percutaneous coronary intervention

Description Results NMA

All cause death 1.04 [0.80; 1.33]

severe bleeding 1.01 [0.54; 1.90]

Serious infection 0.90 [0.65; 1.25]

All cause death 0.42 [0.18; 1.01]

All cause death 0.82 [0.49; 1.40]

pexelizumab given as a 2-mg/kg intravenous bolus prior to PCI followed by 0.05-mg/kg per hour infusion over the subsequent 24 hours (n=2860)

vs.

placebo (n=2885)

double blind

Parallel groups

Sample size: 2860/2885

Primary endpoint: all cause mortality

FU duration: 30 days

pexelizumab 2.0-mg/kg bolus and 0.05-mg/kg per h infusion for 20 hours (n=328)

vs.

placebo (n=315)

3rd arm with pexelizumab 2.0-mg/kg bolus

double blind

Sample size: 328/315

Primary endpoint: creatine kinase-MB area under the curve

FU duration:

pexelizumab 2.0-mg/kg bolus plus 0.05 mg/kg per h for 20 hours (n=315)

vs.

placebo (n=316)

3rd arm with pexelizumab 2.0-mg/kg bolus

double blind

Sample size: 315/316

Primary endpoint:

FU duration:

target vessel revascularization 0.72 [0.40; 1.30]

stroke 1.15 [0.39; 3.43]

MI 0.91 [0.75; 1.11]

death, MI, stroke, or target vessel revascularization 0.87 [0.72; 1.05]

target vessel revascularization 0.56 [0.28; 1.11]

All cause death 1.59 [0.52; 4.86]

MACE 0.67 [0.40; 1.14]

stroke 0.85 [0.29; 2.53]

MI 0.40 [0.12; 1.27]

death, MI, stroke, or target vessel revascularization 1.04 [0.89; 1.22]

MACE 0.80 [0.68; 0.94]

MI 0.81 [0.68; 0.97]

death, MI, stroke, or target vessel revascularization 0.80 [0.68; 0.94]

net benefit 0.80 [0.68; 0.94]

stent thrombosis 0.62 [0.43; 0.90]

all bleeding 1.75 [0.73; 4.17]

All cause death 1.00 [0.52; 1.92]

Cardiovascular mortality 1.00 [0.52; 1.92]

major bleeding 1.50 [0.53; 4.21]

cangrelor up front (cangrelor during PCI followed by 600 mg of clopidogrel) (n=2693)

vs.

delayed clopidogrel (placebo during PCI followed by 600 mg of clopidogrel) (n=2669)

cangrelor up front vs delayed clopidogrel

Patients with stable angina were initially eligible at the beginning of the trial before a protocol amendment

double blind

Parallel groups

Sample size: 2693/2669

Primary endpoint: death, MI, ischemia-driven revascularization

FU duration: 48 h

cangrelor up front (cangrelor administered before percutaneous coronary intervention and followed by clopidogrel) (n=4367)

vs.

clopidogrel up front (clopidogrel followed by placebo) (n=4355)

cangrelor then clopidogrel vs clopidogrel then placebo

double blind

Parallel groups

Sample size: 4367/4355

Primary endpoint: death, MI, ischemia-driven revascularization

FU duration: 48 h

bolus and infusion of cangrelor followed by 600mg clopidogrel immediately post-infusion (n=5472)

vs.

loading dose of 600 mg or 300 mg of clopidogrel (n=5470)

double-blind

Parallel groups

Sample size: 5472/5470

Primary endpoint: all-cause mortality, MI, ischemia-driven revascularization and stent thrombosis

FU duration: 48 hours

(n=-9)

vs.

