High-speed rotational atherectomy in coronary artery calcification: The randomized ROTAXUS and PREPARE-CALC trials
Insights
High-speed rotational atherectomy (RA) improves strategy success for coronary artery calcification (CAC) lesion preparation. While RA shows excellent 9-month clinical outcomes, it is linked to increased in-stent late lumen loss and longer procedure times.
Area of Science:
- Cardiovascular Interventions
- Interventional Cardiology
- Medical Device Technology
Background:
- Coronary artery calcification (CAC) poses challenges for percutaneous coronary intervention.
- High-speed rotational atherectomy (RA) is a technique used to optimize lesion preparation in calcified coronary lesions.
- Previous trials have investigated the clinical outcomes of RA in CAC.
Purpose of the Study:
- To evaluate the safety and efficacy of RA for lesion preparation in patients with CAC.
- To compare the outcomes of RA versus conventional methods for treating calcified coronary lesions.
Main Methods:
- A pooled analysis of patient data from the ROTAXUS and PREPARE-CALC trials was performed.
- The study included 440 patients, randomized into RA and control groups (220 each).
- Primary endpoints included in-stent late lumen loss and major adverse cardiac events at 9 months. Secondary endpoints comprised in-segment late lumen loss, binary restenosis, strategy success, procedural duration, and contrast volume.
Main Results:
- The RA group demonstrated significantly higher strategy success rates (95.0% vs. 82.3%, p < 0.0001) with fewer crossovers compared to the control group (2.3% vs. 14.1%, p < 0.0001).
- 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 (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) and in-segment late lumen loss (0.28 ± 0.66 mm vs. 0.17 ± 0.55 mm, p = 0.05) were comparable between groups, with no significant difference in binary restenosis or contrast volume.
Conclusions:
- Upfront RA is a feasible strategy for lesion preparation in CAC prior to drug-eluting stent implantation.
- RA is associated with improved strategy success and excellent 9-month clinical outcomes.
- The benefits of RA must be weighed against increased in-stent late lumen loss and longer procedural duration.
Background:
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.
Aims:
This study was conducted to evaluate the safety and efficacy of RA for CAC.
Methods:
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.
Results:
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.
Conclusion:
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.
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