Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study

• Published in: The Lancet (British edition) Vol. 369; no. 9562; pp. 667 - 678
• Main Authors: Daemen, Joost, MD, Wenaweser, Peter, MD, Tsuchida, Keiichi, MD, Abrecht, Linda, MD, Vaina, Sophia, MD, Morger, Cyrill, MD, Kukreja, Neville, MBBS, Jüni, Peter, MD, Sianos, Georgios, MD, Hellige, Gerrit, MD, van Domburg, Ron T, PhD, Hess, Otto M, Prof, Boersma, Eric, PhD, Meier, Bernhard, Prof, Windecker, Stephan, Prof, Serruys, Patrick W, Prof
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 24.02.2007; Elsevier Limited
• Subjects: Angioplasty, Balloon, Coronary; Anti-Bacterial Agents - therapeutic use; Cohort Studies; Coronary Thrombosis - complications; Coronary Thrombosis - etiology; Coronary Thrombosis - prevention & control; Female; Heart attacks; Hospitals; Humans; Internal Medicine; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Paclitaxel - therapeutic use; Radiation therapy; Randomized Controlled Trials as Topic; Sirolimus - therapeutic use; Stents; Stents - adverse effects; Survival Analysis; Thromboembolism; Time Factors
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(07)60314-6

Summary Background Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents. Methods Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents (SES; n=3823) or paclitaxel-eluting stents (PES; n=4323) at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early (0–30 days) and late (>30 days) stent thrombosis and between SES and PES. Findings Angiographically documented stent thrombosis occurred in 152 patients (incidence density 1·3 per 100 person-years; cumulative incidence at 3 years 2·9%). Early stent thrombosis was noted in 91 (60%) patients, and late stent thrombosis in 61 (40%) patients. Late stent thrombosis occurred steadily at a constant rate of 0·6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES (1·1%) and PES (1·3%), but late stent thrombosis was more frequent with PES (1·8%) than with SES (1·4%; p=0·031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients (p<0·0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation (hazard ratio 2·28, 95% CI 1·29–4·03) and diabetes (2·03, 1·07–3·83). Interpretation Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.