Prospective Randomized Trial of Paclitaxel versus Sirolimus Eluting

Background • The widespread adoption of DES therapy has led to significant absolute numbers

Background • The optimal treatment strategy for instent restenosis is based on the axiom:

Background • In DES-restenosis the most effective management strategy is unclear • While repeat

Background • SES have proven superior to PES in subsets of patients with high-risk

Study Objective • To compare the anti-restenotic efficacy of SES (Cypher) versus PES (Taxus)

Study Organization Design 450 patients enrolled at two centres in Munich, Germany • DESIGN:

Baseline Characteristics Patients SES n = 225 PES n = 225 Age (years) 66.

Baseline Characteristics Lesions SES n = 243 PES n = 240 Vessel size 2.

Baseline Characteristics Lesions – Restenosis Morphology Focal margin Focal body Multifocal Diffuse/proliferative Occlusive SES

30 -Day Results SES n = 225 PES n = 225 0 0. 4

Primary Endpoint Late Luminal Loss mm P = 0. 75 ISAR DESIRE 2

Secondary Endpoint Binary Restenosis % P = 0. 69 ISAR DESIRE 2

Secondary Endpoint TLR 50 40 rate, % P = 0. 52 30 20 SES

Safety Endpoint Death, MI or Stent Thrombosis 50 40 rate, % P = 0.

Major Adverse Cardiac Events Death, MI or TLR 50 40 rate, % P =

Conclusions • Repeat DES implantation for DESrestenosis is safe out to 1 year •

SES (Cypher) Efficacy Late Luminal Loss mm ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM 2005 ISAR-SMART-3

Conclusions • Drug resistance at an individual patient level may play a contributory role

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Prospective, Randomized Trial of Paclitaxel- versus Sirolimus. Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents Robert A. Byrne, Julinda Mehilli, Klaus Tiroch, Stefanie Schulz, Steffen Massberg, Karl-Ludwig Laugwitz, Albert Schömig, Adnan Kastrati Deutsches Herzzentrum & 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich. Germany ISAR-DESIRE 2

Background • The widespread adoption of DES therapy has led to significant absolute numbers of patients presenting with DES-restenosis • It is estimated that up to 200, 000 cases per annum occur in USA ISAR DESIRE 2

Background • The optimal treatment strategy for instent restenosis is based on the axiom: ¡ maximize ¡ minimize acute gain late loss • In BMS-restenosis this has most effectively been accomplished by DES ISAR-DESIRE JAMA 2005; RIBS-II JACC 2006 TAXUS-V-ISR JAMA 2006; SISR JAMA 2006 ISAR DESIRE 2

Background • In DES-restenosis the most effective management strategy is unclear • While repeat DES implantation seems preferable, optimal stent type is not known ¡ Different DES (“hetero-DES”) ¡ Same DES (“homo-DES”) Lee et al. AJC 2006; Cosgrave et al. AHJ 2007 Garg et al. CCI 2007; Byrne et al. Rev Esp Card 2008 ISAR DESIRE 2

Background • SES have proven superior to PES in subsets of patients with high-risk features • The comparative performance of both stents in SES treatment failure is not known ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM 2005 SIRTAX NEJM 2005; ISAR-SMART-3 EHJ 2006; Schömig et al. JACC 2007 ISAR DESIRE 2

Study Objective • To compare the anti-restenotic efficacy of SES (Cypher) versus PES (Taxus) in patients with SES-restenosis ISAR DESIRE 2

Study Organization Design 450 patients enrolled at two centres in Munich, Germany • DESIGN: Randomized, openlabel, active-control trial • INCLUSION CRITERIA: 1. In-SES restenosis > 50% 2. Symptoms/signs of ischaemia • EXCLUSION CRITERIA: 1. Cardiogenic shock 2. Lesion in LMCA or graft 3. Acute myocardial infarction • PRIMARY ENDPOINT: In-stent late loss SES (Cypher) n = 225 PES (Taxus) n = 225 Angiographic follow-up at 6 -8 months (84. 8%) Angiographic follow-up at 6 -8 months (84. 9%) Clinical followup at 12 months ISAR DESIRE 2

Baseline Characteristics Patients SES n = 225 PES n = 225 Age (years) 66. 4 67. 1 Female Diabetes mellitus Clinical presentation 20. 8 38. 2 25. 7 33. 8 Stable 80. 0 83. 3 ACS 20. 0 16. 7 Numbers shown are percentages ISAR DESIRE 2

Baseline Characteristics Lesions SES n = 243 PES n = 240 Vessel size 2. 78±. 47 2. 75±. 48 Lesion length 12. 7± 8. 3 12. 5± 7. 7 Cypher 38. 7 38. 3 ISAR stent 61. 3 61. 7 Initial SES Numbers shown are mean±SD or percentages ISAR DESIRE 2

Baseline Characteristics Lesions – Restenosis Morphology Focal margin Focal body Multifocal Diffuse/proliferative Occlusive SES n = 243 (%) 21. 0 PES n = 240 (%) 18. 8 37. 5 6. 6 30. 0 4. 9 34. 6 7. 5 35. 8 3. 3 ISAR DESIRE 2

30 -Day Results SES n = 225 PES n = 225 0 0. 4 1. 3 0 1. 3 1. 8 0 0 Death Myocardial infarction TLR Death/MI/TLR Stent thrombosis Numbers shown are percentages; P = ns for all comparisons ISAR DESIRE 2

Primary Endpoint Late Luminal Loss mm P = 0. 75 ISAR DESIRE 2

Secondary Endpoint Binary Restenosis % P = 0. 69 ISAR DESIRE 2

Secondary Endpoint TLR 50 40 rate, % P = 0. 52 30 20 SES 16. 6% 10 PES 14. 6% 0 0 2 4 6 ISAR DESIRE 2 8 10 12 months

Safety Endpoint Death, MI or Stent Thrombosis 50 40 rate, % P = 0. 98 30 20 PES 6. 3% 10 SES 6. 1% 0 0 2 4 6 ISAR DESIRE 2 8 10 12 months

Major Adverse Cardiac Events Death, MI or TLR 50 40 rate, % P = 0. 71 30 SES 20. 4% 20 PES 19. 6% 10 0 0 2 4 6 ISAR DESIRE 2 8 10 12 months

Conclusions • Repeat DES implantation for DESrestenosis is safe out to 1 year • In cases of SES-restenosis, both SES and PES are associated with a comparable degree of anti-restenotic efficacy ISAR DESIRE 2

SES (Cypher) Efficacy Late Luminal Loss mm ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM 2005 ISAR-SMART-3 EHJ 2006 ISAR DESIRE 2

Conclusions • Drug resistance at an individual patient level may play a contributory role in the somewhat lower anti-restenotic efficacy of SES in this study ISAR DESIRE 2

Thank You ISAR DESIRE 2