Navigation Links
SPIRIT IV trial shows everolimus stent sets new standard for event-free survival
Date:9/23/2009

SAN FRANCISCO, CA SEPTEMBER 23, 2009 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.


'/>"/>

Contact: Judy Romero
jromero@crf.org
347-407-2774
Cardiovascular Research Foundation
Source:Eurekalert

Related medicine news :

1. Boston Scientific PROMUS(R) and First-Generation TAXUS(R) Express(R) Stents Continue Excellent Performance in SPIRIT III Trial
2. The Celebrate Wellness Expo Presents Motivational Speaker & Author Dr. Robin L. Smith and Spiritual Teacher & Author Rev. Michael Bernard Beckwith
3. ColorAlchemy Hosts YouTube Mini-workshop Video About How Light and the Color Green Instantly Helps Balance Mind, Body, and Spirit
4. Honor Spirit and Memory of a Special Pet During National Pet Memorial Month
5. Atlanta Cosmetic Plastic Surgeon Thomas Lintner, MD Renewing Bodies and Spirits for New Moms with a Mommy Makeover
6. Spirituality and Medicine: Can the Two Walk Together?
7. Spiritual Outlook Can Affect Mental Health in Breast Cancer
8. Wounded Warrior Project (WWP) Seeks to Provide Mind, Body and Spirit Healing for Combat Stress
9. Provocative New Nonfiction Addresses Spiritual Destiny
10. 2009 ISSSEEM Conference to Have Deepak Chopra Discuss Bridging Science and Spirit
11. Abbott Initiates Trial of Next-Generation XIENCE PRIME(TM) Drug Eluting Stent, Building Upon Superior Outcomes from SPIRIT Family of Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. ... magazine’s Code Talker Award, an essay contest in which patients and their families pay ... be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the upcoming 2016 Miss Arizona pageant as its official Medspa Sponsor. Dr. Josh ... Mesa, and Chandler, Arizona. , Dr. Olson says the decision to support ...
(Date:6/24/2016)... New York (PRWEB) , ... June 24, 2016 , ... ... marijuana patients optimize the ingestion of their medication by matching users with high quality ... users to compare pieces with no commitment. , Inhale was founded by two brothers, ...
(Date:6/23/2016)... Angeles, CA (PRWEB) , ... June 23, 2016 , ... ... conducted that may expose a possible link between head and neck cancer in individuals ... participating in the study were evaluated based on whether they had gum disease, brushed ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology: