Everolimus-Eluting Stents vs BMS in Octogenarians
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)
Improved health care has led to an increase in the proportion of elderly patients in the population. As a consequence, patients are presenting with stable coronary disease and acute coronary syndromes at a much older age, and very elderly patients (age >80 years) are an increasing slice of day-to-day practice. Coronary stenting is feasible for and beneficial to elderly patients with anginal syndromes but is associated with higher complication rates. Many trial protocols exclude elderly patients, and the data for longer-term outcomes with intervention are limited to retrospective analyses.
Elderly patients often have complex coronary artery disease warranting use of drug-eluting stents (DES), but prolonged dual antiplatelet therapy (DAPT) puts them at higher risk for major bleeding complications. Noncompliance with DAPT may also be more likely in elderly patients, and this would put them at higher risk for stent thrombosis.
We designed a prospective randomized trial to examine the hypothesis that treatment of complex coronary disease with DES in patients ≥80 years of age with angina would prove superior to bare-metal stents (BMS) with respect to a combined endpoint of mortality, myocardial infarction (MI), target vessel revascularization (TVR), cerebrovascular accident (CVA), or severe hemorrhage.
Abstract and Introduction
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)
Introduction
Improved health care has led to an increase in the proportion of elderly patients in the population. As a consequence, patients are presenting with stable coronary disease and acute coronary syndromes at a much older age, and very elderly patients (age >80 years) are an increasing slice of day-to-day practice. Coronary stenting is feasible for and beneficial to elderly patients with anginal syndromes but is associated with higher complication rates. Many trial protocols exclude elderly patients, and the data for longer-term outcomes with intervention are limited to retrospective analyses.
Elderly patients often have complex coronary artery disease warranting use of drug-eluting stents (DES), but prolonged dual antiplatelet therapy (DAPT) puts them at higher risk for major bleeding complications. Noncompliance with DAPT may also be more likely in elderly patients, and this would put them at higher risk for stent thrombosis.
We designed a prospective randomized trial to examine the hypothesis that treatment of complex coronary disease with DES in patients ≥80 years of age with angina would prove superior to bare-metal stents (BMS) with respect to a combined endpoint of mortality, myocardial infarction (MI), target vessel revascularization (TVR), cerebrovascular accident (CVA), or severe hemorrhage.