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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.

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Presentation on theme: "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."— Presentation transcript:

1 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 Lesions Clinical, Angiographic and IVUS 2 year results Patrick W. Serruys, MD, PhD Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands SCAI-ACCi2 Late-Breaking Clinical Trials III: DES Monday March 31st, 2008 8.45 am Professor Serruys has no conflict of interest related to this presentation SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

2 SPIRIT II Clinical, Angiographic and IVUS 2 Year Results Patrick W. Serruys on behalf of Germany: J. Neuzner J. Schofer M. Wiemer G. Richardt M. Desaga The Netherlands: J. Piek H. Suryapranata M. Suttorp J.A.M. te Riele France: D. Carrie J. Berland C. Spaulding Denmark: L. Thuesen H. Kelbaek K. Rasmussen New Zealand: P. Ruygrok India: A. Seth Switzerland: E. Camenzind Spain: C. Macaya E. Garcia Belgium: F. Van den Branden V. Legrand J. Boland Poland: W. Ruzyllo Italy: A. Manari Austria: K. Huber SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

3 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) 3:13:1 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) SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

4 n = 300 n = 223n = 77 n = 211 n = 73 XIENCE V TAXUS ® n = 85 n L = 100 n = 32 n L = 35 2 Year QCA 2 Year Clinical n L : number of lesions Clinical Study Population n = 72 n L = 78 n = 31 n L =32 2 Year IVUS Angiographic and IVUS Subgroup* -7 non-cardiac deaths -1 withdrawn at 30 days -3 withdrawn at 1 year -1 lost to FU -4 non-cardiac deaths SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates. *Total angiographic and IVUS subgroup: 152 patients (113 XIENCE TM V, 39 TAXUS®) Angiographic follow-up at 2-year follow-up: XIENCE V: 75%; TAXUS®: 82% IVUS follow-up at 2-year follow-up: XIENCE V: 64%; TAXUS®: 79%

5 n = 300 n = 223n = 77 n = 211 n = 73 XIENCE V TAXUS ® n = 85 n L = 100 n = 32 n L = 35 2 Year QCA 2 Year Clinical n L : number of lesions Clinical Study Population n = 72 n L = 78 n = 31 n L =32 2 Year IVUS *Total angiographic and IVUS subgroup: 152 patients (113 XIENCE TM V, 39 TAXUS®) Angiographic follow-up at 2-year follow-up: XIENCE V: 75%; TAXUS®: 82% IVUS follow-up at 2-year follow-up: XIENCE V: 64%; TAXUS®: 79% -3 deaths -19 refused angio/IVUS -1 withdrawn at 30 days -3 withdrawn at 1 year -2 medical decisions -4 deaths -1 angio not required (did not receive study stent) - 2 refused angio/IVUS SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

6 n = 300 n = 223n = 77 n = 211 n = 73 XIENCE V TAXUS ® n = 85 n L = 100 n = 32 n L = 35 2 Year QCA 2 Year Clinical n L : number of lesions Clinical Study Population n = 72 n L = 78 n = 31 n L =32 2 Year IVUS *Total angiographic and IVUS subgroup: 152 patients (113 XIENCE TM V, 39 TAXUS®) Angiographic follow-up at 2-year follow-up: XIENCE V: 75%; TAXUS®: 82% IVUS follow-up at 2-year follow-up: XIENCE V: 64%; TAXUS®: 79% -3 deaths -19 refused angio/IVUS -1 withdrawn at 30 days -3 withdrawn at 1 year -5 IVUS catheter did not cross -4 pullback issues -2 medical decision -1 patient in another hospital -2 technical problem -1 TLR but no IVUS done -4 deaths -1 angio not required (did not receive study stent) -2 refused angio/IVUS -1 IVUS catheter did not cross SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

7 Baseline Demographics ITT Patients with 6 month & 2 year Angio/IVUS FU XIENCE V 223 pts TAXUS ® 77 pts XIENCE V 113 pts TAXUS ® 39 pts Male (%)71797382 Mean age (years)62 Previous MI (%)352542*18* Prior inter. at target vessel (%) 4 453 Diabetes mellitus (%)23242224 Insulin-dependent diabetes (%)5748 Hyperlipidemia req. med. (%)6975 77 Hypertension req. med.(%)67656151 Current smoker (%)323032 *p=0.007 SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

