Abstract 9000: Long-term Outcomes After Sirolimus-Eluting Stent Implantation for Calcified Coronary Lesions: Insights From the j-Cypher Registry

Abstract

Background: The long-term clinical outcomes of drug-eluting stents for calcified coronary lesions in patients with and without dialysis have not yet been adequately addressed. Methods: Among 10,717 patients (16,947 lesions) who were exclusively treated with sirolimus-eluting stents (SES) in the j-Cypher registry, 5-year clinical outcome was compared between patients with at least 1 lesion with moderate to severe calcification (Calc group), and patients with non-calcified (no to mild calcification) lesions only (Non-calc group). Analyses were made separately according to dialysis status (non-dialysis stratum [Calc group: 3208 patients, and Non-calc group: 6919 patients], and dialysis stratum [Calc group: 419 patients, and Non-calc group: 171 patients]. Results: Cumulative incidence of adjusted risk for 5-year mortality was significantly higher in the Calc group than in the Non-calc group in both non-dialysis stratum (13.5% versus 8.3%: P<0.0001, and hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.07-1.41, P=0.004) and dialysis stratum (49.4% versus 38.6%: P=0.016, and HR 1.53, CI 1.12-2.09, P=0.008). Regardless of dialysis status, the Calc group as compared with the Non-calc group had a significantly higher cumulative incidence of target lesion revascularization (TLR) (non-dialysis, 14.0% versus 11.2%, P<0.0001; dialysis, 33.4% versus 18.7%, P<0.0001) and major adverse cardiac events (MACE) (non-dialysis, 30.4% versus 22.9%, P<0.0001; dialysis, 69.2% versus 53.8%, P<0.0001). In non-dialysis stratum, the cumulative incidence of late TLR beyond 1 year was similar between the Calc and Non-calc groups (7.2% versus 7.0%, P=0.84). However, dialysis patients with calcified lesions had a significantly higher late TLR rate (17.2% versus 8.1%, P=0.014). Stent thrombosis was unrelated to both dialysis and calcification (non-dialysis, 1.5% versus 1.2%, P=0.23; dialysis, 2.6% versus 0.6%, P=0.076). Conclusion: Regardless of dialysis status, patients with calcified coronary artery lesions have an increased long-term risk for adverse events, such as mortality, TLR, and MACE, after SES implantation. Lesion calcification in dialysis patients was associated with higher risk for late TLR through 5 years.