Navigation Links
Results of the ROTAXUS trial reported at TCT 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
Cardiovascular Research Foundation

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:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of ... award to iHire in recognition of their exemplary accomplishments in worksite health promotion. , ... Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... CHAPEL HILL, N.C. , June 24, 2016 ... in healthcare decisions and regulators/payers have placed more ... this new environment, patient support programs in the ... support for patients, medications. Consequently, pharmaceutical companies are ... to ensure they are providing products and services ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
(Date:6/24/2016)... ANDOVER, Mass. and SAN CLEMENTE, Calif. ... California -based mobile pulmonary function testing company, is now ... portable PFT devices developed by ndd Medical Technologies , Inc. ... PFT testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ... CA , can get any needed testing done in the ...
Breaking Medicine Technology: