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.
Judy Romero | EurekAlert!
Münster researchers make a fly’s heartbeat visible / Software automatically recognizes pulse
12.03.2018 | Westfälische Wilhelms-Universität Münster
3-D-written model to provide better understanding of cancer spread
05.03.2018 | Purdue University
An international team of researchers has discovered a new anti-cancer protein. The protein, called LHPP, prevents the uncontrolled proliferation of cancer cells in the liver. The researchers led by Prof. Michael N. Hall from the Biozentrum, University of Basel, report in “Nature” that LHPP can also serve as a biomarker for the diagnosis and prognosis of liver cancer.
The incidence of liver cancer, also known as hepatocellular carcinoma, is steadily increasing. In the last twenty years, the number of cases has almost doubled...
In just a few weeks from now, the Chinese space station Tiangong-1 will re-enter the Earth's atmosphere where it will to a large extent burn up. It is possible that some debris will reach the Earth's surface. Tiangong-1 is orbiting the Earth uncontrolled at a speed of approx. 29,000 km/h.Currently the prognosis relating to the time of impact currently lies within a window of several days. The scientists at Fraunhofer FHR have already been monitoring Tiangong-1 for a number of weeks with their TIRA system, one of the most powerful space observation radars in the world, with a view to supporting the German Space Situational Awareness Center and the ESA with their re-entry forecasts.
Following the loss of radio contact with Tiangong-1 in 2016 and due to the low orbital height, it is now inevitable that the Chinese space station will...
Fraunhofer Institute for Organic Electronics, Electron Beam and Plasma Technology FEP, provider of research and development services for OLED lighting solutions, announces the founding of the “OLED Licht Forum” and presents latest OLED design and lighting solutions during light+building, from March 18th – 23rd, 2018 in Frankfurt a.M./Germany, at booth no. F91 in Hall 4.0.
They are united in their passion for OLED (organic light emitting diodes) lighting with all of its unique facets and application possibilities. Thus experts in...
A new scenario seeking to explain how Mars' putative oceans came and went over the last 4 billion years implies that the oceans formed several hundred million...
For the first time, an interdisciplinary team from the University of Basel has succeeded in integrating artificial organelles into the cells of live zebrafish embryos. This innovative approach using artificial organelles as cellular implants offers new potential in treating a range of diseases, as the authors report in an article published in Nature Communications.
In the cells of higher organisms, organelles such as the nucleus or mitochondria perform a range of complex functions necessary for life. In the networks of...
19.03.2018 | Event News
16.03.2018 | Event News
13.03.2018 | Event News
22.03.2018 | Trade Fair News
22.03.2018 | Earth Sciences
22.03.2018 | Earth Sciences