(n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

prasugrel (60 mg loading, 10 mg maintenance) (n=1769)

vs.

clopidogrel (300 mg loading, 75 mg maintenance) (n=1765)

Sample size: 1769/1765

Primary endpoint:

FU duration:

Non fatal MI 0.00 [0.00; NaN]

Non fatal MI 0.00 [0.00; NaN]

vascular events 0.00 [0.00; NaN]

Non fatal MI 0.51 [0.18; 1.49]

vascular deaths 1.03 [0.06; 16.36]

Non fatal MI 0.51 [0.18; 1.49]

vascular events 0.56 [0.21; 1.50]

aspirin, 100 mg/day after 2 weeks (n=124)

vs.

placebo (n=128)

double blind

Parallel groups

Sample size: 124/128

Primary endpoint:

FU duration: 6m

aspirin 325 mg daily (n=497)

vs.

placebo (n=510)

double blind

Parallel groups

Sample size: 497/510

Primary endpoint: clinical failure at 6 months after successful PTCA

FU duration: 6m

death, MI, urgent TVR, in-hospital major bleeding 0.77 [0.35; 1.69]

All cause death 0.00 [0.00; NaN]

MI 0.95 [0.56; 1.60]

death, MI, revascularization 0.82 [0.51; 1.31]

Unplanned revascularisation for ischaemia 0.56 [0.17; 1.91]

major bleeding 0.39 [0.30; 0.50]

All cause death 2.23 [0.69; 7.22]

Ischaemic complication 0.93 [0.79; 1.10]

MI 0.80 [0.58; 1.11]

Unplanned revascularisation for ischaemia 0.99 [0.62; 1.58]

UFH bolus of 140 U/kg (n=2289)

vs.

bivalirudin (bolus of 0.75 mg/kg, followed by infusion of 1.75 mg/kg/hr) (n=2281)

double blind

Parallel groups

Sample size: 2289/2281

Primary endpoint: death, MI, urgent TVR, in-hospital major bleeding,

FU duration: 30 days (mean)

bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion during the procedure (n=532)

vs.

heparin (70 U/kg initial bolus) adjusted to ACT of 200 to 300s (n=524)

Parallel groups

Sample size: 532/524

Primary endpoint: death, MI, repeat revascularization

FU duration: hospital stay (48h min)

bivalirudin immediately before angioplasty. (n=2059)

vs.

heparin immediately before angioplasty (n=2039)

double blind

Parallel groups

Sample size: 2059/2039

Primary endpoint: death, MI, abrupt clossure, rapide deterioration

FU duration: hospital stay

Although two parallel studies were specified to meet regulatory requirements, the protocol specified that scientific analysis and safety monitoring would involve the combined cohort of 4000 patients

bivalirudin (0.75 mg/kg bolus followed by 1.75 mg/kg per hour during the procedure) (n=140)

vs.

unfractionated heparin (75 IU/kg) (n=0)

Parallel groups

Sample size: 140/0

Primary endpoint: death, MI, target vessel revascularization, or stent thrombosis

FU duration:

All cause death 0.66 [0.44; 1.00]

safety criteria 0.60 [0.46; 0.77]

major bleeding 0.61 [0.44; 0.84]

minor bleeding 0.62 [0.44; 0.88]

net benefit 0.76 [0.63; 0.92]

Ischaemic complication 0.99 [0.76; 1.30]

MI 1.14 [0.64; 2.01]

death, MI, revascularization 0.99 [0.76; 1.30]

Unplanned revascularisation for ischaemia 1.34 [0.87; 2.07]

death, MI, urgent TVR, in-hospital major bleeding 0.57 [0.38; 0.84]

minor bleeding 0.42 [0.23; 0.78]

All cause death NaN [NaN; NaN]

major bleeding 0.25 [0.03; 2.23]

Unplanned revascularisation for ischaemia NaN [NaN; NaN]

bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI (n=2994)

vs.

heparin plus planned Gp IIb/IIIa blockade (n=3008)

double blind

Parallel groups

Sample size: 2994/3008

Primary endpoint: death, MI, urgent revascularization, or in-hospital

FU duration: 30 days

Bivalirudin (n=1800)

vs.

