Adam de Belder1, Jose M de la Torre Hernandez2, Ramon Lopez-Palop3, Peter O'Kane4, Felipe Hernandez Hernandez5, Julian Strange6, Federico Gimeno7, James Cotton8, Jose F Diaz Fernandez9, Pilar Carrillo Saez3, Martyn Thomas10, Eduardo Pinar11, Nick Curzen12, Jose A Baz13, Nina Cooter14, Inigo Lozano15, Nicola Skipper14, Derek Robinson16, David Hildick-Smith14. 1. Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England. Electronic address: adam.debelder@bsuh.nhs.uk. 2. Hospital Marqués de Valdecilla, Santander, Spain. 3. Hospital San Juan de Alicante, Alicante, Spain. 4. Royal Bournemouth Hospital, Bournemouth, England. 5. Hospital 12 de Octubre, Madrid, Spain. 6. Bristol Royal Infirmary, Bristol, England. 7. Hospital Clínico de Valladolid, Valladolid, Spain. 8. Royal Wolverhampton Hospital, Wolverhampton, England. 9. Hospital Juan Ramón Jiménez, Huelva, Spain. 10. St Thomas' Hospital, London, England. 11. Hospital Virgen de la Arrixaca, Murcia, Spain. 12. Southampton University Hospitals National Health Service Trust, Southampton, England. 13. Hospital Meixoeiro, Vigo, Spain. 14. Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England. 15. Hospital Central de Asturias, Oviedo, Spain. 16. Department of Mathematics, University of Sussex, East Sussex, England.
Abstract
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).
RCT Entities:
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).
Authors: Ahmed N Mahmoud; Nikhil H Shah; Islam Y Elgendy; Nayan Agarwal; Akram Y Elgendy; Amgad Mentias; Amr F Barakat; Dhruv Mahtta; R David Anderson; Anthony A Bavry Journal: Clin Cardiol Date: 2018-01-25 Impact factor: 2.882