The SPIRIT V Diabetic Study: A randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberté paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions

• Published in: The American heart journal Vol. 163; no. 5; pp. 867 - 875.e1
• Main Authors: Grube, Eberhard, MD, Chevalier, Bernard, MD, Guagliumi, Giulio, MD, Smits, Peter C., MD, PhD, Stuteville, Marrianne, BSc, Dorange, Cécile, MSc, Papeleu, Peggy, PhD, Kaul, Upendra, MD, DM, Džavík, Vladimír, MD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.05.2012; Mosby; Elsevier Limited
• Subjects: Aged; Angioplasty; Angioplasty, Balloon, Coronary - methods; Angioplasty, Balloon, Coronary - mortality; Asia; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Cardiovascular; Cardiovascular disease; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - epidemiology; Coronary Artery Disease - therapy; Coronary vessels; Diabetes; Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; Diabetes. Impaired glucose tolerance; Diabetic Angiopathies - diagnosis; Diabetic Angiopathies - epidemiology; Diabetic Angiopathies - therapy; Drug-Eluting Stents; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Europe; Evaluation Studies as Topic; Everolimus; Female; Heart attacks; Humans; Hypotheses; Hypothesis testing; Ischemia; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Prognosis; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Risk Assessment; Single-Blind Method; Sirolimus - analogs & derivatives; Sirolimus - pharmacology; Statistics, Nonparametric; Stents; Survival Analysis; Taxus; Thrombosis; Treatment Outcome; Veins & arteries; major adverse cardiac events; DSMB; everolimus-eluting stent; myocardial infarction; TLF; TVR; percutaneous coronary intervention; Data Safety Monitoring Board; MACE; stent thrombosis; target vessel revascularization; TLR; CI-TLR; MI; coronary artery bypass grafting; CEC; ST; clinically indicated target lesion revascularization; drug-eluting stent; target lesion revascularization; Academic Research Consortium; ARC; EES; DES; PCI; target lesion failure; CABG; Clinical Events Committee; Endocrinopathy; Human; Evaluation; Diabetes mellitus; Coronary artery; Instrumentation therapy; Patient; De novo; Randomization; Paclitaxel; Circulatory system; Immunosuppressive agent; Lesion; Cardiology; Everolimus; Drug eluting stent; Comparative study
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2012.02.006

Background Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES). Methods The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non–insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year. Results Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; Psuperiority = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES ( P = .11). Conclusion In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.