Heparin plus GP IIb/IIIa inhibitor (n=1802)

open

Parallel groups

Sample size: 1800/1802

Primary endpoint: MACE, major bleeding

FU duration: 30 days

bivalirudin alone (n=9216)

vs.

unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (n=4603)

open

Parallel groups

Sample size: 9216/4603

Primary endpoint: ischemia events and bleeding

FU duration: 30 days

bivalirudin + eptifibatide (n=-9)

vs.

heparin + eptifibatide (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: none defined

FU duration:

bivalirudin monotherapy (n=167)

vs.

unfractionated heparin plus tirofiban (n=168)

open

Parallel groups

Sample size: 167/168

Primary endpoint: MACE

FU duration: 30 days

Dalteparin 100 IU/kg bolus (n=-9)

vs.

UFH 100 IU/kg bolus (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

Dalteparin 70 IU/kg bolus + GP IIb/IIIa inhibitorse/p (n=-9)

vs.

UFH 70 IU/kg bolus +GPIIb/IIIa inhibitors (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

Non fatal MI 0.28 [0.13; 0.64]

Non fatal MI 0.28 [0.13; 0.64]

vascular events 0.28 [0.13; 0.64]

vascular deaths NaN [NaN; NaN]

Non fatal stroke NaN [NaN; NaN]

non vascular death NaN [NaN; NaN]

Non fatal MI 1.45 [0.66; 3.21]

vascular deaths 2.07 [0.19; 22.72]

Non fatal stroke 0.00 [0.00; NaN]

Non fatal MI 1.45 [0.66; 3.21]

vascular events 1.38 [0.67; 2.86]

non vascular death NaN [NaN; NaN]

Non fatal MI NaN [NaN; NaN]

vascular deaths NaN [NaN; NaN]

Non fatal stroke NaN [NaN; NaN]

Non fatal MI NaN [NaN; NaN]

vascular events NaN [NaN; NaN]

non vascular death NaN [NaN; NaN]

Non fatal MI 1.54 [0.26; 9.05]

vascular deaths NaN [NaN; NaN]

Non fatal MI 1.54 [0.26; 9.05]

vascular events 1.54 [0.26; 9.05]

non vascular death NaN [NaN; NaN]

aspirin 990 + D225 (H) (n=187)

vs.

placebo (n=189)

double blind

Parallel groups

Sample size: 187/189

Primary endpoint:

FU duration: 6m

ticlopidine 500, aspirin 650 + D225 (n=245)

vs.

(n=254)

Parallel groups

Sample size: 245/254

Primary endpoint:

FU duration: 6m

aspirin 300 + D225 (n=35)

vs.

placebo (n=37)

NA

Parallel groups

Sample size: 35/37

Primary endpoint:

FU duration: 12m

aspirin 975 + D225 (n=102)

vs.

(n=105)

Parallel groups

Sample size: 102/105

Primary endpoint:

FU duration: 48h

safety criteria 1.00 [0.07; 15.26]

Ischaemic complication 1.00 [0.22; 4.56]

safety criteria 0.00 [0.00; NaN]

Ischaemic complication 1.13 [0.50; 2.56]

safety criteria 0.25 [0.03; 2.12]

Ischaemic complication 1.63 [0.41; 6.47]

safety criteria NaN [NaN; NaN]

Ischaemic complication 1.25 [0.50; 3.10]

safety criteria NaN [NaN; NaN]

Ischaemic complication 1.00 [0.21; 4.72]

enoxaparin (0.5 or 0.75 mg per kilogram of body weight) (n=-9)

vs.

unfractionated heparin (adjusted for activated clotting time) (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: major or minor bleeding

FU duration:

Enoxaparin 1 mg/kg bolus (n=30)

vs.

UFH 10,000 IU bolus, then titrated to ACT > 300 (n=30)

open

Parallel groups

Sample size: 30/30

Primary endpoint: none defined

FU duration:

Enoxaparin 0.75 mg/kg bolus (n=129)

vs.

UFH 60 IU/kg bolus, then titrated to ACT > 200 (n=132)

open

Parallel groups

Sample size: 129/132

Primary endpoint: hemoglobin

FU duration: 2,7 +30 days

Enoxaparin 0.75 mg/kg bolus (n=50)

vs.