8 Baseline Angiography ITT Patients with 6 month & 2 year Angio/IVUS FU XIENCE V 260 lesions TAXUS ® 91 lesions XIENCE V 132 lesions TAXUS ® 45 lesions Dual Lesions Treated (%)17181715 Type B2/C Lesions78807677 Lesion Location LAD41474358 LCX29*19*27**13** RCA30343029 QCA RVD (mm) 2.70* 2.82*2.67**2.86** MLD (mm)1.06*1.14*0.98**1.13** % DS Lesion Length (mm) Acute Gain (mm) 61 13.0 1.43 59 13.2 1.48 63 13.3 1.52 60 13.8 1.53 *LCX p=0.072, RVD p = 0.099, MLD p=0.033. **LCX p=0.1, RVD p = 0.061, MLD p=0.013. SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

9 In-stent Late Loss in Patients with Serial 6 Month and 2 Year Angio FU 6 Months 2 Years XIENCE V XIENCE TM V TAXUS ® * XIENCE TM V TAXUS ® + XIENCE TM V: 0.17 ± 0.32 (nL=97) TAXUS ® : 0.33 ± 0.32 (nL=35) P=0.0037 XIENCE TM V: 0.33 ± 0.37 (nL=97) TAXUS ® : 0.34 ± 0.34 (nL=35) P=0.6026 In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

10 In-Stent % Diameter Stenosis in Patients with Serial 6 Month and 2 Year Angio FU 6 Months TAXUS XIENCE TM V TAXUS ® * XIENCE TM V: 16.0% ± 11.4% (nL=97) TAXUS ® : 18.3% ± 10.6% (nL=35) XIENCE TM V: 19.2% ± 13.9% (nL=97) TAXUS ® : 18.8% ± 11.4% (nL=35) In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively P = 0.0620 P = 0.9589 SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

11 Angiographic Binary Restenosis in Patients with Serial 6 Month and 2 Year Angio FU XIENCE TM V (nL = 97) TAXUS ® (nL = 35) 6 Months 2 Years In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively P = 0.4615 P = 0.6079 P = 1.0000 P = 0.4400 SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

12 CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates. 2.8 6.5 0 1 2 3 4 5 6 7 % VO IVUS in Patients with Serial 6 Month and 2 Year IVUS FU 6 Months 2 Years mm 3 5.2 5.8 0 1 2 3 4 5 6 7 % VO P=0.0009 P=0.0007 In this serial analysis, for patients having TLR, values of loss and neo-intimal hyperplasia observed prior to 6 month or 2 year FU were imputed at 6 months and 2 years respectively XIENCE TM V (nL = 69) TAXUS ® (nL = 32) P = 0.2527P = 0.4026 SE2926406 REV A

13 ARC Stent Thrombosis Definite and Probable XIENCE V 223 patients TAXUS ® 77 patients Acute stent thrombosis (%)0.0 Sub-acute stent thrombosis (%)0.01.3 220 patients77 patients Late stent thrombosis (%)0.01.3 211 patients73 patients Very late stent thrombosis (%)0.90.0 Total stent thrombosis (%)0.91.4 Acute: 0 to 24 hours after stent implantation Subacute: >24 hours to 30 days after stent implantation Late: >30 days to 1 year after stent implantation Very late: >1 year after stent implantation SE2926406 REV A p=NS CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

14 2 Year Clinical Results Hierarchical XIENCE V 211 patients TAXUS ® 73 patients Cardiac death %0.51.4 Myocardial infarction % Q-wave MI Non Q-wave MI 0 2.8 0 4.1 Ischemia driven TLR % CABG PCI 0 3.3 0 5.5 MACE %6.611.0 Ischemia driven TLR %3.86.8 Non-ischemia driven TLR %1.43.9 Total TLR %4.69.1 MACE: cardiac death, MI, ID-TLR by CABG or PCI Non-hierarchical XIENCE V 218 patients TAXUS ® 77 patients SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

15 6 Months (6M) and 2 Year (2Y) Clinical Results 1 SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

16 Conclusions SPIRIT II 2 year data shows a consistent reduction in clinical events for XIENCE V vs TAXUS ® (MACE 6.6% vs 11.0%) Low stent thrombosis rate for XIENCE V at 2 years (0.9 % XIENCE V vs 1.4% TAXUS ® ) XIENCE V remains numerically lower than TAXUS® in MACE and all it's components at 2 year follow-up, despite a modest increase in late loss and neo-intima in the XIENCE V arm over time. SE2926406 REV A CAUTION: XIENCE V is an Investigational device. Limited by Federal (U.S.) law to investigational use only. TAXUS® Paclitaxel-eluting Coronary Stent System is a registered trademark of Boston Scientific or its affiliates.

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