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


OBJECTIVE
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.
Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
Arun K
AK
Thukkani
Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Boston Medical Center, Boston, Massachusetts.
Kush
K
Agrawal
MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
Lillian
L
Prince
MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
Kyle J
KJ
Smoot
MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts.
Alyssa B
AB
Dufour
MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
Kelly
K
Cho
MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
David R
DR
Gagnon
MAVERIC, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
Galina
G
Sokolovskaya
Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
Samantha
S
Ly
Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.
Sara
S
Temiyasathit
Cardiovascular Division, Veterans Affairs Boston Healthcare System, Boston, Massachusetts; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
David P
DP
Faxon
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.
J Michael
JM
Gaziano
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.
Scott
S
Kinlay
D000368:Aged; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D002423:Cause of Death; D000077144:Clopidogrel; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality* / Q000628:therapy*; D016208:Databases, Factual; D003920:Diabetes Mellitus / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy; D004334:Drug Administration Schedule; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007328:Insulin / Q000008:administration & dosage; D008134:Long-Term Care; D008297:Male; D006278:Medicare / Q000706:statistics & numerical data; D008875:Middle Aged; D015999:Multivariate Analysis; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011182:Postoperative Care / Q000379:methods; D057216:Propensity Score; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014729:Veterans Disability Claims / Q000706:statistics & numerical data
D007328:Insulin; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine
clopidogrel; diabetes mellitus; long-term outcomes; percutaneous coronary interventions