Spirit II ACC 2009

The SPIRIT II Study - A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions3 Year Clinical Results : 

The SPIRIT II Study - A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions3 Year Clinical Results Patrick W. Serruys, MD, PhD Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands On behalf of the SPIRIT II Investigators

SPIRIT II 3 Year Clinical ResultsPatrick W. Serruys on behalf of : 

SPIRIT II 3 Year Clinical ResultsPatrick W. Serruys on behalf of

Study Design : 

Study Design Prospective, randomized (3:1), single-blind, non-inferiority to TAXUS Primary endpoint: Angiographic in-stent late loss at 180 days (powered for sequential non-inferiority and superiority) Secondary endpoint: Angiographic in-segment late loss at 180 days (powered for non-inferiority) Clinical follow-up: 30, 180, 270 days, 1, 2, 3, 4 and 5 years. Angiographic and IVUS follow-up: baseline, 180 days & 2 years (only for 152 patients) 3 : 1 Maximum two de novo lesions 300 patients 2.5 – 4.0 mm n = 300 XIENCE V n = 223 TAXUS n = 77 Sponsor: Abbott Vascular PI: PW Serruys MD, PhD SC: E Garcia MD, J Ormiston MD, M Wiemer MD DSMB: J Tijssen PhD, T Lefèvre MD, P Urban MD CEC: C Hanet MD, D McClean MD, V Umans MD Angiographic and IVUS Corelab: Cardialysis (Rotterdam, NL)

Slide 4: 

n = 300 n = 223 n = 77 n = 195 n = 69 XIENCE V TAXUS 3 Years Clinical Clinical Study Population 8 non-cardiac deaths 4 withdrawn 1 lost to FU 1 missed visit 14 no Inform Consent extensions* 4 non-cardiac deaths 4 no Inform Consent extensions* * Original protocol planned 2-Year follow-up. Extension to 5-Year required new patient informed consent 88% Follow-up

3 Year Clinical Results : 

3 Year Clinical Results MACE: cardiac death, MI, ID-TLR by CABG or PCI Hierarchical 0.5 4.3 0 0 0 0 3.6 4.3 3.1 7.2 7.2 15.9 - 55% - 88% - 17% - 58%

3 Year Clinical Results : 

3 Year Clinical Results Non-hierarchical 0.5 4.3 - 88% 3.6 7.2 4.6 10.1 1.5 5.5 5.4 12.3 - 50% - 55% - 73% - 56%

Cumulative Incidence Rates of MACE : 

Cumulative Incidence Rates of MACE XIENCE V TAXUS Ischemic MACE (%) 0 5 10 15 20 25 Time Post Index Procedure (Months) 0 3 6 9 12 15 18 21 24 27 30 33 36

Cumulative Incidence Rates of Cardiac Death : 

Cumulative Incidence Rates of Cardiac Death XIENCE V TAXUS Cardiac Death (%) 0 1 2 3 4 5 6 Time Post Index Procedure (Months) 0 3 6 9 12 15 18 21 24 27 30 33 36

Cumulative Incidence Rates of MI : 

Cumulative Incidence Rates of MI XIENCE V TAXUS MI (%) 0 5 10 15 Time Post Index Procedure (Months) 0 3 6 9 12 15 18 21 24 27 30 33 36

Cumulative Incidence Rates of ID-TLR : 

Cumulative Incidence Rates of ID-TLR XIENCE V TAXUS Ischemic TLR (%) 0 5 10 15 20 Time Post Index Procedure (Months) 0 3 6 9 12 15 18 21 24 27 30 33 36

3 Year Clinical Results : 

3 Year Clinical Results *Denominator includes patients with 3 year follow-up or TVF event (any death, MI, TLR or TVR)

ARC Stent Thrombosis : 

ARC Stent Thrombosis p=NS * Same patient One new stent thrombosis in the TAXUS arm between 2 years and 3 years, none in the XIENCE V arm

Cumulative Incidence Rates of ARC Stent Thromboses (Definite/Probable) : 

Cumulative Incidence Rates of ARC Stent Thromboses (Definite/Probable) XIENCE V TAXUS ARC Stent Thrombosis (%) 0 1 2 3 4 5 6 Time Post Index Procedure (Months) 0 3 6 9 12 15 18 21 24 27 30 33 36

Summary : 

Summary SPIRIT II 3 year data shows a consistent reduction in clinical events for XIENCE V vs TAXUS (MACE 6.4% vs 14.9%, p=0.029) Observed significant reduction in Cardiac Death in favour of XIENCE V (0.5% vs 4.2%, p=0.024) Observed lower MI (3.3% vs 6.8%) and ID-TLR rates (4.2% vs 9.4%) in the XIENCE V arm Low ARC stent thrombosis rate for XIENCE V compared to TAXUS at 3 years (0.9% vs 2.8%) From Kaplan Meier estimates and logrank test

Conclusion : 

Conclusion At 3 Years Follow-up: The continuing long-term safety and efficacy of XIENCE V is demonstrated XIENCE V continues to be clinically superior to TAXUS, with an 88% reduction in cardiac death and a 55% reduction in overall MACE With a 55% reduction in ID-TLR, XIENCE V continues to show lower clinical restenosis than TAXUS XIENCE V is a trademark of the Abbott Group of Companies. TAXUS is a registered trademark of Boston Scientific