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

SAN FRANCISCO, CA NOVEMBER 11, 2011 A clinical trial testing the efficacy of rotational atherectomy (or rotablation, a process of drilling through plaque deposits) prior to implantation of a drug-eluting stent found that the process was not superior to standard balloon angioplasty and decreased the efficacy of the stent in reducing new tissue growth within the blood vessel.

Results of the ROTAXUS (A Prospective, Randomized Trial of High-Speed Rotational Atherectomy Prior to Paclitaxel-Eluting Stent Implantation in Complex Calcified Coronary Lesions) trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

Drug-eluting stents (DES) are liberally used in complex lesions and patients. Heavily calcified stenoses have not been adequately studied, and form a challenge for immediate and late outcomes. Rotational atherectomy has been shown to effectively modify calcified plaques and facilitate stent delivery and expansion. However, in the DES era, data concerning rotational atherectomy are scarce. In patients with complex calcified lesions, rotablation followed by DES seems a rational combination, but is not supported by randomized studies.

ROTAXUS is a randomized active-controlled superiority trial in patients with documented myocardial ischemia and complex calcified native coronary lesions. Eligible patients who met all clinical and angiographic inclusion criteria and gave written informed consent were randomized 1:1 to a strategy of rotablation followed by stenting, or stenting without prior rotablation (standard therapy). Stenting was performed using the polymer-based slow-release paclitaxel-eluting stent. The primary endpoint of the trial was the in-stent late lumen loss at nine months as measured by follow-up angiography.

240 patients with complex calcified coronary artery disease were enrolled at three investigator sites in Germany, and were assigned to be treated with rotablation followed by stenting (n=120) or stenting without rotablation (n=120).

At nine months, in-stent late lumen loss in the rotablation group was 0.44 mm and 0.31 mm in the standard therapy group. The rotablation group performed better than the standard therapy group in some areas, including acute lumen gain and strategy success (i.e. angiographic success without stent loss or cross-over).

"The superior acute gain obtained by rotablation counterbalanced the increased late loss resulting in a neutral effect on restenosis," said Gert Richardt, MD, PhD, the Study Chair. Dr. Richardt is a Professor at the Heart Center, Segeberger Kliniken in Germany.

"Rotablation remains an important bail-out device for uncrossable or undilatable coronary lesions but does not improve efficacy of DES in complex calcified lesions." Dr. Richardt said.


'/>"/>

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

Related medicine news :

1. Results of the ADVISE trial reported at TCT 2011
2. Results of the COBRA trial reported at TCT 2011
3. Results of the PROFI study reported at TCT 2011
4. Results of the EVOLVE trial reported at TCT 2011
5. Results of the REMEDEE trial reported at TCT 2011
6. Results of the NEXT clinical trial Reported at TCT 2011
7. Results of the PEPCAD-DES trial reported at TCT 2011
8. Results of the STACCATO Trial reported at TCT 2011
9. Results of the DEB-AMI Trial reported at TCT 2011
10. Results of the RIFLE STEACS clinical trial reported at TCT 2011
11. Results of the PARTNER Trial Cohort B 2-year follow up presented at TCT 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... ... 24, 2016 , ... The Haute Beauty Network, affiliated with ... as a prominent plastic surgeon and the network’s newest partner. , Dr. ... handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands by ...
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: