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)

Adam de Belder*, Jose M. de la Torre Hernandez, Ramon Lopez-Palop, Peter O'Kane, Felipe Hernandez Hernandez, Julian Strange, Federico Gimeno, James Cotton, Jose F. Diaz Fernandez, Pilar Carrillo Saez, Martyn Thomas, Eduardo Pinar, Nick Curzen, Jose A. Baz, Nina Cooter, Inigo Lozano, Nicola Skipper, Derek Robinson, David Hildick-Smith, XIMA Investigators

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    85 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)1371-1375
    Number of pages5
    JournalJournal of the American College of Cardiology
    Volume63
    Issue number14
    DOIs
    Publication statusPublished - 15 Apr 2014

    Keywords

    • bare-metal stent(s)
    • drug-eluting stent(s)
    • octogenarians
    • PERCUTANEOUS CORONARY INTERVENTION
    • OUTCOMES
    • REVASCULARIZATION
    • DEFINITIONS
    • THROMBOSIS
    • CARDIOLOGY
    • THERAPY

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