| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | drug-eluting stents | not classified | 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 |
|
| acute myocardial infarction | paclitaxel | not classified | 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 |
|
| acute myocardial infarction | PCI | not classified | versus no systematic PCI No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| WEST, 2006 | systematic PCI (+stent) vs no systematic PCI | | | In-hospital death 0.24 [0.03; 2.11] Major bleeding 1.92 [0.18; 20.88] stroke ∞ [NaN; ∞] Reinfarction 0.64 [0.24; 1.74] | | CAPITAL AMI, 2005 | systematic PCI (+stent) vs no systematic PCI | | | In-hospital death 0.98 [0.20; 4.70] Major bleeding 1.14 [0.40; 3.25] stroke 0.98 [0.06; 15.36] Reinfarction 0.41 [0.15; 1.11] | | GRACIA-1, 2004 | systematic PCI (+stent) vs no systematic PCI | | | In-hospital death 0.57 [0.26; 1.26] Major bleeding 2.02 [0.37; 10.95] stroke 0.00 [0.00; NaN] Reinfarction 0.61 [0.27; 1.36] | | SIAM III, 2002 | systematic PCI (+stent) vs no systematic PCI | | | In-hospital death 0.44 [0.14; 1.37] Major bleeding 1.32 [0.48; 3.63] stroke 0.99 [0.14; 6.85] Reinfarction 0.99 [0.14; 6.85] | | PRAGUE, 2000 | systematic PCI (+stent) vs no systematic PCI | | | In-hospital death 0.66 [0.34; 1.30] Major bleeding ∞ [NaN; ∞] stroke 2.97 [0.31; 28.07] Reinfarction 0.50 [0.19; 1.27] |
| Trial | Treatments | Patients | Method |
|---|
| WEST, 2006 | TNK and mandatory invasive study <= 24 h, including rescue PCI for reperfusion failure (n=104) vs. tenecteplase (TNK) and usual care (n=100) | STEMI patients (> 4 mm ST-elevation/deviation) within 6 h of symptom onse | Parallel groups Sample size: 104/100 Primary endpoint: death, re-MI, refractory ischaemia, HF, shock, major ventricular arrhythmia FU duration: 30 days | | CAPITAL AMI, 2005 | TNK-facilitated angioplasty (n=86) vs. TNK alone (n=84) | patients with high-risk ST-segment elevation myocardial infarction | Parallel groups Sample size: 86/84 Primary endpoint: death, reinfarction, recurrent unstable ischemia, stroke FU duration: 6 months | | GRACIA-1, 2004 | angiography and intervention if indicated within 24 h of thrombolysis (n=248) vs. ischaemia-guided conservative approach (n=251) | patients with thrombolysed STEMI (with recombinant tissue plasminogen activator) | Parallel groups Sample size: 248/251 Primary endpoint: death, reinfarction, or revascularisation FU duration: 12 months | | SIAM III, 2002 | immediate stenting after thrombolysis (n=82) vs. conservative treatment (n=81) | patients receiving thrombolysis in AMI (<12 h) | Parallel groups Sample size: 82/81 Primary endpoint: FU duration: 6 months | | PRAGUE, 2000 | thrombolysis during immediate transportation for coronary angioplasty (n=100) vs. thrombolysis in a community hospital (n=99) | patients with acute ST elevation myocardial infarction presenting to community hospitals | Sample size: 100/99 Primary endpoint: FU duration: 12 months |
|
| acute myocardial infarction | PCI | not classified | versus ballon angioplasty No demonstrated result for efficacy | 13 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Jaksch, 1998 | primary stenting vs balloon angioplasty | revascularization (6 months) 0.35 [0.15; 0.81] revascularization (30 days) 0.29 [0.10; 0.86] | | death (6 months) 0.71 [0.23; 2.22] reinfarctus (6 months) 0.38 [0.10; 1.40] death (30 days) 0.60 [0.15; 2.48] reinfraction (30 days) 0.38 [0.10; 1.40] | | GRAMI (Rodriguez), 1998 | primary stenting vs balloon angioplasty | | | death (30 days) 0.50 [0.10; 2.61] bleeding 1.00 [0.06; 15.57] revascularization (30 days) 0.00 [0.00; NaN] reinfraction (30 days) 0.00 [0.00; NaN] revascularization (12 months) 0.70 [0.29; 1.70] | | Zwolle 5 (Suryapranata), 1998 | primary stenting vs balloon angioplasty | revascularization (6 months) 0.22 [0.08; 0.62] reinfarctus (12 months) 0.10 [0.01; 0.79] revascularization (12 months) 0.39 [0.18; 0.85] | | death (6 months) 0.68 [0.12; 4.02] reinfarctus (6 months) 0.13 [0.02; 1.01] death (30 days) 0.68 [0.12; 4.02] bleeding 2.40 [0.64; 9.03] revascularization (30 days) 0.00 [0.00; NaN] death (12 months) 0.77 [0.18; 3.36] reinfraction (30 days) 0.21 [0.02; 1.73] | | stent-PAMI (Grines), 1999 | primary stenting vs balloon angioplasty | revascularization (6 months) 0.45 [0.31; 0.66] revascularization (30 days) 0.35 [0.14; 0.87] | | death (6 months) 1.55 [0.76; 3.16] reinfarctus (6 months) 1.08 [0.46; 2.51] death (30 days) 1.96 [0.85; 4.53] bleeding 1.33 [0.72; 2.45] death (12 months) 1.82 [0.96; 3.44] reinfraction (30 days) 0.39 [0.08; 2.01] reinfarctus (12 months) 1.06 [0.49; 2.30] | | PASTA (Saito), 1999 | primary stenting vs balloon angioplasty | revascularization (6 months) 0.50 [0.26; 0.94] revascularization (12 months) 0.52 [0.28; 0.96] | | death (6 months) 0.63 [0.16; 2.52] reinfarctus (6 months) 0.00 [0.00; NaN] death (30 days) 0.42 [0.08; 2.08] bleeding 1.04 [0.07; 16.37] revascularization (30 days) 0.46 [0.15; 1.44] death (12 months) 0.52 [0.14; 2.00] reinfraction (30 days) 0.00 [0.00; NaN] reinfarctus (12 months) 0.00 [0.00; NaN] | | PRISAM (Kawashima), 1999 | primary stenting vs balloon angioplasty | | | death (30 days) 0.00 [0.00; NaN] revascularization (30 days) 0.67 [0.44; 1.03] | | STENTIM-2 (Maillard), 2000 | primary stenting vs balloon angioplasty | | | death (6 months) 2.18 [0.20; 23.66] reinfarctus (6 months) 0.73 [0.21; 2.50] revascularization (6 months) 0.64 [0.37; 1.09] death (30 days) ∞ [NaN; ∞] bleeding 0.73 [0.12; 4.26] revascularization (30 days) 0.91 [0.29; 2.88] death (12 months) 1.63 [0.28; 9.58] reinfraction (30 days) 1.09 [0.28; 4.24] reinfarctus (12 months) 0.73 [0.21; 2.50] revascularization (12 months) 0.62 [0.36; 1.05] | | PSSAAMI (Scheller), 2001 | primary stenting vs balloon angioplasty | revascularization (12 months) 0.29 [0.12; 0.73] | | death (30 days) 2.00 [0.19; 21.26] bleeding 0.67 [0.20; 2.20] revascularization (30 days) 0.00 [0.00; NaN] death (12 months) 0.50 [0.16; 1.54] reinfraction (30 days) 0.00 [0.00; NaN] reinfarctus (12 months) 0.25 [0.03; 2.15] | | primary stenting vs balloon angioplasty | | | | | primary stenting vs balloon angioplasty | | | | | primary stenting vs balloon angioplasty | | | | | primary stenting vs balloon angioplasty | | | | | primary stenting vs balloon angioplasty | | | |
| Trial | Treatments | Patients | Method |
|---|
| Jaksch, 1998 | Various stent (n=231) vs. (n=231) | | open Parallel groups Sample size: 231/231 Primary endpoint: FU duration: 6 months | | GRAMI (Rodriguez), 1998 | balloon angioplasty followed electively with Gianturco Roubin II stents (n=52) vs. conventional balloon angioplasty (n=52) | patients with acute myocardial infarction within 24 hours after onset | open Parallel groups Sample size: 52/52 Primary endpoint: FU duration: 12 months | | Zwolle 5 (Suryapranata), 1998 | Stent Palmaz-Schatz (n=112) vs. balloon angioplasty (n=115) | Patients with acute myocardial infarction | open Parallel groups Sample size: 112/115 Primary endpoint: FU duration: 12 months | | stent-PAMI (Grines), 1999 | angioplasty with Stent Heparin-coated (n=452) vs. angioplasty alone (n=448) | patients with acute myocardial infarction and with vessels suitable for stenting | open Parallel groups Sample size: 452/448 Primary endpoint: FU duration: 12 months | | PASTA (Saito), 1999 | Stent Palmaz-Schatz (n=67) vs. primary balloon angioplasty (n=70) | patients with AMI within 12 hr from onset | open Parallel groups Sample size: 67/70 Primary endpoint: FU duration: 12 months | | PRISAM (Kawashima), 1999 | Stent Palmaz-Schatz (n=110) vs. (n=112) | | open Parallel groups Sample size: 110/112 Primary endpoint: FU duration: 6 months | | STENTIM-2 (Maillard), 2000 | systematic stenting with Stent Wiktor (n=101) vs. conventional balloon angioplasty (n=110) | patients with AMI <12 h from symptom onset, with an occluded native coronary artery | open Parallel groups Sample size: 101/110 Primary endpoint: FU duration: 12 months | | PSSAAMI (Scheller), 2001 | Stent Wiktor GX (n=44) vs. primary angioplasty (n=44) | patients within 24 hours after the onset of acute myocardial infarction | open Parallel groups Sample size: 44/44 Primary endpoint: FU duration: 24 months | | FRESCO, 1998 | elective stenting after successful primary PTCA (n=75) vs. no further intervention after successful primary PTCA (n=75) | patient with successful primary PTCA | open Parallel groups Sample size: 75/75 Primary endpoint: FU duration: 12 months | | CADILLAC abciximab., 2002 | stenting plus abciximab therapy (n=524) vs. PTCA plus abciximab therapy (n=528) | patients with acute myocardial infarction | open Parallel groups Sample size: 524/528 Primary endpoint: FU duration: 12 months | | CADILLAC (no abciximab), 2002 | stenting alone with the MultiLink stent (n=512) vs. PTCA alone (n=518) | patients with acute myocardial infarction | open Parallel groups Sample size: 512/518 Primary endpoint: FU duration: 12 months | | ZWOLLE 6, 2005 | stenting (n=785) vs. balloon angioplasty (n=763) randomisation before angiography | unselected patients with STEMI | open Parallel groups Sample size: 785/763 Primary endpoint: FU duration: 12 months | | STOPAMI 3, 2004 | coronary artery stenting (n=305) vs. PTCA (n=306) | patients with AMI ineligible for thrombolysis (lack of ST-segment elevation on the electrocardiogram, late presentation >12 h after symptom onset, and contraindications to thrombolysis) | open Parallel groups Sample size: 305/306 Primary endpoint: FU duration: 6 months |
