Drug-eluting stent thrombosis in routine clinical practice two-year outcomes and predictors from the Taxus arrive registries

John M. Lasala, David A. Cox, David Dobies, Kenneth Baran, William B. Bachinsky, Edwin W. Rogers, Jeffrey Breall, David H. Lewis, Aijun Song, Ruth M. Starzyk, Stephen R. Mascioli, Keith D. Dawkins, Donald S. Baim

Research output: Contribution to journalArticle

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Abstract

Background-Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry. Methods and Results-Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/ exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both. Conclusions-The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations. (Circ Cardiovasc Intervent. 2009;2:285-293.)

Original languageEnglish
Pages (from-to)285-293
Number of pages9
JournalCirculation: Cardiovascular Interventions
Volume2
Issue number4
DOIs
StatePublished - Aug 2009

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Taxus
Drug-Eluting Stents
Stents
Registries
Thrombosis
Brachytherapy
Biological Factors
Percutaneous Coronary Intervention

Keywords

  • Angioplasty
  • Coronary disease
  • Registries
  • Stents
  • Thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Drug-eluting stent thrombosis in routine clinical practice two-year outcomes and predictors from the Taxus arrive registries. / Lasala, John M.; Cox, David A.; Dobies, David; Baran, Kenneth; Bachinsky, William B.; Rogers, Edwin W.; Breall, Jeffrey; Lewis, David H.; Song, Aijun; Starzyk, Ruth M.; Mascioli, Stephen R.; Dawkins, Keith D.; Baim, Donald S.

In: Circulation: Cardiovascular Interventions, Vol. 2, No. 4, 08.2009, p. 285-293.

Research output: Contribution to journalArticle

Lasala, JM, Cox, DA, Dobies, D, Baran, K, Bachinsky, WB, Rogers, EW, Breall, J, Lewis, DH, Song, A, Starzyk, RM, Mascioli, SR, Dawkins, KD & Baim, DS 2009, 'Drug-eluting stent thrombosis in routine clinical practice two-year outcomes and predictors from the Taxus arrive registries', Circulation: Cardiovascular Interventions, vol. 2, no. 4, pp. 285-293. https://doi.org/10.1161/CIRCINTERVENTIONS.109.852178
Lasala, John M. ; Cox, David A. ; Dobies, David ; Baran, Kenneth ; Bachinsky, William B. ; Rogers, Edwin W. ; Breall, Jeffrey ; Lewis, David H. ; Song, Aijun ; Starzyk, Ruth M. ; Mascioli, Stephen R. ; Dawkins, Keith D. ; Baim, Donald S. / Drug-eluting stent thrombosis in routine clinical practice two-year outcomes and predictors from the Taxus arrive registries. In: Circulation: Cardiovascular Interventions. 2009 ; Vol. 2, No. 4. pp. 285-293.
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abstract = "Background-Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry. Methods and Results-Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/ exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94{\%} with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6{\%} (1.0{\%} early ST [<30 days], 0.7{\%} late ST [31 to 365 days], and 0.8{\%} very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4{\%} versus 3.3{\%}, P<0.001; early ST: 0.4{\%} versus 1.4{\%}, P<0.001; late ST: 0.5{\%} versus 0.8{\%}, P=0.14; very late ST: 0.4{\%} versus 1.0{\%}, P=0.008). Within 7 days of ST, 23{\%} of patients died; 28{\%} suffered Q-wave myocardial infarction. Mortality was higher with early ST (39{\%}) than late ST (12{\%}, P<0.001) or very late ST (13{\%}, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4{\%}) and very late ST (23.1{\%}) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both. Conclusions-The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations. (Circ Cardiovasc Intervent. 2009;2:285-293.)",
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AU - Cox, David A.

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AU - Baran, Kenneth

AU - Bachinsky, William B.

AU - Rogers, Edwin W.

AU - Breall, Jeffrey

AU - Lewis, David H.

AU - Song, Aijun

AU - Starzyk, Ruth M.

AU - Mascioli, Stephen R.

AU - Dawkins, Keith D.

AU - Baim, Donald S.

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N2 - Background-Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry. Methods and Results-Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/ exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both. Conclusions-The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations. (Circ Cardiovasc Intervent. 2009;2:285-293.)

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