Two-year results of paclitaxel-eluting stents in patients with medically treated diabetes mellitus from the TAXUS ARRIVE program.
Drug-eluting stents decrease revascularization compared with bare metal stents in diabetic patients, but few studies have compared drug-eluting stent use in diabetic versus nondiabetic patients. The objective of this study was to assess whether paclitaxel provides equivalent revascularization decrease in diabetic and nondiabetic patients. The ARRIVE registries enrolled 7,492 patients receiving TAXUS Express stents, including 2,112 with medically treated diabetes; results were compared with those in the remaining 5,380 nondiabetic patients. Two-year target lesion revascularization (TLR) was comparable in diabetic and nondiabetic patients (8.2% vs 7.7%, p = 0.59) and remained similar after multivariate adjustment for baseline differences (7.1% vs 6.8%, p = 0.41). There were no significant TLR differences between diabetic and nondiabetic patients with small vessels (9.7% vs 9.5%, p = 0.96) or left main coronary artery, 3-vessel, or bifurcation stenting (10.7% vs 13.1%, p = 0.41). Diabetes was not a significant TLR predictor (hazard ratio 0.92, 95% confidence interval 0.77 to 1.12, p = 0.41). Stent thrombosis (2.6% vs 2.4%, p = 0.55) and myocardial infarction (3.8% vs 3.0%, p = 0.09) rates were also similar for diabetic and nondiabetic patients. However, 2-year mortality was significantly increased in diabetic compared with nondiabetic patients (9.7% vs 5.3%, p <0.001). Increased mortality drove significantly increased major cardiac events in diabetics; however, there was no difference in stent-related major cardiac events (8.9% vs 10.1%, p = 0.13). In conclusion, these results suggest that TAXUS paclitaxel-eluting stents abrogate the increased diabetic risk of clinical restenosis previously reported with bare metal stents, with similar low risk of myocardial infarction or stent thrombosis for diabetic and nondiabetic patients. However, diabetic patients still have increased risk of 2-year mortality.
Lasala
John M
JM
Washington University School of Medicine, St Louis, Missouri, USA.
Cox
David A
DA
Morris
D Lynn
DL
Breall
Jeffrey A
JA
Mahoney
Paul D
PD
Horwitz
Phillip A
PA
Shaw
Dinesh
D
Hood
Kristin L
KL
Mandinov
Lazar
L
Dawkins
Keith D
KD
D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D023921:Coronary Stenosis / Q000150:complications / Q000601:surgery*; D003920:Diabetes Mellitus / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D011446:Prospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D000972:Antineoplastic Agents, Phytogenic; D007004:Hypoglycemic Agents; D017239:Paclitaxel