Navigation Links
Results of the REMEDEE trial reported at TCT 2011
Date:11/11/2011

SAN FRANCISCO, CA NOVEMBER 11, 2011 A randomized comparison of a dual therapy stent which combines low-dose sirolimus delivery from an abluminal biodegradable polymer matrix with a covalently bound anti-CD34 antibody layer with a paclitaxel-eluting stent showed that the dual therapy stent effectively controls neointimal proliferation and was shown to be safe and effective. Results of the REMEDEE trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The REMEDEE trial was designed to demonstrate the safety and effectiveness of the new dual therapy stent compared to a clinically proven paclitaxel-eluting stent. The new stent is designed for control of neointimal proliferation as well as accelerated vessel healing. The trial was conducted among patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a single native coronary artery.

In the study, 183 patients were randomized at 17 sites in Australia (4), Belgium (2), Brazil (2), Germany (2), Hong Kong (1), Malaysia (2), Netherlands (2), and Singapore (2). Of all subjects enrolled, 124 subjects were placed in the dual therapy group and 59 in the paclitaxel-eluting group.

Major inclusion criteria included single de-novo lesions in native coronary arteries, lesion length ≤ 20 mm and a diameter of 2.5 mm to 3.5. Major exclusion criteria were acute myocardial infarction, ostial lesions and unprotected left main with ≥ 50% stenosis. Baseline patient characteristics included a mean age of 64.2 in the dual therapy group and 64.0 in the paclitaxel-eluting group; 71.8% male in the dual therapy group and 71.2% in the paclitaxel-eluting group. The mean number of lesions treated per patients was 1.1 in both groups.

The primary endpoint was angiographic in-stent late lumen loss at nine months post-procedure.

Secondary endpoints include the occurrence of death, myocardial infarction, stent thrombosis and clinically-driven revascularization reported as individual events and composites at the time of the procedure and post-procedure at 30 days, nine months, 12 months, and annually to five years.

In-stent late lumen loss at nine months for the dual therapy stent was a mean of .39 0.45 mm and .44 0.56 mm in the paclitaxel-eluting stent. At nine months, there were 1% deaths in the combo group, and 0% in the paclitaxel group. The rate of myocardial infarction at nine months was 2.4% in the combo group and 1.7% in the paclitaxel group. And, the rate of major adverse cardiac events (MACE) at nine months was 8.7% in the combo group and 11.0% in the paclitaxel group. Both groups had 0% stent thrombosis at nine months.

"In this first-in-man study, the dual therapy stent effectively controls neointimal proliferation," said lead researcher Michael Haude, MD. Dr Haude is Professor of Internal Medicine at Lukaskrankenhaus Neuss in Germany.

"There was an overall low rate of clinical events in both study groups, including no stent thrombosis. In-stent and in-segment late loss and binary restenosis rates are accordingly low and comparable to the paclitaxel-eluting stent. The dual therapy stent was shown to be safe and effective, as well as non-inferior to the paclitaxel-eluting stent," Dr. Haude said.


'/>"/>

Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

Related medicine news :

1. Lincare Holdings Inc. Announces Fourth Quarter and Year Ended 2009 Financial Results
2. SXC Health Solutions to Host Fiscal 2009 Fourth Quarter and Year End Results Conference Call
3. Team Health Holdings, Inc., Announces Fourth Quarter and Fiscal 2009 Financial Results
4. First blinded study of venous insufficiency prevalence in MS shows promising results
5. NEJM Publishes Trial Results Demonstrating Bard FLAIR Endovascular Stent Graft Is Superior To Balloon Angioplasty For Failing Dialysis Grafts
6. BioMed Realty Trust Reports Fourth Quarter and Full-Year 2009 Financial Results
7. Kaiser Foundation Health Plan and Hospitals Report Fourth Quarter and Fiscal Year 2009 Financial Results
8. United American Healthcare Corporation Announces Fiscal 2010 Second Quarter Results
9. Fitness Trend Towards Online Personal Training Gets Real-World Weight Loss Results on FitOrbit.com
10. Protein Sciences Corporation Announces Profitable and Cash Flow Positive Results for 2009 and Management Realignment
11. WebMD Announces Fourth Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: