Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials.
OBJECTIVE
We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).


BACKGROUND
Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials.


METHODS
Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6%) with DM.


RESULTS
Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p = 0.61), myocardial infarction (6.9% vs. 8.9%, p = 0.17), or stent thrombosis (1.4% vs. 1.2%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4% vs. 24.7%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin.


CONCLUSIONS
In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis.
Kirtane
Ajay J
AJ
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York 10022, USA.
Ellis
Stephen G
SG
Dawkins
Keith D
KD
Colombo
Antonio
A
Grube
Eberhard
E
Popma
Jeffrey J
JJ
Fahy
Martin
M
Leon
Martin B
MB
Moses
Jeffrey W
JW
Mehran
Roxana
R
Stone
Gregg W
GW
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D003327:Coronary Disease / Q000453:epidemiology / Q000401:mortality / Q000628:therapy*; D003922:Diabetes Mellitus, Type 1 / Q000401:mortality; D003924:Diabetes Mellitus, Type 2 / Q000401:mortality; D003925:Diabetic Angiopathies / Q000453:epidemiology / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D019233:Retreatment / Q000706:statistics & numerical data; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome
D017239:Paclitaxel