|
| acute myocardial infarction | PCI | not classified | versus thrombolytic No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| STAT, 2001 | primary stenting vs accelerated t-PA | | | | | C-PORT, 2002 | primary PCI vs accelerated t-PA | | | | | STOPAMI 2, 2002 | primary stenting vs immediate thrombolysis | | | | | senior PAMI, 2005 | primary PCI vs Thrombolysis | death/reinfarction/stroke 0.64 [0.41; 1.00] | | stroke 0.36 [0.07; 1.86] in-hospital mortality 0.76 [0.46; 1.25] |
| Trial | Treatments | Patients | Method |
|---|
| STAT, 2001 | primary stenting (n=62) vs. accelerated t-PA (n=61) | patients with acute ST-elevation myocardial infarction | open Parallel groups Sample size: 62/61 Primary endpoint: death, reinfarction, stroke, TVR FU duration: 6 months | | C-PORT, 2002 | primary PCI without on-site cardiac surgery (n=225) vs. accelerated tissue plasminogen activator (n=226) | thrombolytic-eligible patients with acute MI of less than 12 hours' duration associated with ST-segment elevation | open Parallel groups Sample size: 225/226 Primary endpoint: death, recurrent MI, and stroke FU duration: 6 months | | STOPAMI 2, 2002 | stenting combined with abciximab (n=81) vs. fibrinolysis by alteplase combined with abciximab (n=81) | patients with acute myocardial infarction within 12 h of onset of symptoms | open Parallel groups Sample size: 81/81 Primary endpoint: salvage index FU duration: | | senior PAMI, 2005 | primary percutaneous coronary intervention (n=252) vs. intravenous thrombolytic therapy (n=229) | elderly (age >= 70 years) patients with acute myocardial infarction | Open Parallel groups Sample size: 252/229 Primary endpoint: death or disabling stroke FU duration: 30 days |
|
| acute myocardial infarction | primary angioplasty | not classified | versus thrombolytic No demonstrated result for efficacy primary ballon angioplasty inferior to streptokinase in terms of MACE in Zwolle, 1994 primary ballon angioplasty inferior to streptokinase in terms of reinfarction in Zwolle, 1994 primary ballon angioplasty inferior to streptokinase in terms of in-hospital mortality in Zwolle, 1994 | 15 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Zwolle, 1994 | primary ballon angioplasty vs streptokinase | | MACE 0.21 [0.08; 0.55] reinfarction 0.13 [0.03; 0.56] in-hospital mortality 0.27 [0.08; 0.94] | major bleeding 0.87 [0.35; 2.20] stroke 0.33 [0.03; 3.11] | | Ribeiro, 1993 | primary ballon angioplasty vs streptokinase | | | | | Grinfeld, 1996 | primary ballon angioplasty vs streptokinase | | | | | Zijlstra, 1997 | primary ballon angioplasty vs streptokinase | | | | | DeWood, 1989 | primary ballon angioplasty vs duteplase | | | | | PAMI, 1993 | primary ballon angioplasty vs t-PA | | | | | Gibbons, 1993 | primary ballon angioplasty vs duteplase | | | | | Ribichini, 1996 | primary ballon angioplasty vs accelerated t-PA | | | | | Garcia, 1997 | primary ballon angioplasty vs accelerated t-PA | | | | | GUSTO 2B, 1997 | primary ballon angioplasty vs accelerated t-PA | | | | | DANAMI-2, 1997 | primary ballon angioplasty vs accelerated t-PA | | | | | Zijlstra , 1993 | primary ballon angioplasty vs streptokinase | | | | | Akhras, 1997 | primary ballon angioplasty vs streptokinase | | | | | O'Neill, 1986 | primary ballon angioplasty vs intracoronary streptokinase | | | | | TRIANA, 2009 | primary ballon angioplasty vs tenecteplase | | | MACE 1.46 [0.81; 2.63] stroke 4.03 [0.44; 36.86] reinfarction 1.60 [0.60; 4.26] in-hospital mortality 1.31 [0.67; 2.56] |
| Trial | Treatments | Patients | Method |
|---|
| Zwolle, 1994 | primary PTCA (n=152) vs. streptokinase 1.5 M IU over 1h (n=149) | patients with acute myocardial infarction | open Parallel groups Sample size: 152/149 Primary endpoint: FU duration: discharge | | Ribeiro, 1993 | primary PTCA (n=50) vs. streptokinase 1.2 M IU over 1h (n=50) | patients with ST segment elevation within 6 h of the onset of chest pain | open Parallel groups Sample size: 50/50 Primary endpoint: FU duration: discharge | | Grinfeld, 1996 | primary PTCA (n=54) vs. streptokinase 1.5 M IU over 1h (n=58) | | open Parallel groups Sample size: 54/58 Primary endpoint: FU duration: 30 d | | Zijlstra, 1997 | primary PTCA (n=45) vs. streptokinase 1.5 M IU over 1h (n=50) | atients