A Prospective Randomized Trial of Everolimus-Eluting Stents Versus Bare-Metal Stents in Octogenarians

• Published in: Journal of the American College of Cardiology 2014-04, Vol.63 (14), p.1371-1375
• Main Authors: de Belder, Adam, MD, de la Torre Hernandez, Jose M., MD, PhD, Lopez-Palop, Ramon, PhD, O'Kane, Peter, MD, Hernandez Hernandez, Felipe, MD, Strange, Julian, MD, Gimeno, Federico, PhD, Cotton, James, MD, Diaz Fernandez, Jose F., MD, Carrillo Saez, Pilar, PhD, Thomas, Martyn, MD, Pinar, Eduardo, PhD, Curzen, Nick, PhD, Baz, Jose A., MD, Cooter, Nina, RCN, Lozano, Inigo, PhD, Skipper, Nicola, RCN, Robinson, Derek, PhD, Hildick-Smith, David, MD
• Format: Article
• Language: English
• Subjects: Angina pectoris; bare-metal stent(s); Cardiology; Cardiovascular; Coronary vessels; drug-eluting stent(s); Heart attacks; Internal Medicine; octogenarians; Stents
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2013.10.053

Objectives The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina. Background Patients ≥80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy. Methods This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage. Results In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group. Conclusions BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent–Management of Angina in the Elderly [XIMA]; ISRCTN92243650 )