Introduction
Patients and methods
Study population
Study treatment
Study outcome
Statistical methods
All patients n = 1240 | Pooled bivalirudin n = 287 | UFH monotherapy n = 596 | UHF + GPI n = 357 |
p-value* | ||
---|---|---|---|---|---|---|
Clinical characteristics
| ||||||
Gender | Male | 66.80 % | 64.80 % | 63.30 % | 74.20 % | 0.002 |
– | Female | 33.20 % | 35.20 % | 36.70 % | 25.80 % | – |
Clinical presentation | NSTEMI | 48.60 % | 59.60 % | 54.90 % | 29.40 % | <0.001 |
– | STEMI | 51.40 % | 40.40 % | 45.10 % | 70.60 % | – |
Drug-eluting Stent | drug eluting stent | 48.10 % | 67.90 % | 44.60 % | 38.10 % | <0.001 |
Access site | Femoral | 93.30 % | 90.90 % | 93.10 % | 95.50 % | 0.067 |
Age (years, median) | 63 | 63 | 65 | 59 | <0.001 | |
BMI (median kg/m2) | 27.17 | 27.34 | 27.02 | 27.34 | 0.119 | |
eGFR (median ml/min) | 88.68 | 91.61 | 82.73 | 96.52 | <0.001 | |
Baseline creatinine (median mg/dl) | 0.9 | 0.9 | 0.97 | 0.9 | 0.053 | |
SBP (median mm Hg) | 140 | 140 | 135 | 140 | 0.758 | |
CRP (median mg/l) | 4 | 3.5 | 4.7 | 4 | 0.155 | |
Baseline Hb (median g/dl) | 14.15 | 14.1 | 13.8 | 14.5 | <0.001 | |
Baseline PLTs (median g/l) | 232 | 230 | 233 | 231 | 0.603 | |
Peak troponin (median ng/ml)b
| 13.97 | 9.55 | 9.53 | 26.62 | <0.001 | |
CK-MB (median U/l) | 119 | 93 | 99.5 | 170 | <0.001 | |
Cardiovascular risk factors
| ||||||
Hypertension | 77.50 % | 80.80 % | 78.00 % | 73.90 % | 0.105 | |
Hyperlipidaemia | 81.40 % | 81.20 % | 80.40 % | 83.20 % | 0.553 | |
Smoking (current or prior) | 50.80 % | 54.00 % | 44.30 % | 59.10 % | <0.001 | |
Diabetes | 26.00 % | 30.30 % | 27.30 % | 20.40 % | 0.011 | |
Comorbidities
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Previous MCI | 15.00 % | 14.60 % | 16.80 % | 12.30 % | 0.173 | |
Previous PCI | 14.20 % | 16.40 % | 14.40 % | 12.00 % | 0.286 | |
Previous CABG | 2.90 % | 3.50 % | 3.20 % | 2.00 % | 0.440 | |
Prior stroke or TIA | 6.40 % | 7.00 % | 8.10 % | 3.10 % | 0.009 | |
PAD | 5.90 % | 5.90 % | 7.00 % | 3.90 % | 0.140 | |
Atrial fibrillation | 6.50 % | 5.60 % | 8.70 % | 3.40 % | 0.004 | |
History for malignancies | 5.30 % | 5.60 % | 6.70 % | 2.80 % | 0.033 | |
Heart failure | 11.60 % | 11.10 % | 11.20 % | 12.60 % | 0.786 | |
Diseased vessels
| ||||||
1-VD (one vessel disease) | 52.00 % | 50.20 % | 52.00 % | 53.50 % | 0.286 | |
2-VD (two vessel disease) | 30.60 % | 33.10 % | 31.90 % | 26.60 % | – | |
3-VD (three vessel disease) | 17.30 % | 16.70 % | 16.10 % | 19.90 % | – | |
