| pathology | Demonstrated benefit and harm | k | | | |
|---|
| coronary artery disease | versus bare-metal No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FUTURE I, 2004 | everolimus eluting stent vs bare-metal stent | | | all cause mortality ∞ [NaN; ∞] MACE 1.08 [0.11; 10.86] target lesion revascularisation (TLR ) 0.56 [0.04; 8.26] | | FUTURE II, 2006 | everolimus eluting stent vs bare-metal stent | | | | | SPIRIT I, 2005 | everolimus eluting stent vs bare-metal stent | | | all cause mortality NaN [NaN; NaN] MACE 0.38 [0.08; 1.74] MI ∞ [NaN; ∞] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 0.19 [0.02; 1.49] | | BASKET-PROVE (EES), 2010 | everolimus eluting stent vs bare-metal stent | target-vessel revascularization 0.36 [0.24; 0.55] | | 2yr stent thrombosis 0.91 [0.42; 1.99] all cause mortality 0.73 [0.44; 1.21] MACE 0.67 [0.41; 1.10] MI 0.64 [0.32; 1.28] cardiac death 0.58 [0.30; 1.15] Stent thrombosis (any, end of follow-up) 0.91 [0.42; 1.99] stent thrombosis (ARC) 0.33 [0.07; 1.63] 2 yr MACE 0.67 [0.41; 1.10] 2 yr Death (all cause) 0.73 [0.44; 1.21] |
| Trial | Treatments | Patients | Method |
|---|
| FUTURE I, 2004 | everolimus coated S-Stent (n=27) vs. S-Stent (n=15) | de novo coronary lesions | single-blind Parallel groups Sample size: 27/15 Primary endpoint: MACE FU duration: 12 months | | FUTURE II, 2006 | CHAMPION (n=43) vs. bare-metal stent (n=21) | Patients with de novo lesions in vessels with a reference diameter of 2.75-4.0 mm and length | double-blind Parallel groups Sample size: 43/21 Primary endpoint: angiographic late loss at 6 months FU duration: 6 months | | SPIRIT I, 2005 | everolimus eluting sent, XIENCE (n=28) vs. bare etal stent, MULTI-LINK VISION (n=32) | patients with de novo native coronary artery lesions | single-blind Parallel groups Sample size: 28/32 Primary endpoint: in-stent late loss FU duration: 6 months (5yr) | | BASKET-PROVE (EES), 2010 | second generation everolimus-eluting stent (n=774) vs. BMS
(n=765) 3 arms: sirolimus-eluting, everolimus-eluting and bare metal stent
| patients needing stents 3.0 mm or larger
| open Sample size: 774/765 Primary endpoint: death from cardiac causes or nonfatal myocardial at 2y FU duration: 2 years
|
|
| coronary artery disease | versus drug-eluting stents No demonstrated result for efficacy | 10 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SPIRIT II, 2006 | everolimus eluting stent vs paclitaxel eluting stent | | | angioplastie 0.69 [0.13; 3.70] MACE 0.41 [0.13; 1.32] MI 0.35 [0.05; 2.41] cardiac death 0.00 [0.00; NaN] target lesion revascularisation (TLR ) 0.46 [0.11; 2.01] CABG NaN [NaN; NaN] late stent thrombosis (31d - 1year) 0.35 [0.02; 5.45] Acute stent thrombosis (<=24h) NaN [NaN; NaN] sub acute stent thrombosis (1-30 days) NaN [NaN; NaN] | | SPIRIT IV, 2010 | everolimus eluting stent vs paclitaxel eluting stent | target vessel failure 0.62 [0.46; 0.83] 2yr stent thrombosis 0.33 [0.15; 0.74] 2y target lesion failure 0.70 [0.56; 0.87] clinically driven TVR 0.67 [0.50; 0.91] MACE 0.62 [0.47; 0.83] MI 0.61 [0.40; 0.93] Stent thrombosis (any, end of follow-up) 0.20 [0.06; 0.64] target lesion revascularisation (TLR ) 0.55 [0.38; 0.79] stent thrombosis (ARC) 0.27 [0.11; 0.67] target-vessel revascularization 0.67 [0.50; 0.91] 2 yr TLR 0.65 [0.50; 0.86] | | all cause mortality 0.83 [0.44; 1.57] cardiac death 1.00 [0.34; 2.92] late stent thrombosis (31d - 1year) 0.13 [0.01; 1.12] Acute stent thrombosis (<=24h) 0.30 [0.07; 1.25] sub acute stent thrombosis (1-30 days) 0.00 [0.00; NaN] | | SPIRIT III, 2008 | everolimus eluting stent vs paclitaxel eluting stent | MACE 0.57 [0.37; 0.88] | | all cause mortality 0.98 [0.30; 3.23] MI 0.68 [0.34; 1.38] cardiac death 0.82 [0.20; 3.42] Stent thrombosis (any, end of follow-up) 1.23 [0.24; 6.34] target lesion revascularisation (TLR ) 0.59 [0.32; 1.10] stent thrombosis (ARC) 1.35 [0.43; 4.19] | | SORT OUT IV, 2012 | everolimus eluting stent vs sirolimus eluting stent | | | | | COMPARE, 2009 | everolimus eluting stent vs paclitaxel eluting stent | target vessel failure 0.69 [0.50; 0.95] 2yr stent thrombosis 0.23 [0.11; 0.49] clinically driven TVR 0.38 [0.22; 0.63] MACE 0.62 [0.41; 0.93] MI 0.52 [0.33; 0.84] Stent thrombosis (any, end of follow-up) 0.26 [0.11; 0.64] target lesion revascularisation (TLR ) 0.35 [0.20; 0.63] stent thrombosis (ARC) 0.22 [0.08; 0.66] target-vessel revascularization 0.38 [0.22; 0.63] 2 yr MACE 0.66 [0.50; 0.86] sub acute stent thrombosis (1-30 days) 0.07 [0.01; 0.55] | | all cause mortality 1.21 [0.61; 2.38] cardiac death 1.11 [0.47; 2.59] Acute stent thrombosis (<=24h) 1.01 [0.06; 16.07] | | SPIRIT III (small vessel subgroup), 2009 | everolimus eluting stent vs paclitaxel eluting stent | clinically driven TVR 0.20 [0.07; 0.58] MACE 0.26 [0.09; 0.79] target lesion revascularisation (TLR ) 0.10 [0.02; 0.49] target-vessel revascularization 0.20 [0.07; 0.58] | | all cause mortality ∞ [NaN; ∞] MI ∞ [NaN; ∞] cardiac death ∞ [NaN; ∞] Stent thrombosis (any, end of follow-up) ∞ [NaN; ∞] CABG NaN [NaN; NaN] | | PLATINUM, 2011 | everolimus eluting stent vs everolimus eluting stent | | | | | ISAR-TEST 4 (EES vs SES) | everolimus eluting stent vs sirolimus eluting stent | 2 yr TLR 0.74 [0.55; 1.00] | | Stent thrombosis (any, end of follow-up) 0.75 [0.32; 1.77] 2 yr MACE 0.85 [0.67; 1.07] | | ESSENCE diabetes | everolimus eluting stent vs sirolimus ES | | | | | RESET, 2011 | everolimus eluting stent vs sirolimus eluting stent | | | |
| Trial | Treatments | Patients | Method |
|---|
| SPIRIT II, 2006 | everolimus eluting stent, XIENCE V (n=223) vs. placitaxel eluting stent, TAXUS EXPRESS2 (n=77) | De novo lesions (maximim two) | single-blind (patient) Parallel groups Sample size: 223/77 Primary endpoint: In-stent late loss FU duration: 6 months | | SPIRIT IV, 2010 | XIENCE V Everolimus Eluting Coronary Stent System (n=2458) vs. TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System (TAXUS). (n=1229) | patients with de novo native coronary artery lesions and reference vessel diameters between 2.5 mm to 4.25 mm and lesion lengths <= 28 mm | 270 days (5 years) Parallel groups Sample size: 2458/1229 Primary endpoint: target lesion failure FU duration: 1 y (2y) | | SPIRIT III, 2008 | everolimus-eluting stent, XIENCE V (n=669) vs. paclitaxel-eluting stent, Taxus (n=333) | lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 m | single-blind Parallel groups Sample size: 669/333 Primary endpoint: in-segment late loss FU duration: 12 months | | SORT OUT IV, 2012 | everolimus-eluting stents (n=1390) vs. sirolimus-eluting stents (n=1384) | unselected patients with coronary artery disease | open Parallel groups Sample size: 1390/1384 Primary endpoint: MACE (death, MI, definite stent thrombosis, clinical TVR) FU duration: 9 months (3 years) | | COMPARE, 2009 | polymer based, everolimus-eluting stent (Xience V) (n=897) vs. polymer-based,
