7th ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines.

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7th ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines

Transcript of 7th ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines.

Page 1: 7th ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines.

7th ACCP Conference on Antithrombotic and Thrombolytic Therapy:

7th ACCP Conference on Antithrombotic and Thrombolytic Therapy:

Evidence-Based GuidelinesEvidence-Based Guidelines

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Grade 1 Recommendations Grade 1 Recommendations

Grade Risk/

Benefit

Methodologic Strength Strength of Recommendation

1A Clear RCTs w/o significant limitations

Strong; applies to most patients and circumstances

1C+ Clear No RCTs; strong results extrapolated or strong observational studies

Strong; most patients, circumstances

1B Clear RCTs with limitations Strong; most patients

1C Clear Observational studies Intermediate

RCT = randomized controlled trial

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Grade 2 Recommendations Grade 2 Recommendations

Grade Risk/

Benefit

Methodologic Strength Strength of Recommendation

2A Unclear RCTs w/o important limitations

Intermediate; action depends on circumstances, values

2C+ Unclear No RCTs; strong results extrapolated or strong observational studies

Weak; action depends on circumstances, values

2B Unclear RCTs with limitations Weak; alternatives likely better for some

2C Unclear Observational studies Very weak

RCT = randomized controlled trial

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Treatment of Venous Thromboembolic Disease

Treatment of Venous Thromboembolic Disease

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Initial Therapy for Acute DVT of the LegInitial Therapy for Acute DVT of the Leg

• We recommend that patients receive anticoagulants as soon as the diagnosis of DVT is confirmed

• Interim treatment should be started if suspicion is high and confirmation is delayed

• We recommend that patients receive anticoagulants as soon as the diagnosis of DVT is confirmed

• Interim treatment should be started if suspicion is high and confirmation is delayed

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Guidelines for Initial Treatment Guidelines for Initial Treatment

CLINICAL SITUATION RECOMMENDED TREATMENT

Confirmed acute DVT of the leg Options: SC LMWH, IV UFH, or SC UFH (all Grade 1A)

High suspicion of DVT of the leg Anticoagulants, while awaiting the outcome of diagnostic tests (Grade 1C+)

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Initial UFH or LMWH Therapy Initial UFH or LMWH Therapy

SELECTION RECOMMENDED TREATMENT

IV UFH Continuous infusion; adjust dosage to prolong the APTT to a range that corresponds to a plasma heparin level of 0.3 to 0.7 IU/mL antifactor Xa activity by amidolytic antifactor Xa assay (Grade 1C+)

If therapeutic levels of APTT are not reached despite large daily doses of UFH: measure antifactor Xa levels for dosage guidance (Grade 1B)

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Initial UFH or LMWH Therapy, continuedInitial UFH or LMWH Therapy, continued

SELECTION RECOMMENDED TREATMENT

SC UFH SC UFH is an alternative to IV UFH (Grade 1A); initial dose 35,000 U/24 h, then maintain the APTT within therapeutic range (Grade 1C+)

SC LMWH We recommend initial treatment with SC LMWH qd or bid, over UFH, as outpatient therapy if possible (Grade 1C), as inpatient therapy if necessary (Grade 1A)

We recommend against routinely monitoring antifactor Xa levels (Grade 1A)

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Systemic Thrombolysis as Initial Therapy Systemic Thrombolysis as Initial Therapy

THERAPY RECOMMENDATIONS

IV thrombolytic therapy We recommend against routine use (Grade 1A)

We suggest use in selected patients* (Grade 2C)

Catheter-directed thrombolysis

We recommend against routine use (Grade 1C)

We suggest confining use to selected patients, eg, those requiring limb salvage (Grade 2C)

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Systemic Thrombolysis as Initial Therapy, continued Systemic Thrombolysis as Initial Therapy, continued

THERAPY RECOMMENDATIONS

Venous thrombectomy

We recommend against routine use (Grade 1C)

We suggest use in selected patients* (Grade 2C)

