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EXPEDITED PUBLICATION

The Everolimus-Eluting Stent in Real-World Patients

6-Month Follow-Up of the X-SEARCH (Xience V Stent Evaluated at Rotterdam Cardiac Hospital) Registry

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands

Manuscript received February 26, 2009; revised manuscript received April 6, 2009, accepted May 13, 2009.

^_* Reprint requests and correspondence: Dr. Patrick W. Serruys, Thoraxcenter, Ba-583, 's Gravendijkwal 230, Rotterdam 3015 CE, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).

Objectives: The purpose of this study was to investigate the impact of everolimus-eluting stents (EES) in comparison with bare-metal stents (BMS), sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES) on the 6-month clinical outcomes in an all-comer population.

Background: EES have been shown to be effective in the context of randomized trials with selected patients. The effect of EES implantation in more complex, unselected patients cannot be directly extrapolated from these findings.

Methods: In total, 649 consecutive unselected patients treated exclusively with EES were enrolled. Six-month clinical end points were compared with 3 historical cohorts (BMS, n = 450; SES, n = 508; and PES, n = 576). Major adverse cardiac events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, or target vessel revascularization (TVR).

Results: The patients treated with EES were older, presented more frequently with acute myocardial infarction, and had more complicated lesions than the other groups. The EES group demonstrated a higher incidence of all-cause mortality than the SES group and a lower incidence of TVR than the BMS group. Multivariate adjustment demonstrated that BMS was associated with higher TVR and MACE risk than EES (adjusted hazard ratio [HR] for TVR: 2.02 [95% confidence interval (CI): 1.11 to 3.67]; adjusted HR for MACE: 2.15 [95% CI: 1.36 to 3.42]); that SES had a clinical outcome similar to that of EES, and that PES had a higher risk of MACE than did EES (adjusted HR: 1.57 [95% CI: 1.02 to 2.44]).

Conclusions: This study suggests that the use of EES in an unselected population may be as safe as and more effective than BMS, may be as safe and effective as SES, may be as safe as PES, and may be more effective than PES.

Key Words: everolimus-eluting stent • all-comer registry • sirolimus-eluting stent • paclitaxel-eluting stent

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   EES = everolimus-eluting stent(s)   HR = hazard ratio   MACE = major adverse cardiac event(s)   MI = myocardial infarction   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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