Impact of insulin-treated diabetes and hemodialysis on long-term clinical outcomes following sirolimus-eluting stent deployment. Insights from a sub-study of the Cypher Stent Japan Post-Marketing Surveillance(Cypher J-PMS) Registry.
BACKGROUND
Long-term clinical outcomes of diabetes mellitus (DM) patients who underwent drug-eluting stent deployment has not well investigated.


RESULTS
A total of 2,050 cases were enrolled consecutively from 50 sites in Japan into the Cypher stent Japan Post-Marketing Surveillance (Cypher J-PMS) registry, and the 3-year outcomes of DM patients were analyzed. Subjects were divided into 2 groups based on the treatment of DM (insulin-treated diabetes (IT) group, n=207; and non insulin-treated diabetes (NIT) group, n=682). Major adverse cardiac event (MACE) rates in the IT group and the NIT group were 26.0% and 14.5% at 3 years, respectively (P<0.001). There were no significant differences in stent thrombosis rates (definite and probable by Academic Research Consortium (ARC) definition) (0% and 1.08%, respectively). Multivariate analysis suggested that hemodialysis and insulin-treated DM were independent predictors for MACE, and insulin-treated DM, hemodialysis and long lesions were strong independent predictors for target-lesion revascularization (TLR).


CONCLUSIONS
Hemodialysis and insulin-treated DM were strong independent predictors of mortality and TLR in DM patients. These results might suggest that special attention to patients with hemodialysis and insulin-treated DM is warranted in the setting of sirolimus-eluting stent deployment for DM patients.
Toho University Ohashi Medical Center, Tokyo, Japan. masato@oha.toho-u.ac.jp
Masato
M
Nakamura
Hiroyoshi
H
Yokoi
Yuji
Y
Hamazaki
Masato
M
Watarai
Mikihiro
M
Kijima
Kazuaki
K
Mitsudo
D000368:Aged; D048909:Diabetes Complications / Q000401:mortality* / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000209:etiology / Q000401:mortality* / Q000628:therapy; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D007328:Insulin / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012042:Registries; D006435:Renal Dialysis; D020123:Sirolimus / Q000494:pharmacology*; D013927:Thrombosis / Q000209:etiology / Q000401:mortality*; D013997:Time Factors
D007004:Hypoglycemic Agents; D007166:Immunosuppressive Agents; D007328:Insulin; D020123:Sirolimus