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
Novel PET tracer identifies most bacterial infections
06.10.2017 | Society of Nuclear Medicine and Molecular Imaging
Teleoperating robots with virtual reality
05.10.2017 | Massachusetts Institute of Technology, CSAIL
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.
It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...
17.10.2017 | Event News
10.10.2017 | Event News
10.10.2017 | Event News
20.10.2017 | Information Technology
20.10.2017 | Materials Sciences
20.10.2017 | Interdisciplinary Research