TY - JOUR
T1 - Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent
T2 - 2-year results from the prospectively pooled analysis of the International Global RESOLUTE Program
AU - Silber, Sigmund
AU - Serruys, Patrick W.
AU - Leon, Martin B.
AU - Meredith, Ian T.
AU - Windecker, Stephan
AU - Neumann, Franz Josef
AU - Belardi, Jorge
AU - Widimsky, Petr
AU - Massaro, Joe
AU - Novack, Victor
AU - Yeung, Alan C.
AU - Saito, Shigeru
AU - Mauri, Laura
N1 - Funding Information:
This work was supported by Medtronic. Dr. Silber has received grant, travel, and analysis support from Medtronic . Drs. Leon, Belardi, and Yeung serve as advisors to Medtronic. Dr. Meredith serves as a consultant to Boston Scientific and Medtronic. Dr. Widimsky has received speaker's honoraria from Medtronic. Dr. Windecker has received research grant support via institutional grants from Abbott , Biotronik , Biosensors , Boston Scientific , and Cordis . Dr. Belardi has received support from Eli Lilly and Medtronic. Dr. Massaro is a paid consultant for Harvard Clinical Research Institute, which was funded by the sponsor. Dr. Novack has served as consultant to Harvard Clinical Research Institute, which received payment from Medtronic for data management and analysis. Dr. Mauri has served as consultant to Medtronic; and has received support from institutional grants from Abbott , Boston Scientific , Cordis , Medtronic , Eli Lilly , Daiichi Sankyo , Bristol-Myers Squibb , and Sanofi aventis . All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2013/4/1
Y1 - 2013/4/1
N2 - Objectives: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. Background: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). Conclusions: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset.
AB - Objectives: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. Background: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). Conclusions: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset.
KW - clinical outcome
KW - diabetes mellitus
KW - percutaneous coronary intervention (PCI)
KW - zotarolimus-eluting stent
UR - http://www.scopus.com/inward/record.url?scp=84876417156&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2012.11.006
DO - 10.1016/j.jcin.2012.11.006
M3 - Article
C2 - 23523454
AN - SCOPUS:84876417156
SN - 1936-8798
VL - 6
SP - 357
EP - 368
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 4
ER -
