Trial details
Patients enrolled in PREPARE-CALC had severely calcified coronary lesions according to angiographic criteria. For lesion preparation, half underwent high-speed rotational atherectomy (Rotablator), and half underwent treatment with either a cutting balloon (Flextome, Boston Scientific) or a scoring balloon (AngioSculpt, AngioScore, or Scoreflex, OrbusNeich Medical). Thereafter, all received sirolimus-eluting stents (Orsiro, Biotronik).
Results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation, showed that, compared with the modified balloons, rotational atherectomy yielded a higher rate of strategy success, defined as successful stent delivery and expansion with less than 20% in-stent residual stenosis and TIMI 3 flow, without crossover to the other arm or stent failure. The rotational atherectomy patients had a success rate of 98%, compared with 81% for the balloon patients (P = .0001).
“This difference was mainly driven by a high rate of crossovers from balloon to rotablation,” Dr. Richardt, noted, with 16% of patients assigned to the former modality ultimately receiving the latter. “These crossovers were due to noncrossable or nondilated lesions.”
Analyses suggested three subgroups did not benefit from rotational atherectomy when it came to strategy success: women, patients in whom the left anterior descending artery was the target, and patients not having type C lesions.
Quantitative coronary analysis showed that the acute lumen gain, whether in-stent or in-segment, did not differ significantly between the two preparation methods. “This is different from what we know from historical studies where the Rotablator was always achieving more acute gain than standard balloons,” Dr. Richardt commented.
Rotational atherectomy and modified balloons were similar with respect to the magnitude of in-stent late lumen loss (0.22 vs. 0.16 mm, P = .021 for superiority; P = .01 for noninferiority) and the rate of target-vessel failure (6% vs. 8%) at 9 months. Those failure rates were lower than the 10% expected from previous trials, he pointed out. “This might increase over time, but it’s not so far away from what we see in contemporary drug-eluting stent trials.”
Fluoroscopy time was about 4 minutes longer with rotational atherectomy than with modified balloons. “You may say that’s a lot. I would say in these 75-year-old patients, it is acceptable,” Dr. Richardt commented. “But to be honest, we had some cases where we had to place a pacemaker, and this increases the duration of the fluoroscopy time.”
The PREPARE-CALC findings should improve the rate of rotational atherectomy use in Europe, he said. “If you believe my data, then the rate should go up to 10% or 12%.”
Dr. Richardt disclosed that he receives speaker’s honoraria from Boston Scientific and Biotronik. The trial was sponsored by the Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH.