Abstract 17162: Early and Late Stent Thrombosis are Associated with Long-Term Cardiac Mortality: Results from Pooled PROTECT Trials
Background: Trials of coronary stents have indicated high mortality risks associated with stent thrombosis (ST), but there have been few adequately powered studies with prospective late follow-up.
Methods: The Patient-Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT) randomized 8709 subjects to either Endeavor zotarolimus-eluting or Cypher sirolimus-eluting stents, and the PROTECT Continued Access Trial enrolled 1018 patients treated with Endeavor zotarolimus-eluting stents in the U.S. and Canada. Subjects in each were consented for 5 years of follow-up and completed 4 and 3 year follow-up to date respectively. The primary endpoint was ARC definite and probable ST. All potential ST events were stratified by time from index procedure: early (≤30 days), late (>30 and ≤360 days) and very late (>360 days). Baseline characteristics and rates of death and myocardial infarction (MI) were analyzed according to time of ST.
Results: The median follow up was 4.1 years. There were 184 ST events: 61 early (0.6%), 27 late (0.3%) and 96 very late (1.0%). Patient characteristics were similar between groups. There was no difference in DAPT use at discharge (97%) or 1 year follow-up (84%). The combined rate of cardiac death and MI did not differ according to time of ST; however, early ST was associated with acute cardiac death (34% vs 0% (late ST) vs 9.4% (very late ST); p<0.001; Figure). ST at any time point was associated with substantial cumulative cardiac mortality (51%, 19% and 24%; p<0.001). The relationship between timing of ST and clinical outcomes did not differ between stent types.
Conclusions: In this analysis of prospective trial data, acute cardiac death occurred more frequently in patients with early ST, while subsequent mortality remained high regardless of ST timing. While ST remains an uncommon event, continued efforts to determine how to reduce ST are warranted. Updated analysis with PROTECT Trial 5 year follow-up will be available at time of presentation.
Author Disclosures: E.A. Secemsky: None. P. Steg: Research Grant; Significant; Sanofi, Servier. Honoraria; Modest; Amarin, Bayer, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Lilly, Merck, Pfizer, The Medicines Company, Vivus. Honoraria; Significant; AstraZeneca, Sanofi, Servier. Ownership Interest; Significant; Aterovax. Consultant/Advisory Board; Modest; Novartis, Otsuka. E. Camenzind: None. W. Wijns: Research Grant; Modest; Medtronic, Cordis J&J, Boston Scientific, Biosensors, Terumo, MI-CELL, Pfizer, Boehringer Ingelheim, Abbott Vascular, Astra Zeneca, Biotronik, Cardio3 BioSciences, St Jude. Ownership Interest; Modest; Genae Inc. Ownership Interest; Significant; Cardio3BioSciences, Argonauts. E. McFadden: Consultant/Advisory Board; Modest; Abbott Vascular. Consultant/Advisory Board; Significant; Medtronic. L. Mauri: Research Grant; Significant; Abbott, Medtronic, Boston Scientific, Cordis, Eli Lilly, Daiichi Sankyo, Bristol Myers Squibb, sanofi-aventis. Consultant/Advisory Board; Modest; Biotronik, Medtronic.
- © 2014 by American Heart Association, Inc.