TY - JOUR
T1 - Two-Year Results of Paclitaxel-Eluting Stents in Patients With Medically Treated Diabetes Mellitus from the TAXUS ARRIVE Program
AU - Lasala, John M.
AU - Cox, David A.
AU - Morris, D. Lynn
AU - Breall, Jeffrey A.
AU - Mahoney, Paul D.
AU - Horwitz, Phillip A.
AU - Shaw, Dinesh
AU - Hood, Kristin L.
AU - Mandinov, Lazar
AU - Dawkins, Keith D.
N1 - Funding Information:
The ARRIVE 1 and ARRIVE 2 registries and this analysis were sponsored and funded by Boston Scientific Corporation, Natick, Massachusetts. Dr. Breall, Dr. Shaw, and Dr. Horwitz received grant support from Boston Scientific Corporation. Dr. Lasala, Dr. Cox, Dr. Morris, and Dr. Mahoney receive consulting fees from or serve on the advisory board to Boston Scientific Corporation. Dr. Hood, Dr. Dawkins, and Dr. Mandinov are full-time employees of Boston Scientific Corporation and have stock options or equity interest in Boston Scientific Corporation.
PY - 2009/6/15
Y1 - 2009/6/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=67649404696&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2009.02.035
DO - 10.1016/j.amjcard.2009.02.035
M3 - Article
C2 - 19539073
AN - SCOPUS:67649404696
SN - 0002-9149
VL - 103
SP - 1663
EP - 1671
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 12
ER -