieved with drug-eluting stents without sacrificing safety," said principal investigator Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation.
The primary endpoint of the trial was target-lesion failure (TLF) at one year, a composite measure of cardiac death, target-vessel heart attack or ischemia-driven target-lesion revascularization (TLR). Major secondary endpoints of the trial were ischemia-driven TLR at one year, and the composite rate of cardiac death or target-vessel heart attack at one year.
For everolimus-eluting stents, TLF at one year was 4.2 percent, and for paclitaxel-eluting stents, TLF was 6.8 percent, a significant 38 percent reduction.
At one-year, ischemia-driven TLR was 2.5 percent for everolimus-eluting stents and 4.6 percent for paclitaxel-eluting stents, a significant 45 percent reduction.
The composite rates of cardiac death or target-vessel myocardial infarction through one year were not statistically different with the 2 stents (2.2 percent for everolimus-eluting stents and 3.2 percent for paclitaxel-eluting stents). The one-year rates of myocardial infarction and stent thrombosis, however, were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9 percent vs. 3.1 percent for myocardial infarction and 0.17 percent vs. 0.85 percent stent thrombosis.)
The results were consistent regardless of lesion length, vessel size and the number of lesions treated. However, in the diabetic-patient subgroup, the study found a comparable rate of TLF with both stents, whereas in patients without diabetes, everolimus-eluting stents reduced TLF by 53 percent compared to paclitaxel-eluting stents.
"Outcomes in patients with diabetes may still be improved, and should represent an area of focus for future development of novel drugs and enhanced stent design," Dr. Stone said.
About NewYork-Presbyterian Hospital
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,353 beds. The Hospital has more than 1 million inpatient and outpatient visits in a year, including more than 220,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian/The Allen Hospital and NewYork-Presbyterian Hospital/Westchester Division. One of the most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S. News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.
About Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine. For more information, please visit www.crf.org.
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