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Comparison of Paclitaxel-Eluting vs. Everolimus-Eluting Stents in Diabetes Mellitus and Coronary Disease: 1-Year Results

Investigating the efficacy of two stents in diabetic patients with coronary artery disease over one year. Results show non-inferiority in clinical outcomes.

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Comparison of Paclitaxel-Eluting vs. Everolimus-Eluting Stents in Diabetes Mellitus and Coronary Disease: 1-Year Results

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  1. Paclitaxel Eluting Versus Everolimus Eluting Stents in Patients with Diabetes Mellitus and Coronary Artery Disease One Year Clinical Results Upendra Kaul, MDfor the TUXEDO INDIA Investigators

  2. Tuxedo India Disclosures • Upendra Kaul, MD • Boston Scientific: Research Grant and Lecture Fee • Abbott Vascular: Lecture Fee

  3. Tuxedo India PCI in Patients With Diabetes Why are They at Increased Risk ? • More extensive disease, more complex lesions • Clustering of risk factors and co-morbidities • Profound proliferative vascular response High risk for restenosis • Prothrombotic state: Increased platelet activation, increased levels of tissue factor, fibrinogen and PAI-I • Endothelial dysfunction High risk for stent thrombosis DES have replaced BMS in diabetics because of reduced ISR and need for TVR

  4. Tuxedo India TUXEDO- India Background • Choice of a DES in diabetic population has been debatable • Results between Limusanalogues and Paclitaxel have been contradictory • A meta analysis of Spirit II, III, IV and Compare studies showed equivalent results between PES and EES in diabetics (Stone GW et al. Circulation 2011;124:893-900) • On the contrary, in a mixed treatment analysis of 48 randomized trials EES was shown to be the best in diabetics (Bangalore S, et al. BMJ 2012;345:e5170) • In the absence of a dedicated adequately powered randomized study a definitive answer is not possible

  5. Tuxedo India Tuxedo India Study Algorithm RVD ≥2.25 mm - ≤4 mm; Lesion length ≤34 mm Upto 3 lesions with a maximum of 2 per epicardial vessel 1830 patients enrolled at 46 Indian sites Pre-rand: ASA ≥300 mg, clopidogrel ≥300 mg load unless on chronic Rx or Prasugrel 60 mg or Ticagrelor 180 mg Randomized 1:1 TAXUS ElementTM : XIENCE PrimeTM Pre-dilatation mandatory Paclitaxel-eluting TAXUS Everolimus-eluting XIENCE Aspirin ≥75 mg QD for long term; clopidogrel 75mg QD for at least 12 months or Ticagralor 90 mg BD or Prasugrel 10 mg OD (if not at high risk for bleeding) Clinical f/u only: 1, 6 months, 1 year and 2 years

  6. Tuxedo India End Points Patients with Stable CHD or ACS undergoing PCI 1:1 Randomization Paclitaxel-eluting stent (TAXUS ) Everolimus-eluting stent (XIENCE) Primary Endpoint: TVF: Composite of Cardiac Death, Target vessel MI or Ischemia-Driven TVR at 1-Year Secondary Endpoints: Death, Cardiac Death, MI, TLR, TVR, MACE, Definite and Probable ST

  7. Tuxedo India Sample Size Calculation • Statistical Method • A two-group Farrington-Manning test was used to test the one-sided hypothesis of non inferiority in proportions. • Sample Size Parameters • Expected TAXUS Element™TVF rate = 8.4% • Expected XIENCE Prime™TVF rate = 8.4% (based on data from the SPIRIT trials) • Non-inferiority margin (Δ) = 4.0% (absolute) • Test significance level () = 0.05 (1-sided) • Power (1) = approximately 0.90 • Expected rate of attrition = 10% • N=1,830 patients

  8. Tuxedo India Key Eligibility Criteria For Enrolment

  9. Tuxedo India Tuxedo India Patient Flow Enrolled (N=1851) 21 = Screen Failed Randomized (N=1830) XIENCE(N=916) TAXUS (N=914) Withdrawal = 12 Lost to f/u = 10 Investigator decision = 5 9 = Withdrawal 9 = Lost to f/u 2 = Investigator decision 1-Year Follow-up(N=1783; 97.4%) XIENCE(N=896) TAXUS (N=887)

  10. Tuxedo India Baseline Demographics (ITT Analysis)

  11. Tuxedo India Baseline Clinical Data (ITT Analysis)

  12. Tuxedo India Lesion Details (ITT Analysis)

  13. Tuxedo India Procedural Characteristics (ITT Analysis) * Statistically significant

  14. Tuxedo India Antiplatelet Agent Used XIENCE TAXUS P=0.04 NA P=0.04 (%) 916/916 914/914 647/914 688/916 647/914 688/916 Aspirin + Ticagrelor/Prasugrel or Clopidogrel Aspirin + Clopidogrel Aspirin + Ticagrelor/Prasugrel

  15. Tuxedo India Non-inferiority Assessment for the Primary Efficacy Endpoint Target Vessel Failure TAXUS 5.6% vs. XIENCE 2.9% P non-inferiority = 0.38 Difference: 2.7% Upper one-sided 95% CI: 4.48% 3.0% −1.0% 0% 1.0% 4.0% 2.0% 5.0% Non-inferiority margin

  16. Tuxedo India Target Vessel Failure Rate at 1 Year HR [95%CI] = 1.64 [1.09-2.47] P=0.02 by log-rank test PNI=0.38 by F-M test PSUP= 0.005 PES EES *5.9% Cumulative Incidence (%) *3.2% Months *Events calculated with Kaplan-Meier methods and compared with the use of the log-rank test. Differs slightly from graph which were calculated as categorical variables and compared with use of Chi-Square test.

  17. Tuxedo India Components of TVF XIENCE TAXUS P=0.002 P<0.001 P=1.00 (%) 26/914 5/916 16/914 16/916 11/916 31/914

  18. Ischemia Driven TLR Rate at 1 Year HR [95%CI] = 2.18 [1.20-3.95] P=0.009 by log-rank test TAXUS XIENCE Cumulative Incidence (%) Months *Events calculated with Kaplan-Meier methods and compared with the use of the log-rank test. Differs slightly from graph which were calculated as categorical variables and compared with use of Chi-Square test.

  19. Tuxedo India Death and MI at 1 Year

  20. Tuxedo India Cardiac Death or TV-MI Rate at 1 Year HR [95%CI] = 1.69 [1.04-2.75] P=0.03 by log-rank test TAXUS XIENCE Cumulative Incidence (%) Months *Events calculated with Kaplan-Meier methods and compared with the use of the log-rank test. Differs slightly from graph which were calculated as categorical variables and compared with use of Chi-Square test.

  21. Tuxedo India Stent Thrombosis Rate at 1 Year HR [95%CI] = 5.08 [1.74-14.87] P<0.001 by log-rank test TAXUS XIENCE Cumulative Incidence (%) Months *Events calculated with Kaplan-Meier methods and compared with the use of the log-rank test. Differs slightly from graph which were calculated as categorical variables and compared with use of Chi-Square test.

  22. Tuxedo India Stent Thrombosis Acute (<24 hours) Subacute (24 hours – 30 days) Late (>30 days – 1 year) 2.1% TAXUS n=914 P=0.002 0.4% XIENCEn=916 Stent thrombosis (%)

  23. Tuxedo India Tuxedo India: 12 Subgroups Examined Age < 65 (n=1372) No. of Treated Lesions = 1 (n=1344) Age ≥ 65 (n=458) No. of Lesion Treated Lesion ≥ 2 (n=457) Male (n=1377) Female (n=453) Insulin Therapy Requirement (n=747) Lesion Type A (n=84) No requirement (n=1083) Lesion Type B (n=969) Lesion Type C (n=987) Hb1Ac < 7% (n=419) Lesion Length ≤ 20 mm (n=1186) Hb1Ac ≥ 7% (n=1259) Lesion Length > 20 mm (n=824) eGFR ≤ 60 ml/min (n=347) Target Vessel LAD (n=1056) eGFR > 60 ml/min (n=1474) Non-LAD (n=1027) ACS (n=1186) Stable angina (n=644) RVD ≤ 2.75 mm (n=949) Duration of Diabetes < 5 Years (n=893) Duration of Diabetes ≥ 5 Years (n=837) RVD > 2.75 mm (n=1048)

  24. Tuxedo India Tuxedo India Sub group Analysis: TVF at 1 Year PES better EES better TVF = cardiac death, target vessel MI, or ischemia-driven TVR

  25. Tuxedo India Tuxedo India Sub group Analysis: TVF at 1 Year PES better EES better

  26. Tuxedo India Tuxedo India Conclusions In this largest trial of patients with diabetes, paclitaxel-eluting stent compared to everolimus-eluting stent at 1-year follow-up demonstrated: • Primary endpoint: PES failed to meet non-inferiority as compared to EES. Had higher rates of TVF. On superiority testing EES proved superior. • Major secondary endpoints: Significantly higher rates of MI, stent thrombosis, TVR, TLR, composite of cardiac death or TV-MI and MACE for PES arm. • Subgroup Analysis: Insulin requiring diabetics behaved like non insulin requiring with EES superior to PES. • The only subgroup where PES and EES had similar results were patients with an e GFR of <60 ml/min.

  27. Tuxedo India Clinical Implications • The study supports the current worldwide practice of use of new generation limus stents even in patients with insulin requiring diabetes mellitus. This may have important implications for PES. • The results question the outcomes of FREEDOM and BARI-2D showing superiority of CABG since Ist generation stents which are inferior to EES were used as comparators.

  28. Tuxedo India TUXEDO – Study OrganizationInvestigator Initiated Study Principal Investigator : Upendra Kaul Operations Committee : Priyadarshini Arambam (Head) Steering Committee : Ashok Seth (Chair) CEC : Sanjay Tyagi MD (Chair) DSMB : Rajendra Tandon MD (Chair) Randomization Service : Max Neeman International Data Management : Max NeemanInternational Funded by : Boston Scientific Corp

  29. Tuxedo India TUXEDO – Participating Centres (N=46)

  30. Tuxedo India TUXEDO –Top 15 Enrollers

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