with acute myocardial infarction | open Parallel groups Sample size: 45/50 Primary endpoint: death, nonfatal stroke or reinfarcti FU duration: 6 months | | DeWood, 1989 | primary PTCA (n=46) vs. duteplase 0.5 MU/kg for 1 h then 0.7 MU/kg/h for 3h (n=44) | | open Parallel groups Sample size: 46/44 Primary endpoint: FU duration: 30 d | | PAMI, 1993 | primary PTCA (n=195) vs. t-PA 100mg (or 1.25mg/kg for patients weighting less than 65kg) over 3 h (n=200) | patients who presented within 12 hours of the onset of myocardial infarction | open Parallel groups Sample size: 195/200 Primary endpoint: FU duration: discharge | | Gibbons, 1993 | primary PTCA (n=47) vs. duteplase 0.6 MU/kg over 5h (n=56) | patients with acute myocardial infarction | open Parallel groups Sample size: 47/56 Primary endpoint: FU duration: discharge | | Ribichini, 1996 | primary PTCA (n=24) vs. accelerated alteplase 90 min (15 mg IV bolus followed by an infusion of 0.75 mg/kg over 30min not to exceed 50mg, and then 0.5 mg/kg over the next 60min not to exceed 35mg for a total maximun of 100mg) (n=26) | | open Parallel groups Sample size: 24/26 Primary endpoint: FU duration: discharge | | Garcia, 1997 | primary PTCA (n=95) vs. accelerated t-PA 90 min (15 mg IV bolus followed by an infusion of 0.75 mg/kg over 30min not to exceed 50mg, and then 0.5 mg/kg over the next 60min not to exceed 35mg for a total maximun of 100mg) (n=94) | patients with anterior AMI | open Parallel groups Sample size: 95/94 Primary endpoint: FU duration: 30 d | | GUSTO 2B, 1997 | primary PTCA (n=573) vs. accelerated t-PA 90 min (15 mg IV bolus followed by an infusion of 0.75 mg/kg over 30min not to exceed 50mg, and then 0.5 mg/kg over the next 60min not to exceed 35mg for a total maximun of 100mg) (n=565) | patients within 12 hours of acute myocardial infarction (with ST-segment elevation on the electrocardiogram) | open factorial design Sample size: 573/565 Primary endpoint: death, nonfatal reinfarction, and nonfatal disabling stroke FU duration: 30 d | | DANAMI-2, 1997 | angioplasty (n=-9) vs. accelerated treatment with intravenous alteplase (n=-9) | patients who received thrombolytic treatment for a first acute myocardial infarction and with inducible myocardial ischemia (either symptomatic angina pectoris presenting spontaneously > 36 hours after admission or during a predischarge exercise test or ST changes during exercise compatible with ischemia) | open Parallel groups Sample size: -9/-9 Primary endpoint: mortality, reinfarction, and admission with unstable angina FU duration: 2.4y | | Zijlstra , 1993 | immediate coronary angioplasty (without previous thrombolytic therapy) (n=70) vs. intravenous streptokinase (n=72) | patients with acute myocardial infarction | open Parallel groups Sample size: 70/72 Primary endpoint: FU duration: | | Akhras, 1997 | primary angioplasty (n=42) vs. streptokinase (n=45) | patient within 12hr from onset of AMI | open Parallel groups Sample size: 42/45 Primary endpoint: none FU duration: | | O'Neill, 1986 | coronary angioplasty (n=-9) vs. intracoronary streptokinase (n=-9) | patients within 12 hours of their first symptoms of acute myocardial infarction | open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | | TRIANA, 2009 | Tenecteplase + UFH (+/- clopidogrel) (n=132) vs. Primary angioplasty (n=134) | >=75 years old with ST-segment elevation or LBBB AMI <6 hours of evolution without contraindications for thrombolytic therapy | open Parallel groups Sample size: 132/134 Primary endpoint: Death or Reinfarction or Disabling stroke FU duration: 30 days (12 months) |
|
| acute myocardial infarction | PTCA | not classified | versus No demonstrated result for efficacy rescue PTCA inferior to no rescue PTCA in terms of Minor bleeding in REACT (rescue PCI), 2005 rescue PTCA inferior to no rescue PTCA in terms of Minor bleeding in MERLIN, 2004 | 11 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| REACT (rescue PCI), 2005 | rescue PTCA vs no rescue PTCA | reinfarction 0.24 [0.07; 0.85] | Minor bleeding 4.04 [1.93; 8.44] | mortaliyy 0.49 [0.23; 1.05] Heart failure 0.62 [0.25; 1.56] stroke 2.94 [0.31; 27.91] | | MERLIN, 2004 | rescue PTCA vs no rescue PTCA | | Minor bleeding 8.56 [2.01; 36.40] | mortaliyy 0.89 [0.46; 1.71] Heart failure 0.81 [0.56; 1.17] stroke 7.05 [0.88; 56.59] reinfarction 0.69 [0.33; 1.44] | | RESCUE II, 2000 | rescue PTCA vs no rescue PTCA | | | mortaliyy ∞ [NaN; ∞] | | RESCUE, 1994 | rescue PTCA vs no rescue PTCA | | | mortaliyy 0.53 [0.16; 1.75] Heart failure 0.19 [0.02; 1.56] | | MAASTRICHT (Vermeer), 1999 | primary angioplasty vs immediate thrombolysis | | | stroke 1.00 [0.14; 6.91] death, reinfarctus, stroke 0.57 [0.25; 1.28] | | PRAGUE-1, 2000 | primary angioplasty vs immediate thrombolysis | death, reinfarctus, stroke 0.34 [0.16; 0.73] | | stroke 0.00 [0.00; NaN] | | AIR-PAMI, 2002 | primary angioplasty vs immediate thrombolysis | | | stroke 0.00 [0.00; NaN] death, reinfarctus, stroke 0.62 [0.23; 1.65] | | CAPTIM, 2002 | primary angioplasty vs immediate thrombolysis | | | stroke 0.00 [0.00; NaN] death, reinfarctus, stroke 0.76 [0.47; 1.25] | | DANAMI-2, 2003 | primary angioplasty vs immediate thrombolysis | reinfarction 0.31 [0.16; 0.61] death, reinfarctus, stroke 0.59 [0.42; 0.83] | | death 0.76 [0.51; 1.15] stroke 0.81 [0.34; 1.94] | | PRAGUE-2, 2003 | primary angioplasty vs immediate thrombolysis | stroke 0.11 [0.01; 0.86] death, reinfarctus, stroke 0.55 [0.38; 0.81] | | | | Belenkie, 1992 | rescue PTCA vs no rescue PTCA | | | mortaliyy 0.19 [0.02; 1.47] |
| Trial | Treatments | Patients | Method |
|---|
| REACT (rescue PCI), 2005 | rescue PCI (n=144) vs. conservative treatment (with unfractionated heparin for 24 hours) (n=141) 3 arms: thrombolysis versus rescue angioplasty versus conservative management without additional treatment | patients with ST-segment elevation myocardial infarction and failed reperfusion (less than 50 percent ST-segment resolution) within 90 minutes after thrombolytic treatment | open Parallel groups Sample size: 144/141 Primary endpoint: death, MI, CVA, HF FU duration: 6-month | | MERLIN, 2004 | emergency coronary angiography with or without rescue PCI (n=153) vs. conservative treatment (n=154) | patients with STEMI and failed fibrinolysis | Parallel groups Sample size: 153/154 Primary endpoint: FU duration: 30-day | | RESCUE II, 2000 | PCI (n=14) vs. conservative (n=15) | patient with TIMI II flow after fibrinolytic therapy for moderate to large MI | Parallel groups Sample size: 14/15 Primary endpoint: FU duration: 30-day | | RESCUE, 1994 | balloon angioplasty supplemented by further thrombolytic therapy as needed (n=78) vs. conservative therapy (aspirin, heparin, and coronary vasodilators) (n=73) | patients with first anterior wall infarction and angiographically demonstrated occluded infarct vessel within 8 hours of chest pain onset after thrombolysis | Parallel groups Sample size: 78/73 Primary endpoint: FU duration: 30-day | | MAASTRICHT (Vermeer), 1999 | Transfer for primary PTCA (n=75) vs. immediate thrombolysis with tPA (n=75) | patients with acute myocardial infarction initially admitted to a hospital without PTCA facilities | open Sample size: 75/75 Primary endpoint: Test safety and feasibility of acute transfer for PCI FU duration: | | PRAGUE-1, 2000 | immediate transportation for primary angioplasty without pre-treatment with thrombolysis (n=101) vs. immediate thrombolysis with streptokinase (n=99) | patients with acute myocardial infarction, presenting within 6 h of symptom onset at community hospitals without a catheterization laboratory | open Sample size: 101/99 Primary endpoint: Death, re-MI, or stroke (30 days) FU duration: 30 days | | AIR-PAMI, 2002 | Transfer for Primary Angioplasty (n=71) vs. immediate thrombolysis (various thrombolytic) (n=66) | Patients with high-risk AMI (age >70 years, anterior MI, Killip class II/III, heart rate >100 beats/min or systolic BP <100 mm Hg), eligible for thrombolytic therapy | open Sample size: 71/66 Primary endpoint: Death, re-MI, or disabling stroke (30 days) FU duration: | | CAPTIM, 2002 | Transfer for Primary Angioplasty (n=421) vs. prehospital fibrinolysis with accelerated alteplase (n=419) | patients within 6 h of acute myocardial infarction with ST-segment elevation, initially managed by mobile emergency-care units | open Sample size: 421/419 Primary endpoint: Death, re-MI or stroke (30 days) FU duration: | | DANAMI-2, 2003 | Transfer for Primary Angioplasty (n=567) vs. immediate thrombolysis with tPA (accelared infusion) (n=562) | patients with myocardial
infarction with ST-segment elevation | open Parallel groups Sample size: 567/562 Primary endpoint: Death, re-MI, or disabling stroke (30 days) FU duration: 30 days | | PRAGUE-2, 2003 | immediate transport for primary percutaneous coronary intervention (n=429) vs. immediate thrombolysis with streptokinase (n=421) | patients with acute ST elevation myocardial infarction presenting within <12 h to the nearest community hospital without a catheter laboratory | open Sample size: 429/421 Primary endpoint: Mortality (30 days) FU duration: 30 days | | Belenkie, 1992 | rescue PTCA (n=16) vs. conservative treatment (n=12) | patients with a persistently occluded infarct artery following thrombolytic therapy more than 3 h after symptom onset | open Parallel groups Sample size: 16/12 Primary endpoint: FU duration: hospital stay |
