Stent Thrombosis and Bleeding Complications After Implantation of Sirolimus-Eluting Coronary Stents in an Unselected Worldwide Population: A Report From the e-SELECT (Multi-Center Post-Market Surveillance) Registry

Study Questions:

What is the 1-year outcome of unselected patients treated with sirolimus-eluting stents (SES)?

Methods:

The authors reported the results of the eSELECT registry. This registry enrolled patients at 320 medical centers in 56 countries. The authors reported the results of 15,147 patients who underwent implantation of 23,492 SES for treatment of 19,988 lesions. One-year follow-up was available for 92% of the patients.

Results:

The average age of the cohort was 62 years and 30% had diabetes mellitus. Stent length ranged between 8 and 33 mm, and more than one stent was implanted in 38% of patients. Dual antiplatelet therapy was continued uninterrupted in 86.3% of patients. Stent thrombosis and major bleeding occurred in 1% of patients, respectively. The 1-year incidence of death was 1.7%, myocardial infarction occurred in 1.9%, and target lesion revascularization was required in 2.3%. All-cause mortality over the 1-year follow-up after stent thrombosis was 30% compared with 10% in patients with major bleeding. In the week following the event, the mortality was 30% in patients with stent thrombosis and 1.5% in those with major bleeding. Only two patients suffered both major bleeding and stent thrombosis and in both, the stent thrombosis followed discontinuation of dual antiplatelet therapy after major bleeding.

Conclusions:

The use of SES in a large unselected patient population is associated with a favorably low rate of adverse events at 1 year.

Perspective:

This study provides further confirmation of the remarkable clinical efficacy of the SES. It also provides robust data that would help physicians balance the risks of stent thrombosis versus bleeding. Although both the complications occurred in 1% of patients, stent thrombosis was associated with a much more grave prognosis with almost a third of patients dying within a week, while the immediate mortality associated with major bleeding was much lower. The minimum overlap between patients who developed major bleeding versus those who developed stent thrombosis invokes the need for further studies to identify patients who are at risk of one or the other complications so that targeted therapy can be used to best optimize patient outcomes.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Prognosis, Registries, Myocardial Infarction, Follow-Up Studies, Thrombosis, Sirolimus, Stents


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