Comparison of Outcomes Using the Sirolimus-Eluting Stent in Calcified Versus Non-Calcified Native Coronary Lesions in Patients On- Versus Not On-Chronic Hemodialysis (from the j-Cypher Registry)

Abstract

The impact of lesion calcium on long-term outcomes after drug-eluting stent implantation has not been adequately addressed. In 10,595 patients (16,803 lesions) who were exclusively treated with sirolimus-eluting stents in the j-Cypher registry, 5-year outcomes were compared between patients with ≥1 lesion with moderate or severe calcification (the calcium group) and those with noncalcified lesions only (the noncalcium group). Analyses were stratified by hemodialysis (HD) status (non-HD stratum [calcium n = 3,191, noncalcium n = 6,824] and HD stratum [calcium n = 415, noncalcium n = 165]). Adjusted risk in the calcium group for death and target lesion revascularization was significant in the non-HD stratum (hazard ratio [HR] 1.34, 95% confidence interval [CI] 1.18 to 1.52, p <0.0001, and HR 1.2, 95% CI 1.07 to 1.36, p = 0.003) and the HD stratum (HR 1.4, 95% CI 1.06 to 1.86, p = 0.02, and HR 2.25, 95% CI 1.51 to 3.36, p <0.0001). Risk for definite stent thrombosis tended to be higher in the calcium group in the HD stratum (HR 5.05, 95% CI 0.66 to 38.9, p = 0.12) but not in then non-HD stratum (HR 1.16, 95% CI 0.81 to 1.67, p = 0.41). The use of rotational atherectomy in patients with severe calcification did not have a significant impact on the cumulative incidence of target lesion revascularization in the non-HD stratum (17.7% [n = 268] with vs 18.2% [n = 588] without rotational atherectomy, p = 0.68) and the HD stratum (54.7% [n = 115] with vs 51.9% [n = 118] without rotational atherectomy, p = 0.19). In conclusion, regardless of HD status, patients with calcified lesions have increased long-term risk for death and target lesion revascularization after sirolimus-eluting stent implantation.