|
| acute myocardial infarction | PTCA | not classified | versus no systematic PCI No demonstrated result for efficacy systematic ballon angioplasty inferior to no systematic angioplasty in terms of all CABG in SWIFT, 1991 systematic ballon angioplasty inferior to no systematic angioplasty in terms of Emergency CABG in TIMI 2, 1989 | 20 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TAMI 1 pilot, 1987 | immediate systematic ballon angioplastyte vs no immediate angioplasty | In-hospital death 0.26 [0.09; 0.77] | | all CABG 0.99 [0.51; 1.91] Reocclusion 0.84 [0.39; 1.78] | | ECSG, 1988 | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | In-hospital death 2.41 [0.87; 6.71] Reinfarction 0.67 [0.28; 1.60] Recurrent ischemia 1.10 [0.63; 1.92] | | SWIFT, 1991 | systematic ballon angioplasty vs no systematic angioplasty | | all CABG 8.56 [3.96; 18.50] | In-hospital death 1.20 [0.54; 2.65] Long term mortality 1.17 [0.65; 2.09] Major bleeding 0.63 [0.21; 1.92] | | SIAM, 1992 | systematic ballon angioplasty vs no systematic angioplasty | | | In-hospital death 1.47 [0.67; 3.21] | | TIMI 2, 1989 | systematic ballon angioplasty vs no systematic angioplasty | | Emergency CABG 2.37 [1.43; 3.92] | In-hospital death 1.11 [0.82; 1.50] Major bleeding 1.28 [0.94; 1.73] Reinfarction 1.11 [0.85; 1.45] all CABG 1.14 [0.94; 1.38] | | Guerci, 1987 | systematic ballon angioplasty vs no systematic angioplasty | | | In-hospital death ∞ [NaN; ∞] | | Van den Brand, 1991 | systematic ballon angioplasty vs no systematic angioplasty | | | In-hospital death 0.31 [0.03; 2.90] Long term mortality 0.61 [0.10; 3.60] | | TOPS, 1992 | systematic ballon angioplasty vs no systematic angioplasty | | | In-hospital death NaN [NaN; NaN] Reinfarction NaN [NaN; NaN] | | systematic ballon angioplasty vs no systematic angioplasty | | | | | TAMI-5 (Califf), 1991 | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | Ellis, 1994 | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | Vermeer, 1999 | systematic ballon angioplasty vs no systematic angioplasty | | | | | Erbel, 1989 | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | MERLIN (Sutton), 2004 | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | SWISS-SMASH, 1999 | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | In-hospital death 0.88 [0.64; 1.21] Long term mortality 0.87 [0.65; 1.16] stroke 0.00 [0.00; NaN] Reinfarction 0.72 [0.05; 10.91] all CABG ∞ [NaN; ∞] | | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | immediate systematic ballon angioplastyte vs no immediate angioplasty | | | | | systematic ballon angioplasty vs no systematic angioplasty | | | | | systematic ballon angioplasty vs no systematic angioplasty | | | |
| Trial | Treatments | Patients | Method |
|---|
| TAMI 1 pilot, 1987 | Angioplasty within 120 min (after rtPA) (n=99) vs. defered CA (7-10 days) and angioplasty if indicated (n=98) | patients with acute myocardial infarction. | open parallel group Sample size: 99/98 Primary endpoint: LV function FU duration: in hospital | | ECSG, 1988 | angioplasty as soon as possible (after rtPA) (n=183) vs. non-invasive strategy without immediate CA and PTCA (n=184)
| patients with acute myocardial infarction within 5 h after onset of symptoms
| open parallel group Sample size: 183/184 Primary endpoint: no primary endpoint specified FU duration: 1 y
| | SWIFT, 1991 | CA 72h with a view to PTCA or CABG (n=397) vs. elective angioplasty (only if required by clinical indication) (n=403) | patients presenting with clinical and electrocardiographic features of acute myocardial infarction up to three hours after the onset of major symptoms | Open Parallel groups Sample size: 397/403 Primary endpoint: death or reinfraction FU duration: 1 y | | SIAM, 1992 | CA with CABG/PTCA 14-48 hours (n=158) vs. no CA within the first 21days unless evidence of ischemia (n=166) | patients treated by thrombolysis for AMI | Open Parallel groups Sample size: 158/166 Primary endpoint: NA FU duration: <3 years | | TIMI 2, 1989 | CA 18 to 48 hrs (n=1636) vs. no CA unless spontaneous or exercise induced ischemia (n=1626) | patients treated with intravenous recombinant tissue plasminogen activator (rt-PA) within four hours of the onset of chest pain thought to be caused by myocardial infarction | Open Factorial plan Sample size: 1636/1626 Primary endpoint: death + reinfarction at 42 days FU duration: 6 we | | Guerci, 1987 | PTCA at 4 day
