Impact of CKD and Hemodialysis on Treatment of Severely Calcified Lesions: The ECLIPSE Trial

Background: Chronic kidney disease (CKD) and coronary calcification increase risk for adverse events following drug-eluting stent (DES) implantation. We evaluated whether outcomes following vessel preparation with orbital atherectomy (OA) versus balloon angioplasty (BA) vary according to CKD. Methods: This pre-specified CKD sub-analysis of the prospective, multicenter ECLIPSE trial evaluated 2,001 patients with severely calcified lesions randomized to OA versus BA prior to DES. Independent predictors of two-year target-vessel failure (TVF)—a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target-vessel revascularization (ID-TVR)—were determined using multivariable Cox proportional hazards modeling. Results: CKD (eGFR <60 mL/min/1.73m² or hemodialysis) was present in 694 (34.7%) patients; 112 required hemodialysis. Two-year TVF was significantly higher with versus without CKD (21.2% vs. 11.6%; p<0.001), driven by increased cardiac death and ID-TVR. Hemodialysis independently predicted TVF (adjusted HR 2.14, 95% CI 1.30-3.53; p=0.003), whereas reduced eGFR alone did not (p=0.070). In patients on hemodialysis, OA versus BA was associated with higher rates of TVF (52.3% vs. 30.7%; adjusted HR 2.50, 95% CI 1.16–5.41; P=0.020), driven by higher rates of TV-MI and ID-TVR, whereas TVF was similar after OA versus BA in patients not on hemodialysis (13.5% vs. 13.1%; adjusted HR 1.05, 95% CI 0.81–1.35; P=0.730); however, the interaction between treatment assignment and hemodialysis status was not significant (Pint=0.244). Conclusions: 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.