Late-breaking data from SPIRIT IV, a large-scale multi-center study of nearly 4,000 patients in the U.S., shows that an everolimus-eluting stent demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to a paclitaxel-eluting stent, and showed that "low late loss" may be achieved with drug-eluting stents without sacrificing safety.
Unlike similar prior studies (SPIRIT FIRST, SPIRIT II and SPIRIT III), the SPIRIT-IV trial was powered for superiority for clinical endpoints without angiographic follow up.
The trial also examined the differences in performance of the two stents in patients with diabetes.
"The results with the everolimus stent demonstrate enhanced safety and efficacy compared to the paclitaxel stent in this large-scale study without routine angiographic follow-up and sets a new standard for event-free survival after [implantation of a drug-eluting stent]," said principal investigator Gregg W. Stone, MD, immediate past chairman of CRF, professor of medicine at Columbia University Hospital and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center.
Results of the study were presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).
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 TLR at one year, and a composite of cardiac death or target vessel heart attack at one year.
For the everolimus stent, TLF at one year was 4.2 percent, and for the paclitaxel-eluting stent, TLF was 6.8 percent, a significant 38 percent reduction.
At one-year, ischemia-driven TLR was 2.5 percent for the everolimus stent and 4.6 percent for the paclitaxel stent, 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 the everolimus stent and 3.2 percent for the paclitaxel stent). The rates of stent thrombosis, however, were significantly reduced with the everolimus stent compared to the paclitaxel-eluting stent (0.3 percent vs. 1.1 percent respectively).
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, the everolimus stent reduced TLF by 53 percent compared to the paclitaxel-eluting stent.
"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 CRF and TCT
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.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field of interventional cardiology and vascular medicine.
Judy Romero | EurekAlert!
Further reports about: > CRF > Cardiovascular Research Foundation > Diabetes > Spirit > TCT > TLF > TLR7 > Therapeutics > Transcatheter Cardiovascular > cardiac death > cardiovascular disease > interventional cardiology > ischemia-driven target lesion revascularization > myocardial infarction > paclitaxel-eluting stent
Virtual Reality in Medicine: New Opportunities for Diagnostics and Surgical Planning
07.12.2016 | Universität Basel
3-D printed kidney phantoms aid nuclear medicine dosing calibration
06.12.2016 | Society of Nuclear Medicine
In recent years, lasers with ultrashort pulses (USP) down to the femtosecond range have become established on an industrial scale. They could advance some applications with the much-lauded “cold ablation” – if that meant they would then achieve more throughput. A new generation of process engineering that will address this issue in particular will be discussed at the “4th UKP Workshop – Ultrafast Laser Technology” in April 2017.
Even back in the 1990s, scientists were comparing materials processing with nanosecond, picosecond and femtosesecond pulses. The result was surprising:...
Have you ever wondered how you see the world? Vision is about photons of light, which are packets of energy, interacting with the atoms or molecules in what...
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...
In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.
“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...
The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.
The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...
16.11.2016 | Event News
01.11.2016 | Event News
14.10.2016 | Event News
07.12.2016 | Earth Sciences
07.12.2016 | Earth Sciences
07.12.2016 | Materials Sciences