| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | versus bare-metal No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PASSION, 2006 | paclitaxel eluting stent vs bare-metal stent | | | MACE at 5yr 0.81 [0.57; 1.16] all cause mortality 0.70 [0.36; 1.36] MI 0.84 [0.26; 2.71] target lesion revascularisation (TLR ) 0.70 [0.38; 1.29] 4 yr TLR 0.67 [0.39; 1.16] 4 yr MI 1.49 [0.72; 3.09] 4 yr stent thrombosis 1.98 [0.67; 5.84] | | HAAMU-STENT, 2006 | paclitaxel eluting stent vs bare-metal stent | | | all cause mortality 2.14 [0.67; 6.80] Stent thrombosis (any, end of follow-up) 0.36 [0.04; 3.35] | | HORIZONS-AMI Stent, 2008 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.59 [0.42; 0.83] angiographic restenosis 0.44 [0.33; 0.58] target-vessel revascularization 0.65 [0.49; 0.86] 2 yr TLR 0.58 [0.44; 0.76] | | all cause mortality 1.01 [0.65; 1.56] MACE 1.02 [0.77; 1.35] MI 0.82 [0.56; 1.21] Stent thrombosis (any, end of follow-up) 0.93 [0.59; 1.46] 2 yr MACE 0.98 [0.77; 1.25] 2 yr Death (all cause) 0.83 [0.57; 1.20] |
| Trial | Treatments | Patients | Method |
|---|
| PASSION, 2006 | Taxus Express2 (n=310) vs. Express2 or Liberté (n=309) | Myocardial Infarction with ST-Segment Elevation | open Parallel groups Sample size: 310/309 Primary endpoint: cardiac death, AMI, TLR FU duration: 12 months (5y) | | HAAMU-STENT, 2006 | Taxus Express (n=70) vs. Bare-metal-stent (n=75) | AMI - STEMI patients undergoing PCI | open Parallel groups Sample size: 70/75 Primary endpoint: none FU duration: 12 months | | HORIZONS-AMI Stent, 2008 | paclitaxel-eluting stents (Taxus) (n=2257) vs. BMS (Express) (n=749) Patients received either unfractionated heparin and a glycoprotein (GP) IIb/IIIa inhibitor (eptifibatide or abciximab) or bivalirudin with provisional GP IIb/IIIa inhibitors in a 2 x 2 factorial design | ST-elevation myocardial infarction | open Factorial plan Sample size: 2257/749 Primary endpoint: MACE death, MI, stroke,stent thrombosis FU duration: 1 year |
|
| advanced breast cancer (metastatic) | versus combination chemotherapy No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
| Trial | Treatments | Patients | Method |
|---|
| Jassem, 2001 | (n=-9) vs. (n=-9) | first-line therapy for women with metastatic breast cancer | Sample size: -9/-9 Primary endpoint: FU duration: | | ANZ TITG, 1999 | paclitaxel 200 mg/m(2) intravenously (IV) over 3 hours for eight cycles (24 weeks) (n=-9) vs. standard cyclophosphamide 100 mg/m(2)/d orally on days 1 to 14, methotrexate 40 mg/m(2) IV on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8, and prednisone 40 mg/m(2)/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin re (n=-9) | front-line therapy in untreated metastatic breast cancer | Sample size: -9/-9 Primary endpoint: FU duration: | | TOG, 2005 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | | CECOG BM1, 2005 | gemcitabine (1,000 mg/m(2), days 1 and 4), epirubicin (90 mg/m(2), day 1), and paclitaxel (175 mg/m(2), day 1) (n=-9) vs. FU (500 mg/m(2), day 1), epirubicin (90 mg/m(2), day 1), and cyclophosphamide (500 mg/m(2), day 1) (n=-9) | first-line chemotherapy in metastatic breast cancer | Sample size: -9/-9 Primary endpoint: FU duration: | | UKCCCR AB01, 1997 | EP (epirubicin 75 mg/m2 and paclitaxel 200 mg/m2) (n=-9) vs. EC (epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for a maximum of six cycles (n=-9) | first-line chemotherapy for metastatic breast cancer | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| advanced breast cancer (metastatic) | versus Every three weeks regimen No demonstrated result for efficacy Weekly Paclitaxel inferior to Every three weeks Paclitaxel in terms of overall response in Frasci , 2005 Weekly Paclitaxel inferior to Every three weeks Paclitaxel in terms of progression free survival in Sikov , 2002 | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CLGB 9840 (Seidman), 2008 | Weekly Paclitaxel vs Every three weeks Paclitaxel | overall survival 0.78 [0.65; 0.94] progression free survival 0.74 [0.63; 0.86] | | overall response 1.19 [0.96; 1.48] | | Gradishar , 2009 | Weekly Paclitaxel vs Every three weeks Docetaxel | | | overall response 1.27 [0.90; 1.79] | | Fountzilas , 2008 | Weekly Paclitaxel vs Every three weeks Docetaxel | | | overall response 1.29 [0.98; 1.69] overall survival 0.72 [0.50; 1.04] progression free survival 1.04 [0.78; 1.39] | | Frasci , 2006 | Weekly Paclitaxel vs Every three weeks Paclitaxel | | | overall response 1.13 [0.99; 1.28] overall survival 0.60 [0.34; 1.05] progression free survival 0.99 [0.62; 1.59] | | Frasci , 2005 | Weekly Paclitaxel vs Every three weeks Paclitaxel | | overall response 1.61 [1.18; 2.19] | overall survival 0.79 [0.46; 1.34] progression free survival 1.09 [0.73; 1.63] | | Sikov , 2002 | Weekly Paclitaxel vs Every three weeks Paclitaxel | | progression free survival 1.67 [1.05; 2.65] | overall response 0.99 [0.72; 1.36] overall survival 0.98 [0.62; 1.55] | | Khoo , 2006 | split dose vs Every three weeks Paclitaxel | | | overall response 1.07 [0.77; 1.49] progression free survival 1.04 [0.70; 1.54] |
| Trial | Treatments | Patients | Method |
|---|
| CLGB 9840 (Seidman), 2008 | Weekly Paclitaxel 80 mg/m2 (n=-9) vs. Every three weeks Paclitaxel 175 mg/m2 (n=-9) | Metastatic | Sample size: -9/-9 Primary endpoint: FU duration: | | Gradishar , 2009 | Weekly Nab-paclitaxel 100 mg/m2 (n=-9) vs. Every three weeks Docetaxel 100 mg/m2 (n=-9) | Metastatic | Sample size: -9/-9 Primary endpoint: FU duration: | | Fountzilas , 2008 | Weekly Paclitaxel 80 mg/m2 (n=-9) vs. Every three weeks Gemc. Docetaxel 75 mg/m2 (n=-9) | Metastatic | Sample size: -9/-9 Primary endpoint: overall survival FU duration: | | Frasci , 2006 | Weekly Epi CDDP Paclitaxel 120 mg/m2 (n=-9) vs. Every three weeks Epi Paclitaxel 175 mg/m2 (n=-9) | LABC | Sample size: -9/-9 Primary endpoint: FU duration: | | Frasci , 2005 | Weekly Epi CDDP Paclitaxel 120 mg/m2 (n=-9) vs. Every three weeks Epi Paclitaxel 175 mg/m2 (n=-9) | Metastatic | Sample size: -9/-9 Primary endpoint: FU duration: | | Sikov , 2002 | Weekly Paclitaxel 150 mg/m2 (n=-9) vs. Split D1,8 every three weeks Paclitaxel 175 mg/m2 (n=-9) | Metastatic | Sample size: -9/-9 Primary endpoint: FU duration: | | Khoo , 2006 | split-dose paclitaxel or docetaxel in combination with gemcitabine (n=-9) vs. Every three weeks Gemc. Paclitaxel 175 mg/m2 (n=-9) | Metastatic patients with metastatic breast cancer (MBC) who had previously received anthracyclines | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| advanced breast cancer (metastatic) | versus single-agent chemotherapy No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
| Trial | Treatments | Patients | Method |
|---|
| Dieras, 1995 | paclitaxel 175 mg/m2 given as a 3-hour infusion every 3 weeks (n=-9) vs. mitomycin 12 mg/m2 given as an intravenous infusion every 6 weeks (n=-9) | advanced breast cancer | Sample size: -9/-9 Primary endpoint: FU duration: | | ECOG E1193 (B), 2003 | paclitaxel (175 mg/m(2)/24 h), (n=-9) vs. doxorubicin (60 mg/m(2)), (n=-9) | patients with metastatic breast cancer | Sample size: -9/-9 Primary endpoint: FU duration: | | EORTC 10923, 2000 | (n=-9) vs. (n=-9) | first-line therapy of advanced breast cancer | Sample size: -9/-9 Primary endpoint: progression-free survival FU duration: | | Talbot, 2002 | i.v. paclitaxel (175 mg m(-2), (n=-9) vs. 3-week cycles of intermittent oral capecitabine (1255 mg m(-2) twice daily, days 1-14, (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| coronary artery disease | versus bare-metal No demonstrated result for efficacy paclitaxel eluting stent inferior to bare-metal stent in terms of Stent thrombosis (any, end of follow-up) in SCORE, 2004 | 20 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TAXUS I, 2003 | paclitaxel eluting stent vs bare-metal stent | | | all cause mortality NaN [NaN; NaN] MACE 0.32 [0.04; 2.93] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 0.00 [0.00; NaN] angiographic restenosis 0.00 [0.00; NaN] late stent thrombosis (31d - 1year) NaN [NaN; NaN] | | TAXUS II, 2003 | paclitaxel eluting stent vs bare-metal stent | MACE 0.48 [0.31; 0.73] target lesion revascularisation (TLR ) 0.29 [0.15; 0.56] angiographic restenosis 0.33 [0.20; 0.53] | | all cause mortality 0.00 [0.00; NaN] MI 2.39 [0.60; 9.45] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] late stent thrombosis (31d - 1year) ∞ [NaN; ∞] | | TAXUS IV, 2004 | paclitaxel eluting stent vs bare-metal stent | MACE 0.56 [0.41; 0.77] target lesion revascularisation (TLR ) 0.27 [0.16; 0.43] angiographic restenosis 0.23 [0.17; 0.31] target-vessel revascularization 0.39 [0.26; 0.58] in-lesion binary restenosis 0.30 [0.19; 0.47] | | all cause mortality 1.11 [0.43; 2.85] MI 2.46 [0.48; 12.65] cardiac death 1.27 [0.48; 3.37] Stent thrombosis (any, end of follow-up) 0.79 [0.21; 2.92] late stent thrombosis (31d - 1year) 1.97 [0.67; 5.78] sub acute stent thrombosis (1-30 days) 0.98 [0.14; 6.87] | | ASPECT, 2003 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | angiographic restenosis 0.29 [0.13; 0.65] | | all cause mortality ∞ [NaN; ∞] MACE 1.65 [0.47; 5.77] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] target lesion revascularisation (TLR ) ∞ [NaN; ∞] late stent thrombosis (31d - 1year) NaN [NaN; NaN] | | ELUTES, 2004 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | | | all cause mortality ∞ [NaN; ∞] MACE 0.54 [0.24; 1.22] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) 0.25 [0.02; 3.91] target lesion revascularisation (TLR ) ∞ [NaN; ∞] angiographic restenosis 0.64 [0.29; 1.40] late stent thrombosis (31d - 1year) NaN [NaN; NaN] | | DELIVER, 2004 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | | | all cause mortality 0.25 [0.03; 2.21] MACE 0.77 [0.50; 1.18] MI 1.98 [0.18; 21.78] Stent thrombosis (any, end of follow-up) 0.99 [0.14; 7.00] target lesion revascularisation (TLR ) 0.25 [0.03; 2.21] angiographic restenosis 0.74 [0.51; 1.09] late stent thrombosis (31d - 1year) 0.99 [0.06; 15.85] | | PATENCY, 2002 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | | | all cause mortality 0.00 [0.00; NaN] MACE 0.54 [0.15; 1.93] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 0.00 [0.00; NaN] angiographic restenosis 1.08 [0.46; 2.51] | | SCORE, 2004 | paclitaxel eluting stent vs bare-metal stent | angiographic restenosis 0.17 [0.08; 0.39] | Stent thrombosis (any, end of follow-up) 14.44 [1.92; 108.85] | all cause mortality ∞ [NaN; ∞] MACE 1.17 [0.79; 1.74] MI ∞ [NaN; ∞] cardiac death ∞ [NaN; ∞] target-vessel revascularization 0.84 [0.53; 1.33] | | TAXUS V (all patients), 2005 | paclitaxel eluting stent vs bare-metal stent | MACE 0.70 [0.54; 0.91] target lesion revascularisation (TLR ) 0.55 [0.39; 0.77] angiographic restenosis 0.43 [0.33; 0.57] target-vessel revascularization 0.70 [0.53; 0.92] | | all cause mortality 0.89 [0.32; 2.46] MI 1.17 [0.70; 1.97] Stent thrombosis (any, end of follow-up) 1.01 [0.25; 4.04] Acute stent thrombosis (<=24h) 3.01 [0.31; 29.10] sub acute stent thrombosis (1-30 days) 0.34 [0.04; 3.04] | | TAXUS VI, 2005 | paclitaxel eluting stent vs bare-metal stent | angiographic restenosis 0.35 [0.23; 0.52] | | all cause mortality 0.00 [0.00; NaN] MACE 0.73 [0.50; 1.07] MI 1.04 [0.21; 5.08] Stent thrombosis (any, end of follow-up) 0.35 [0.04; 3.30] | | PASSION, 2006 | paclitaxel eluting stent vs bare-metal stent | | | MACE at 5yr 0.81 [0.57; 1.16] all cause mortality 0.70 [0.36; 1.36] MI 0.84 [0.26; 2.71] target lesion revascularisation (TLR ) 0.70 [0.38; 1.29] 4 yr TLR 0.67 [0.39; 1.16] 4 yr MI 1.49 [0.72; 3.09] 4 yr stent thrombosis 1.98 [0.67; 5.84] | | HAAMU-STENT, 2006 | paclitaxel eluting stent vs bare-metal stent | | | all cause mortality 2.14 [0.67; 6.80] Stent thrombosis (any, end of follow-up) 0.36 [0.04; 3.35] | | TAXUS II (diabetics), 2003 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.16 [0.03; 0.94] | | angiographic restenosis 0.07 [0.00; 34.64] | | TAXUS IV (diabetics), 2005 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.37 [0.20; 0.69] angiographic restenosis 0.16 [0.06; 0.43] | | | | TAXUS V (diabetics), 2005 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.54 [0.31; 0.94] | | | | TAXUS VI (diabetics), 2005 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.20 [0.05; 0.82] angiographic restenosis 0.20 [0.06; 0.67] | | | | Erglis, 2007 | paclitaxel eluting stent vs bare-metal stent | MACE 0.44 [0.20; 0.99] target lesion revascularisation (TLR ) 0.12 [0.02; 0.91] | | all cause mortality 0.94 [0.06; 14.68] MI 0.67 [0.23; 1.99] cardiac death ∞ [NaN; ∞] | | TAXUS V small vessels sub groups | paclitaxel eluting stent vs bare-metal stent | | | | | HORIZONS-AMI Stent, 2008 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.59 [0.42; 0.83] angiographic restenosis 0.44 [0.33; 0.58] target-vessel revascularization 0.65 [0.49; 0.86] 2 yr TLR 0.58 [0.44; 0.76] | | all cause mortality 1.01 [0.65; 1.56] MACE 1.02 [0.77; 1.35] MI 0.82 [0.56; 1.21] Stent thrombosis (any, end of follow-up) 0.93 [0.59; 1.46] 2 yr MACE 0.98 [0.77; 1.25] 2 yr Death (all cause) 0.83 [0.57; 1.20] | | SOS, 2008 | paclitaxel eluting stent vs bare-metal stent | target lesion revascularisation (TLR ) 0.17 [0.04; 0.73] | | all cause mortality 2.38 [0.49; 11.55] MACE 0.75 [0.45; 1.26] MI 0.48 [0.20; 1.14] Stent thrombosis (any, end of follow-up) 0.19 [0.02; 1.56] target-vessel revascularization 0.48 [0.20; 1.14] |
| Trial | Treatments | Patients | Method |
|---|
| TAXUS I, 2003 | TAXUS NIR (n=31) vs. NIR stent (n=30) | Stable or unstable AP, silent ischaemia; single de novo or restenotic coronary lesions | double-blind Parallel groups Sample size: 31/30 Primary endpoint: Combination of death,AMI, TVR, stent thrombosis FU duration: 12 months | | TAXUS II, 2003 | TAXUS (n=266) vs. NIR stent (n=270) | Stable or unstable AP, silent ischaemia; single de novo target lesion with estimatedstenosis >50% and <99%, | double-blind Parallel groups Sample size: 266/270 Primary endpoint: Neointimal proliferation FU duration: 12 months | | TAXUS IV, 2004 | TAXUS (n=662) vs. EXPRESS (n=652) | Stable or unstable AP, provokable ischaemia with a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm) | double-blind Parallel groups Sample size: 662/652 Primary endpoint: TVR FU duration: 9 months | | ASPECT, 2003 | coated Supra-G stent (n=117) vs. Supra-G stent (n=58) 3 arms study with 2 dose of paclitaxel: 3.1 µg/mm2 and 1.2 µg/mm2 | patientswith discrete coronary lesions (<15 mm in length, 2.25 to 3.5 mm in diameter) | double-blind Parallel groups Sample size: 117/58 Primary endpoint: stenosis percentage FU duration: 6 months | | ELUTES, 2004 | coated V-Flex Plus (n=152) vs. V-Flex Plus (n=38) dose ranging (4 doses) | single de novo type A or type B1 lesions 15 mm length in a nativecoronary artery | open Parallel groups Sample size: 152/38 Primary endpoint: percent diameter stenosis FU duration: 12 months | | DELIVER, 2004 | non-polymer-based paclitaxel-coated ACHIEVE stent (n=524) vs. stainless steel Multi-Link (ML) PENTA stent (n=519) | patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels | single-blind Parallel groups Sample size: 524/519 Primary endpoint: target-vessel failure FU duration: 9 months | | PATENCY, 2002 | Logic PTX paclitaxel Eluting CoronaryStents (n=24) vs. uncoated control stents (n=26) | Patients with de
novo lesions of 2.7- to 4.0-mm diameter and 25-mm length received
3.0, 3.5, or 4.0 mm 10- or 15-mm | double blind Parallel groups Sample size: 24/26 Primary endpoint: NA FU duration: 9 months | | SCORE, 2004 | QuaDDS stents (paclitaxel) (n=126) vs. uncoated control stents (n=140) | patients with focal, de novo coronary lesions | open Parallel groups Sample size: 126/140 Primary endpoint: none FU duration: 12 months | | TAXUS V (all patients), 2005 | TAXUS (n=577) vs. bare metal EXPRESS-2 (n=579) | Stable or unstable AP, silent ischaemia
with single coronary artery stenosis including complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) | double-blind Parallel groups Sample size: 577/579 Primary endpoint: TVR FU duration: 9 months | | TAXUS VI, 2005 | TAXUS (n=219) vs. Express2 stent (n=227) | Stable or unstable AP, silent ischaemia with long, complex coronary artery lesions | double-blind Parallel groups Sample size: 219/227 Primary endpoint: TVR FU duration: 9 months (2y) | | PASSION, 2006 | Taxus Express2 (n=310) vs. Express2 or Liberté (n=309) | Myocardial Infarction with ST-Segment Elevation | open Parallel groups Sample size: 310/309 Primary endpoint: cardiac death, AMI, TLR FU duration: 12 months (5y) | | HAAMU-STENT, 2006 | Taxus Express (n=70) vs. Bare-metal-stent (n=75) | AMI - STEMI patients undergoing PCI | open Parallel groups Sample size: 70/75 Primary endpoint: none FU duration: 12 months | | TAXUS II (diabetics), 2003 | TAXUS (n=37) vs. NIR stent (n=41) | Diabetic patients with stable or unstable AP, silent ischaemia; single de novo target lesion with estimatedstenosis >50% and <99%,
| double-blind Parallel groups Sample size: 37/41 Primary endpoint: Neointimal proliferation FU duration: 12 months
| | TAXUS IV (diabetics), 2005 | TAXUS (n=155) vs. EXPRESS (n=163) | Diabetic patients with stable or unstable AP, provokable ischaemia with a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm)
| double-blind Parallel groups Sample size: 155/163 Primary endpoint: TVR FU duration: 9 months
| | TAXUS V (diabetics), 2005 | TAXUS (n=178) vs. BMS (n=171) | Diabetic patients with stable or unstable AP, silent ischaemia with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents)
| double-blind Parallel groups Sample size: 178/171 Primary endpoint: TVR FU duration: 9 months
| | TAXUS VI (diabetics), 2005 | TAXUS (n=39) vs. Express2 stent (n=50) | Diabetic patients with stable or unstable AP, silent ischaemia with long, complex coronary artery lesions
| double-blind Parallel groups Sample size: 39/50 Primary endpoint: TVR FU duration: 9 months
| | Erglis, 2007 | IVUS-guided paclitaxel-eluting stent (Taxus Express) after lesion pre-treatment with cutting balloon (n=53) vs. IVUS-guided bare-metal (Express or Liberte) after lesion pre-treatment with cutting balloon (n=50) | percutaneous coronary intervention for unprotected left main artery stenosis | open Parallel groups Sample size: 53/50 Primary endpoint: FU duration: 6 months | | TAXUS V small vessels sub groups | paclitaxel-eluting stents (n=-9) vs. bare metal stents (n=-9) | patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), subgroup of small vessel patients | Sample size: -9/-9 Primary endpoint: FU duration: | | HORIZONS-AMI Stent, 2008 | paclitaxel-eluting stents (Taxus) (n=2257) vs. BMS (Express) (n=749) Patients received either unfractionated heparin and a glycoprotein (GP) IIb/IIIa inhibitor (eptifibatide or abciximab) or bivalirudin with provisional GP IIb/IIIa inhibitors in a 2 x 2 factorial design | ST-elevation myocardial infarction | open Factorial plan Sample size: 2257/749 Primary endpoint: MACE death, MI, stroke,stent thrombosis FU duration: 1 year | | SOS, 2008 | Paclitaxel-Eluting Stent (Taxus) (n=41) vs. bare metal stent (Express-2) (n=39) | patients undergoing percutaneous coronary intervention of saphenous vein bypass grafts | open Parallel groups Sample size: 41/39 Primary endpoint: binary angiographic in-stent restenosis FU duration: 1.5y median |
|
| coronary artery disease | versus PTCA No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ISAR-DESIRE (PES vs PTCA), 2005 | paclitaxel eluting stent vs balloon angioplasty | target-vessel revascularization 0.58 [0.35; 0.94] | | all cause mortality 0.33 [0.04; 3.15] MI ∞ [NaN; ∞] |
| Trial | Treatments | Patients | Method |
|---|
| ISAR-DESIRE (PES vs PTCA), 2005 | TAXUS (n=100) vs. ballon angioplasty (n=100) | In-stent restenosis. AP and/or positive test, previously stented, no AMI | open Parallel groups Sample size: 100/100 Primary endpoint: Binary restenosis FU duration: 1y |
|
| coronary artery disease | versus brachytherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TAXUS V ISR, 2006 | paclitaxel eluting balloon vs brachytherapy | | | |
| Trial | Treatments | Patients | Method |
|---|
| TAXUS V ISR, 2006 | TAXUS Express2 (n=195) vs. angioplasty followed by vascular brachytherapy with a beta source (n=201) | patients with restenotic lesions after prior stent implantation
in native coronary arteries | open Parallel groups Sample size: 195/201 Primary endpoint: Ischemia-driven TVR at 9 months FU duration: |
|
| coronary artery disease | versus drug-eluting stents No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ISAR-test (diabetics), 2006 | paclitaxel eluting stent vs sirolimus eluting stent | | | |
| Trial | Treatments | Patients | Method |
|---|
| ISAR-test (diabetics), 2006 | Taxus (n=73) vs. rapamycin stent (n=58) | diabetics patients
with de novo lesions in native coronary vessels, excluding the left main trunk | open Parallel groups Sample size: 73/58 Primary endpoint: FU duration: 9 months |
|
| coronary artery disease | versus surgery No demonstrated result for efficacy paclitaxel eluting stent inferior to CABG in terms of angioplastie in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of 2 yr MI (all) in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of MACE in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of cardiac death in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of target lesion revascularisation (TLR ) in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of CABG in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of 2 yr TLR in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of 2 yr MACE in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of sub acute stent thrombosis (1-30 days) in SYNTAX, 2009 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SYNTAX, 2009 | paclitaxel eluting stent vs CABG | late stent thrombosis (31d - 1year) 0.43 [0.20; 0.92] | angioplastie 2.53 [1.78; 3.61] 2 yr MI (all) 1.75 [1.13; 2.72] MACE 1.50 [1.20; 1.89] cardiac death 1.82 [1.03; 3.21] target lesion revascularisation (TLR ) 2.32 [1.71; 3.16] CABG 2.26 [1.12; 4.56] 2 yr TLR 2.03 [1.57; 2.62] 2 yr MACE 1.44 [1.19; 1.74] sub acute stent thrombosis (1-30 days) 5.96 [1.76; 20.16] | Recurrent myocardial infarction 1.53 [0.96; 2.43] all cause mortality 1.25 [0.79; 1.98] MI 1.47 [0.93; 2.34] Stent thrombosis (any, end of follow-up) 1.03 [0.61; 1.73] stent thrombosis (ARC) 1.03 [0.61; 1.73] 2 yr Death (all cause) 1.26 [0.86; 1.86] Acute stent thrombosis (<=24h) 0.66 [0.11; 3.95] |
| Trial | Treatments | Patients | Method |
|---|
| SYNTAX, 2009 | paclitaxel (taxus Express SR) (n=903) vs. Coronary Artery Bypass Surgery (on- or off-pump bypass) (n=897) | patients with previously untreated three-vessel or left
main coronary artery disease (or both) (complex lesions) | open Parallel groups Sample size: 903/897 Primary endpoint: major adverse cardiac or cerebrovascular event FU duration: 1 year |
|
| Head and neck cancer | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hitt paclitaxel, 2005 | paclitaxel based CT vs PF | Overall response (CR + PR) to induction CT 1.18 [1.05; 1.34] Overall response (CR + PR) to study treatment 1.71 [1.36; 2.14] Complete response to induction CT 2.47 [1.64; 3.73] complete response to study treatment 1.75 [1.36; 2.25] | | All grade 3 to 4 events during induction CT 0.90 [0.68; 1.20] frebrile neutropenia (grade 3-4) during induction CT 1.63 [0.54; 4.90] neutropenia (grade 3-4) during induction CT 1.05 [0.69; 1.59] Toxic death during induction CT 0.51 [0.09; 2.75] death (overall survival) 0.85 [0.69; 1.06] progression or death (progression free survival) 1.00 [1.00; 1.00] |
| Trial | Treatments | Patients | Method |
|---|
| Hitt paclitaxel, 2005 | induction chemotherapy with paclitaxel, cisplatin, and fluorouracil (n=189) vs. induction chemotherapy with cisplatin and FU (n=193) | locally advanced head and neck cancer | Open Parallel groups Sample size: 189/193 Primary endpoint: CR FU duration: 1.93y (0.025-5y) |
|
| stable angina | versus bare-metal No demonstrated result for efficacy paclitaxel eluting stent inferior to bare-metal stent in terms of Stent thrombosis (any, end of follow-up) in SCORE, 2004 | 10 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TAXUS I, 2003 | paclitaxel eluting stent vs bare-metal stent | | | all cause mortality NaN [NaN; NaN] MACE 0.32 [0.04; 2.93] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 0.00 [0.00; NaN] angiographic restenosis 0.00 [0.00; NaN] late stent thrombosis (31d - 1year) NaN [NaN; NaN] | | TAXUS II, 2003 | paclitaxel eluting stent vs bare-metal stent | MACE 0.48 [0.31; 0.73] target lesion revascularisation (TLR ) 0.29 [0.15; 0.56] angiographic restenosis 0.33 [0.20; 0.53] | | all cause mortality 0.00 [0.00; NaN] MI 2.39 [0.60; 9.45] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] late stent thrombosis (31d - 1year) ∞ [NaN; ∞] | | TAXUS IV, 2004 | paclitaxel eluting stent vs bare-metal stent | MACE 0.56 [0.41; 0.77] target lesion revascularisation (TLR ) 0.27 [0.16; 0.43] angiographic restenosis 0.23 [0.17; 0.31] target-vessel revascularization 0.39 [0.26; 0.58] in-lesion binary restenosis 0.30 [0.19; 0.47] | | all cause mortality 1.11 [0.43; 2.85] MI 2.46 [0.48; 12.65] cardiac death 1.27 [0.48; 3.37] Stent thrombosis (any, end of follow-up) 0.79 [0.21; 2.92] late stent thrombosis (31d - 1year) 1.97 [0.67; 5.78] sub acute stent thrombosis (1-30 days) 0.98 [0.14; 6.87] | | ASPECT, 2003 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | angiographic restenosis 0.29 [0.13; 0.65] | | all cause mortality ∞ [NaN; ∞] MACE 1.65 [0.47; 5.77] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] target lesion revascularisation (TLR ) ∞ [NaN; ∞] late stent thrombosis (31d - 1year) NaN [NaN; NaN] | | ELUTES, 2004 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | | | all cause mortality ∞ [NaN; ∞] MACE 0.54 [0.24; 1.22] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) 0.25 [0.02; 3.91] target lesion revascularisation (TLR ) ∞ [NaN; ∞] angiographic restenosis 0.64 [0.29; 1.40] late stent thrombosis (31d - 1year) NaN [NaN; NaN] | | DELIVER, 2004 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | | | all cause mortality 0.25 [0.03; 2.21] MACE 0.77 [0.50; 1.18] MI 1.98 [0.18; 21.78] Stent thrombosis (any, end of follow-up) 0.99 [0.14; 7.00] target lesion revascularisation (TLR ) 0.25 [0.03; 2.21] angiographic restenosis 0.74 [0.51; 1.09] late stent thrombosis (31d - 1year) 0.99 [0.06; 15.85] | | PATENCY, 2002 | paclitaxel, non-polymeric eluting stent vs bare-metal stent | | | all cause mortality 0.00 [0.00; NaN] MACE 0.54 [0.15; 1.93] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 0.00 [0.00; NaN] angiographic restenosis 1.08 [0.46; 2.51] | | SCORE, 2004 | paclitaxel eluting stent vs bare-metal stent | angiographic restenosis 0.17 [0.08; 0.39] | Stent thrombosis (any, end of follow-up) 14.44 [1.92; 108.85] | all cause mortality ∞ [NaN; ∞] MACE 1.17 [0.79; 1.74] MI ∞ [NaN; ∞] cardiac death ∞ [NaN; ∞] target-vessel revascularization 0.84 [0.53; 1.33] | | TAXUS V (all patients), 2005 | paclitaxel eluting stent vs bare-metal stent | MACE 0.70 [0.54; 0.91] target lesion revascularisation (TLR ) 0.55 [0.39; 0.77] angiographic restenosis 0.43 [0.33; 0.57] target-vessel revascularization 0.70 [0.53; 0.92] | | all cause mortality 0.89 [0.32; 2.46] MI 1.17 [0.70; 1.97] Stent thrombosis (any, end of follow-up) 1.01 [0.25; 4.04] Acute stent thrombosis (<=24h) 3.01 [0.31; 29.10] sub acute stent thrombosis (1-30 days) 0.34 [0.04; 3.04] | | TAXUS VI, 2005 | paclitaxel eluting stent vs bare-metal stent | angiographic restenosis 0.35 [0.23; 0.52] | | all cause mortality 0.00 [0.00; NaN] MACE 0.73 [0.50; 1.07] MI 1.04 [0.21; 5.08] Stent thrombosis (any, end of follow-up) 0.35 [0.04; 3.30] |
| Trial | Treatments | Patients | Method |
|---|
| TAXUS I, 2003 | TAXUS NIR (n=31) vs. NIR stent (n=30) | Stable or unstable AP, silent ischaemia; single de novo or restenotic coronary lesions | double-blind Parallel groups Sample size: 31/30 Primary endpoint: Combination of death,AMI, TVR, stent thrombosis FU duration: 12 months | | TAXUS II, 2003 | TAXUS (n=266) vs. NIR stent (n=270) | Stable or unstable AP, silent ischaemia; single de novo target lesion with estimatedstenosis >50% and <99%, | double-blind Parallel groups Sample size: 266/270 Primary endpoint: Neointimal proliferation FU duration: 12 months | | TAXUS IV, 2004 | TAXUS (n=662) vs. EXPRESS (n=652) | Stable or unstable AP, provokable ischaemia with a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm) | double-blind Parallel groups Sample size: 662/652 Primary endpoint: TVR FU duration: 9 months | | ASPECT, 2003 | coated Supra-G stent (n=117) vs. Supra-G stent (n=58) 3 arms study with 2 dose of paclitaxel: 3.1 µg/mm2 and 1.2 µg/mm2 | patientswith discrete coronary lesions (<15 mm in length, 2.25 to 3.5 mm in diameter) | double-blind Parallel groups Sample size: 117/58 Primary endpoint: stenosis percentage FU duration: 6 months | | ELUTES, 2004 | coated V-Flex Plus (n=152) vs. V-Flex Plus (n=38) dose ranging (4 doses) | single de novo type A or type B1 lesions 15 mm length in a nativecoronary artery | open Parallel groups Sample size: 152/38 Primary endpoint: percent diameter stenosis FU duration: 12 months | | DELIVER, 2004 | non-polymer-based paclitaxel-coated ACHIEVE stent (n=524) vs. stainless steel Multi-Link (ML) PENTA stent (n=519) | patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels | single-blind Parallel groups Sample size: 524/519 Primary endpoint: target-vessel failure FU duration: 9 months | | PATENCY, 2002 | Logic PTX paclitaxel Eluting CoronaryStents (n=24) vs. uncoated control stents (n=26) | Patients with de
novo lesions of 2.7- to 4.0-mm diameter and 25-mm length received
3.0, 3.5, or 4.0 mm 10- or 15-mm | double blind Parallel groups Sample size: 24/26 Primary endpoint: NA FU duration: 9 months | | SCORE, 2004 | QuaDDS stents (paclitaxel) (n=126) vs. uncoated control stents (n=140) | patients with focal, de novo coronary lesions | open Parallel groups Sample size: 126/140 Primary endpoint: none FU duration: 12 months | | TAXUS V (all patients), 2005 | TAXUS (n=577) vs. bare metal EXPRESS-2 (n=579) | Stable or unstable AP, silent ischaemia
with single coronary artery stenosis including complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) | double-blind Parallel groups Sample size: 577/579 Primary endpoint: TVR FU duration: 9 months | | TAXUS VI, 2005 | TAXUS (n=219) vs. Express2 stent (n=227) | Stable or unstable AP, silent ischaemia with long, complex coronary artery lesions | double-blind Parallel groups Sample size: 219/227 Primary endpoint: TVR FU duration: 9 months (2y) |
|
| stable angina | versus surgery No demonstrated result for efficacy paclitaxel eluting stent inferior to CABG in terms of angioplastie in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of 2 yr MI (all) in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of MACE in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of cardiac death in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of target lesion revascularisation (TLR ) in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of CABG in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of 2 yr TLR in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of 2 yr MACE in SYNTAX, 2009 paclitaxel eluting stent inferior to CABG in terms of sub acute stent thrombosis (1-30 days) in SYNTAX, 2009 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SYNTAX, 2009 | paclitaxel eluting stent vs CABG | late stent thrombosis (31d - 1year) 0.43 [0.20; 0.92] | angioplastie 2.53 [1.78; 3.61] 2 yr MI (all) 1.75 [1.13; 2.72] MACE 1.50 [1.20; 1.89] cardiac death 1.82 [1.03; 3.21] target lesion revascularisation (TLR ) 2.32 [1.71; 3.16] CABG 2.26 [1.12; 4.56] 2 yr TLR 2.03 [1.57; 2.62] 2 yr MACE 1.44 [1.19; 1.74] sub acute stent thrombosis (1-30 days) 5.96 [1.76; 20.16] | Recurrent myocardial infarction 1.53 [0.96; 2.43] all cause mortality 1.25 [0.79; 1.98] MI 1.47 [0.93; 2.34] Stent thrombosis (any, end of follow-up) 1.03 [0.61; 1.73] stent thrombosis (ARC) 1.03 [0.61; 1.73] 2 yr Death (all cause) 1.26 [0.86; 1.86] Acute stent thrombosis (<=24h) 0.66 [0.11; 3.95] |
| Trial | Treatments | Patients | Method |
|---|
| SYNTAX, 2009 | paclitaxel (taxus Express SR) (n=903) vs. Coronary Artery Bypass Surgery (on- or off-pump bypass) (n=897) | patients with previously untreated three-vessel or left
main coronary artery disease (or both) (complex lesions) | open Parallel groups Sample size: 903/897 Primary endpoint: major adverse cardiac or cerebrovascular event FU duration: 1 year |
|
