SAN FRANCISCO--Rotablation followed by implantation of a drug-eluting stent (DES) in patients with complex, calcified lesions was not superior to standard balloon angioplasty and reduced the stent’s efficacy, according to study results from the ROTAXUS trial released Nov. 11 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT). Nonetheless, the clinical trial’s study chair and panelists agreed that rotablation should continue to play a role in the treatment of complex, calcified patients.
“We treat more and more elderly patients with complex and severely calcified lesions,” said Gert Richardt, MD, PhD, of the Heart Center Segeberger Kliniken in Bad Segeberg, Germany. Severe calcification potentially can damage the coating on a DES, making the stent less effective. Rotablation, or rotational atherectomy, has been shown to be effective at debulking plaque and facilitating stenting, but little is known about rotablation combined with DES.
Richardt and colleagues designed the prospective randomized ROTAXUS trial to assess the feasibility of rotablation followed by stenting in patients with MI and complex calcified native coronary lesions. To be eligible, patients needed to have stable or unstable angina and coronary artery disease, de novo lesion on a native coronary artery, moderate to severe calcification and either ostial location, bifurcational lesion or a lesion greater than or equal to 15 mm.
The study enrolled 240 patients between August 2008 and March 2010 at three sites in Germany. They were randomized to a rotablation followed by stenting group (120 patients) or a standard therapy of stenting without prior rotablation (120 patients). Polymer-based slow-release paclitaxel-eluting stents were used in both groups. The primary endpoint of the trial was the in-stent late lumen loss at nine months, determined by follow-up angiography.
In-stent late lumen loss in the rotablation group was 0.44 mm at nine months compared with 0.31 mm in the standard therapy group. Angiographic success, which was defined as less than 20 percent residual stenosis and TIMI 3 flow grade, was “excellent in both groups, at more than 95 percent,” Richardt said.
"But at the primary endpoint [late lumen loss], things went the other way around,” he said. “The in-stent late lumen loss was lower in the control group than in the rotablation group. Clinical events at nine months showed no difference.”
He offered this recommendation to physicians: “Balloon dilation in addition to rotablation prior to stenting remains the default strategy for complex calcified patients in a DES era.”
Panel moderator Roxana Mehran, MD, director of cardiovascular research and interventional clinical trials at Mount Sinai Medical Center in New York City, stated at the beginning of the presentation, “We need to understand better the role of rotational atherectomy.”
At the conclusion, she reiterated that rotablation still is relevant as a treatment for severely calcified patients with complex morphologies, and may facilitate procedures.