| acute myocardial infarction | versus drug-eluting stents No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ZEST AMI (vs PES), 2009 | zotarolimus eluting stent vs paclitaxel eluting stent | | | all cause mortality ∞ [NaN; ∞] MACE 1.22 [0.55; 2.71] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) 0.00 [0.00; NaN] target-vessel revascularization 1.15 [0.46; 2.86] | | ZEST AMI (vs SES), 2009 | zotarolimus eluting stent vs sirolimus eluting stent | | | all cause mortality 0.76 [0.18; 3.33] MACE 1.22 [0.55; 2.71] MI 0.00 [0.00; NaN] Stent thrombosis (any, end of follow-up) 0.00 [0.00; NaN] target-vessel revascularization 1.53 [0.56; 4.15] |
| Trial | Treatments | Patients | Method |
|---|
| ZEST AMI (vs PES), 2009 | zotarolimus-eluting stent (Endeavor) (n=108) vs. paclitaxel-eluting stent (Taxus Liberté)
(n=110)
| Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours
| open Sample size: 108/110 Primary endpoint: death, MI, or ischemia-driven TVR FU duration: 1 year (mean)
| | ZEST AMI (vs SES), 2009 | zotarolimus-eluting stent (Endeavor) (n=108) vs. sirolimus-eluting stents (Cypher)
(n=110)
| Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours
| open Parallel groups Sample size: 108/110 Primary endpoint: death, MI, or ischemia-driven TVR FU duration: 1 year (mean)
|
|
| coronary artery disease | versus drug-eluting stents No demonstrated result for efficacy zotarolimus eluting stent inferior to sirolimus eluting stent in terms of angiographic restenosis in ENDEAVOR III, 2006 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of in-lesion binary restenosis in ENDEAVOR III, 2006 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of 2 yr MI (all) in SORT-OUT-3, 2010 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of MI in SORT-OUT-3, 2010 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of Stent thrombosis (any, end of follow-up) in SORT-OUT-3, 2010 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of target lesion revascularisation (TLR ) in SORT-OUT-3, 2010 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of 2 yr TLR in SORT-OUT-3, 2010 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of 2 yr MACE in SORT-OUT-3, 2010 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of 2 yr Death (all cause) in SORT-OUT-3, 2010 | 11 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ENDEAVOR III, 2006 | zotarolimus eluting stent vs sirolimus eluting stent | MI 0.18 [0.03; 0.96] | angiographic restenosis 4.33 [1.05; 17.91] in-lesion binary restenosis 2.75 [1.00; 7.56] | all cause mortality 0.70 [0.06; 7.65] MACE 0.97 [0.47; 2.02] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 1.84 [0.64; 5.24] | | ENDEAVOR IV, 2009 | zotarolimus eluting stent vs paclitaxel eluting stent | target vessel failure 0.77 [0.60; 0.99] MI 0.44 [0.25; 0.79] | | all cause mortality 0.91 [0.55; 1.48] MACE 0.83 [0.63; 1.09] cardiac death 0.70 [0.34; 1.47] target lesion revascularisation (TLR ) 1.09 [0.73; 1.62] stent thrombosis (ARC) 0.67 [0.27; 1.62] target-vessel revascularization 0.91 [0.67; 1.23] | | PROTECT, 2012 | zotarolimus eluting stent vs sirolimus eluting stent | | | | | ZEST (vs SES), 2009 | zotarolimus eluting stent vs sirolimus eluting stent | | | all cause mortality 0.85 [0.29; 2.53] MACE 1.21 [0.90; 1.63] MI 0.85 [0.58; 1.24] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] target-vessel revascularization 1.21 [0.90; 1.63] | | ZEST AMI (vs PES), 2009 | zotarolimus eluting stent vs paclitaxel eluting stent | | | all cause mortality ∞ [NaN; ∞] MACE 1.22 [0.55; 2.71] MI NaN [NaN; NaN] Stent thrombosis (any, end of follow-up) 0.00 [0.00; NaN] target-vessel revascularization 1.15 [0.46; 2.86] | | ZEST AMI (vs SES), 2009 | zotarolimus eluting stent vs sirolimus eluting stent | | | all cause mortality 0.76 [0.18; 3.33] MACE 1.22 [0.55; 2.71] MI 0.00 [0.00; NaN] Stent thrombosis (any, end of follow-up) 0.00 [0.00; NaN] target-vessel revascularization 1.53 [0.56; 4.15] | | SORT-OUT-3, 2010 | zotarolimus eluting stent vs sirolimus eluting stent | | 2 yr MI (all) 2.22 [1.09; 4.53] MI 3.47 [1.15; 10.48] Stent thrombosis (any, end of follow-up) 4.62 [1.34; 15.93] target lesion revascularisation (TLR ) 4.19 [2.12; 8.28] 2 yr TLR 3.66 [2.23; 6.01] 2 yr MACE 2.19 [1.58; 3.04] 2 yr Death (all cause) 1.61 [1.03; 2.51] | all cause mortality 1.45 [0.76; 2.77] cardiac death 1.51 [0.73; 3.13] | | ZoMaxx I, 2008 | zotarolimus eluting stent vs paclitaxel eluting stent | | | | | ZEST (vs PES), 2009 | zotarolimus eluting stent vs paclitaxel eluting stent | MACE 0.71 [0.55; 0.91] target lesion revascularisation (TLR ) 0.65 [0.45; 0.95] | | all cause mortality 0.60 [0.22; 1.65] MI 0.76 [0.53; 1.10] Stent thrombosis (any, end of follow-up) 0.67 [0.19; 2.36] | | RESOLUTE All comers, 2010 | zotarolimus eluting stent vs everolimus eluting stent | | | target vessel failure 0.95 [0.73; 1.22] angioplastie 1.24 [0.78; 1.98] clinically driven TVR 1.03 [0.71; 1.48] all cause mortality 0.59 [0.33; 1.04] MI 1.03 [0.69; 1.54] cardiac death 0.80 [0.41; 1.56] Stent thrombosis (any, end of follow-up) 1.55 [0.84; 2.83] target lesion revascularisation (TLR ) 1.17 [0.76; 1.79] stent thrombosis (ARC) 1.55 [0.84; 2.83] CABG 0.76 [0.26; 2.18] late stent thrombosis (31d - 1year) 2.53 [0.49; 13.00] target-vessel revascularization 1.03 [0.71; 1.48] Acute stent thrombosis (<=24h) 4.04 [0.45; 36.11] sub acute stent thrombosis (1-30 days) ∞ [NaN; ∞] | | TWENTE, 2012 | zotarolimus eluting stent vs everolimus eluting stent | | | |
| Trial | Treatments | Patients | Method |
|---|
| ENDEAVOR III, 2006 | ABT-578 coated Endeavor (n=327) vs. Cypher (n=109)
| single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter
| open Parallel groups Sample size: 327/109 Primary endpoint: in-segment late lumen loss FU duration: 12 months (and 24 months)
| | ENDEAVOR IV, 2009 | zotarolimus-eluting stent (Endeavor) (n=773) vs. paclitaxel-eluting stent (Taxus) (n=775) | single de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-3.5 mm | open Parallel groups Sample size: 773/775 Primary endpoint: target vessel failure (death,MI, TVR) FU duration: mean 36 mo | | PROTECT, 2012 | Medtronic Endeavor Zotarolimus Eluting Coronary Stent System (n=4357) vs. Cordis Cypher Sirolimus-eluting Coronary Stent (n=4352) | unselected patients (patients 18 years or older who were undergoing stenting for elective, unplanned, or emergency procedures in native coronary arteries) | open-label Parallel groups Sample size: 4357/4352 Primary endpoint: definite or probable stent thrombosis FU duration: | | ZEST (vs SES), 2009 | zotarolimus-eluting stents (n=883) vs. sirolimus-eluting stents
(n=878) 3 arms: ZES compared vs SES (Cypher) and PES (Taxus) | Patients with coronary artery disease | Open Parallel groups Sample size: 883/878 Primary endpoint: death, myocardial infarction, TLR FU duration: 1 year clinical follow-up at 12 months; angiographic follow-up at 9 months | | ZEST AMI (vs PES), 2009 | zotarolimus-eluting stent (Endeavor) (n=108) vs. paclitaxel-eluting stent (Taxus Liberté)
(n=110)
| Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours
| open Sample size: 108/110 Primary endpoint: death, MI, or ischemia-driven TVR FU duration: 1 year (mean)
| | ZEST AMI (vs SES), 2009 | zotarolimus-eluting stent (Endeavor) (n=108) vs. sirolimus-eluting stents (Cypher)
(n=110)
| Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours
| open Parallel groups Sample size: 108/110 Primary endpoint: death, MI, or ischemia-driven TVR FU duration: 1 year (mean)
| | SORT-OUT-3, 2010 | Zotarolimus-eluting stents (n=1162) vs. sirolimus-eluting stents (SES)
(n=1171)
| Patients With Coronary Artery Disease undergoing PCI for any indication
| open Sample size: 1162/1171 Primary endpoint: MACE FU duration: 9 months (18 mo,3yrs)
| | ZoMaxx I, 2008 | ZoMaxx zotarolimus-eluting stent (n=199) vs. Taxus paclitaxel-eluting stent (n=197) | patients with single de novo coronary lesions and with lesion length 10-30 mm and reference vessel diameter 2.5-3.5 mm
| open Parallel groups Sample size: 199/197 Primary endpoint: Late lumen loss FU duration: 9 months | | ZEST (vs PES), 2009 | zotarolimus-eluting stents (n=883) vs. paclitaxel-eluting stents
(n=884)
| Patients with coronary artery disease
| NA Sample size: 883/884 Primary endpoint: death, myocardial infarction, TLR FU duration: 1 year
| | RESOLUTE All comers, 2010 | zotarolimus-eluting stent (n=1140) vs. everolimus-eluting stent (Xience) (n=1152) | adult patients with chronic, stable
coronary artery disease or acute coronary syndromes,
including myocardial infarction with or
