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:11/24/2015)... ... November 24, 2015 , ... It takes only three to ... it is critical that the first impression be positive and reflects business values. If ... to buy anything or want to return. They will also share their thoughts about ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... In response ... growing epidemic as deaths from prescription opioids in the United States grew 400 percent ... In 2013 alone, opioids were involved in 37 percent of all fatal drug overdoses. ...
(Date:11/24/2015)... ... November 24, 2015 , ... The American Association of ... local poison centers through donations on Tuesday, Dec. 1, 2015. Since 2012, the ... that inspires people to collaborate in improving their local communities and help give ...
(Date:11/24/2015)... ... ... With Thanksgiving right around the corner, holiday travel season is about to ... and vehicle. , According to the National Highway Traffic Safety Administration, 301 people were ... following safety tips from the NHTSA: , Inspect ...
(Date:11/24/2015)... ... November 24, 2015 , ... Abington ... an Aetna Institute of Quality® Bariatric Surgery Facility for treating individuals living with ... of health care services available to its members to help them make informed ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , Nov. 24, 2015 Avery Biomedical Devices ... pleased to announce the appointment of Anders Jonzon ... Dr. Jonzon is ... at Children,s Hospital, Uppsala University, Uppsala and Children,s Hospital, ... he was a fellow at the Cardiovascular Institute (UCSF). ...
(Date:11/24/2015)... , November 24, 2015 ... --> adds Latest Guidebook for ... of 217 pages published in November 2015 to ... online business intelligence library at . ... of the fastest growing global economies with a ...
(Date:11/24/2015)... 24, 2015  Ascendant Solutions, Inc. (Pink Sheets: ASDS ... of Directors has declared a special 1 percent stock dividend ... payable December 14, 2015, to shareholders of record December 7, ... additional shares of common stock. --> ... a strong endorsement of our confidence in Ascendant,s growth strategy ...
Breaking Medicine Technology: