Dr. Lorenz Raber
Dr. Jean Fajadet,
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List of Authors: Lorenz Räber, MD, Michael Magro, MD, Giulio G. Stefanini, MD, Bindu Kalesan, MD, Ron T. van Domburg, PhD, Peter Wenaweser, MD, Joost Daemen, MD PhD, Yoshinobu Onuma, MD, Bernhard Meier, MD, Peter Jüni, MD, Patrick W. Serruys, MD PhD, Stephan Windecker, MD
Background: Early generation drug-eluting stents (DES) releasing sirolimus (SES) or paclitaxel (PES) are associated with an increased risk of very late stent thrombosis (VLST). It is unknown whether the risk of VLST persists with newer generation DES releasing everolimus (EES). Methods: A cohort of 12,339 patients treated with the unrestricted use of DES (3,819 SES, 4,308 PES, 4,212 EES) at two academic institutions between 2002 and 2009 were followed for a median of 2.9 years. The primary endpoint was ARC definite ST through 4 years. Results are reported as cumulative incidence per 100 person-years (CIR) and hazards are weighted using inverse probability of treatment weight to adjust for group differences. Results: During follow-up to 4 years, the overall CIR of definite ST was lower with EES (1.4%) compared with SES (2.9%, hazard ratio (HR) 0.41, 95% CI 0.27-0.62, p<0.0001) and PES (4.4%, HR 0.33, 95% CI 0.23-0.48, p<0.0001). The CIR of early, late, and VLST amounted to 0.6%, 0.1%, and 0.6% among EES, 1.0%, 0.3%, and 1.6% among SES, and 1.3%, 0.7%, and 2.4% among PES treated patients, respectively. Differences in favour of EES were most pronounced during the very late period with a 67% (EES vs SES p=0.006) and 76% (EES vs PES p<0.0001) risk reduction, respectively. There was a trend towards a lower risk of cardiac death or MI with EES compared with SES (HR 0.88, 95%CI 0.75-1.02, p=0.09) and a significant reduction with EES compared with PES (HR 0.67, 95% CI 0.58-0.77, p<0.0001), which was directly related to the lower risk of ST associated events (EES vs. SES: HR 0.46, 95% CI 0.26-0.81, EES vs. PES: HR 0.36, 95% CI 0.23-0.57). The Kaplan-Meier curves show the cumulative incidence of definite ST up to 4 years. EES in blue, SES in red, and PES in green, respectively. P values are from using Cox proportional hazards models.
Conclusions: Newer generation EES reduce the risk of definite ST compared with early generation DES during long-term follow-up. The near elimination of VLST with the unrestricted use of EES overcomes the principal limitation of early generation DES and constitutes an important advance in DES safety.
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Jean Fajadet (France)Presentation webcastPresentation slides
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