| acute myocardial infarction | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ZEST AMI (vs PES), 2009 | 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 | vs paclitaxel 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 | All results are NS for efficacy inferior to sirolimus eluting stent in terms of angiographic restenosis in ENDEAVOR III, 2006 inferior to sirolimus eluting stent in terms of in-lesion binary restenosis in ENDEAVOR III, 2006 inferior to sirolimus eluting stent in terms of 2 yr MI (all) in SORT-OUT-3, 2010 inferior to sirolimus eluting stent in terms of MI in SORT-OUT-3, 2010 inferior to sirolimus eluting stent in terms of Stent thrombosis (any, end of follow-up) in SORT-OUT-3, 2010 inferior to sirolimus eluting stent in terms of target lesion revascularisation (TLR ) in SORT-OUT-3, 2010 inferior to sirolimus eluting stent in terms of 2 yr TLR in SORT-OUT-3, 2010 inferior to sirolimus eluting stent in terms of 2 yr MACE in SORT-OUT-3, 2010 inferior to sirolimus eluting stent in terms of 2 yr Death (all cause) in SORT-OUT-3, 2010 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ENDEAVOR II, 2006 | vs sirolimus eluting stent | MACE 0.50 [0.36; 0.71] angiographic restenosis 0.39 [0.28; 0.55] | | Stent thrombosis (any, end of follow-up) 0.43 [0.11; 1.65] | | ENDEAVOR III, 2006 | 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 | vs sirolimus 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 | vs sirolimus eluting stent | | | | | ZEST (vs SES), 2009 | 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 | vs sirolimus 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 | 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 | 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 | vs sirolimus eluting stent | | | | | ZEST (vs PES), 2009 | vs sirolimus 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 | vs sirolimus 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 | vs sirolimus eluting stent | | | |
| Trial | Treatments | Patients | Method |
|---|
| ENDEAVOR II, 2006 | AVE Zotarolimus-Eluting Driver (n=598) vs. Driver (n=599) | single de novo native coronary artery stenosis | double-blind Parallel groups Sample size: 598/599 Primary endpoint: target vessel failure FU duration: 12 months | | 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 | All results are NS for efficacy inferior to sirolimus eluting stent in terms of angiographic restenosis in ENDEAVOR III, 2006 inferior to sirolimus eluting stent in terms of in-lesion binary restenosis in ENDEAVOR III, 2006 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ENDEAVOR II, 2006 | vs sirolimus eluting stent | MACE 0.50 [0.36; 0.71] angiographic restenosis 0.39 [0.28; 0.55] | | Stent thrombosis (any, end of follow-up) 0.43 [0.11; 1.65] | | ENDEAVOR III, 2006 | 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 | vs sirolimus 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 | vs sirolimus eluting stent | | | | | ZEST (vs SES), 2009 | 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 | vs sirolimus 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 II, 2006 | AVE Zotarolimus-Eluting Driver (n=598) vs. Driver (n=599) | single de novo native coronary artery stenosis | double-blind Parallel groups Sample size: 598/599 Primary endpoint: target vessel failure FU duration: 12 months | | 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) |
|
