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Robert A. Byrne, MB MRCPI

ISAR-TEST-2 Trial Two-year Clinical and Angiographic Outcomes from a Randomized Trial of Polymer-Free Dual Drug-Eluting Stents versus Polymer-Based Cypher and Endeavor Drug-Eluting Stents. Robert A. Byrne, MB MRCPI

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Robert A. Byrne, MB MRCPI

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  1. ISAR-TEST-2 TrialTwo-year Clinical and Angiographic Outcomes from a Randomized Trial of Polymer-Free Dual Drug-Eluting Stents versus Polymer-Based Cypher and Endeavor Drug-Eluting Stents Robert A. Byrne, MB MRCPI Adnan Kastrati, MD; Klaus Tiroch, MD; Stefanie Schulz, MD; Jürgen Pache, MD; Susanne Pinieck; Steffen Massberg, MD; Melchior Seyfarth, MD; Karl-Ludwig Laugwitz, MD; Katrin A. Birkmeier, MD; Albert Schömig, MD; Julinda Mehilli, MD Deutsches Herzzentrum & 1. Med. Klinikum rechts der IsarTechnische Universität Munich Germany ACC/i2 2010 – LBCT III

  2. Presenter Disclosure Information Lecture fees from Medtronic

  3. Background • First generation DES systems deliver high antirestenotic efficacy in comparison with BMS but do so at the cost of a delay in structural and functional healing of stented segment

  4. Delayed Arterial Healing * Incomplete Endothelialisation Late Fibrin Deposition Chronic Inflammation Platelet Activation Byrne, Joner, Kastrati Minerva Cardioangiol 2009

  5. Delayed Arterial Healing * Incomplete Endothelialisation Late Fibrin Deposition Inflammatory Response to Polymer Residue May Play a Central Role Chronic Inflammation Platelet Activation Byrne, Joner, Kastrati Minerva Cardioangiol 2009

  6. Background • Avoidance of polymer imposes efficacy limitations related to suboptimal drug release kinetics • The incorporation of a second active agent targeted at a different element of the restenotic response cascade is a potential option to enhance anti-restenotic performance • Probucol is a potent antioxidant which is also highly lipophilic and enhances the release kinetics of sirolimus

  7. Aim of ISAR-TEST-2 Study to compare the anti-restenotic efficacy of: polymer-free sirolimus+probucol-eluting stent (Dual-DES) with permanent polymer sirolimus-eluting stent (Cypher) and permanent polymer zotarolimus-eluting stent (Endeavor) in patients with coronary artery disease

  8. Patient Selection Inclusion Criteria • “De novo” lesions in native coronary arteries • Written informed consent Exclusion Criteria • Left main lesion • Cardiogenic shock • Comorbidities with a life expectancy < 12 months • Contraindication to aspirin, limus agents, probucol, stainless steel, thienopyridines

  9. ISAR-TEST-2 Study Endpoints Two-year Safety Endpoints: • Composite of death and myocardial infarction • Stent thrombosis according to ARC criteria Two-year Efficacy Endpoints: • Target lesion revascularization (TLR) due to restenosis in the presence of symptoms or signs of ischemia • Compositebinary restenosisat 2 yearsbased on latest available angiogram (whether at 6-8 months or 2 years)

  10. ISAR-TEST-2 Study Flow 1007 pts randomized Cypher 335 pts Dual-DES 333 pts Endeavor 339 pts 828 pts (82.2%) with 6-8-mo. angiogram 493 pts(67.3% eligible) with 2-yr. angiogram 942 pts(93.6%) with 2-year clinical FU* *Among n=65 patients without 2-yr FU, median FU was 21 [20-22] months

  11. Age, years 67±11 67±11 67±11 Women 23 25 23 Arterial hypertension 65 68 64 Diabetes 29 26 27 Current smoker 20 18 17 Hypercholesterolemia 63 66 69 History of MI 25 26 30 Baseline Clinical Characteristics Dual-DES n=333 Endeavor n=339 Cypher n=335 Data are percentage or mean ± standard deviation; Percentages may not total 100 due to rounding

  12. Endeavor n=339 Dual-DES n=333 Cypher n=335 15 13 12 30 25 30 56 58 61 55±10 53±12 52±12 Baseline Clinical Characteristics Acute MI Unstable angina Stable angina LV ejection fraction (%) Data are percentage or mean ± standard deviation; Percentages may not total 100 due to rounding

  13. Dual-DES n=427 Cypher n=419 Endeavor n=420 44 49 41 25 25 31 31 26 29 81 86 83 73 70 75 12 12 12 Angiographic Characteristics Target vessel LAD LCx RCA Multivessel disease Complex lesions Total occlusions Data are percentage; percentages may not total 100 due to rounding

  14. Vessel size, mm 2.69±.52 2.75±.46 2.71±.49 Lesion length, mm 14.0±8.2 14.8±8.3 14.7±8.0 MLD after PCI, mm 2.49±.48 2.55±.43 2.51±.47 DS after PCI, % 11.6±5.0 10.8±5.7 10.7±7.0 QCA Measurements Dual-DES n=427 Cypher n=419 Endeavor n=420 Data are mean ± standard deviation

  15. Primary Results ISAR-TEST-2

  16. ISAR-TEST-2 ISAR-TEST-2 Eur Heart J 2009

  17. Binary Angiographic Restenosis 6-8 months p=0.003 % Dual-DES Cypher Endeavor

  18. p=0.68 p=0.002 Binary Angiographic Restenosis 6-8 months % Dual-DES Cypher Endeavor

  19. Two-year Results ISAR-TEST-2

  20. 50 % 40 30 20 10 0 mos 24 0 2 4 6 8 10 12 14 16 18 20 22 Death or myocardial infarction p=0.61 Cypher SES 10.2% Dual-DES 7.8% Endeavor ZES 9.2%

  21. Cypher Dual-DES Endeavor Stent Thrombosis at 2 years Incidence % p=0.87 p=0.37 p=0.67 Definite Probable Possible

  22. Cypher Dual-DES Endeavor Target Lesion Revascularization p=0.009 % 1 yr 2 yrs 1 yr 2 yrs 1 yr 2 yrs

  23. Cypher Dual-DES Endeavor Target Lesion Revascularization p=0.009 p=0.72 % Δ = 3.5% Δ = 0.9% Δ = 0.7% 1 yr 2 yrs 1 yr 2 yrs 1 yr 2 yrs

  24. Cypher Dual-DES Endeavor Binary restenosis p=0.045 % 6-8 m 2 yrs* 6-8 m 2 yrs* 6-8 m 2 yrs*

  25. Cypher Dual-DES Endeavor Binary restenosis p=0.016 p=0.28 % Δ = 6.8% Δ = 2.9% Δ = 1.6% 6-8 m 2 yrs* 6-8 m 2 yrs* 6-8 m 2 yrs*

  26. Conclusions • The occurrence of safety events beyond 1 year was rare; there was no signal of a differential safety profile between the Dual-DES, Cypher and Endeavor out to 2 years • The antirestenotic efficacy of both Dual-DES and Endeavor remained durable between 1 and 2 years with Dual-DES maintaining an edge • There was evidence of a slight decrement in efficacy with Cypher from 1 to 2 years

  27. Thank You ISAR-TEST-2 Trial Deutsches Herzzentrum, Munich. Germany

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