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We previously reported that the incidence of 1-year major adverse cardiac events (MACE) in patients treated with paclitaxel-eluting stents (PES) was lower than that in the sirolimus-eluting stents, mainly due to reduction of target lesion revascularization (TLR) in dialysis patients. However, it is unclear whether there are differences in clinical outcomes between everolimus-eluting stents (EES) and PES in dialysis patients.
Between February 2010 and September 2013, 248 maintenance dialysis patients were treated with coronary stents. In this study, 102 maintenance dialysis patients with 135 lesions treated with EES were compared to 107 maintenance dialysis patients with 147 lesions treated with PES. Of these, 60 patients were prospectively randomized to either EES (32 patients) or PES (28 patients) between March 2011 and September 2013. Angiographic and 1-year clinical outcomes were investigated.
Diabetes mellitus (DM) was present in 64.7% in the EES group and 71.0% in the PES group (p=0.33). Dialysis period was 6.4 ± 6.3 years vs 6.2 ± 5.9 years respectively (p=0.77). Heavy calcification was in 27.4% vs 34.0% (p=0.23). In-stent restenosis lesion was in 14.1% vs 10.9% (p=0.42). There were no significant differences in reference diameter (2.62 ± 0.64mm vs 2.66 ± 0.60mm, p=0.52) and lesion length (15.0 ± 12.2mm vs 16.5 ± 11.4mm, p=0.29). Rotational atherectomy was undergone in 11.1% vs 23.1% (p<0.01). Total stented length was not significantly different (23.5 ± 14.6mm vs 24.4 ± 13.2mm, p=0.60). One patient in the EES group was lost to follow up. Angiographic follow-up was obtained in 73.3% vs 74.8% (p=0.77). Restenosis rate was not significantly different (18.2% vs 13.6%, p=0.37). At 12 months, MACE occurred in 13.2% in the EES group and 17.4% in the PES group (p=0.25). TLR was observed in 9.5% vs 10.4% respectively (p=0.77). Mortality was 11.8% vs 13.1% (p=0.35). Cardiac death was 5.0% vs 7.7% (p=0.09). Definite stent thrombosis was observed in 2.0% vs 0% (p=0.14). Subgroup analysis in patients with DM revealed no significant differences in MACE (12.7% vs 14.9%, p=0.36), TLR (8.3% vs 7.4%, p=0.42), mortality (13.7% vs 13.2%, p=0.28), and cardiac death (6.3% vs 8.0%, p=0.15) between the two groups. Subgroup analysis in randomized patients showed no significant differences in MACE (9.4% vs 18.4%, p=0.39), TLR (3.3% vs 12.0%, p=0.17), mortality (6.3% vs 14.3%, p=0.20), and cardiac death (6.3% vs 7.3%, p=0.90).
One-year clinical outcomes following EES and PES implantations are similar in dialysis patients.