(n=42) vs. no PTCA during the 10 days study period
(n=43) | patients candidate to PTCA determined at the 1st day CA | Factorial plan Sample size: 42/43 Primary endpoint: ventricular function FU duration: 10 days | | Van den Brand, 1991 | CA at 2-5 days, PTCA if suitable lesion
(n=113) vs. CA at 2-5 days but no PTCA
(n=104) | suitable lesion | NA Parallel groups Sample size: 113/104 Primary endpoint: NA FU duration: 3 mo | | TOPS, 1992 | PTCA to be performed 4-14 days after MI (n=42) vs. conservative management, no PTCA (n=45) | patients with residual stenoses after thrombolytic treatment of myocardial infarction | Parallel groups Sample size: 42/45 Primary endpoint: ventricular function FU duration: 12 months | | TIMI II-A (defered) | delayed invasive strategy, deferred angiography and PTCA for 18-48 hours (n=194) vs. conservative approach (n=197) | | Sample size: 194/197 Primary endpoint: FU duration: | | TAMI-5 (Califf), 1991 | immediate catheterization with angioplasty for failed thrombolysis (90min after rtPA/urokinase) (n=287) vs. deferred predischarge catheterization on days 5-10, no PTCA planned (n=288) 3 x 2 factorial design (2nd factor: t-PA vs urokinase vs both) | patient with acute myocardial infarction | Factorial plan Sample size: 287/288 Primary endpoint: FU duration: | | Ellis, 1994 | balloon angioplasty supplemented by further thrombolytic therapy as needed (n=78) vs. conservative therapy (n=73) | patients with first anterior wall infarction treated with any accepted intravenous thrombolytic regimen and angiographically demonstrated to have an occluded infarct vessel within 8 hours of chest pain onset | Sample size: 78/73 Primary endpoint: FU duration: | | Vermeer, 1999 | alteplase followed by transfer to the PTCA centre and (if indicated) rescue PTCA (n=-9) vs. thrombolytic treatment with alteplase (n=-9) 3rd arms: transfer for primary PTCA | patients with acute myocardial infarction initially admitted to a hospital without PTCA facilities | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 42 days | | Erbel, 1989 | combined intravenous and intracoronary streptokinase with immediate coronary angioplasty (n=103) vs. combined intravenous and intracoronary streptokinase without immediate coronary angioplasty (n=103) | patients with acute transmural myocardial infarction | Parallel groups Sample size: 103/103 Primary endpoint: FU duration: 3 years | | MERLIN (Sutton), 2004 | emergency coronary angiography with rescue PCI (n=-9) vs. conservative treatment (n=-9) | patients with STEMI and failed fibrinolysis | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 30 days | | SWISS-SMASH, 1999 | emergency angiography, followed immediately by revascularization when indicated (n=32) vs. initial medical management (n=23) | Patients with acute myocardial infarction and early shock | open Parallel groups Sample size: 32/23 Primary endpoint: death FU duration: 30 days (1y) | | TIMI 2A, 1988 | CA within 120 min of the start of the rtPA infusion. PTCA whether the artery is open or closed (n=195) vs. CA within 18-48hrs. PTCA only if artery open (TIMI 2 or 3) (n=194) | patient thrombolyzed for a AMI | open parallel group Sample size: 195/194 Primary endpoint: LV function FU duration: 21 days | | Belenkie, 1991 | immediate PTCA (n=50) vs. delayed PTCA (18-38h) (n=39) | patients with a patent infarct-related artery after thrombolytic therapy suitable for angioplasty | open parallel group Sample size: 50/39 Primary endpoint: infarct region wall motion FU duration: 4 months | | Topol, 1987 | immediate PTCA (n=15) vs. no PTCA (n=13) | patients with evolving transmural myocardial infarction | open parallel group Sample size: 15/13 Primary endpoint: myocardial function FU duration: in hospital | | TAMI 6, 1992 | PTCA 6-24h after rtPA (n=34) vs. no PTCA planned (n=37) | | Sample size: 34/37 Primary endpoint: FU duration: | | Barbash, 1990 | PTCA>72h after rtPA if stenosis>70% (n=97) vs. PTCA>72h after rtPA if stenosis>50% and ischemia (n=104) | | Sample size: 97/104 Primary endpoint: FU duration: |
|
