Evaluation des endoprothèses coronaires à libération de principe actif - Drug eluting stents - A systematic review and meta-analysis of randomized clinical trials ; Cucherat M., 2008
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Evaluation des endoprothèses coronaires à libération de principe actif - Drug eluting stents - A systematic review and meta-analysis of randomized clinical trials ; Cucherat M., 2008

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Posted on Feb 19 2010 Rapport d'évaluation de la CEPP A summary statement in English will be available in due course. Posted on Feb 19 2010

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Publié par
Publié le 01 juillet 2009
Nombre de lectures 13
Licence : En savoir +
Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
Langue Français

Exrait

Prepared by:
Michel Cucherat, MD, PhD
Faculte de medecine Laennec
Lyon, France
mcu@upcl.univ-lyon1.fr
Drug eluting stents
A systematic review and meta-analysis of randomized clinical trials
2008 - 10 - 14
Prepared for
HAS
Part or all of the information presented in this document may be unpublished material and should be treated as
the con dential property of HAS, not to be divulged to unauthorized persons, in any form, including
publications and presentations, without the written consent of HAS.2CONTENTS 3
Contents
I Unparticular patients 7
1 Overview of available evidence for unparticular patients 9
1.1 Main results for Unparticular patients . . . . . . . . . . . . . . . . . . . . . . . . 14
1.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 14
1.3 versus paclitaxel eluting stent - summary of results . . . . . . . . . . 14
1.4 comparison versus sirolimus stent - of . . . . . . . . . . 15
2 Details for comparison versus bare-metal stent 29
2.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3 Details for comparison versus paclitaxel eluting stent 53
3.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4 Details for comparison versus sirolimus eluting stent 66
4.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
5 Ongoing studies of Unparticular patients 75
5.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
II Diabetic patients 77
6 Overview of available evidence for diabetic patients 79
6.1 Main results for Diabetic patients . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
6.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 83
6.3 versus paclitaxel eluting stent - summary of results . . . . . . . . . . 83
6.4 comparison versus rapamycin stent - of . . . . . . . . . 83
7 Details for comparison versus bare-metal stent 92
7.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
7.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
8 Details for comparison versus paclitaxel eluting stent 103
8.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
8.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
9 Details for comparison versus rapamycin eluting stent 110
9.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
9.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
10 Ongoing studies of Diabetic patients 113
10.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1134 CONTENTS
III Acute myocardial infarction 115
11 Overview of available evidence for acute myocardial infarction 117
11.1 Main results for Acute myocardial infarction . . . . . . . . . . . . . . . . . . . . . 120
11.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 120
11.3 versus paclitaxel eluting stent - summary of results . . . . . . . . . . 120
12 Details for comparison versus bare-metal stent 129
12.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
12.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
13 Details for comparison versus paclitaxel eluting stent 140
13.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
13.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
14 Ongoing studies of Acute myocardial infarction 147
14.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
IV Small vessels 149
15 Overview of available evidence for small vessels 151
15.1 Main results for small vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
15.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 154
15.3 versus paclitaxel eluting stent - summary of results . . . . . . . . . . 154
16 Details for comparison versus bare-metal stent 160
16.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
16.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
17 Details for comparison versus paclitaxel eluting stent 166
17.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
17.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
18 Ongoing studies of small vessels 173
18.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
V Long or complex lesion 175
19 Overview of available evidence for long or complex lesion 177
19.1 Main results for long or complex lesion . . . . . . . . . . . . . . . . . . . . . . . . 181
19.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 181
19.3 versus CABG - summary of results . . . . . . . . . . . . . . . . . . . 181
19.4 comparison versus paclitaxel eluting stent - summary of results . . . . . . . . . . 181
20 Details for comparison versus bare-metal stent 189
20.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
20.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
21 Details for comparison versus CABG 197
21.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
21.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199CONTENTS 5
22 Details for comparison versus paclitaxel eluting stent 202
22.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
22.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
23 Ongoing studies of long or complex lesion 211
23.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
VI In-stent restenosis 213
24 Overview of available evidence for in-stent restenosis 215
