High-speed rotational atherectomy in coronary artery calcification: The randomized ROTAXUS and PREPARE-CALC trials.

Abstract

The clinical outcomes of high-speed rotational atherectomy (RA) to optimize target lesion preparation in coronary artery calcification (CAC) have been examined in several trials. This study was conducted to evaluate the safety and efficacy of RA for CAC. Patient data were pooled from ROTAXUS and PREPARE-CALC. The primary endpoint was the in-stent late lumen loss and major adverse cardiac events at 9 months. Secondary endpoints included in-segment late lumen loss, binary restenosis, strategy success, procedural duration, and contrast amount. Four hundred and forty patients were enrolled from Germany in this study, 220 patients were randomized to the RA group and 220 patients were randomized to the Control group. Despite similar baseline characteristics, significantly more patients in the Control group were crossover (14.1% vs. 2.3%, p < 0.0001), resulting in higher strategy success in the RA group (95.0% vs. 82.3%, p < 0.0001). At 9 months, in-stent late lumen loss was higher in the RA group (0.34 ± 0.52 mm vs. 0.24 ± 0.47 mm, p = 0.03) and procedural duration was longer in the RA group (76.3 ± 41.8 min vs. 67.0 ± 38.8 min, p = 0.02). major adverse cardiac events (17.8% vs. 25.2%, p = 0.06), in-segment late lumen loss (0.28 ± 0.66 mm vs. 0.17 ± 0.55 mm, p = 0.05), binary restenosis (7.3% vs. 8.2%, p = 0.71 in-stent; 7.7% vs. 9.0%, p = 0.62 in-segment), and contrast amount (215.5 ± 112.5 ml vs. 203.7 ± 96.5 ml, p = 0.24) were similar in both groups. Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in CAC, is more strategy successful, and is associated with excessive in-stent late lumen loss and excellent clinical outcomes at 9 months although longer procedural duration.