Placement of a

vena cava filter We recommend against routine use in most patients during anticoagulant therapy (Grade 1A)

We suggest use in patients with a contraindication for, or complication of, anticoagulant therapy (Grade 2C), and those with recurrent thromboembolism despite adequate anticoagulant therapy (Grade 2C)

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Long-term Therapy for DVT of the LegLong-term Therapy for DVT of the Leg

PATIENT CHARACTERISTICS RECOMMENDED TREATMENT

First DVT episode, secondary to a transient (reversible) risk factor (proximal vein thrombosis or symptomatic DVT confined to calf veins)

VKA therapy for 3 months, over use for shorter periods (Grade 1A)

First episode of idiopathic DVT VKA therapy for ≥ 6 to 12 months (Grade 1A)

Consider giving anticoagulants indefinitely (Grade 2A)

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Long-term Therapy for DVT of the Leg, continuedLong-term Therapy for DVT of the Leg, continued

PATIENT CHARACTERISTICS RECOMMENDED TREATMENT

DVT and cancer LMWH for the first 3 to 6 months of anticoagulant therapy* (Grade 1A)

We recommend giving anticoagulants indefinitely, or until the cancer is resolved (Grade 1C)

*Established LMWH regimens for long-term treatment: dalteparin, 200 IU/kg body weight qd for 1 month, then 150 IU/kg qd; or tinzaparin, 175 IU/kg body weight SC qd.

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Long-term Therapy for DVT of the Leg, continuedLong-term Therapy for DVT of the Leg, continued

PATIENT CHARACTERISTICS RECOMMENDED TREATMENT

First DVT episode and either documented antiphospholipid antibodies (APLAs) or two or more thrombophilic conditions, eg, combined factor V Leiden and prothrombin 20210 gene mutation

VKA therapy for 12 months (Grade 1C+)

We suggest giving anticoagulants indefinitely (Grade 2C)

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Long-term Therapy for DVT of the Leg, continuedLong-term Therapy for DVT of the Leg, continued

PATIENT CHARACTERISTICS RECOMMENDED TREATMENT

First DVT episode and any of the following: documented antithrombin deficiency, deficiency of protein C or protein S, factor V Leiden, prothrombin 20210 gene mutation, homocystinemia, factor VIII levels > 90th percentile of normal

VKA therapy for 6 to 12 months (Grade 1A)

We suggest continuing treatment indefinitely (Grade 2C)

2 or more episodes of documented DVT We suggest continuing treatment indefinitely (Grade 2A)

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Initial Therapy for PE: LMWH Or UFH Therapy Initial Therapy for PE: LMWH Or UFH Therapy

CLINICAL SITUATION RECOMMENDATION

Confirmed, non-massive PE SC LMWH or IV UFH (both Grade 1A)

High suspicion of PE Anticoagulants, while awaiting test outcomes (Grade 1C+)

Coexisting severe renal failure IV UFH over LMWH (Grade 2C)

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Initial Therapy for PE: Thrombolytic Agents Initial Therapy for PE: Thrombolytic Agents

CLINICAL SITUATION RECOMMENDATION

Most patients We recommend clinicians not use systemic thrombolytic therapy (Grade 1A)

Selected patients, eg, hemodynamically unstable patients

Systemic thrombolytic therapy (Grade 2B)*

Patients receiving thrombolytic therapy

We suggest regimens with a short infusion time over those with a prolonged infusion time (Grade 2C)

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Initial Therapy for PE: Additional Recommendations

Initial Therapy for PE: Additional Recommendations

INITIAL TREATMENT OF PE RECOMMENDATION

Most patients We recommend against mechanical approaches (Grade 1C) We recommend against pulmonary embolectomy (Grade 1C)

Selected, highly compromised patients (those who are unable to receive thrombolytic therapy, or whose critical status does not allow enough time for infusion)

Mechanical approaches may be used (Grade 2C)

Pulmonary embolectomy may be used (Grade 2C)

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Initial Therapy for PE: Additional Recommendations, continued

