Late thrombosis of paclitaxel-eluting stents: Long-term incidence, clinical consequences, and risk factors in a cohort of 604 patients

• Published in: The American heart journal Vol. 155; no. 4; pp. 648 - 653
• Main Authors: Flores-Ríos, Xacobe, MD, Marzoa-Rivas, Raquel, MD, Abugattás-de Torres, Juan Pablo, MD, Piñón-Esteban, Pablo, MD, Aldama-López, Guillermo, MD, Salgado-Fernández, Jorge, MD, Calviño-Santos, Ramón, MD, Vázquez-Rodríguez, José Manuel, MD, Vázquez-González, Nicolás, MD, Castro-Beiras, Alfonso, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.04.2008; Elsevier; Elsevier Limited
• Subjects: Aged; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular; Coronary Disease - mortality; Coronary Disease - therapy; Coronary Restenosis - epidemiology; Coronary Thrombosis - epidemiology; Drug Administration Schedule; Drug therapy; Drug Therapy, Combination; Drug-Eluting Stents - adverse effects; Female; Follow-Up Studies; Heart attacks; Humans; Incidence; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Myocardial Infarction - epidemiology; Paclitaxel - administration & dosage; Platelet Aggregation Inhibitors - therapeutic use; Risk Factors; Statistics, Nonparametric; Stents; Studies; Antineoplastic agent; Human; Late; Cardiovascular disease; Epidemiology; Long term; Thrombosis; Incidence; Vascular disease; Cohort study; Risk factor; Paclitaxel; Circulatory system; Cardiology; Drug eluting stent
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2007.11.027

Background Late thrombosis is the major safety concern of drug-eluting stents, but its incidence in common clinical practice remains controversial to date, especially beyond the first year after stent implantation. We sought to investigate the incidence, clinical consequences, and risk factors of late thrombosis after drug-eluting stent implantation. Methods Consecutive patients (N = 604) who received ≥1 paclitaxel-eluting stent(s) (PES) between June 2003 and February 2005 at our institution were enrolled. Clinical characteristics and major outcomes were reviewed to detect cases and predictors of late and very late definite PES thrombosis (LDT) of PES, as currently defined by the Academic Research Council. Results During long-term follow-up (median 34.3 months, IQR 8.6), 17 cases of LDT were noted (cumulative incidence 2.8%, 95% CI 1.7%-4.5%). Most of LDT were very late thromboses (14 cases, 82%). Late and very late definite PES thrombosis appeared at a steady rate (incidence density 1.1% patient-years). Late and very late definite PES thrombosis was related to a high risk of all-cause death (HR 3.2, 95% CI 1.3-7.9) and cardiac death (HR 6.0, 95% CI 2.3-15.6). Withdrawal of antiplatelet therapy, left ventricular ejection fraction, and average stent diameter per patient were independent predictors of LDT in multivariate analysis. Conclusions Late and very late definite PES thrombosis may be more frequent in a real setting than anticipated by initial experimental and observational studies but is keeping with more recent scientific evidence. It seems to occur at a constant rate during long-term follow-up and is associated with a high risk of overall and cardiac death.