Coronary disease & ACSRandomised controlled trial
Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial
- Randomised controlled trial
- multicentre
- open-label
Authors' conclusion
Routine treatment with orbital atherectomy before drug-eluting stent implantation did not increase minimal stent area or reduce the rate of target vessel failure at 1 year compared with a balloon angioplasty-based approach in severely calcified lesions deemed eligible for both treatment strategies.
Study context
- Population
- Adults with severely calcified coronary lesions eligible for both strategies, 104 US centres
- Participants
- 2,005 adults · 2,492 lesions
- Comparison
- Orbital atherectomy vs balloon angioplasty before DES implantation
- Orbital atherectomyn = 1,008
- Balloon angioplastyn = 997reference
- Primary endpoint
- Coprimary: target vessel failure (cardiac death, target vessel MI or ischaemia-driven target vessel revascularisation); post-procedural minimal stent area at maximal calcification by OCT (imaging cohort)
- Follow-up
- 1 year
Primary result
As reported in the abstract
Target vessel failure
Each group vs balloon angioplastyAbsolute difference (96% CI)
Orbital atherectomy
1.5%(−1.4 to 4.4)
Each group vs balloon angioplastyHazard ratio (96% CI)P value
Orbital atherectomy
1.16(0.87–1.54)
P = 0.28Further findings
Mean, mm²
| Outcome | Orbital atherectomy | Balloon angioplasty | mean difference (99% CI) | P value | |
|---|---|---|---|---|---|
| Minimal stent area at maximal calcification (OCT substudy; coprimary) | 7.67 (SD 2.27) | 7.42 (SD 2.54) | 0.26 (−0.31 to 0.82) | P = 0.078 | |
| −0.500.51Difference (linear scale) |
events
| Outcome | Orbital atherectomy | Balloon angioplasty | Estimate | P value |
|---|---|---|---|---|
| Cardiac death · 1 year | 39 | 26 |
- Minimal stent area at maximal calcification (OCT substudy; coprimary): 276 vs 279 patients in OCT substudy
Original publication
Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial. Lancet. Published 30 March 2025. doi:10.1016/s0140-6736(25)00450-7
Summarised from the published abstract; every number is checked against it