E1664 JACC March 12, 2013 Volume 61, Issue 10 TCT@ACC-i2: Invasive and Interventional Cardiology EVEROLIMUS-ELUTING VERSUS BARE METAL STENTS IN OCTOGENARIANS: RESULTS FROM THE RANDOMIZED XIMA (XIENCE OR VISION STENT - MANAGEMENT OF ANGINA IN THE ELDERLY ) TRIAL Poster Contributions Poster Sessions, Expo North Saturday, March 09, 2013, 10:00 a.m.-10:45 a.m. Session Title: Coronary Stents Abstract Category: 47. TCT@ACC-i2: Coronary Intervention, Devices Presentation Number: 2101-242 Authors: Jose M. de la Torre Hernandez, Adam De Belder, Ramon Lopez Palop, David Hildick-Smith, Felipe Hernandez, Peter O´Kane, Federico Gimeno, Martin Thomas, Jose F. Diaz, Nick Curzen, Pliar Carrillo, Julian Strange, Eduardo Pinar, James Cotton, Jose A. Baz, Dawn Adamson, Iñigo Lozano, Daniel Blackman, Carlos Cuellas, Nicola Skipper, Nina Cooter, Jose A. Diarte, David Smith, Josepa Mauri, Hospital Marques de Valdecilla, Santander, Spain, Sussex Cardiac Centre, Brighton, United Kingdom Background: There is scarce data on interventional outcomes in octogenarians. Drug-eluting stents (DES) should be advantageous over bare metal stent (BMS) in reducing restenosis but a higher toleration for restenosis could decrease effectiveness. The potential downside of DES is the prolonged course of dual antiplatelet therapy. Methods: We designed a multicentre randomised trial of Xience DES and Vision BMS in octogenarians. Patients with STEMI were excluded. Primary outcome was the combined of death, infarction, TVR, stroke and major bleeding (TIMI) at one year. Estimated sample size was 329 patients in each group. Results: 800 patients were recruited in 22 centres across the UK and Spain. The patients were well matched between the 2 groups with only significant differences in prior infarction (21.5% in BMS group and 29.8% in DES group) and total stent length (24±13 mm with BMS and 26±14 mm with DES). A 68% of patients were treated after and ACS. Recommended DAPT period was 1 month after BMS and 12 months after DES. One year outcomes for both groups are shown in the table. In subgroup analysis DES was more beneficial in males, 85-90 yrs, stable angina, 2-vessel disease and radial access. Conclusions: This trial evaluating DES and BMS in octogenarians has shown at 1 year no difference in mortality between groups, similar rates of major haemorrhage despite differing DAPT regimes and significantly lower rates of target vessel revascularization and myocardial infarction among DES-treated patients. Clinical outcomes Vision (BMS) N=401 Xience (DES) N=399 p Death 7.2% 8.5% 0.5 Infarction 8.7% 4.3% 0.01 TVR 7% 2% 0.0009 Major bleeding 1.7% 2.3% 0.6 Stroke 1.2% 1.5% 0.7 Primary endpoint 18.7% 14.5% 0.09

EVEROLIMUS–ELUTING VERSUS BARE METAL STENTS IN OCTOGENARIANS: RESULTS FROM THE RANDOMIZED XIMA (XIENCE OR VISION STENT – MANAGEMENT OF ANGINA IN THE ELDERLY) TRIAL

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Page 1: EVEROLIMUS–ELUTING VERSUS BARE METAL STENTS IN OCTOGENARIANS: RESULTS FROM THE RANDOMIZED XIMA (XIENCE OR VISION STENT – MANAGEMENT OF ANGINA IN THE ELDERLY) TRIAL

E1664JACC March 12, 2013Volume 61, Issue 10

TCT@ACC-i2: Invasive and Interventional Cardiologyeverolimus-eluTing versus Bare meTal sTenTs in ocTogenarians: resulTs from The randomized xima (xience or vision sTenT - managemenT of angina in The elderly ) Trial

Poster ContributionsPoster Sessions, Expo NorthSaturday, March 09, 2013, 10:00 a.m.-10:45 a.m.

Session Title: Coronary StentsAbstract Category: 47. TCT@ACC-i2: Coronary Intervention, DevicesPresentation Number: 2101-242

Authors: Jose M. de la Torre Hernandez, Adam De Belder, Ramon Lopez Palop, David Hildick-Smith, Felipe Hernandez, Peter O´Kane, Federico Gimeno, Martin Thomas, Jose F. Diaz, Nick Curzen, Pliar Carrillo, Julian Strange, Eduardo Pinar, James Cotton, Jose A. Baz, Dawn Adamson, Iñigo Lozano, Daniel Blackman, Carlos Cuellas, Nicola Skipper, Nina Cooter, Jose A. Diarte, David Smith, Josepa Mauri, Hospital Marques de Valdecilla, Santander, Spain, Sussex Cardiac Centre, Brighton, United Kingdom

Background: There is scarce data on interventional outcomes in octogenarians. Drug-eluting stents (DES) should be advantageous over bare metal stent (BMS) in reducing restenosis but a higher toleration for restenosis could decrease effectiveness. The potential downside of DES is the prolonged course of dual antiplatelet therapy.

methods: We designed a multicentre randomised trial of Xience DES and Vision BMS in octogenarians. Patients with STEMI were excluded. Primary outcome was the combined of death, infarction, TVR, stroke and major bleeding (TIMI) at one year. Estimated sample size was 329 patients in each group.

results: 800 patients were recruited in 22 centres across the UK and Spain. The patients were well matched between the 2 groups with only significant differences in prior infarction (21.5% in BMS group and 29.8% in DES group) and total stent length (24±13 mm with BMS and 26±14 mm with DES). A 68% of patients were treated after and ACS. Recommended DAPT period was 1 month after BMS and 12 months after DES. One year outcomes for both groups are shown in the table. In subgroup analysis DES was more beneficial in males, 85-90 yrs, stable angina, 2-vessel disease and radial access.

conclusions: This trial evaluating DES and BMS in octogenarians has shown at 1 year no difference in mortality between groups, similar rates of major haemorrhage despite differing DAPT regimes and significantly lower rates of target vessel revascularization and myocardial infarction among DES-treated patients.

Clinical outcomes

Vision (BMS)N=401

Xience (DES)N=399

Death 7.2% 8.5% 0.5Infarction 8.7% 4.3% 0.01TVR 7% 2% 0.0009Major bleeding 1.7% 2.3% 0.6Stroke 1.2% 1.5% 0.7Primary endpoint 18.7% 14.5% 0.09