Impact of Chronic Kidney Disease (CKD) and Hemodialysis on Treatment of Severely Calcified Lesions: The ECLIPSE Trial
Authors' conclusion
CKD remains a major predictor of adverse outcomes after DES implantation in severely calcified lesions, with the highest risks in patients on hemodialysis. In the ECLIPSE trial, higher two-year rates of TVF were observed after vessel preparation with OA compared with BA in patients on hemodialysis but not in patients with CKD not on hemodialysis or in those without CKD. Given the modest hemodialysis subgroup size and non-significant interaction testing, confirmation of these findings in additional studies is warranted.
Study context
- Population
- Patients with severely calcified lesions undergoing vessel preparation prior to drug-eluting stent (DES) implantationCKD (eGFR <60 mL/min/1.73m² or hemodialysis) in 694 (34.7%) patients, 112 required hemodialysis
- Participants
- 2,001 patients
- Comparison
- Orbital atherectomy (OA) versus balloon angioplasty (BA) prior to DES, according to CKD
- CKDn = 694 (34.7%)
- Hemodialysisn = 112
Methodological detailsrandomized
- Randomized
Primary result
As reported in the abstract
TVF (composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ID-TVR), with versus without CKD · Two-year
P < 0.001
Further findings
| Outcome | OA | BA | Adjusted HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Independent predictors of TVF · two-yearHemodialysisvs BA | 2.14 (1.30–3.53) | P = 0.003 | |||
| TVF in patients on hemodialysis · two-yearDriven by higher rates of TV-MI and ID-TVR | 52.3% | 30.7% | 2.50 (1.16–5.41) | P = 0.020 | |
| TVF in patients not on hemodialysis · two-year | 13.5% | 13.1% | 1.05 (0.81–1.35) | P = 0.730 | |
| 0.20.5125Adjusted hazard ratio (log scale) |
- Independent predictors of target-vessel failure (TVF) — Reduced eGFR alone did not independently predict TVF
- p=0.070
- TVF in patients on hemodialysis: interaction between treatment assignment and hemodialysis status not significant (Pint=0.244)
- TVF in patients not on hemodialysis: interaction between treatment assignment and hemodialysis status not significant (Pint=0.244)
Original publication
Impact of CKD and Hemodialysis on Treatment of Severely Calcified Lesions: The ECLIPSE Trial. Circ Cardiovasc Interv. Published 2 November 2026. doi:10.
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