Table 11.
—[Section 2.9, 2.10, 5.6, 9.2] Risk Factors for Bleeding With and Contraindications to Use of Thrombolytic Therapy (Both Systemic and Locally Administered)
| Major contraindicationsa |
| Structural intracranial disease |
| Previous intracranial hemorrhage |
| Ischemic stroke within 3 mo |
| Active bleeding |
| Recent brain or spinal surgery |
| Recent head trauma with fracture or brain injury |
| Bleeding diathesis |
| Relative contraindicationsb |
| Systolic BP > 180 mm Hg |
| Diastolic BP > 110 mm Hg |
| Recent bleeding (nonintracranial) |
| Recent surgery |
| Recent invasive procedure |
| Ischemic stroke more that 3 mo previously |
| Anticoagulation (eg, VKA therapy) |
| Traumatic cardiopulmonary resuscitation |
| Pericarditis or pericardial fluid |
| Diabetic retinopathy |
| Pregnancy |
| Age > 75 y |
| Low body weight (eg, < 60 kg) |
| Female sex |
| Black race |
Among 32,000 Medicare patients (≥ 65 y) with myocardial infarction who were treated with thrombolytic therapy, the following factors were independently associated with intracranial hemorrhage: age ≥ 75 y (OR, 1.6), black race (OR, 1.6), female sex (OR, 1.4), previous stroke (OR, 1.5), systolic BP ≥ 160 mm Hg (OR, 1.8), women weighing ≤ 65 kg or men weighing ≤ 80 kg (OR, 1.5), and INR > 4 (OR, 2.2).110 The rate of intracranial hemorrhage increased from 0.7% with none or one of these risk factors to 4.1% with five or more of these risk factors. Among 32,000 patients with myocardial infarction who were treated with thrombolytic therapy in five clinical trials, the following factors were independently associated with moderate or severe bleeding: older age (OR, 1.04 per year), black race (OR, 1.4), female sex (OR, 1.5), hypertension (OR, 1.2), and lower weight (OR, 0.99/kg).111 We estimated that systemic thrombolytic therapy is associated with a relative risk of major bleeding of 3.5 within 35 d (RR, ∼7 for intracranial bleeding); about three-fourths of the excess of major bleeds with thrombolytic therapy occur in the first 24 h.112 See Table 1 legend for expansion of abbreviations.
The presence of major contraindications usually precludes use of thrombolytic therapy and, consequently, these factors have not been well studied as risk factors for bleeding associated with thrombolytic therapy. The factors listed in this table are consistent with other recommendations for the use of thrombolytic therapy in patients with PE.72,259,260,454 104,111,113,114
Risk factors for bleeding during anticoagulant therapy noted in Table 10 that are not included in this table are also likely to be relative contraindications to thrombolytic therapy. The increase in bleeding associated with a risk factor will vary with (1) severity of the risk factor (eg, extent of trauma or recent surgery) and (2) temporal relationships (eg, interval from surgery or a previous bleeding episode believed to decrease markedly after ∼2 wk). Risk factors for bleeding at critical sites (eg, intracranial, intraocular) or noncompressible sites are stronger contraindications for thrombolytic therapy.