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J Am Coll Cardiol, 2005; 45:947-953, doi:10.1016/j.jacc.2004.09.079
© 2005 by the American College of Cardiology Foundation
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Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation

Andrew T.L. Ong, MBBS, FRACP, Angela Hoye, MBChB, MRCP, Jiro Aoki, MD, Carlos A.G. van Mieghem, MD, Gaston A. Rodriguez Granillo, MD, Karel Sonnenschein, Evelyn Regar, MD, PhD, Eugene P. McFadden, MBChB, MD, FRCPI, FACC, Georgios Sianos, MD, PhD, Willem J. van der Giessen, MD, PhD, Peter P.T. de Jaegere, MD, PhD, Pim de Feyter, MD, PhD, FACC, Ron T. van Domburg, PhD and Patrick W. Serruys, MD, PhD, FACC*

Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands

Manuscript received August 26, 2004; revised manuscript received September 23, 2004, accepted September 28, 2004.

* Reprint requests and correspondence: Dr. Patrick W. Serruys, Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015-GD Rotterdam, Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).

OBJECTIVES: We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation.

BACKGROUND: Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice.

METHODS: The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES.

RESULTS: In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST.

CONCLUSIONS: The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.

Abbreviations and Acronyms
  AMI = acute myocardial infarction
  BMS = bare-metal stents
  CI = confidence interval
  DES = drug-eluting stents
  MI = myocardial infarction
  OR = odds ratio
  PES = paclitaxel-eluting stents
  SES = sirolimus-eluting stents
  ST = stent thrombosis
  TIMI = Thrombolysis In Myocardial Infarction




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