paclitaxel-eluting stent (Taxus Liberte) (n=903) | unselected patients | open Parallel groups Sample size: 897/903 Primary endpoint: death, MI,TVR FU duration: 1 y (2y) | | SPIRIT III (small vessel subgroup), 2009 | 2.5-mm everolimus-eluting stent (n=160) vs. 2.5-mm paclitaxel-eluting stent (n=59) | patients included in SPIRIT III that received at least one 2.5-mm stent | open Parallel groups Sample size: 160/59 Primary endpoint: FU duration: 9 months | | PLATINUM, 2011 | platinum chromium everolimus-eluting stent (n=768) vs. cobalt chromium everolimus-eluting stent (n=762) | patients with up to 2 de novo atherosclerotic coronary artery lesions | single-blind Parallel groups Sample size: 768/762 Primary endpoint: 12-mo TLF FU duration: 12 months | | ISAR-TEST 4 (EES vs SES) | everolimus-eluting stent (n=652) vs. sirolimus-eluting stent (n=652) 3 arms: rapamycin (sirolimus)-coated stent with a biodegradable polymer, permanent-polymer everolimus-eluting and permanent-polymer sirolimus-eluting | patients with de novo coronary artery stenosis >50% and symptoms or objective evidence of ischemia | Parallel groups Sample size: 652/652 Primary endpoint: FU duration: 2 years | | ESSENCE diabetes | everolimus-eluting stent (n=149) vs. sirolimus-eluting stent (n=151) | diabetic patients with angina or documented ischemia | open Parallel groups Sample size: 149/151 Primary endpoint: maximal regional late loss at 8-month FU duration: 1y for clinical events | | RESET, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| stable angina | versus bare-metal No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FUTURE I, 2004 | everolimus eluting stent vs bare-metal stent | | | all cause mortality ∞ [NaN; ∞] MACE 1.08 [0.11; 10.86] target lesion revascularisation (TLR ) 0.56 [0.04; 8.26] | | FUTURE II, 2006 | everolimus eluting stent vs bare-metal stent | | | | | SPIRIT I, 2005 | everolimus eluting stent vs bare-metal stent | | | all cause mortality NaN [NaN; NaN] MACE 0.38 [0.08; 1.74] MI ∞ [NaN; ∞] Stent thrombosis (any, end of follow-up) NaN [NaN; NaN] target lesion revascularisation (TLR ) 0.19 [0.02; 1.49] |
| Trial | Treatments | Patients | Method |
|---|
| FUTURE I, 2004 | everolimus coated S-Stent (n=27) vs. S-Stent (n=15) | de novo coronary lesions | single-blind Parallel groups Sample size: 27/15 Primary endpoint: MACE FU duration: 12 months | | FUTURE II, 2006 | CHAMPION (n=43) vs. bare-metal stent (n=21) | Patients with de novo lesions in vessels with a reference diameter of 2.75-4.0 mm and length | double-blind Parallel groups Sample size: 43/21 Primary endpoint: angiographic late loss at 6 months FU duration: 6 months | | SPIRIT I, 2005 | everolimus eluting sent, XIENCE (n=28) vs. bare etal stent, MULTI-LINK VISION (n=32) | patients with de novo native coronary artery lesions | single-blind Parallel groups Sample size: 28/32 Primary endpoint: in-stent late loss FU duration: 6 months (5yr) |
|
| stable angina | versus drug-eluting stents No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SPIRIT II, 2006 | everolimus eluting stent vs paclitaxel eluting stent | | | angioplastie 0.69 [0.13; 3.70] MACE 0.41 [0.13; 1.32] MI 0.35 [0.05; 2.41] cardiac death 0.00 [0.00; NaN] target lesion revascularisation (TLR ) 0.46 [0.11; 2.01] CABG NaN [NaN; NaN] late stent thrombosis (31d - 1year) 0.35 [0.02; 5.45] Acute stent thrombosis (<=24h) NaN [NaN; NaN] sub acute stent thrombosis (1-30 days) NaN [NaN; NaN] | | SPIRIT IV, 2010 | everolimus eluting stent vs paclitaxel eluting stent | target vessel failure 0.62 [0.46; 0.83] 2yr stent thrombosis 0.33 [0.15; 0.74] 2y target lesion failure 0.70 [0.56; 0.87] clinically driven TVR 0.67 [0.50; 0.91] MACE 0.62 [0.47; 0.83] MI 0.61 [0.40; 0.93] Stent thrombosis (any, end of follow-up) 0.20 [0.06; 0.64] target lesion revascularisation (TLR ) 0.55 [0.38; 0.79] stent thrombosis (ARC) 0.27 [0.11; 0.67] target-vessel revascularization 