24.1 Main results for in-stent restenosis . . . . . . . . . . . . . . . . . . . . . . . . . . 219
24.2 comparison versus ballon angioplasty - summary of results . . . . . . . . . . . . 219
24.3 versus brachytherapy - summary of results . . . . . . . . . . . . . . 219
24.4 comparison versus paclitaxel eluting stent - summary of results . . . . . . . . . . 219
25 Details for comparison versus ballon angioplasty 225
25.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
25.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
26 Details for comparison versus brachytherapy 230
26.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
26.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
27 Details for comparison versus paclitaxel eluting stent 236
27.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
27.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
28 Ongoing studies of in-stent restenosis 241
28.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
VII Bypass graft lesions 243
29 Overview of available evidence for bypass graft lesions 245
29.1 Main results for bypass graft lesions . . . . . . . . . . . . . . . . . . . . . . . . . 247
29.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 247
30 Details for comparison versus bare-metal stent 251
30.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
30.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
31 Ongoing studies of bypass graft lesions 257
31.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
VIII Unprotected left main coronary artery stenosis 259
32 Overview of available evidence for unprotected left main coronary artery
stenosis 261
32.1 Main results for unprotected left main coronary artery stenosis . . . . . . . . . . 263
32.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 2636 CONTENTS
33 Details for comparison versus bare-metal stent 266
33.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
33.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
34 Ongoing studies of unprotected left main coronary artery stenosis 271
34.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271
IX Total occlusion 273
35 Overview of available evidence for total occlusion 275
35.1 Main results for total occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
35.2 comparison versus bare-metal stent - summary of results . . . . . . . . . . . . . 277
36 Details for comparison versus bare-metal stent 280
36.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
36.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
37 Ongoing studies of total occlusion 287
37.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
X Bifurcation 289
38 Overview of available evidence for bifurcation 291
38.1 Main results for bifurcation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293
38.2 comparison versus paclitaxel eluting stent - summary of results . . . . . . . . . . 293
39 Details for comparison versus paclitaxel eluting stent 295
39.1 Available RCTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
39.2 Meta-analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
40 Ongoing studies of bifurcation 299
40.1 List of ongoing trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299Part I
Unparticular patients
789
1 Overview of available evidence for unparticular
patients
A total of 34 RCTs which randomized 19365 patients were identi ed. (see tables 1.1 to 1.3 )
In all, 22 reports concerned comparison versus bare-metal stent , 10 the comparison versus
paclitaxel eluting stent and 2 the versus sirolimus eluting stent.
The detailed descriptions of trials and meta-analysis results is given in section 2 (page 29)
for comparison versus bare-metal stent, in section 3 (page 53 ) for comparison versus paclitaxel
eluting stent and in section 4 (page 66 ) for comparison versus sirolimus eluting stent.
The average study size was 605 patients per arm (range 15 to 1065 per arm). The rst study
was published in 2002, and the last study was published in 2008. 10 trials were double blind
and 14 were open-label in design. All included studies were reported in English language. We
found one unpublished trial.10CHAPTER1. OVERVIEWOFAVAILABLEEVIDENCEFORUNPARTICULARPATIENTS
Table 1.1: Main study characteristics - Unparticular patients - comparison versus bare-metal stent
Trial Comparison E ectives Blinding Design Primary Localisation
endpoint
comparison versus bare-metal stent
Dactinomycin eluting stent versus bare-metal stent
ACTION, 2004 [1, 2] Multilink Tetra stent 241 vs. 119 single-blind Parallel groups major adverse worldwide
vs. uncoated Multilink cardiac events at
Tetra stent 30d
Everolimus eluting stent versus bare-metal stent
SPIRIT III, 2008 XIENCE V vs. Taxus 669 vs. 333 single-blind Parallel groups in-segment late US
[3, 4] loss
FUTURE II, 2006 CHAMPION vs. 43 vs. 21 double-blind Parallel groups angiographic late NA
[5, 6, 7] bare-metal stent loss at 6 months
unpublished
FUTURE I, 2004 [8] everolimus coated 27 vs. 15 single-blind Parallel groups MACE Germany
S-Stent vs. S-Stent
SPIRIT I, 0 XIENCE vs. 28 vs. 32 single-blind Parallel groups in-stent late loss NA
[9, 10, 11] MULTI-LINK VISION
unpublished
SPIRIT II, 0 [] XIENCE V vs. TAXUS 223 vs. 77 single-blind Parallel groups In-stent late loss NA
unpublished EXPRESS2 (patient)
Paclitaxel eluting stent versus bare-metal stent
SCORE, 2004 QuaDDS stents 126 vs. 140 open Parallel groups none Worldwide
[12, 13] (paclitaxel) vs.
uncoated control stents
TAXUS IV, 2004 TAXUS vs. EXPRESS 662 vs. 652 double-blind Parallel groups TVR United States
[14]
TAXUS I, 2003 [15] TAXUS NIR vs. NIR 31 vs. 30 double-blind Parallel groups Combination of Germany
stent death,AMI,
TVR, stent
thrombosis
TAXUS II, 2003 [16] TAXUS vs. NIR stent 266 vs. 270 double-blind Parallel groups Neointimal Global
proliferation
Paclitaxel, non-polymeric eluting stent versus bare-metal stent
continued...

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