without ST-segment elevation | open Parallel groups Sample size: 1140/1152 Primary endpoint: target-lesion failure FU duration: 12 months (5y) | | TWENTE, 2012 | zotarolimus-eluting stent (n=-9) vs. everolimus-eluting stent (n=-9) | "real-world" patients | single (patient-blinded) Parallel groups Sample size: -9/-9 Primary endpoint: target vessel failure FU duration: 1 year |
|
| stable angina | versus drug-eluting stents No demonstrated result for efficacy zotarolimus eluting stent inferior to sirolimus eluting stent in terms of angiographic restenosis in ENDEAVOR III, 2006 zotarolimus eluting stent inferior to sirolimus eluting stent in terms of in-lesion binary restenosis in ENDEAVOR III, 2006 | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ENDEAVOR III, 2006 | zotarolimus eluting stent vs sirolimus eluting stent | MI 0.18 [0.03; 0.96] | angiographic restenosis 4.33 [1.05; 17.91] in-lesion binary restenosis 2.75 [1.00; 7.56] | all cause mortality 0.70 [0.06; 7.65] MACE 0.97 [0.47; 2.02] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 1.84 [0.64; 5.24] | | ENDEAVOR IV, 2009 | zotarolimus eluting stent vs paclitaxel eluting stent | target vessel failure 0.77 [0.60; 0.99] MI 0.44 [0.25; 0.79] | | all cause mortality 0.91 [0.55; 1.48] MACE 0.83 [0.63; 1.09] cardiac death 0.70 [0.34; 1.47] target lesion revascularisation (TLR ) 1.09 [0.73; 1.62] stent thrombosis (ARC) 0.67 [0.27; 1.62] target-vessel revascularization 0.91 [0.67; 1.23] | | PROTECT, 2012 | zotarolimus eluting stent vs sirolimus eluting stent | | | | | ZEST (vs SES), 2009 | zotarolimus eluting stent vs sirolimus eluting stent | | | all cause mortality 0.85 [0.29; 2.53] MACE 1.21 [0.90; 1.63] MI 0.85 [0.58; 1.24] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] target-vessel revascularization 1.21 [0.90; 1.63] | | RESOLUTE All comers, 2010 | zotarolimus eluting stent vs everolimus eluting stent | | | target vessel failure 0.95 [0.73; 1.22] angioplastie 1.24 [0.78; 1.98] clinically driven TVR 1.03 [0.71; 1.48] all cause mortality 0.59 [0.33; 1.04] MI 1.03 [0.69; 1.54] cardiac death 0.80 [0.41; 1.56] Stent thrombosis (any, end of follow-up) 1.55 [0.84; 2.83] target lesion revascularisation (TLR ) 1.17 [0.76; 1.79] stent thrombosis (ARC) 1.55 [0.84; 2.83] CABG 0.76 [0.26; 2.18] late stent thrombosis (31d - 1year) 2.53 [0.49; 13.00] target-vessel revascularization 1.03 [0.71; 1.48] Acute stent thrombosis (<=24h) 4.04 [0.45; 36.11] sub acute stent thrombosis (1-30 days) ∞ [NaN; ∞] |
| Trial | Treatments | Patients | Method |
|---|
| ENDEAVOR III, 2006 | ABT-578 coated Endeavor (n=327) vs. Cypher (n=109)
| single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter
| open Parallel groups Sample size: 327/109 Primary endpoint: in-segment late lumen loss FU duration: 12 months (and 24 months)
| | ENDEAVOR IV, 2009 | zotarolimus-eluting stent (Endeavor) (n=773) vs. paclitaxel-eluting stent (Taxus) (n=775) | single de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-3.5 mm | open Parallel groups Sample size: 773/775 Primary endpoint: target vessel failure (death,MI, TVR) FU duration: mean 36 mo | | PROTECT, 2012 | Medtronic Endeavor Zotarolimus Eluting Coronary Stent System (n=4357) vs. Cordis Cypher Sirolimus-eluting Coronary Stent (n=4352) | unselected patients (patients 18 years or older who were undergoing stenting for elective, unplanned, or emergency procedures in native coronary arteries) | open-label Parallel groups Sample size: 4357/4352 Primary endpoint: definite or probable stent thrombosis FU duration: | | ZEST (vs SES), 2009 | zotarolimus-eluting stents (n=883) vs. sirolimus-eluting stents
(n=878) 3 arms: ZES compared vs SES (Cypher) and PES (Taxus) | Patients with coronary artery disease | Open Parallel groups Sample size: 883/878 Primary endpoint: death, myocardial infarction, TLR FU duration: 1 year clinical follow-up at 12 months; angiographic follow-up at 9 months | | RESOLUTE All comers, 2010 | zotarolimus-eluting stent (n=1140) vs. everolimus-eluting stent (Xience) (n=1152) | adult patients with chronic, stable
coronary artery disease or acute coronary syndromes,
including myocardial infarction with or
without ST-segment elevation | open Parallel groups Sample size: 1140/1152 Primary endpoint: target-lesion failure FU duration: 12 months (5y) |
|
