- Question
- In patients with severely calcified coronary lesions, is orbital atherectomy before drug-eluting stent implantation superior to a balloon angioplasty-based strategy?
- Design
- Multicentre, open-label randomised trial (104 centres in the USA) with 1:1 allocation and intention-to-treat analysis. A total of 2005 patients with 2492 lesions were randomised; an optical coherence tomography (OCT) imaging cohort provided the stent area endpoint.
- Population
- Adults (≥18 years) with severely calcified coronary lesions that operators judged eligible for both lesion preparation strategies. Median age was 70.0 years and 27.0% were female.
- Intervention
- Lesion preparation with orbital atherectomy before drug-eluting stent implantation.
- Control
- Lesion preparation with balloon angioplasty before drug-eluting stent implantation.
- Primary outcome
- Two coprimary endpoints: target vessel failure at 1 year (composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation) and post-procedural minimal stent area at the site of maximal calcification, assessed by OCT in an imaging cohort.
- Results
- One-year target vessel failure was 11.5% with orbital atherectomy and 10.0% with balloon angioplasty (HR 1.16; 96% CI 0.87 to 1.54; p=0.28). Minimal stent area was 7.67 mm² with atherectomy and 7.42 mm² with balloon (mean difference 0.26; 99% CI -0.31 to 0.82; p=0.078).
- Safety
- One-year cardiac death occurred in 39 of 1008 patients with orbital atherectomy and in 26 of 997 with balloon angioplasty.
- Conclusion
- Routine orbital atherectomy did not increase minimal stent area or reduce 1-year target vessel failure compared with a balloon-based strategy.
- Why it matters
- It supports a balloon-first approach, guided by intravascular imaging, for most calcified lesions that can be crossed and dilated, reserving calcium ablation techniques for selected cases.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026