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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. 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 • This pathophysiological process underlies the surfeit of late adverse events seen with this technology • Polymer residue seems to play a key role

  3. 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 lipophilic antioxidant which has proven effects in reducing restenosis

  4. 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

  5. ISAR-TEST-2 Study Flow 1007 pts randomized Cypher 335 pts Dual-DES 333 pts Endeavor 339 pts 274 pts with 6-8-mo. angiogram 268 ptswith 6-8-mo. angiogram 286 ptswith 6-8-mo. angiogram 167 pts with 2 year angiogram 164 ptswith 2 year angiogram 162 ptswith 2 year angiogram Clinical follow-up data to 2 years was available for all but 65 of 1007 enrolled patients Among patients without 2-yr FU, median FU was 21 [20-22] months

  6. 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 • Pregnancy

  7. ISAR-TEST-2 Study Endpoints Two-year Safety Endpoints: • Composite of death and myocardial infarction • Definite stent thrombosis Two-year Efficacy Endpoints: • Target lesion revascularization (TLR) due to restenosis in the presence of symptoms or signs of ischemia • Delta-TLR between 1 and 2 years • Compositebinary restenosis at 2 years based on latest available angiogram available (whether at 6-8 months or 2 years)

  8. ISAR-TEST-2 Study Stent Types 100 µm 10 µm • Sirloimus-eluting stent with permanent polymer (Cypher) • Sirolimus+probucol-eluting stent (Dual-DES) • Zotarolimus-eluting stent with permanent polymer (Endeavor) Microporous thin-strut (87 μm) 316L Stainless Steel Polymer-free; dual drug-eluting Developed in setting of ISAR Project

  9. Statistical Analysis Study hypothesis: • Cypher, Dual-DES and Endeavor stents would have different anti-restenotic efficacy based on an angiographic endpoint (binary restenosis) at 6-8 months • Additional analyses are exploratory in nature and should be regarded as hypothesis generating

  10. 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

  11. 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

  12. 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

  13. 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

  14. Primary Results ISAR-TEST-2

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

  16. p=0.68 p=0.002 Binary Angiographic Restenosis 6-8 months p=0.003 % Dual-DES Cypher Endeavor

  17. Two-year Results ISAR-TEST-3

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

  19. Definite Stent Thrombosis - 2 years - Cypher Incidence, % Dual-DES P = ns Endeavor

  20. 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

  21. Cypher Dual-DES Endeavor Binary restenosis * 2-year composite 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*

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

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

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