Five-Year Clinical and Angiographic Outcomes of a Randomized Comparison of Sirolimus-Eluting and Paclitaxel-Eluting Stents

Abstract

Background-Long-term comparative data of first-generation drug-eluting stents are scarce. We investigated clinical and angiographic outcomes of sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) at 5 years as part of the Pϭ0.29). Between 1 and 5 years, the annual rate of target lesion revascularization was 2.0% (95% confidence interval, 1.4% to 2.6%) for SES and 1.4% (95% confidence interval, 0.9% to 2.0%) for PES. Among patients undergoing paired angiography at 8 months and 5 years, delayed lumen loss amounted to 0.37Ϯ0.73 mm for SES and 0.29Ϯ0.59 mm for PES (Pϭ0.32). The overall rate of definite stent thrombosis was 4.6% for SES and 4.1% for PES (Pϭ0.74), and very late definite stent thrombosis occurred at an annual rate of 0.65% (95% confidence interval, 0.40% to 0.90%). Conclusions-Long-term follow-up of first-generation drug-eluting stents shows no significant differences in clinical and angiographic outcomes between SES and PES. The continuous increase in late lumen loss in conjunction with the ongoing risk of very late stent thrombosis suggests that vascular healing remains incomplete up to 5 years after implantation of first-generation drug-eluting stents. Clinical Trial Registration-http://www.clinicaltrials.gov.

Long-term comparison of everolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for percutaneous coronary intervention of saphenous vein grafts

“…Although rates of target lesion revascularisation during the first year in the present study were very much comparable to those observed following treatment of native coronary artery lesions, recurrent ischaemia related to the stented segment became increasingly apparent at a later time, suggesting a considerable lack of long-term efficacy. Specifically, annual rates of TLR between the first and fourth year of follow-up were 50 to 70% higher compared with annual rates previously reported in the context of native coronary artery disease 16 . Therefore, SVG lesions continue to represent an important lesion subset with inadequate efficacy following the use of newergeneration DES.…”

“…Similarly, in the Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent (DELAYED RRISC) study 15 , rates of MACE amounted to 58% among SES-treated patients at a median follow-up of 32 months. These figures contrast with rates of MACE in the range of 20% among unselected patients enrolled in all-comers studies with the predominant treatment of native coronary artery lesions [16][17][18] .…”

Long‐term (8 year) outcomes and predictors of major adverse cardiac events after full metal jacket drug‐eluting stent implantation

“…However, a 5-year follow-up showed no differences in clinical and angiographic outcomes between the two DES [12]. In our study, there was no difference in target lesion revascularization between sirolimus-and paclitaxel-eluting stents (21.0% vs. 16.4% at 8 years, respectively, Log rank P ¼ 0.654), supporting a late catch-up phenomenon of sirolimus-eluting stents.…”

Long time clinical outcomes of limus-eluting stent versus paclitaxel-eluting stent in patients undergoing percutaneous coronary artery intervention: A meta-analysis of randomized controlled clinical trials

“…There were 3 trials [14][15][16] Table 2). Most trials addressed the method for sequence generation and allocation concealment.…”