Author + information
- Received August 26, 2004
- Revision received September 23, 2004
- Accepted September 28, 2004
- Published online March 15, 2005.
- 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* ()
- ↵*Reprint requests and correspondence:
Dr. Patrick W. Serruys, Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015-GD Rotterdam, Netherlands
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.
Supported by Erasmus Medical Center, Rotterdam, and by an unrestricted institutional grant from Cordis a Johnson and Johnson Company and Boston Scientific Corporation.
- Received August 26, 2004.
- Revision received September 23, 2004.
- Accepted September 28, 2004.
- American College of Cardiology Foundation