Byrne Isar Desire 2
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Prospective, Randomized Trial of Paclitaxel- versus SirolimusEluting 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 acute gain
minimize 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
Clinical followup at 12 months
ISAR DESIRE 2
Baseline Characteristics Patients SES n = 225 66.4 20.8 38.2
PES n = 225 67.1 25.7 33.8
Stable
80.0
83.3
ACS
20.0
16.7
Age (years) Female Diabetes mellitus Clinical presentation
Numbers shown are percentages
ISAR DESIRE 2
Baseline Characteristics Lesions SES n = 243 2.78±.47 12.7±8.3
PES n = 240 2.75±.48 12.5±7.7
Cypher
38.7
38.3
ISAR stent
61.3
61.7
Vessel size Lesion length 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 37.5 6.6 30.0 4.9
ISAR DESIRE 2
PES n = 240 (%) 18.8 34.6 7.5 35.8 3.3
30-Day Results
Death Myocardial infarction TLR Death/MI/TLR
SES n = 225 0 1.3 0 1.3
PES n = 225 0.4 1.8 0 1.8
0
0
Stent thrombosis
Numbers shown are percentages; P = ns for all comparisons
ISAR DESIRE 2
Primary Endpoint Late Luminal Loss 0.9
mm
SES
PES P = 0.75
0.6 0.40
0.38
0.3
0.0
Late loss, in-stent
ISAR DESIRE 2
Secondary Endpoint Binary Restenosis 40
SES
PES
% 30 20
P = 0.69 19.0
20.6
10 0
Restenosis, in-segment
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 0.6
mm 0.40 0.3 0.21
0.19
DESIRE
DIABETES
0.23
0.0
SMART-3
DESIRE-2
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
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 acute gain
minimize 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
Clinical followup at 12 months
ISAR DESIRE 2
Baseline Characteristics Patients SES n = 225 66.4 20.8 38.2
PES n = 225 67.1 25.7 33.8
Stable
80.0
83.3
ACS
20.0
16.7
Age (years) Female Diabetes mellitus Clinical presentation
Numbers shown are percentages
ISAR DESIRE 2
Baseline Characteristics Lesions SES n = 243 2.78±.47 12.7±8.3
PES n = 240 2.75±.48 12.5±7.7
Cypher
38.7
38.3
ISAR stent
61.3
61.7
Vessel size Lesion length 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 37.5 6.6 30.0 4.9
ISAR DESIRE 2
PES n = 240 (%) 18.8 34.6 7.5 35.8 3.3
30-Day Results
Death Myocardial infarction TLR Death/MI/TLR
SES n = 225 0 1.3 0 1.3
PES n = 225 0.4 1.8 0 1.8
0
0
Stent thrombosis
Numbers shown are percentages; P = ns for all comparisons
ISAR DESIRE 2
Primary Endpoint Late Luminal Loss 0.9
mm
SES
PES P = 0.75
0.6 0.40
0.38
0.3
0.0
Late loss, in-stent
ISAR DESIRE 2
Secondary Endpoint Binary Restenosis 40
SES
PES
% 30 20
P = 0.69 19.0
20.6
10 0
Restenosis, in-segment
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 0.6
mm 0.40 0.3 0.21
0.19
DESIRE
DIABETES
0.23
0.0
SMART-3
DESIRE-2
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
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