Long-Term Outcomes in Patients With Diabetes Mellitus Related to Prolonging Clopidogrel More Than 12 Months After Coronary Stenting

• Published in: Journal of the American College of Cardiology Vol. 66; no. 10; pp. 1091 - 1101
• Main Authors: Thukkani, Arun K., MD, PhD, Agrawal, Kush, MD, Prince, Lillian, MS, Smoot, Kyle J., MA, Dufour, Alyssa B., PhD, Cho, Kelly, MPH, PhD, Gagnon, David R., MD, PhD, Sokolovskaya, Galina, MS, Ly, Samantha, MA, Temiyasathit, Sara, PhD, Faxon, David P., MD, Gaziano, J. Michael, MD, PhD, Kinlay, Scott, MBBS, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 08.09.2015; Elsevier Limited
• Subjects: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary - methods; Angioplasty, Balloon, Coronary - mortality; Cardiology; Cardiovascular; Cause of Death; Clinical outcomes; clopidogrel; Cohort Studies; Coronary Artery Disease - complications; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Databases, Factual; Diabetes Mellitus - diagnosis; Diabetes Mellitus - mortality; Diabetes Mellitus - therapy; diabetes mellitus; Drug Administration Schedule; Drug-Eluting Stents; Female; Follow-Up Studies; Heart attacks; Humans; Insulin - administration & dosage; Internal Medicine; Long-Term Care; long-term outcomes; Male; Medicare - statistics & numerical data; Middle Aged; Multivariate Analysis; percutaneous coronary interventions; Platelet Aggregation Inhibitors - administration & dosage; Postoperative Care - methods; Propensity Score; Proportional Hazards Models; Retrospective Studies; Risk Assessment; Severity of Illness Index; Stents; Survival Rate; Ticlopidine - administration & dosage; Ticlopidine - analogs & derivatives; Time Factors; Treatment Outcome; United States; Veterans Disability Claims - statistics & numerical data; United States; clopidogrel; myocardial infarction; DM; diabetes mellitus; HR; drug-eluting stent(s); dual antiplatelet therapy; percutaneous coronary intervention; diabetes mellitus; percutaneous coronary interventions; MI; DAPT; bare-metal stent(s); coronary artery bypass grafting; CI; International Classification of Diseases-Ninth Revision; BMS; VA; ICD-9; DES; PCI; hazard ratio; Veterans Affairs; confidence interval; long-term outcomes; CABG
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2015.06.1339

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.