ROTAXUS: Rotablation Does Not Improve Stenting Results in Calcified Lesions

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SAN FRANCISCO, CA—Rotational atherectomy does not increase efficacy of drug-eluting stents (DES) in complex calcified lesions compared with standard balloon dilatation, according to data presented November 11, 2011, at the Transcatheter Cardiovascular Therapeutics scientific symposium. In fact, the early angiographic gain is more than offset by late loss.

For the prospective multicenter ROTAXUS trial, Gert Richardt, MD, PhD, of Herzzentrum (Bad Segeberg, Germany), and colleagues randomized 240 patients with moderate to severe calcification in a de novo coronary lesion to high-speed rotablation (n = 120) or standard balloon angioplasty (n = 120) followed by paclitaxel-eluting stent implantation.

Better Results with Balloon

At 9 months, the control arm had less in-stent late lumen loss, the primary endpoint, than the atherectomy arm (0.31 mm vs. 0.44 mm; P = 0.01). QCA data showed similar results but no significant difference in MLD, percent diameter stenosis, or binary restenosis between the 2 arms (figure 1).

Nine-month rates of death, MI, TVR, TLR, MACE (composite of death, MI, or TVR), and definite stent thrombosis did not differ between the 2 groups (table 1).

Table 1. ROTAXUS: 9-Month Clinical Outcomes

“The superior acute gain obtained by rotablation was counterbalanced by an increased late loss resulting in a neutral effect on restenosis,” Dr. Richardt concluded. “Nevertheless, rotablation is useful. I suggest that balloon dilatation with provisional rotablation prior to stenting remain the default strategy for complex calcified lesions even in the DES era.”

Taxus Performed Better Than Expected

Despite the investigators’ hypothesis that rotational atherectomy would be more beneficial than balloon angioplasty for this patient group, Sorin J. Brener, MD, of Weill Cornell Medical College (New York, NY), told TCTMD in an interview that he was not surprised by results indicating the opposite.

“They found out that the late loss was less with balloon angioplasty, and we’ve known this now for a while. The damage caused inside the vessel can incite more restenosis,” he said. “What’s surprising is the very low late loss for the balloon arm, which is lower than you would expect for Taxus, particularly in such complex lesions.”

Dr. Brenner noted the higher rate of angiographic procedural success in the atherectomy arm with no crossover or stent loss (92.5% vs. 83.3%; P = 0.03). “This means that there are cases where you need to do [rotational atherectomy just to] finish the procedure, not because you get better long-term results,” he said.

“[However,] rotational atherectomy is an art that is disappearing. [Fewer and fewer] people are actually comfortable doing it,” Dr. Brener observed.

Study Details

Baseline characteristics were similar between the 2 arms except for a higher rate of hypertension in the rotablation group (89.1% vs. 79.8%; P = 0.05). Rotablation patients also had longer lesions (20.6 ± 9.3 mm vs. 18.5 ± 9.2 mm; P = 0.04) and were more likely to have grade B2/C lesions (93.8% vs. 86.3%; P = 0.03).

The control group received predilatation with higher balloon pressure (15.8 ± 4.9 atm vs. 13.6 ± 5.1 atm; P = 0.04). Procedure duration (66.4 ± 44.5 min vs. 57.4 ± 34.5 min; P = 0.05) and fluoroscopy time (22.8 ± 21.9 min vs. 18.1 ± 16.7 min; P = 0.04) were both slightly longer with rotablation.

 

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Source:
Richardt G. ROTAXUS: A prospective, randomized trial of high-speed rotational atherectomy prior to paclitaxel-eluting stent implantation in complex calcified coronary lesions. Presented at: Transcatheter Cardiovascular Therapeutics 2011; November 11, 2011; San Francisco, CA.