Elsevier

The Lancet

Volume 369, Issue 9562, 24 February–2 March 2007, Pages 667-678
The Lancet

Articles
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

https://doi.org/10.1016/S0140-6736(07)60314-6Get rights and content

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.

Introduction

Drug-eluting stents significantly reduce rates of restenosis and target lesion revascularisation compared with bare metal stent. Since the publication of pivotal randomised trials on the two DES approved by the US Food and Drug Administration (polymer-based sirolimus-eluting stents [SES] and polymer-based paclitaxel-eluting stents [PES]),1, 2, 3, 4 these devices have been widely used in the percutaneous treatment of coronary artery disease worldwide.5, 6, 7, 8 However, several pre-clinical and clinical safety concerns9, 10, 11, 12, 13, 14, 15 related to the use of drug-eluting stents have been expressed since then. One of the most important issues raised is stent thrombosis, a catastrophic, albeit infrequent, complication that results in abrupt coronary artery closure, which can lead to myocardial infarction or sudden cardiac death. This problem is not restricted to drug-eluting stents, and its incidence does not seem to exceed that seen with bare metal stents up to 1 year of follow-up.16, 17, 18, 19, 20, 21, 22 However, case reports and observational studies have noted that some patients develop stent thrombosis unusually late after implantation of drug-eluting stents.23, 24, 25

To date, no large-scale study has focused on late stent thrombosis later than 1 year after drug-eluting stent implantation. Although variables such as acute coronary syndromes, bifurcation stenting, diabetes, discontinuation of antiplatelet therapy, renal failure, and stent length seem to be consistently associated with overall stent thrombosis,19, 26, 27, 28 predictors specific for late stent thrombosis have not yet been identified. We therefore assessed all angiographically documented stent thrombosis following unrestricted use of SES and PES in routine clinical practice at two academic referral hospitals between April, 2002, and December, 2005. The purposes of this investigation were to: estimate the incidence and time course of stent thrombosis with drug-eluting stents in routine clinical practice; identify predictors of stent thrombosis; identify differences between early and late stent thrombosis; and assess differences between SES and PES.

Section snippets

Study group and design

Between April 16, 2002, and Dec 31, 2005, a total of 8146 consecutive patients underwent percutaneous coronary intervention with SES or PES at two academic referral hospitals in the Netherlands and Switzerland. 3823 patients were treated with SES (Cypher, Cordis Corporation, Johnson and Johnson, Warren, NJ, USA) and 4323 patients with PES (TAXUS, Express2, or Liberté, Boston Scientific, Natick, MA, USA). In the Dutch institution, SES have been used as a default strategy for PCI as part of the

Results

Between April, 2002, and December, 2005, 8146 patients underwent percutaneous coronary intervention with SES (3823 patients) or PES (4323 patients) at the two academic hospitals. Table 1 summarises clinical and procedural characteristics of the overall study population. Compared with patients treated with PES, those who received SES were more likely to have hypertension, a family history of coronary heart disease, dyslipidaemia, and diabetes, and were more frequently smokers. Left ventricular

Discussion

Our findings from a large cohort of patients with stent thrombosis after implantation of drug-eluting stents add to the evidence about late stent thrombosis23, 24, 25, 26, 27, 28, 35 with the following observations: stent thrombosis occurred with an incidence density of 1·3 per 100 person-years and a cumulative incidence of 2·9% at 3 years; the incidence of late stent thrombosis did not diminish, but continued at a steady rate of 0·6% per year during the first 3 years; acute coronary syndrome

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