| pathology | Benefit (demonstrated or suggested) and harm | | | |
|---|
| acute coronary syndrome | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PLATO, 2009 | vs clopidogrel | vascular death, MI, stroke 0.85 [0.78; 0.92] Vasc events 0.88 [0.82; 0.95] all cause death 0.78 [0.69; 0.89] Vasc deaths 0.80 [0.69; 0.91] fatal and non fatal MI 0.85 [0.75; 0.95] cardiovascular events 0.85 [0.78; 0.92] death, MI, stroke 0.84 [0.77; 0.92] | | Severe recurrent ischemia 0.87 [0.75; 1.01] Hemorrhagic stoke 1.76 [0.89; 3.47] all bleeding (major and minor) 1.04 [0.95; 1.13] Major bleeds 1.03 [0.92; 1.14] Ischemic stroke 1.05 [0.79; 1.40] Non vasc deaths 0.72 [0.49; 1.04] fatala and non fatal stroke 1.17 [0.91; 1.52] fatal bleeding 0.87 [0.48; 1.58] | | DISPERSE-2 (90mg), 2007 | vs clopidogrel | | | Vasc events 1.09 [0.58; 2.07] all cause death 1.37 [0.44; 4.27] all bleeding (major and minor) 1.11 [0.70; 1.77] Major bleeds 0.98 [0.58; 1.65] Vasc deaths 1.47 [0.42; 5.16] fatala and non fatal stroke 1.96 [0.18; 21.49] fatal and non fatal MI 0.78 [0.37; 1.65] cardiovascular events 1.09 [0.58; 2.07] |
| Trial | Treatments | Patients | Method |
|---|
| PLATO, 2009 | ticagrelor 90mg twice daily (n=9333) vs. clopidogrel 75mg once daily (n=9291) Patients undergoing PCI after randomization received,
in a blind fashion, an additional dose of
their study drug at the time of PCI | patients with an acute coronary syndrome, with or without
ST-segment elevation (onset
of symptoms within the previous 24h). | double blind Parallel groups Sample size: 9333/9291 Primary endpoint: Cv death, MI, stroke FU duration: 1 y | | DISPERSE-2 (90mg), 2007 | ticagrelor 90 mg twice daily (n=334) vs. clopidogrel (n=327) 3 arms trial: AZD6140 90 mg and 180mg twice daily, Clopidogrel 75 mg
daily | patients with NSTE-ACS, treated with aspirin and standard therapy for ACS | double blind Parallel groups Sample size: 334/327 Primary endpoint: major or minor bleeding through 4 weeks FU duration: 12 weeks |
|
| cardiovascular prevention | All results are NS for efficacy inferior to placebo (on top aspirin) in terms of Major hemorrhage in PEGASUS 60mg, 2015 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Major hemorrhage in PEGASUS 90mg, 2015 (secondary prevention patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PEGASUS 60mg, 2015 | vs placebo (on top aspirin) | Stroke (any) 0.75 [0.57; 0.98] myocardial infarction 0.85 [0.73; 0.99] all vascular event 0.85 [0.75; 0.95] CV death, MI, stroke 0.85 [0.75; 0.95] | Major hemorrhage 2.16 [1.56; 2.99] | All cause mortality 0.89 [0.76; 1.04] death from CHD 0.81 [0.63; 1.04] cardiovascular death 0.83 [0.68; 1.01] fatal bleeding 0.92 [0.41; 2.08] Intracranial haemorrhage 1.10 [0.67; 1.81] | | PEGASUS 90mg, 2015 | vs placebo (on top aspirin) | death from CHD 0.74 [0.57; 0.96] myocardial infarction 0.82 [0.70; 0.95] all vascular event 0.85 [0.76; 0.96] CV death, MI, stroke 0.85 [0.76; 0.96] | Major hemorrhage 2.36 [1.72; 3.24] | All cause mortality 1.00 [0.86; 1.16] cardiovascular death 0.87 [0.71; 1.06] fatal bleeding 0.50 [0.19; 1.33] Intracranial haemorrhage 1.26 [0.73; 2.18] Stroke (any) 0.82 [0.63; 1.07] | | EUCLID, 2016 | vs placebo (on top aspirin) | | | |
