| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | versus bare-metal No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DEDICATION, 2008 | drug-eluting stents vs bare-metal stent | MACE 0.62 [0.40; 0.97] target-vessel revascularization 0.39 [0.22; 0.68] 2 yr TLR 0.37 [0.22; 0.61] 2 yr MACE 0.63 [0.43; 0.93] | | MACE at 5yr 0.81 [0.57; 1.16] 2 yr MI (all) 0.60 [0.22; 1.63] all cause mortality 2.00 [0.87; 4.61] cardiac death 2.60 [0.94; 7.21] Stent thrombosis (any, end of follow-up) 0.88 [0.32; 2.38] 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; 5.85] 2 yr Death (all cause) 1.64 [0.97; 2.80] | | PASEO, 2009 | drug-eluting stents vs bare-metal stent | | | |
| Trial | Treatments | Patients | Method |
|---|
| DEDICATION, 2008 | DES currently used with or without distal protection (n=313) vs. BMS with or without distal protection
(n=313) patients were also randomized to treatment with or without distal protection using a filter wire system (factorial design)
| patients referred within 12 hours from symptom onset of an ST-elevation myocardial infarction
| open Factorial plan Sample size: 313/313 Primary endpoint: loss of the lumen diameter FU duration: 8 mo (15 mo, 3y)
| | PASEO, 2009 | paclitaxel-eluting stents and sirolimus-eluting stents (n=180) vs. bare metal stent (n=90) 3 arms : SES, PES, BM | patients with ST-elevation myocardial infarction within 12 hours from symptom onset | open Parallel groups Sample size: 180/90 Primary endpoint: TLR 1 year FU duration: 4.3 years |
|
| coronary artery disease | versus bare-metal No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DEDICATION, 2008 | drug-eluting stents vs bare-metal stent | MACE 0.62 [0.40; 0.97] target-vessel revascularization 0.39 [0.22; 0.68] 2 yr TLR 0.37 [0.22; 0.61] 2 yr MACE 0.63 [0.43; 0.93] | | MACE at 5yr 0.81 [0.57; 1.16] 2 yr MI (all) 0.60 [0.22; 1.63] all cause mortality 2.00 [0.87; 4.61] cardiac death 2.60 [0.94; 7.21] Stent thrombosis (any, end of follow-up) 0.88 [0.32; 2.38] 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; 5.85] 2 yr Death (all cause) 1.64 [0.97; 2.80] | | GENIUS-STEMI, 2009 | Genous stent vs bare-metal stent | | | MACE 2.00 [NaN; NaN] MI -∞ [NaN; NaN] target lesion revascularisation (TLR ) -∞ [NaN; NaN] stent thrombosis (ARC) ∞ [NaN; ∞] | | PASEO, 2009 | drug-eluting stents vs bare-metal stent | | | |
| Trial | Treatments | Patients | Method |
|---|
| DEDICATION, 2008 | DES currently used with or without distal protection (n=313) vs. BMS with or without distal protection
(n=313) patients were also randomized to treatment with or without distal protection using a filter wire system (factorial design)
| patients referred within 12 hours from symptom onset of an ST-elevation myocardial infarction
| open Factorial plan Sample size: 313/313 Primary endpoint: loss of the lumen diameter FU duration: 8 mo (15 mo, 3y)
| | GENIUS-STEMI, 2009 | endothelial progenitor cell capture stent (n=50) vs. cobalt chromium stent (n=50) | patients with ST-elevation myocardial infarction | NA Parallel groups Sample size: 50/50 Primary endpoint: MACE FU duration: 6 months | | PASEO, 2009 | paclitaxel-eluting stents and sirolimus-eluting stents (n=180) vs. bare metal stent (n=90) 3 arms : SES, PES, BM | patients with ST-elevation myocardial infarction within 12 hours from symptom onset | open Parallel groups Sample size: 180/90 Primary endpoint: TLR 1 year FU duration: 4.3 years |
|
| coronary artery disease | versus surgery No demonstrated result for efficacy PCI with drug-eluting stents inferior to CABG in terms of 5 year cardiovascular events in FREEDOM, 2012 PCI with drug-eluting stents inferior to CABG in terms of long term death in FREEDOM, 2012 PCI with drug-eluting stents inferior to CABG in terms of long term cardiovascular events in FREEDOM, 2012 | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FREEDOM, 2012 | PCI with drug-eluting stents vs CABG | | 5 year cardiovascular events 1.36 [1.12; 1.65] long term death 1.36 [1.05; 1.77] long term cardiovascular events 1.39 [1.14; 1.68] | 5 year death 1.40 [0.99; 1.97] Death 1.5 to 2 years 1.08 [0.76; 1.53] Events 2 years 1.11 [0.87; 1.42] | | Hong, 2005 | PCI withdrug-eluting stents vs CABG | | | | | Boudriot, 2008 | DES vs CABG | | | all cause mortality 0.39 [0.06; 2.46] target-vessel revascularization 2.33 [0.77; 7.05] |
| Trial | Treatments | Patients | Method |
|---|
| FREEDOM, 2012 | percutaneous coronary stenting (n=953) vs. CABG (n=947) | patients with diabetes and multivessel coronary artery disease | open Parallel groups Sample size: 953/947 Primary endpoint: death, MI, stroke FU duration: 3.8 yrs (median) | | Hong, 2005 | drug-eluting stents (n=119) vs. invasive direct coronary artery bypass (MIDCAB) surgery (n=70) | proximal left anterior descending (LAD) coronary artery stenosis | open Parallel groups Sample size: 119/70 Primary endpoint: FU duration: 9 months | | Boudriot, 2008 | DES (n=83) vs. CABG (n=84) | | open Parallel groups Sample size: 83/84 Primary endpoint: FU duration: 12 months |
|
| stable angina | versus surgery No demonstrated result for efficacy PCI with drug-eluting stents inferior to CABG in terms of 5 year cardiovascular events in FREEDOM, 2012 PCI with drug-eluting stents inferior to CABG in terms of long term death in FREEDOM, 2012 PCI with drug-eluting stents inferior to CABG in terms of long term cardiovascular events in FREEDOM, 2012 | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FREEDOM, 2012 | PCI with drug-eluting stents vs CABG | | 5 year cardiovascular events 1.36 [1.12; 1.65] long term death 1.36 [1.05; 1.77] long term cardiovascular events 1.39 [1.14; 1.68] | 5 year death 1.40 [0.99; 1.97] Death 1.5 to 2 years 1.08 [0.76; 1.53] Events 2 years 1.11 [0.87; 1.42] | | Hong, 2005 | PCI withdrug-eluting stents vs CABG | | | | | Boudriot, 2008 | DES vs CABG | | | all cause mortality 0.39 [0.06; 2.46] target-vessel revascularization 2.33 [0.77; 7.05] |
| Trial | Treatments | Patients | Method |
|---|
| FREEDOM, 2012 | percutaneous coronary stenting (n=953) vs. CABG (n=947) | patients with diabetes and multivessel coronary artery disease | open Parallel groups Sample size: 953/947 Primary endpoint: death, MI, stroke FU duration: 3.8 yrs (median) | | Hong, 2005 | drug-eluting stents (n=119) vs. invasive direct coronary artery bypass (MIDCAB) surgery (n=70) | proximal left anterior descending (LAD) coronary artery stenosis | open Parallel groups Sample size: 119/70 Primary endpoint: FU duration: 9 months | | Boudriot, 2008 | DES (n=83) vs. CABG (n=84) | | open Parallel groups Sample size: 83/84 Primary endpoint: FU duration: 12 months |
|
