A prospective randomized trial of everolimus-eluting stents versus bare-metal stents in octogenarians: the XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly).
OBJECTIVE
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).
Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England. Electronic address: adam.debelder@bsuh.nhs.uk.
Adam
A
de Belder
Hospital Marqués de Valdecilla, Santander, Spain.
Jose M
JM
de la Torre Hernandez
Hospital San Juan de Alicante, Alicante, Spain.
Ramon
R
Lopez-Palop
Royal Bournemouth Hospital, Bournemouth, England.
Peter
P
O'Kane
Hospital 12 de Octubre, Madrid, Spain.
Felipe
F
Hernandez Hernandez
Bristol Royal Infirmary, Bristol, England.
Julian
J
Strange
Hospital Clínico de Valladolid, Valladolid, Spain.
Federico
F
Gimeno
Royal Wolverhampton Hospital, Wolverhampton, England.
James
J
Cotton
Hospital Juan Ramón Jiménez, Huelva, Spain.
Jose F
JF
Diaz Fernandez
Hospital San Juan de Alicante, Alicante, Spain.
Pilar
P
Carrillo Saez
St Thomas' Hospital, London, England.
Martyn
M
Thomas
Hospital Virgen de la Arrixaca, Murcia, Spain.
Eduardo
E
Pinar
Southampton University Hospitals National Health Service Trust, Southampton, England.
Nick
N
Curzen
Hospital Meixoeiro, Vigo, Spain.
Jose A
JA
Baz
Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England.
Nina
N
Cooter
Hospital Central de Asturias, Oviedo, Spain.
Inigo
I
Lozano
Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England.
Nicola
N
Skipper
Department of Mathematics, University of Sussex, East Sussex, England.
Derek
D
Robinson
Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England.
David
D
Hildick-Smith
D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000401:mortality* / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D015577:Geriatric Assessment; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012720:Severity of Illness Index; D013030:Spain; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
D008670:Metals
bare-metal stent(s); drug-eluting stent(s); octogenarians