| acute myocardial infarction | sirolimus eluting stent | not classified | versus bare-metal No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TYPHOON, 2006 | sirolimus eluting stent vs bare-metal stent | target-vessel revascularization 0.43 [0.26; 0.71] | | Recurrent myocardial infarction 0.80 [0.22; 2.97] all cause mortality 1.01 [0.38; 2.65] Stent thrombosis (any, end of follow-up) 0.93 [0.43; 2.01] | | SESAMI, 2007 | sirolimus eluting stent vs bare-metal stent | MACE 0.40 [0.21; 0.79] target lesion revascularisation (TLR ) 0.39 [0.17; 0.90] angiographic restenosis 0.44 [0.20; 0.96] target-vessel revascularization 0.36 [0.17; 0.79] | | all cause mortality 0.43 [0.11; 1.62] MI 0.99 [0.20; 4.85] Stent thrombosis (any, end of follow-up) 1.99 [0.18; 21.69] stent thrombosis (ARC) 1.99 [0.18; 21.69] | | MISSION, 2008 | sirolimus eluting stent vs bare-metal stent | angioplastie 0.55 [0.31; 0.95] MACE 0.53 [0.33; 0.85] target lesion revascularisation (TLR ) 0.32 [0.11; 0.97] angiographic restenosis 0.10 [0.03; 0.33] target-vessel revascularization 0.38 [0.17; 0.85] | | Recurrent myocardial infarction 0.62 [0.28; 1.39] all cause mortality 0.48 [0.09; 2.59] MI 0.62 [0.28; 1.39] cardiac death 0.96 [0.14; 6.74] Stent thrombosis (any, end of follow-up) 0.64 [0.11; 3.79] stent thrombosis (ARC) 0.96 [0.06; 15.24] CABG 0.38 [0.08; 1.95] sub acute stent thrombosis (1-30 days) 0.96 [0.14; 6.74] | | Díaz de la Llera, 2007 | sirolimus eluting stent vs bare-metal stent | | | | | DEBATER (SES vs BMS), 2009 | sirolimus eluting stent vs bare-metal stent | target vessel failure 0.66 [0.44; 1.00] angiographic restenosis 0.31 [0.14; 0.68] 2 yr MACE 0.65 [0.48; 0.89] | | |
| Trial | Treatments | Patients | Method |
|---|
| TYPHOON, 2006 | Cypher or CypherSelect (n=356) vs. any commerciallyavailable uncoated stent (n=359) | AMI | open Parallel groups Sample size: 356/359 Primary endpoint: Combination of vesselrelateddeath, AMI, TVR FU duration: 12 months | | SESAMI, 2007 | Cypher (n=160) vs. BX stent, Cordis (n=160) | AMI | open Parallel groups Sample size: 160/160 Primary endpoint: Binary restenosis at 1y FU duration: 12 months | | MISSION, 2008 | Cypher (n=158) vs. Vision (n=152) | primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (<9h) | single-blind Parallel groups Sample size: 158/152 Primary endpoint: in segment Late lumen loss at 9mo FU duration: 12 months | | Díaz de la Llera, 2007 | sirolimus-eluting stents (n=60) vs. uncoated stents (n=54) | primary percutaneous coronary intervention for acute myocardial infarction with ST-segment elevation | open Parallel groups Sample size: 60/54 Primary endpoint: cardiac death, MI, TLR FU duration: 1y | | DEBATER (SES vs BMS), 2009 | sirolimus-eluting stents (n=424) vs. bare-metal stents (n=446) factorial design: sirolimus-eluting stents (SES) vsbare-metal stents (BMS), and abciximab vs no abciximab | patients undergoing PCI for STEMI withon 12 hours | Factorial plan Sample size: 424/446 Primary endpoint: TVF( TV MI, TVR, stent thrombosis, in-stent restenosis) FU duration: 1 y |
|
| acute myocardial infarction | sirolimus eluting stent | not classified | versus drug-eluting stents No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PROSIT, 2006 | sirolimus eluting stent vs paclitaxel eluting stent | | | all cause mortality 0.82 [0.36; 1.83] MACE 0.50 [0.23; 1.08] MI 0.98 [0.20; 4.78] cardiac death 0.56 [0.17; 1.87] Stent thrombosis (any, end of follow-up) 0.00 [0.00; NaN] target lesion revascularisation (TLR ) 0.62 [0.25; 1.57] stent thrombosis (ARC) 0.98 [0.14; 6.87] late stent thrombosis (31d - 1year) NaN [NaN; NaN] Acute stent thrombosis (<=24h) 0.00 [0.00; NaN] sub acute stent thrombosis (1-30 days) 0.00 [0.00; NaN] | | Di Lorenzo et al., 2005 | sirolimus eluting stent vs paclitaxel eluting stent | | | all cause mortality 0.75 [0.17; 3.26] MI 1.33 [0.31; 5.79] Stent thrombosis (any, end of follow-up) 0.00 [0.00; NaN] target lesion revascularisation (TLR ) 0.75 [0.17; 3.26] stent thrombosis (ARC) 0.00 [0.00; NaN] | | Juwana, 2009 | sirolimus eluting stent vs paclitaxel eluting stent | | | all cause mortality 1.44 [0.46; 4.45] MACE 1.03 [0.56; 1.88] MI 1.03 [0.34; 3.13] target-vessel revascularization 0.87 [0.40; 1.89] |
| Trial | Treatments | Patients | Method |
|---|
| PROSIT, 2006 | SES Cordis (n=154) vs. PES Boston Scientific (n=154) | AMI or persistent ischaemia 12-24h | open Parallel groups Sample size: 154/154 Primary endpoint: Late lumen loss FU duration: 1 year | | Di Lorenzo et al., 2005 | sirolimus (n=90) vs. paclitaxel (n=90) | ST-segment elevation myocardial infarction | open Parallel groups Sample size: 90/90 Primary endpoint: FU duration: | | Juwana, 2009 | sirolimus coated Cypher stent (n=196) vs. paclitaxel coated
Taxus stent (n=201) | patients with STEMI undergoing primary PCI | open Parallel groups Sample size: 196/201 Primary endpoint: late lumen loss FU duration: 9 months (12 months) |
|
| acute myocardial infarction | zotarolimus eluting stent | not classified | 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)
|
|
