ArticlesEarly and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study
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
References (56)
- et al.
The unrestricted use of paclitaxel- versus sirolimus-eluting stents for coronary artery disease in an unselected population: one-year results of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry
J Am Coll Cardiol
(2005) - et al.
Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk
J Am Coll Cardiol
(2006) - et al.
Late complications following the deployment of drug eluting stents
Int J Cardiol
(2006) - et al.
Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project
J Am Coll Cardiol
(2006) - et al.
Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction
J Am Coll Cardiol
(2005) - et al.
A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents
Lancet
(2004) - et al.
Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies
J Am Coll Cardiol
(2005) - et al.
Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation
J Am Coll Cardiol
(2005) - et al.
What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention? A meta-analysis
J Am Coll Cardiol
(2005) - et al.
Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy
Lancet
(2004)
Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes: insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry
J Am Coll Cardiol
ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina)
J Am Coll Cardiol
Late angiographic stent thrombosis (LAST) events with drug-eluting stents
J Am Coll Cardiol
Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings
J Am Coll Cardiol
Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up
Am J Cardiol
Survival of patients with diabetes and multivessel coronary artery disease after surgical or percutaneous coronary revascularization: results of a large regional prospective study
J Am Coll Cardiol
Potential mechanisms promoting restenosis in diabetic patients
J Am Coll Cardiol
Stent thrombosis is associated with an impaired response to antiplatelet therapy
J Am Coll Cardiol
Clopidogrel effect on platelet reactivity in patients with stent thrombosis: results of the CREST Study
J Am Coll Cardiol
Catastrophic outcomes of noncardiac surgery soon after coronary stenting
J Am Coll Cardiol
A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization
N Engl J Med
Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery
N Engl J Med
A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease
N Engl J Med
Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial
Jama
Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization
N Engl J Med
Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the “real world”: the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry
Circulation
Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial (BASKET)
Lancet
Pathology of acute and chronic coronary stenting in humans
Circulation
Cited by (1610)
Long-Term Percutaneous Coronary Intervention Outcomes in Chronic Versus Acute Coronary Syndromes (TARGET All Comers Trial)
2024, American Journal of CardiologyNatural history of coronary stents: 14 year follow-up of drug eluting stents versus bare metal stents
2023, Indian Heart Journal