Late thrombosis of paclitaxel-eluting stents: Long-term incidence, clinical consequences, and risk factors in a cohort of 604 patients
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 la...
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Published in | The American heart journal Vol. 155; no. 4; pp. 648 - 653 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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New York, NY
Mosby, Inc
01.04.2008
Elsevier Elsevier Limited |
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Abstract | 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. |
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AbstractList | BACKGROUNDLate 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.METHODSConsecutive patients (N = 604) who received > or = 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.RESULTSDuring 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.CONCLUSIONSLate 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. 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. Consecutive patients (N = 604) who received > or = 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. 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. 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. 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. 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. 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. 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. 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. |
Author | Marzoa-Rivas, Raquel, MD Salgado-Fernández, Jorge, MD Aldama-López, Guillermo, MD Flores-Ríos, Xacobe, MD Abugattás-de Torres, Juan Pablo, MD Castro-Beiras, Alfonso, MD, PhD Piñón-Esteban, Pablo, MD Vázquez-Rodríguez, José Manuel, MD Calviño-Santos, Ramón, MD Vázquez-González, Nicolás, MD |
Author_xml | – sequence: 1 fullname: Flores-Ríos, Xacobe, MD – sequence: 2 fullname: Marzoa-Rivas, Raquel, MD – sequence: 3 fullname: Abugattás-de Torres, Juan Pablo, MD – sequence: 4 fullname: Piñón-Esteban, Pablo, MD – sequence: 5 fullname: Aldama-López, Guillermo, MD – sequence: 6 fullname: Salgado-Fernández, Jorge, MD – sequence: 7 fullname: Calviño-Santos, Ramón, MD – sequence: 8 fullname: Vázquez-Rodríguez, José Manuel, MD – sequence: 9 fullname: Vázquez-González, Nicolás, MD – sequence: 10 fullname: Castro-Beiras, Alfonso, MD, PhD |
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Keywords | Antineoplastic agent Human Late Cardiovascular disease Epidemiology Long term Thrombosis Incidence Vascular disease Cohort study Risk factor Paclitaxel Circulatory system Cardiology Drug eluting stent |
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Snippet | Background Late thrombosis is the major safety concern of drug-eluting stents, but its incidence in common clinical practice remains controversial to date,... Late thrombosis is the major safety concern of drug-eluting stents, but its incidence in common clinical practice remains controversial to date, especially... BACKGROUNDLate thrombosis is the major safety concern of drug-eluting stents, but its incidence in common clinical practice remains controversial to date,... |
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SubjectTerms | 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 |
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Title | Late thrombosis of paclitaxel-eluting stents: Long-term incidence, clinical consequences, and risk factors in a cohort of 604 patients |
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