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Gregg W. Stone, MD Manejeh Yaqub, MD; Poornima Sood, MD, MBA; Ali Rizvi, MD;

A Large-Scale Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents: Two-Year Clinical Outcomes from the SPIRIT IV Trial. Gregg W. Stone, MD Manejeh Yaqub, MD; Poornima Sood, MD, MBA; Ali Rizvi, MD;

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Gregg W. Stone, MD Manejeh Yaqub, MD; Poornima Sood, MD, MBA; Ali Rizvi, MD;

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  1. A Large-Scale Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents:Two-Year Clinical Outcomes from the SPIRIT IV Trial Gregg W. Stone, MD Manejeh Yaqub, MD; Poornima Sood, MD, MBA; Ali Rizvi, MD; William Newman, MD; Kourosh Mastali, MD; John C. Wang, MD; Ronald E. Caputo, MD; Kyoko Hattori, RN, BSN; Xiaolu Su, MS; Charles A. Simonton, MD; Alexandra J. Lansky, MD; Donald E. Cutlip, MD; Krishnankutty Sudhir MD, PhD; and Dean J. Kereiakes, MD for the SPIRIT IV Investigators

  2. Disclosures • Gregg W. Stone, MD • Scientific advisory boards for and honoraria from Abbott Vascular and Boston Scientific

  3. Background • In SPIRIT IV, the largest clinical trial to date comparing 2 DES, treatment with the everolimus-eluting XIENCE V stent compared to the paclitaxel-eluting TAXUS Express stent resulted in significantly reduced 1-year rates of target lesion failure (TLF), ischemia-driven TLR, MI and stent thrombosis • Whether these results are sustained at 2 years has not been reported

  4. Study Algorithm RVD ≥2.5 mm - ≤3.75 mm; Lesion length ≤28 mm Max. 3 lesions with a maximum of 2 per epicardial vessel 3690 pts enrolled at 66 U.S. sites Pre-rand:ASA≥300 mg, clopidogrel ≥300 mg load unless on chronic Rx Randomized 2:1 XIENCE V:TAXUS Express2 Stratified by diabetes and presence of complex lesions Pre-dilatation mandatory Everolimus-eluting XIENCE V Paclitaxel-eluting TAXUS Aspirin ≥80 mg QD for 5 years; clopidogrel 75 mg QD for at least 12 mos (if not at high risk for bleeding) Clinical f/u only: 1, 6, 9 months and yearly for 1-5 years

  5. Major Exclusion Criteria • Any target lesion or vessel meets any of the following: • Left main or ostial LAD/LCX • In or distal to a bypass graft conduit • Bifurcation with sidebranch diameter ≥2 mm AND ostial DS >50% OR requiring pre-dilatation • Total occlusion, thrombus, restenotic, excessive tortuosity, angulation or heavy calcification • Prior coronary brachytherapy • High probability of additional PCI within 9 months

  6. Patient Flow and Follow-up Enrolled (N=3690) 3 = Randomization errors Randomized (N=3687) TAXUS(N=1229) XIENCE V (N=2458) Lost to f/u = 40 Withdrawal = 8 Other = 0 22 = Lost to f/u 8 = Withdrawal 1 = Other 1-Year Follow-up*(N=3608; 97.9%) TAXUS(N=1198) XIENCE V (N=2410) Lost to f/u = 9 Withdrawal = 13 3 = Lost to f/u 5 = Withdrawal 2-Year Follow-up*(N=3578; 97.0%) TAXUS(N=1190) XIENCE V (N=2388) *F/U window: ± 28 days

  7. Baseline Demographics

  8. Baseline Angiography

  9. Procedural Results

  10. Antiplatelet Agent Utilization

  11. TLF* Through 2 Years HR [95%CI] = 0.70 [0.55, 0.89] XIENCE V (n=2458) TAXUS (n=1229) p=0.003 HR [95%CI] = 0.62 [0.46, 0.82] 9.9% p=0.0009 Δ 3.0% Target lesion failure (%) 6.7% 6.9% Δ 2.7% 4.0% Months *TLF (primary endpoint at 1 year) = cardiac death, target vessel MI, or ischemia-driven TLR

  12. Multivariable Predictors of TLF at 2 Years 0 1 2 TLF = cardiac death, target-vessel MI, or ischemia-driven TLR

  13. Ischemia-Driven TLR* Through 2 Years HR [95%CI] = 0.66 [0.50, 0.88] XIENCE V (n=2458) TAXUS (n=1229) p=0.004 HR [95%CI] = 0.54 [0.38, 0.78] 6.9% p=0.0007 Δ 2.4% Ischemia-driven TLR (%) 4.6% 4.5% Δ 2.2% 2.4% Months *Major secondary endpoint at 1 year

  14. Cardiac Death or TV MI* Through 2 Years HR [95%CI] = 0.75 [0.53, 1.07] XIENCE V (n=2458) TAXUS (n=1229) p=0.11 HR [95%CI] = 0.71 [0.47, 1.07] 4.2% p=0.10 Δ 1.1% 3.1% Cardiac death or MI (%) 3.1% Δ 0.9% 2.2% Months *Major secondary endpoint at 1 year; TV MI = Target-Vessel MI

