Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program.

Abstract

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. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [R-Int]; NCT00752128; RESOLUTE Japan-The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940).

• Authors: Sigmund Silber, Patrick W Serruys, Martin B Leon, Ian T Meredith, Stephan Windecker, Franz-Josef Neumann, Jorge Belardi, Petr Widimsky, Joe Massaro, Victor Novack, Alan C Yeung, Shigeru Saito, Laura Mauri
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 6 Issue 4 Pg. 357-68 (Apr 2013) ISSN: 1876-7605 [Electronic] United States
• PMID: 23523454 (Publication Type: Comparative Study, Journal Article, Meta-Analysis, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Cardiovascular Agents
• Hypoglycemic Agents
• Insulin
• zotarolimus
• Sirolimus

Topics

• Aged
• Cardiovascular Agents (administration & dosage)
• Coronary Artery Disease (epidemiology, mortality, therapy)
• Coronary Thrombosis (epidemiology)
• Device Approval
• Diabetes Mellitus (drug therapy, epidemiology, mortality)
• Drug-Eluting Stents
• Female
• Humans
• Hypoglycemic Agents (therapeutic use)
• Insulin (therapeutic use)
• Japan (epidemiology)
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Prospective Studies
• Prosthesis Design
• Risk Factors
• Sirolimus (administration & dosage, analogs & derivatives)
• Time Factors
• Treatment Outcome
• United States (epidemiology)
• United States Food and Drug Administration