Real World, Long‐Term Outcomes Comparison Between Paclitaxel‐Eluting and Sirolimus‐Eluting Stent Platforms

Abstract

We compare real-world, extended target vessel revascularization (TVR)-free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) following an index drug-eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES-supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in-hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan-Meier and Cox's proportional hazard survival methods were performed. TVR-free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan-Meier survival curves did not significantly differ (adjusted hazard ratio -1.39 [95% CI 0.99-1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3-97.6] vs. 95.7% for PES [95% CI 94.1-96.9]) and two (95.0%[95% CI 93.0-96.4] for SES vs. 93.7% for PES [95% CI 91.6-95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7-97.3) and 95.3% for PES (95% CI 93.7-96.5). SES and PES drug-eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI.

The Association of Diabetes Mellitus with Clinical Outcomes after Coronary Stenting: A Meta-Analysis

“…Fourth, due to the limited data available, we could not be able to further analyze the effect of DM on different type of DES, such as sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES). Several studies reported that the incidence of ISR and some other post-procedural complications are different between SES and PES [39], [40]. Fifth, there was a moderate publication bias in the analysis of DM and MACE (Egger's test: P  = 0.046), which indicates a bias of literature selection.…”

A Comparison of Drug-Eluting Stents versus Bare Metal Stents in Saphenous Vein Graft PCI Outcomes: A Meta-Analysis

“…Thirdly, previous studies have shown that sirolimus and paclitaxel DES platforms have similar efficacy and MACE outcomes in native coronary vessels. [38][39][40] However, our analysis cannot address whether sirolimuseluting stents (SES) and paclitaxel-eluting stents (PES) have similar outcome data when compared to BMS since many of the studies used in this analysis use both PES and SES and do not provide a separate analysis according to stent type used (see Table 1). Furthermore, there is currently a lack of clear data comparing everolimus-eluting stents (EES) and BMS outcomes in SVG or data related to newer generation DES platforms.…”

Long‐Term Outcomes after Drug‐Eluting Stent Implantation: Get Your Feet Wet in the Real‐World

“…Third, the global safety profiles of first‐generation DES are identical or even better than BMS with no difference in the overall risk of mortality. But finally, we learned something even more essential: Large real‐world registries (such as the Bern‐Rotterdam 2 or the Dartmouth Hospital Dynamic Registry published in this edition 3 ) still belong to the current armamentarium of clinical research and that only trials with long‐term follow‐up are able to detect and circumscribe rare problems, such as late stent thrombosis.…”

“…As several millions of DES have been implanted worldwide since 2002 (real‐world maximum follow‐up of >8 years), trials with long‐term outcomes are still warranted. In the present edition of the Journal of Interventional Cardiology, Brown, et al focused on clinical outcomes up to 28 months in 2,362 consecutive patients treated with first‐generation DES 3 …”

“…Several RCTs directly compared the PES with the SES in all-comers, but few studies report a clinical follow-up of longer than 1 year. Only Danish Organization on Randomized Trials With Clinical Outcome (SORT-OUT II-2,098 patients, maximum follow-up: 18 months), 4 TAXi (202 patients, maximum follow-up: 36 months) 5 and Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization (SirTax-1,012 patients, maximum followup: 60 months) 6 have reported such extended follow-up EDITORIAL 3 This registry used modern statistical techniques and adjusted for nine different variables using a propensity score and modeling Cox's proportional hazard. The overall number of patients included in the present trial makes it the fifth largest registry directly comparing PES to SES worldwide after STENT, 7 Evaluation of Drug Eluting Stents and Ischemic Events (EVENT), 8 Bern-Rotterdam, 2 and Western Denmark Heart Registry 9 and the second most important within the United States.…”