UFH 70 U/kg bolus, then titrated to ACT > 200 (n=49)

Sample size: 50/49

Primary endpoint:

FU duration:

Enoxaparin 1 mg/kg bolus (n=200)

vs.

UFH titrated to ACT > 300 (n=200)

Sample size: 200/200

Primary endpoint:

FU duration: 3à days

Enoxaparin 1 mg/kg bolus (n=-9)

vs.

UFH titrated to ACT > 300 (n=50)

Sample size: -9/50

Primary endpoint:

FU duration:

Enoxaparin 1 mg/kg bolus (n=50)

vs.

UFH 100 IU/kg bolus (n=50)

Sample size: 50/50

Primary endpoint:

FU duration: 24hrs, 30 days

Enoxaparin 0.75 mg/kg bolus + abciximab (n=-9)

vs.

UFH titrated to ACT > 300 (n=50)

Sample size: -9/50

Primary endpoint:

FU duration:

IV enoxaparin (n=450)

vs.

UFH (n=460)

open

Parallel groups

Sample size: 450/460

Primary endpoint: Death, Complication of MI, Procedure Failure or Major Bleeding

FU duration: 30 days

cardiovascular death, MI, stroke 0.78 [0.47; 1.31]

All cause death ∞ [NaN; ∞]

Non–CABG-related TIMI major bleeding 0.59 [0.10; 3.49]

Major or minor TIMI bleeding 1.43 [0.40; 5.09]

Prasugrel 3 doses (n=650)

vs.

clopidogrel 300mg loading dose followed by 75 mg daily) (n=254)

double blind

Parallel groups

Sample size: 650/254

Primary endpoint: non–CABG-related bleeding

FU duration: 30 days

phase 2

Ischaemic complication 0.48 [0.25; 0.94]

safety criteria 0.88 [0.32; 2.38]

Reviparin 7,000 IU anti-Xa (n=306)

vs.

UFH 10,000 IU bolus (n=306)

double blind

Parallel groups

Sample size: 306/306

Primary endpoint: MACE

FU duration: 3 days

(n=752)

vs.

placebo (n=0)

double blind

Parallel groups

Sample size: 752/0

Primary endpoint: clinical failure at 6 months after successful PTCA

FU duration: 6 months

Non fatal MI 0.49 [0.17; 1.40]

vascular deaths ∞ [NaN; ∞]

Non fatal stroke 0.98 [0.06; 15.50]

Non fatal MI 0.49 [0.17; 1.40]

vascular events 0.62 [0.25; 1.57]

non vascular death NaN [NaN; NaN]

ticlopidine 500, aspirin 650 + D225 (n=177)

vs.

(n=173)

Parallel groups

Sample size: 177/173

Primary endpoint:

FU duration: 6m

ticlopidine 500, aspirin 650 + D225 (n=-9)

vs.

placebo (n=254)

Parallel groups

Sample size: -9/254

Primary endpoint:

FU duration: 6m

re-PTCA 0.48 [0.23; 0.99]

restenosis 0.99 [0.73; 1.33]

death 0.50 [0.05; 5.47]

AMI 0.72 [0.30; 1.78]

CABG 0.78 [0.39; 1.53]

amlodipine (10 mg/day) (n=236)

vs.

placebo (n=215)

double blind

Sample size: 236/215

Primary endpoint:

FU duration: 4months

restenosis 0.70 [0.29; 1.68]

restenosis 1.01 [0.63; 1.64]

restenosis 0.56 [0.34; 0.91]

diltiazem (90 mg tid) (n=46)

vs.

