Association between off-label use of drug-eluting stents and subsequent stent thrombosis: A case-control analysis

Asaf Rabinovitz, Dara M. Bier, Gabriel M. Wagman, Esti Charlap, Reza Nazari, Jaime Ghitelman, Sulejman Celaj, Basel Skeif, Mark A. Menegus, V. S. Srinivas

Research output: Contribution to journalArticle

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Abstract

Objectives: We sought to examine the association between off-label drug-eluting stent (DES) use and stent thrombosis (ST) in unselected patients undergoing percutaneous coronary intervention (PCI). Background: DES are frequently used in clinical and angiographic scenarios not initially tested and approved by the FDA (off-label use) resulting in lingering concerns about the higher risk of ST in these situations. Methods: Out of 5,383 patients undergoing PCI at a single center between 2004 and 2006, 380 had death or myocardial infarction within 1 year. After adjudication using Academic Research Consortium definitions, patients with possible, probable or definite ST were termed cases. Cases were matched with controls, free of ST at 1 year, using geographic and temporal similarities. Off-label usage was defined using manufacturer's instructions and other standard criteria. Results: Overall, the proportion of off-label usage was higher among cases than controls (58% vs. 43%; p = 0.002) and both cases with definite/probable ST (77% vs. 59%; p = 0.08) and possible ST (54% vs. 37%; p = 0.002) had a higher off-label use than respective controls. Off-label use among cases with ST remained higher within the following subgroups: off-label by manufacturer's criteria (36% vs. 27%; p = 0.05), left main stent implantation (2% vs. 0%; p = 0.01), ostial (12% vs. 6%; p = 0.04) and bifurcated lesions (26% vs. 9%; p < 0.001). In multivariate analysis, being a case independently predicted off-label use (OR 1.68, 95% CI: 1.10-2.57; p = 0.02). Conclusions. In this case-control analysis, off-label use of DES was independently associated with ST within 1 year, although the increased risk was moderate.

Original languageEnglish (US)
Pages (from-to)15-19
Number of pages5
JournalJournal of Invasive Cardiology
Volume22
Issue number1
StatePublished - Jan 2010

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Off-Label Use
Drug-Eluting Stents
Stents
Thrombosis
Percutaneous Coronary Intervention
Multivariate Analysis
Myocardial Infarction

Keywords

  • Drug-eluting stent
  • Off-label
  • Stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Rabinovitz, A., Bier, D. M., Wagman, G. M., Charlap, E., Nazari, R., Ghitelman, J., ... Srinivas, V. S. (2010). Association between off-label use of drug-eluting stents and subsequent stent thrombosis: A case-control analysis. Journal of Invasive Cardiology, 22(1), 15-19.

Association between off-label use of drug-eluting stents and subsequent stent thrombosis : A case-control analysis. / Rabinovitz, Asaf; Bier, Dara M.; Wagman, Gabriel M.; Charlap, Esti; Nazari, Reza; Ghitelman, Jaime; Celaj, Sulejman; Skeif, Basel; Menegus, Mark A.; Srinivas, V. S.

In: Journal of Invasive Cardiology, Vol. 22, No. 1, 01.2010, p. 15-19.

Research output: Contribution to journalArticle

Rabinovitz, A, Bier, DM, Wagman, GM, Charlap, E, Nazari, R, Ghitelman, J, Celaj, S, Skeif, B, Menegus, MA & Srinivas, VS 2010, 'Association between off-label use of drug-eluting stents and subsequent stent thrombosis: A case-control analysis', Journal of Invasive Cardiology, vol. 22, no. 1, pp. 15-19.
Rabinovitz A, Bier DM, Wagman GM, Charlap E, Nazari R, Ghitelman J et al. Association between off-label use of drug-eluting stents and subsequent stent thrombosis: A case-control analysis. Journal of Invasive Cardiology. 2010 Jan;22(1):15-19.
Rabinovitz, Asaf ; Bier, Dara M. ; Wagman, Gabriel M. ; Charlap, Esti ; Nazari, Reza ; Ghitelman, Jaime ; Celaj, Sulejman ; Skeif, Basel ; Menegus, Mark A. ; Srinivas, V. S. / Association between off-label use of drug-eluting stents and subsequent stent thrombosis : A case-control analysis. In: Journal of Invasive Cardiology. 2010 ; Vol. 22, No. 1. pp. 15-19.
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abstract = "Objectives: We sought to examine the association between off-label drug-eluting stent (DES) use and stent thrombosis (ST) in unselected patients undergoing percutaneous coronary intervention (PCI). Background: DES are frequently used in clinical and angiographic scenarios not initially tested and approved by the FDA (off-label use) resulting in lingering concerns about the higher risk of ST in these situations. Methods: Out of 5,383 patients undergoing PCI at a single center between 2004 and 2006, 380 had death or myocardial infarction within 1 year. After adjudication using Academic Research Consortium definitions, patients with possible, probable or definite ST were termed cases. Cases were matched with controls, free of ST at 1 year, using geographic and temporal similarities. Off-label usage was defined using manufacturer's instructions and other standard criteria. Results: Overall, the proportion of off-label usage was higher among cases than controls (58{\%} vs. 43{\%}; p = 0.002) and both cases with definite/probable ST (77{\%} vs. 59{\%}; p = 0.08) and possible ST (54{\%} vs. 37{\%}; p = 0.002) had a higher off-label use than respective controls. Off-label use among cases with ST remained higher within the following subgroups: off-label by manufacturer's criteria (36{\%} vs. 27{\%}; p = 0.05), left main stent implantation (2{\%} vs. 0{\%}; p = 0.01), ostial (12{\%} vs. 6{\%}; p = 0.04) and bifurcated lesions (26{\%} vs. 9{\%}; p < 0.001). In multivariate analysis, being a case independently predicted off-label use (OR 1.68, 95{\%} CI: 1.10-2.57; p = 0.02). Conclusions. In this case-control analysis, off-label use of DES was independently associated with ST within 1 year, although the increased risk was moderate.",
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AU - Bier, Dara M.