Medication therapy
| ||||||
ARB | 13.10 % | 15.60 % | 11.40 % | 13.80 % | 0.217 | |
Beta blocker | 85.30 % | 86.10 % | 84.30 % | 86.40 % | 0.639 | |
Statins | 92.40 % | 96.50 % | 88.40 % | 95.80 % | <0.001 | |
Acetylsalicylic acid | 99.20 % | 99.10 % | 98.80 % | 100 % | 0.191 | |
Antiplatelet substance
| ||||||
Clopidogrel | 76.10 % | 68.30 % | 80.00 % | 75.90 % | <0.001 | |
Prasugrel | 13.90 % | 24.00 % | 9.40 % | 13.20 % | – | |
Ticagrelor | 2.00 % | 4.20 % | 1.80 % | 0.60 % | – | |
Othera
| 8.00 % | 3.50 % | 8.70 % | 10.40 % | – |
Results
Study population
Mortality outcome
Univariate outcomes
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– |
All-cause death
|
CV death
| ||||
HR
|
95 % CI
|
p-value
|
HR
|
95 % CI
|
p-value
| |
Pooled bivalirudin vs. UFH monotherapy | 0.84 | 0.53; 1.34 | 0.47 | 0.76 | 0.41; 1.40 | 0.38 |
Pooled bivalirudin vs. UFH +GPI | 1.16 | 0.67; 2.00 | 0.59 | 1.04 | 0.51; 2.10 | 0.92 |
Pooled bivalirudin vs. pooled UFH | 0.94 | 0.60; 1.47 | 0.79 | 0.85 | 0.47; 1.52 | 0.57 |
UFH vs. UFH +GPI | 1.34 | 0.88; 2.20 | 0.17 | 1.36 | 0.77; 2.41 | 0.29 |
Adjusted outcomes
| ||||||
– |
All-cause death
|
CV death
| ||||
HR
|
95 % CI
|
p-value
|
HR
|
95 % CI
|
p-value
| |
Pooled bivalirudin vs. UFH monotherapy | 1.12 | 0.68; 1.84 | 0.66 | 1.12 | 0.58; 2.16 | 0.73 |
Pooled bivalirudin vs. UFH +GPI | 0.9 | 0.48; 1.71 | 0.75 | 0.91 | 0.40; 2.10 | 0.83 |
Pooled bivalirudin vs. pooled UFH | 1.09 | 0.68; 1.76 | 0.71 | 1.08 | 0.58; 2.01 | 0.81 |
UFH monotherapy vs. UFH +GPI | 0.76 | 0.46; 1.25 | 0.29 | 0.75 | 0.40; 1.41 | 0.37 |
Stent thrombosis
| ||||||
– |
All
|
Definite
|
Probable
|
Acute
|
Subacute
|
p = 0.748* |
Pooled bivalirudin | 0.4 % | 0.4 % | 0 % | 0 % | 0.4 % | – |
UFH monotherapy | 0.8 % | 0.5 % | 0.3 % | 0.3 % | 0.5 % | – |
UFH +GPI | 1.1 % | 0.6 % | 0.6 % | 0.3 % | 0.8 % | – |
Stent thrombosis
Bleeding outcome
Univariate outcomes
| |||
OR
|
95 % CI
|
p-value
| |
Pooled bivalirudin vs. UFH monotherapy | 0.61 | 0.35; 1.06 | 0.08 |
Pooled bivalirudin vs. UFH +GPI | 0.33 | 0.19; 0.58 | <0.01 |
Pooled bivalirudin vs. pooled UFH | 0.47 | 0.28; 0.79 | <0.01 |
UFH monotherapy vs. UFH +GPI | 0.55 | 0.37; 0.81 | <0.01 |
Adjusted outcomes
| |||
OR
|
95 % CI
|
p-value
| |
Pooled bivalirudin vs. UFH monotherapy | 0.82 | 0.45; 1.51 | 0.53 |
Pooled bivalirudin vs. UFH +GPI | 0.41 | 0.22; 0.78 | 0.01 |
Pooled bivalirudin vs. pooled UFH | 0.62 | 0.36; 1.08 | 0.09 |
UFH monotherapy vs. UFH +GPI | 0.65 | 0.43; 0.99 | 0.047 |