(n=46)

open

Sample size: 46/46

Primary endpoint:

FU duration: 3 months

diltiazem (240-360 mg/day) (n=61)

vs.

placebo (n=59)

double blind

Sample size: 61/59

Primary endpoint:

FU duration: 12 months

diltiazem (180 mg/day) (n=84)

vs.

placebo (n=86)

double blind

Sample size: 84/86

Primary endpoint:

FU duration: 4 months

restenosis 0.95 [0.61; 1.47]

nifedipine (10 mg qid) (n=100)

vs.

placebo (n=98)

double blind

Sample size: 100/98

Primary endpoint:

FU duration: 6 months

CABG 0.08 [0.01; 0.64]

restenosis 0.89 [0.77; 1.03]

death 2.19 [0.20; 24.09]

AMI 0.44 [0.09; 2.25]

re-PTCA 0.82 [0.65; 1.03]

nisoldipine (40 mg/day) (n=308)

vs.

placebo (n=338)

double blind

Sample size: 308/338

Primary endpoint:

FU duration: 6 months

restenosis 0.77 [0.59; 1.01]

verapamil (240 mg bid) (n=89)

vs.

placebo (n=83)

double blind

Sample size: 89/83

Primary endpoint:

FU duration: 6 months

All-cause mortality NaN [NaN; NaN]

Cardiovascular mortality NaN [NaN; NaN]

Revascularization 0.44 [0.20; 1.01]

Nonfatal MI 0.00 [0.00; NaN]

Stroke ∞ [NaN; ∞]

Nonfatal MI 0.29 [0.10; 0.84]

Stroke 0.29 [0.10; 0.84]

MI (CK-MB >3x ULN at 6 and 12 hours after PCI) 0.56 [0.40; 0.79]

MI (troponin I >3x ULN at 6 and 12 hours after PCI) 0.56 [0.35; 0.91]

MACE 0.39 [0.16; 0.91]

Nonfatal MI 0.41 [0.17; 0.97]

All-cause mortality 0.00 [0.00; NaN]

Revascularization 0.00 [0.00; NaN]

Atorvastatin 20–40 mg/d 1 d after PCI (n=65)

vs.

usual care (n=66)

open

Sample size: 65/66

Primary endpoint:

FU duration: 12 mo

atorvastatin 40 mg/day seven days prior to the procedure (n=76)

vs.

placebo (n=77)

double blind

Sample size: 76/77

Primary endpoint:

FU duration: 1 mo

atorvastatin 80 mg loading dose administered within 24 hours prior to elective PCI (n=338)

vs.

no statin therapy (n=330)

open

Parallel groups

Sample size: 338/330

Primary endpoint: periprocedural MI by cardiac enzyme

FU duration: 24h

atorvastatin reload (80 mg 12 h before intervention, with a further 40-mg pre-procedural dose) (n=229)

vs.

placebo (n=228)

double blind

Parallel groups

Sample size: 229/228

Primary endpoint: MACE

FU duration: 30 days

All-cause mortality 0.45 [0.12; 1.71]

Revascularization 1.09 [0.83; 1.43]

Nonfatal MI 0.31 [0.09; 1.12]

All-cause mortality 0.73 [0.48; 1.10]

Cardiovascular mortality 0.53 [0.27; 1.04]

Revascularization 0.85 [0.71; 1.03]

Nonfatal MI 0.78 [0.49; 1.25]

Stroke 1.97 [0.18; 21.73]

Fluvastatin 40 mg twice daily 15–30 d before PCI (n=409)

vs.

placebo (n=425)

double blind

Sample size: 409/425

Primary endpoint: angiographic restenosis

FU duration: 10 mo

Fluvastatin 40 mg twice daily 0–22 d after PCI (n=844)

vs.

placebo (n=833)

double blind

Sample size: 844/833

Primary endpoint: MACE

FU duration: 45 mo (median)

All-cause mortality 4.01 [0.45; 35.71]

Cardiovascular mortality ∞ [NaN; ∞]

Revascularization 0.88 [0.66; 1.19]

Nonfatal MI 1.00 [0.25; 3.98]

Stroke ∞ [NaN; ∞]

Pravastatin 40 mg/d 1 d after PCI (n=347)

vs.

placebo (n=348)

double blind

Sample size: 347/348

Primary endpoint: minimal lumen diameter

FU duration: 6 mo