Prospective, Randomized Trial of Paclitaxel- versus...
Transcript of Prospective, Randomized Trial of Paclitaxel- versus...
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
Prospective, Randomized Trial of Paclitaxel- versus Sirolimus-Eluting Stents for Treatment of
Coronary Restenosis in Sirolimus-Eluting Stents
Intracoronary Stenting and Angiographic Results: Drug Eluting
Stents for In-Stent Restenosis ISAR-DESIRE 2
ISAR DESIRE 2ISAR DESIRE 2
Study Organization
450 patients enrolled at two centres in Munich, Germany
Angiographic follow-up at 6-8 months (84.8%)
Clinical follow-up at 12 months
Clinical follow-up at 12 months
Angiographic follow-up at 6-8 months (84.9%)
SES (Cypher)n = 225
PES (Taxus)n = 225
Design
• DESIGN: Randomized, open-label, active-control trial
• INCLUSION CRITERIA: 1. In-SES restenosis > 50%2. Symptoms/signs of ischemia
• EXCLUSION CRITERIA:1. Cardiogenic shock2. Lesion in LMCA or graft3. Acute myocardial infarction
ISAR DESIRE 2ISAR DESIRE 2
Study Organization
450 patients enrolled at two centres in Munich, Germany
Angiographic follow-up at 6-8 months (84.8%)
Clinical follow-up at 12 months
Clinical follow-up at 12 months
Angiographic follow-up at 6-8 months (84.9%)
SES (Cypher)n = 225
PES (Taxus)n = 225
Design
• PRIMARY ENDPOINT:In-stent late loss
• ASSUMPTIONS: Late loss SES = 0.60mmLate loss PES = 0.40mmPower: 90%α-level: 0.05
• SAMPLE SIZE ESTIMATION:190 patients with angiographic follow-up in each group
ISAR DESIRE 2ISAR DESIRE 2
Primary EndpointLate Luminal Loss
P = 0.75
Cum
ulat
ive
rate
, %
0
20
40
60
80
100
-2 -1 0 1 2 3 LLL, mm
PESSES
ISAR DESIRE 2ISAR DESIRE 2
Secondary EndpointBinary Restenosis
19.020.6
0
10
20
30
40
Restenosis, in-segment
SES PES
P = 0.69%
ISAR DESIRE 2ISAR DESIRE 2
Secondary EndpointTLR
0
10
20
30
40
50
0 2 4 6 8 10 12
rate
, %
months
SES 16.6%SES 16.6%
PES 14.6%PES 14.6%
P P = 0.52= 0.52
ISAR DESIRE 2ISAR DESIRE 2
Death, MI or Stent Thrombosisra
te, %
months
0
10
20
30
40
50
0 2 4 6 8 10 12
SES 6.1%SES 6.1%
P P = 0.98= 0.98
Safety Endpoint
PES 6.3%PES 6.3%
ISAR DESIRE 2ISAR DESIRE 2
Death, MI or TLRra
te, %
months
0
10
20
30
40
50
0 2 4 6 8 10 12
Major Adverse Cardiac Events
P P = 0.71= 0.71
SES 20.4%SES 20.4%
PES 19.6%PES 19.6%
ISAR DESIRE 2ISAR DESIRE 2
Conclusions
• Repeat DES implantation for DES-restenosis 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 2ISAR DESIRE 2
0.40
0.230.190.21
0.0
0.3
0.6
DESIRE DIABETES SMART-3 DESIRE-2
Late Luminal Loss
mm
SES (Cypher) Efficacy
ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM 2005 ISAR-SMART-3 EHJ 2006