AU - Wagman, Gabriel M.

AU - Charlap, Esti

AU - Nazari, Reza

AU - Ghitelman, Jaime

AU - Celaj, Sulejman

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N2 - Objectives: We sought to examine the association between off-label drug-eluting stent (DES) use and stent thrombosis (ST) in unselected patients undergoing percutaneous coronary intervention (PCI). Background: DES are frequently used in clinical and angiographic scenarios not initially tested and approved by the FDA (off-label use) resulting in lingering concerns about the higher risk of ST in these situations. Methods: Out of 5,383 patients undergoing PCI at a single center between 2004 and 2006, 380 had death or myocardial infarction within 1 year. After adjudication using Academic Research Consortium definitions, patients with possible, probable or definite ST were termed cases. Cases were matched with controls, free of ST at 1 year, using geographic and temporal similarities. Off-label usage was defined using manufacturer's instructions and other standard criteria. Results: Overall, the proportion of off-label usage was higher among cases than controls (58% vs. 43%; p = 0.002) and both cases with definite/probable ST (77% vs. 59%; p = 0.08) and possible ST (54% vs. 37%; p = 0.002) had a higher off-label use than respective controls. Off-label use among cases with ST remained higher within the following subgroups: off-label by manufacturer's criteria (36% vs. 27%; p = 0.05), left main stent implantation (2% vs. 0%; p = 0.01), ostial (12% vs. 6%; p = 0.04) and bifurcated lesions (26% vs. 9%; p < 0.001). In multivariate analysis, being a case independently predicted off-label use (OR 1.68, 95% CI: 1.10-2.57; p = 0.02). Conclusions. In this case-control analysis, off-label use of DES was independently associated with ST within 1 year, although the increased risk was moderate.

AB - Objectives: We sought to examine the association between off-label drug-eluting stent (DES) use and stent thrombosis (ST) in unselected patients undergoing percutaneous coronary intervention (PCI). Background: DES are frequently used in clinical and angiographic scenarios not initially tested and approved by the FDA (off-label use) resulting in lingering concerns about the higher risk of ST in these situations. Methods: Out of 5,383 patients undergoing PCI at a single center between 2004 and 2006, 380 had death or myocardial infarction within 1 year. After adjudication using Academic Research Consortium definitions, patients with possible, probable or definite ST were termed cases. Cases were matched with controls, free of ST at 1 year, using geographic and temporal similarities. Off-label usage was defined using manufacturer's instructions and other standard criteria. Results: Overall, the proportion of off-label usage was higher among cases than controls (58% vs. 43%; p = 0.002) and both cases with definite/probable ST (77% vs. 59%; p = 0.08) and possible ST (54% vs. 37%; p = 0.002) had a higher off-label use than respective controls. Off-label use among cases with ST remained higher within the following subgroups: off-label by manufacturer's criteria (36% vs. 27%; p = 0.05), left main stent implantation (2% vs. 0%; p = 0.01), ostial (12% vs. 6%; p = 0.04) and bifurcated lesions (26% vs. 9%; p < 0.001). In multivariate analysis, being a case independently predicted off-label use (OR 1.68, 95% CI: 1.10-2.57; p = 0.02). Conclusions. In this case-control analysis, off-label use of DES was independently associated with ST within 1 year, although the increased risk was moderate.

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