November 11, 2011 (San Francisco, California) — Rotational atherectomy prior to the implantation of a drug-eluting stent (DES) failed to have any impact on in-stent late lumen loss in elderly patients with calcified lesions, according to the results of a new study.

Presenting the results of ROTAXUS today at TCT 2011, lead investigator Dr Gert Richardt (Segeberger Kliniken, Germany) noted the results of the study "went the other way around," with patients treated with the paclitaxel-eluting stent (Taxus, Boston Scientific) alone having less in-stent late lumen loss than those treated with atherectomy prior to receiving the paclitaxel stent. Although he concluded by stating that rotational atherectomy does not increase the efficacy of drug-eluting stents in calcified lesions, he, as well as others, stressed that provisional atherectomy still has a role in patients with complex, calcified lesions and remains useful as a bailout strategy for lesions that cannot be crossed or dilated.

"We did not include the most complex patients [in ROTAXUS]," said Richardt during a morning press conference announcing the results. "Maybe if we treated a group of patients even more complex than in this study we would show a benefit of the rotablator."

The ROTAXUS study included 240 patients with stable or unstable angina and coronary artery disease. The primary angiographic inclusion criteria included treatment of a lesion in a native coronary artery with moderate to severe calcification. The primary end point of the study--in-stent late lumen loss at nine months--was 0.44 mm in the atherectomy/paclitaxel-stent arm and 0.31 mm in patients who received the paclitaxel-eluting stent alone. There was no difference in any clinical end points at nine months.

Despite the negative results, Dr Roxana Mehran (Mount Sinai School of Medicine, New York), who was not involved in the trial, stressed that rotational atherectomy still plays a role in clinical practice. "It's important to note that rotational atherectomy still does have a place in our armamentarium, but it would be in the very severely calcified lesions or complex morphologies that would make our procedures easier."


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