  15. Cardiac Death and TV MI Through 2 Years Cardiac Death Target Vessel MI 2-year HR 2-year HR 1-year HR 1-year HR 0.73 [0.38, 1.40] 0.64 [0.41, 1.00] 0.66 [0.44, 0.99] 0.99 [0.34, 2.91] XIENCE V XIENCE V p=0.99 p=0.04 p=0.05 p=0.34 TAXUS TAXUS 3.5% 2.9% ∆1.2% ∆1.1% 2.3% 1.3% 1.8% ∆0.4% 0.4% ∆0.0% 0.9% 0.4% Months Months

  16. Clinical Outcomes at 2 Years Rates (%) are Kaplan-Meier estimates

  17. Stent Thrombosis (Protocol Definition)* HR [95%CI] = 0.30 [0.13, 0.68] XIENCE V (n=2458) TAXUS (n=1229) p=0.002 HR [95%CI] = 0.25 [0.09, 0.73] 1.25% p=0.006 Stent thrombosis (%) 0.82% Δ 0.92% Δ 0.62% 0.33% 0.20% Months *ACS + angiographic thrombus, or unexplained death or STEMI/Q-wave MI in TL distribution within 30 days

  18. Stent Thrombosis (Protocol Definition)* Early (0 – 30 days) Late (>30 days – 1 year) Very Late (>1 year) 0.04 XIENCE V N=2458 0.33% p=0.002 TAXUS N=1229 1.25% Stent thrombosis (%) *ACS + angiographic thrombus, or unexplained death or STEMI/Q-wave MI in TL distribution within 30 days Rates (%) are Kaplan-Meier estimates.

  19. Stent Thrombosis (ARC Def or Prob) HR [95%CI] = 0.36 [0.17, 0.79] XIENCE V (n=2458) TAXUS (n=1229) p=0.008 HR [95%CI] = 0.27 [0.11, 0.67] 1.23% p=0.003 1.06% Stent thrombosis (%) Δ 0.81% Δ 0.77% 0.42% 0.29% Months

  20. Stent Thrombosis (ARC Def or Prob) Early (0 – 30 days) Late (>30 days – 1 year) Very Late (>1 year) XIENCE V N=2458 0.42% p=0.008 TAXUS N=1229 1.23% Stent thrombosis (%) Rates (%) are Kaplan-Meier estimates.

  21. SPIRIT IV: 11 Subgroups Examined Diabetes (n=1131) Age ≥ 65 (n=1600) Age < 65 (n=1978) No diabetes (n=2443) Male (n=2433) Lesion number = Single (n=2686) Female (n=1145) Lesion number = Multi (≥2) (n=892) Hypertension* (n=2754) Lesion length > median (13.3 mm; n=1337) No hypertension* (n=819) Lesion length ≤ median (13.3 mm; n=1335) Hypercholesterolemia* (n=2679) RVD > median (2.75 mm; n=1343) No hypercholesterolemia* (n=841) RVD ≤ median (2.75 mm; n=1336) BMI ≥ 30 (n=1744) Bailout (n=312) BMI < 30 (n=1834) No bailout (n=3266) Stable angina (n=2068) No stable angina (n=1443) RVD and lesion length from the single lesion treated subgroup. * Requiring medication

  22. SPIRIT IV Subgroup Analysis: TLF at 2 Years 0.1 1 10 EES better PES better TLF = cardiac death, target vessel MI, or ischemia-driven TLR; 2 Years = 730 ± 28 days; *Requiring medication

  23. SPIRIT IV Subgroup Analysis: TLF at 2 Years 1 10 0.1 EES better PES better TLF = cardiac death, target vessel MI, or ischemia-driven TLR; 2 Years = 730 ± 28 days Single lesion treated data are used for RVD & lesion length subgroup analyses

  24. Impact of Diabetes on TLF at 2 years Pint=0.08 XIENCE V TAXUS RR = 0.61 [0.46, 0.81] p=0.0009 RR = 0.93 [0.65, 1.34] p=0.68 TLF (%) 97/1632 79/811 74/753 40/378 No Diabetes Diabetes TLF = cardiac death, target-vessel MI, or ischemia-driven TLR

  25. SPIRIT IV Conclusions • In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of the everolimus-eluting XIENCE V stent compared to the paclitaxel-eluting TAXUS Express stent present at 1-year were sustained at 2-years • At 2 year follow-up, treatment with XIENCE V rather than TAXUS resulted in: • A 30% relative (3.0% absolute) reduction in TLF • A 34% relative (2.4% absolute) reduction in ID-TLR • A 36% relative (1.4% absolute) reduction in MI • A 64% relative (0.8% absolute) reduction in stent thrombosis (ARC) • A 39% relative (3.8% absolute) reduction in TLF in pts without diabetes, and non significantly different rates of TLF in pts with diabetes • Consistent relative reductions in TLF in other complex subgroups (including multiple lesions, long lesions and small vessels)

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