Arun K Thukkani1, Kush Agrawal2, Lillian Prince3, Kyle J Smoot3, Alyssa B Dufour4, Kelly Cho3, David R Gagnon3, Galina Sokolovskaya3, Samantha Ly5, Sara Temiyasathit5, David P Faxon6, J Michael Gaziano7, Scott Kinlay8. 1. Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. 2. Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Boston Medical Center, Boston, Massachusetts. 3. MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts. 4. MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts. 5. Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts. 6. Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. 7. Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts; MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. 8. Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. Electronic address: scott.kinlay@va.gov.
Abstract
BACKGROUND: Recent large clinical trials show lower rates of late cardiovascular events by extending clopidogrel >12 months after percutaneous coronary revascularization (PCI). However, concerns of increased bleeding have elicited support for limiting prolonged treatment to high-risk patients. OBJECTIVES: The aim of this analysis was to determine the effect of prolonging clopidogrel therapy >12 months versus ≤12 months after PCI on very late outcomes in patients with diabetes mellitus (DM). METHODS: Using the Veterans Health Administration, 28,849 patients undergoing PCI between 2002 and 2006 were categorized into 3 groups: 1) 16,332 without DM; 2) 9,905 with DM treated with oral medications or diet; and 3) 2,612 with DM treated with insulin. Clinical outcomes, stratified by stent type, ≤4 years after PCI were determined from the Veterans Health Administration and Medicare databases and risk was assessed by multivariable and propensity score analyses using a landmark analysis starting 1 year after the index PCI. The primary endpoint of the study was the risk of all-cause death or myocardial infarction (MI). RESULTS: In patients with DM treated with insulin who received drug-eluting stents (DES), prolonged clopidogrel treatment was associated with a decreased risk of death (hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.42 to 0.82) and death or MI (HR: 0.67; 95% CI: 0.49 to 0.92). Similarly, in patients with noninsulin-treated DM receiving DES, prolonged clopidogrel treatment was associated with less death (HR: 0.61; 95% CI: 0.48 to 0.77) and death or MI (HR: 0.61; 95% CI: 0.5 to 0.75). Prolonged clopidogrel treatment was not associated with a lower risk in patients without DM or in any group receiving bare-metal stents. CONCLUSIONS: Extending the duration of clopidogrel treatment >12 months may decrease very late death or MI only in patients with DM receiving first-generation DES. Future studies should address this question in patients receiving second-generation DES.
BACKGROUND: Recent large clinical trials show lower rates of late cardiovascular events by extending clopidogrel >12 months after percutaneous coronary revascularization (PCI). However, concerns of increased bleeding have elicited support for limiting prolonged treatment to high-risk patients. OBJECTIVES: The aim of this analysis was to determine the effect of prolonging clopidogrel therapy >12 months versus ≤12 months after PCI on very late outcomes in patients with diabetes mellitus (DM). METHODS: Using the Veterans Health Administration, 28,849 patients undergoing PCI between 2002 and 2006 were categorized into 3 groups: 1) 16,332 without DM; 2) 9,905 with DM treated with oral medications or diet; and 3) 2,612 with DM treated with insulin. Clinical outcomes, stratified by stent type, ≤4 years after PCI were determined from the Veterans Health Administration and Medicare databases and risk was assessed by multivariable and propensity score analyses using a landmark analysis starting 1 year after the index PCI. The primary endpoint of the study was the risk of all-cause death or myocardial infarction (MI). RESULTS: In patients with DM treated with insulin who received drug-eluting stents (DES), prolonged clopidogrel treatment was associated with a decreased risk of death (hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.42 to 0.82) and death or MI (HR: 0.67; 95% CI: 0.49 to 0.92). Similarly, in patients with noninsulin-treated DM receiving DES, prolonged clopidogrel treatment was associated with less death (HR: 0.61; 95% CI: 0.48 to 0.77) and death or MI (HR: 0.61; 95% CI: 0.5 to 0.75). Prolonged clopidogrel treatment was not associated with a lower risk in patients without DM or in any group receiving bare-metal stents. CONCLUSIONS: Extending the duration of clopidogrel treatment >12 months may decrease very late death or MI only in patients with DM receiving first-generation DES. Future studies should address this question in patients receiving second-generation DES.
Authors: Frederick G Kushner; Mary Hand; Sidney C Smith; Spencer B King; Jeffrey L Anderson; Elliott M Antman; Steven R Bailey; Eric R Bates; James C Blankenship; Donald E Casey; Lee A Green; Judith S Hochman; Alice K Jacobs; Harlan M Krumholz; Douglass A Morrison; Joseph P Ornato; David L Pearle; Eric D Peterson; Michael A Sloan; Patrick L Whitlow; David O Williams Journal: J Am Coll Cardiol Date: 2009-12-01 Impact factor: 24.094
Authors: Robert W Yeh; Dean J Kereiakes; Philippe Gabriel Steg; Stephan Windecker; Michael J Rinaldi; Anthony H Gershlick; Donald E Cutlip; David J Cohen; Jean-Francois Tanguay; Alice Jacobs; Stephen D Wiviott; Joseph M Massaro; Adrian C Iancu; Laura Mauri Journal: J Am Coll Cardiol Date: 2015-03-15 Impact factor: 24.094
Authors: Ashish K Jha; Jonathan B Perlin; Michael A Steinman; John W Peabody; John Z Ayanian Journal: J Gen Intern Med Date: 2005-08 Impact factor: 5.128
Authors: S Elezi; A Kastrati; J Pache; A Wehinger; M Hadamitzky; J Dirschinger; F J Neumann; A Schömig Journal: J Am Coll Cardiol Date: 1998-12 Impact factor: 24.094
Authors: A Abizaid; R Kornowski; G S Mintz; M K Hong; A S Abizaid; R Mehran; A D Pichard; K M Kent; L F Satler; H Wu; J J Popma; M B Leon Journal: J Am Coll Cardiol Date: 1998-09 Impact factor: 24.094
Authors: Stephen D Wiviott; Eugene Braunwald; Dominick J Angiolillo; Simha Meisel; Anthony J Dalby; Freek W A Verheugt; Shaun G Goodman; Ramon Corbalan; Drew A Purdy; Sabina A Murphy; Carolyn H McCabe; Elliott M Antman Journal: Circulation Date: 2008-08-31 Impact factor: 29.690
Authors: Neil J Wimmer; Alyssa B Dufour; Kelly Cho; David R Gagnon; Lien Quach; Samantha Ly; Jacquelyn-My Do; Simon Ostrowski; J Michael Gaziano; David P Faxon; Scott Kinlay Journal: Catheter Cardiovasc Interv Date: 2016-11-10 Impact factor: 2.692
Authors: Giuseppe Gargiulo; Stephan Windecker; Bruno R da Costa; Fausto Feres; Myeong-Ki Hong; Martine Gilard; Hyo-Soo Kim; Antonio Colombo; Deepak L Bhatt; Byeong-Keuk Kim; Marie-Claude Morice; Kyung Woo Park; Alaide Chieffo; Tullio Palmerini; Gregg W Stone; Marco Valgimigli Journal: BMJ Date: 2016-11-03