0.67 [0.50; 0.91] 2 yr TLR 0.65 [0.50; 0.86] | | all cause mortality 0.83 [0.44; 1.57] cardiac death 1.00 [0.34; 2.92] late stent thrombosis (31d - 1year) 0.13 [0.01; 1.12] Acute stent thrombosis (<=24h) 0.30 [0.07; 1.25] sub acute stent thrombosis (1-30 days) 0.00 [0.00; NaN] | | SPIRIT III, 2008 | everolimus eluting stent vs paclitaxel eluting stent | MACE 0.57 [0.37; 0.88] | | all cause mortality 0.98 [0.30; 3.23] MI 0.68 [0.34; 1.38] cardiac death 0.82 [0.20; 3.42] Stent thrombosis (any, end of follow-up) 1.23 [0.24; 6.34] target lesion revascularisation (TLR ) 0.59 [0.32; 1.10] stent thrombosis (ARC) 1.35 [0.43; 4.19] | | SORT OUT IV, 2012 | everolimus eluting stent vs sirolimus eluting stent | | | | | COMPARE, 2009 | everolimus eluting stent vs paclitaxel eluting stent | target vessel failure 0.69 [0.50; 0.95] 2yr stent thrombosis 0.23 [0.11; 0.49] clinically driven TVR 0.38 [0.22; 0.63] MACE 0.62 [0.41; 0.93] MI 0.52 [0.33; 0.84] Stent thrombosis (any, end of follow-up) 0.26 [0.11; 0.64] target lesion revascularisation (TLR ) 0.35 [0.20; 0.63] stent thrombosis (ARC) 0.22 [0.08; 0.66] target-vessel revascularization 0.38 [0.22; 0.63] 2 yr MACE 0.66 [0.50; 0.86] sub acute stent thrombosis (1-30 days) 0.07 [0.01; 0.55] | | all cause mortality 1.21 [0.61; 2.38] cardiac death 1.11 [0.47; 2.59] Acute stent thrombosis (<=24h) 1.01 [0.06; 16.07] | | ISAR-TEST 4 (EES vs SES) | everolimus eluting stent vs sirolimus eluting stent | 2 yr TLR 0.74 [0.55; 1.00] | | Stent thrombosis (any, end of follow-up) 0.75 [0.32; 1.77] 2 yr MACE 0.85 [0.67; 1.07] |
| Trial | Treatments | Patients | Method |
|---|
| SPIRIT II, 2006 | everolimus eluting stent, XIENCE V (n=223) vs. placitaxel eluting stent, TAXUS EXPRESS2 (n=77) | De novo lesions (maximim two) | single-blind (patient) Parallel groups Sample size: 223/77 Primary endpoint: In-stent late loss FU duration: 6 months | | SPIRIT IV, 2010 | XIENCE V Everolimus Eluting Coronary Stent System (n=2458) vs. TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System (TAXUS). (n=1229) | patients with de novo native coronary artery lesions and reference vessel diameters between 2.5 mm to 4.25 mm and lesion lengths <= 28 mm | 270 days (5 years) Parallel groups Sample size: 2458/1229 Primary endpoint: target lesion failure FU duration: 1 y (2y) | | SPIRIT III, 2008 | everolimus-eluting stent, XIENCE V (n=669) vs. paclitaxel-eluting stent, Taxus (n=333) | lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 m | single-blind Parallel groups Sample size: 669/333 Primary endpoint: in-segment late loss FU duration: 12 months | | SORT OUT IV, 2012 | everolimus-eluting stents (n=1390) vs. sirolimus-eluting stents (n=1384) | unselected patients with coronary artery disease | open Parallel groups Sample size: 1390/1384 Primary endpoint: MACE (death, MI, definite stent thrombosis, clinical TVR) FU duration: 9 months (3 years) | | COMPARE, 2009 | polymer based, everolimus-eluting stent (Xience V) (n=897) vs. polymer-based,
paclitaxel-eluting stent (Taxus Liberte) (n=903) | unselected patients | open Parallel groups Sample size: 897/903 Primary endpoint: death, MI,TVR FU duration: 1 y (2y) | | ISAR-TEST 4 (EES vs SES) | everolimus-eluting stent (n=652) vs. sirolimus-eluting stent (n=652) 3 arms: rapamycin (sirolimus)-coated stent with a biodegradable polymer, permanent-polymer everolimus-eluting and permanent-polymer sirolimus-eluting | patients with de novo coronary artery stenosis >50% and symptoms or objective evidence of ischemia | Parallel groups Sample size: 652/652 Primary endpoint: FU duration: 2 years |
|
