Temporal trends in the use of drug-eluting stents for approved and off-label indications

A longitudinal analysis of a large multicenter percutaneous coronary intervention registry

Sarah K. Gualano, Hitinder S. Gurm, David Share, Dean Smith, Herbert D. Aronow, Thomas Lalonde, Eric R. Bates, Hameem Changezi, Richard McNamara, Mauro Moscucci

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Background: We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patientswith DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis: To determine whether the decrease in use of DES has affected both on and off-label indications. Methods: The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as STsegment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions,were evaluated. Results: The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISRwas less affected, though it also fell 25%(from 79%-56%). Conclusions: The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.

Original languageEnglish (US)
Pages (from-to)111-116
Number of pages6
JournalClinical Cardiology
Volume33
Issue number2
DOIs
StatePublished - Feb 2010

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Drug-Eluting Stents
Percutaneous Coronary Intervention
Registries
Stents
Blue Cross Blue Shield Insurance Plans
Off-Label Use
Cardiology
Metals
Myocardial Infarction
Saphenous Vein
Angioplasty
Observational Studies
Thrombosis
Cohort Studies
Demography
Guidelines
Transplants

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Temporal trends in the use of drug-eluting stents for approved and off-label indications : A longitudinal analysis of a large multicenter percutaneous coronary intervention registry. / Gualano, Sarah K.; Gurm, Hitinder S.; Share, David; Smith, Dean; Aronow, Herbert D.; Lalonde, Thomas; Bates, Eric R.; Changezi, Hameem; McNamara, Richard; Moscucci, Mauro.

In: Clinical Cardiology, Vol. 33, No. 2, 02.2010, p. 111-116.

Research output: Contribution to journalArticle

Gualano, Sarah K. ; Gurm, Hitinder S. ; Share, David ; Smith, Dean ; Aronow, Herbert D. ; Lalonde, Thomas ; Bates, Eric R. ; Changezi, Hameem ; McNamara, Richard ; Moscucci, Mauro. / Temporal trends in the use of drug-eluting stents for approved and off-label indications : A longitudinal analysis of a large multicenter percutaneous coronary intervention registry. In: Clinical Cardiology. 2010 ; Vol. 33, No. 2. pp. 111-116.
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abstract = "Background: We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patientswith DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis: To determine whether the decrease in use of DES has affected both on and off-label indications. Methods: The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as STsegment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions,were evaluated. Results: The overall deployment of DES fell sharply from 83{\%} pre-ESC to a plateau of 58{\%} in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78{\%} to only 36{\%}. Off-label use in SVGs showed a similar trend, from 74{\%} to 43{\%}. Drug-eluting stent deployment for ISRwas less affected, though it also fell 25{\%}(from 79{\%}-56{\%}). Conclusions: The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.",
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T2 - A longitudinal analysis of a large multicenter percutaneous coronary intervention registry

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AU - Gurm, Hitinder S.

AU - Share, David

AU - Smith, Dean

AU - Aronow, Herbert D.

AU - Lalonde, Thomas

AU - Bates, Eric R.

AU - Changezi, Hameem

AU - McNamara, Richard

AU - Moscucci, Mauro

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Y1 - 2010/2

N2 - Background: We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patientswith DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis: To determine whether the decrease in use of DES has affected both on and off-label indications. Methods: The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as STsegment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions,were evaluated. Results: The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISRwas less affected, though it also fell 25%(from 79%-56%). Conclusions: The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.

AB - Background: We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patientswith DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis: To determine whether the decrease in use of DES has affected both on and off-label indications. Methods: The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as STsegment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions,were evaluated. Results: The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISRwas less affected, though it also fell 25%(from 79%-56%). Conclusions: The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.

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