Rotational Atherectomy, Lithotripsy, or Laser for Calcified Coronary Stenosis: The ROLLER COASTR-EPIC22 Trial.
Summary
In the first randomized 3-arm comparison of plaque-modification strategies for calcified lesions, IVL was noninferior to RA for OCT-assessed stent expansion, whereas ELCA did not meet noninferiority. Minimum stent area, procedural success, and complications were similar, with numerically fewer complications in IVL.
Key Findings
- IVL met noninferiority vs RA for OCT-measured stent expansion; ELCA did not meet noninferiority.
- Minimum stent area, procedural success, and complication rates were similar across arms, with numerically fewer complications in IVL.
- Trial enrolled 171 patients with predominantly severe calcification (82.5%) across CCS and ACS presentations.
Clinical Implications
For heavily calcified lesions, IVL can be considered an alternative to RA to achieve adequate stent expansion; ELCA may be reserved given failure to meet noninferiority.
Why It Matters
Directly informs device selection in calcified PCI, an area with procedural risk and uncertainty, by providing randomized evidence across three commonly used techniques.
Limitations
- Modest sample size limits power for clinical endpoints and subgroup analyses
- Noninferiority margin selection and device-specific operator experience may influence outcomes
Future Directions
Larger pragmatic trials powered for clinical outcomes and stratified by calcium severity, vessel size, and combination strategies (e.g., RA+IVL).
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial directly comparing three plaque modification strategies
- Study Design
- OTHER