| Trial | Treatments | Patients | Method |
|---|
| PEGASUS 60mg, 2015 | ticagrelor at a dose of 60 mg twice daily (n=7045) vs. placebo (n=7067) | patients who had
had a myocardial infarction 1 to 3 years earlier | double-blind Parallel groups Sample size: 7045/7067 Primary endpoint: cardiovascular death, myocardial FU duration: 2.75 y (median) | | PEGASUS 90mg, 2015 | ticagrelor at a dose of 90 mg twice daily
(n=7050) vs. (n=7067)
| patients who had
had a myocardial infarction 1 to 3 years earlier
| double-blind Sample size: 7050/7067 Primary endpoint: cardiovascular death, myocardial FU duration: 2.75 y (median)
| | EUCLID, 2016 | ticagrelor (90 mg twice daily) (n=-9) vs. clopidogrel (75 mg once daily) (n=-9) | patients with symptomatic peripheral artery disease | Sample size: -9/-9 Primary endpoint: FU duration: 30 months (median) |
|
| peripheral vascular diseases | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EUCLID, 2016 | vs clopidogrel | | | |
| Trial | Treatments | Patients | Method |
|---|
| EUCLID, 2016 | ticagrelor (90 mg twice daily) (n=-9) vs. clopidogrel (75 mg once daily) (n=-9) | patients with symptomatic peripheral artery disease | Sample size: -9/-9 Primary endpoint: FU duration: 30 months (median) |
|
| post myocardial infarction | All results are NS for efficacy inferior to placebo (on top aspirin) in terms of Major hemorrhage in PEGASUS 60mg, 2015 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Major hemorrhage in PEGASUS 90mg, 2015 (secondary prevention patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PEGASUS 60mg, 2015 | vs placebo (on top aspirin) | Stroke (any) 0.75 [0.57; 0.98] myocardial infarction 0.85 [0.73; 0.99] all vascular event 0.85 [0.75; 0.95] CV death, MI, stroke 0.85 [0.75; 0.95] | Major hemorrhage 2.16 [1.56; 2.99] | All cause mortality 0.89 [0.76; 1.04] death from CHD 0.81 [0.63; 1.04] cardiovascular death 0.83 [0.68; 1.01] fatal bleeding 0.92 [0.41; 2.08] Intracranial haemorrhage 1.10 [0.67; 1.81] | | PEGASUS 90mg, 2015 | vs placebo (on top aspirin) | death from CHD 0.74 [0.57; 0.96] myocardial infarction 0.82 [0.70; 0.95] all vascular event 0.85 [0.76; 0.96] CV death, MI, stroke 0.85 [0.76; 0.96] | Major hemorrhage 2.36 [1.72; 3.24] | All cause mortality 1.00 [0.86; 1.16] cardiovascular death 0.87 [0.71; 1.06] fatal bleeding 0.50 [0.19; 1.33] Intracranial haemorrhage 1.26 [0.73; 2.18] Stroke (any) 0.82 [0.63; 1.07] |
| Trial | Treatments | Patients | Method |
|---|
| PEGASUS 60mg, 2015 | ticagrelor at a dose of 60 mg twice daily (n=7045) vs. placebo (n=7067) | patients who had
had a myocardial infarction 1 to 3 years earlier | double-blind Parallel groups Sample size: 7045/7067 Primary endpoint: cardiovascular death, myocardial FU duration: 2.75 y (median) | | PEGASUS 90mg, 2015 | ticagrelor at a dose of 90 mg twice daily
(n=7050) vs. (n=7067)
| patients who had
had a myocardial infarction 1 to 3 years earlier
| double-blind Sample size: 7050/7067 Primary endpoint: cardiovascular death, myocardial FU duration: 2.75 y (median)
|
|
