The two groups had statistically indistinguishable rates of clinical outcomes such as myocardial infarction, major adverse cardiovascular events, and death. The target lesion revascularization rate – a clinical indicator of restenosis – was about 12% in each group. There was only a single case of definite stent thrombosis, seen in the rotablation group.
"Rotablation and paclitaxel-eluting stent implantation was not superior to balloon dilatation and paclitaxel-eluting stent implantation in reducing the primary end point of late lumen loss at 9 months, indicating that rotablation does not increase the efficacy of drug-eluting stents in calcified lesions," he concluded.
The trial was sponsored by Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH. Dr. Richardt reported that he is a consultant to, is a speaker for, or receives honoraria from Abbott Vascular and Boston Scientific. Dr. Mehran reported that she receives research or grant support from Bristol-Myers Squibb and The Medicines Company; is a consultant to, is a speaker for, or receives honoraria from AstraZeneca and Ortho-McNeil; and receives other, noncategorized financial support from Abbott Vascular. Dr. Waksman reported that he has no relevant conflicts of interest.