Initial Therapy for PE: Additional Recommendations, continued

INITIAL TREATMENT OF PE RECOMMENDATION

Patients with a contraindication for, or complication of, anticoagulant treatment; or patients with recurrent thromboembolism, despite adequate anticoagulation therapy

We suggest clinicians place an IVC filter (Grade 2C)

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Long-Term Therapy for PE: VKA Therapy Long-Term Therapy for PE: VKA Therapy

PATIENT CHARACTERISTICS RECOMMENDATION

First episode of PE, secondary to a transient (reversible) risk factor

VKA therapy for ≥ 3 months (Grade 1A)

First episode of idiopathic PE VKA therapy for ≥ 6 to 12 months (Grade 1A)

Consider giving anticoagulants indefinitely (Grade 2A)

Concomitant cancer Most patients: LMWH for 3 to 6 months (Grade 1A); then anticoagulants indefinitely, or until the cancer is resolved (Grade 1C)

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Long-Term Therapy for PE:VKA Therapy, continued

Long-Term Therapy for PE:VKA Therapy, continued

PATIENT CHARACTERISTICS RECOMMENDATION

First episode of PE, and either documented APLAs or ≥ 2 thrombophilic conditions (eg, combined factor V Leiden and prothrombin 20210 gene mutations)

Treat for 12 months (Grade 1C+) ;We suggest giving anticoagulants indefinitely (Grade 2C)

First episode of PE, and any of the following: documented antithrombin deficiency, protein C or protein S deficiency, factor V Leiden, prothrombin 20210 gene mutation, homocystinemia, high factor VIII levels (> 90th percentile of normal)

Treat for 6 to 12 months (Grade 1A)

We suggest giving anticoagulants indefinitely (Grade 2C)

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Long-Term Therapy for PE:VKA Therapy, continued

Long-Term Therapy for PE:VKA Therapy, continued

PATIENT CHARACTERISTICS RECOMMENDATION

≥ 2 episodes of documented PE We suggest giving anticoagulants indefinitely (Grade 2A)

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Postthrombotic Syndrome Postthrombotic Syndrome

THERAPEUTIC GOAL RECOMMENDATION

Prevent postthrombotic syndrome GCS (ankle pressure 30 to 40 mm Hg) for 2 yr after a DVT episode (Grade 1A)

Treat severe edema of the leg A course of therapy with an IPC device (Grade 2B)

Treat mild edema of the leg GCS (Grade 2C) or rutosides (Grade 2B)

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Other Thrombotic ConditionsOther Thrombotic Conditions

PATIENT CHARACTERISTICS RECOMMENDATION

Chronic thromboembolic pulmonary hypertension

Selected patients, ie, those with central disease being treated by experienced surgical & medical team: pulmonary thrombo-endarterectomy (Grade 1C)

After pulmonary thromboendarterectomy, and for patients who are ineligible: life-long VKA therapy (INR 2.0 to 3.0) (Grade 1C)

We suggest placing a vena cava filter before or at the time of pulmonary thrombo-endarterectomy (Grade 2C)

Superficial thrombophlebitis, as a complication of infusion

Topical diclofenac gel (Grade 1B) or oral diclofenac (Grade 2B)

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Other Thrombotic Conditions, continuedOther Thrombotic Conditions, continued

PATIENT CHARACTERISTICS

RECOMMENDATION

Spontaneous superficial thrombophlebitis

Intermediate doses of UFH or LMWH for ≥ 4 wk (Grade 2B)

Acute upper-extremity DVT (initial treatment)

UFH or LMWH (both Grade 1C+)

Initial treatment for selected patients:

Those with a low risk of bleeding and symptoms of recent onset: short course of thrombolytic therapy (Grade 2C)

Those with failure of anticoagulant or thrombolytic treatment, and persistent symptoms: surgical embolectomy or catheter extraction (both Grade 2C)

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Other Thrombotic Conditions, continuedOther Thrombotic Conditions, continued

PATIENT CHARACTERISTICS RECOMMENDATION

Acute upper-extremity DVT (initial treatment)

Continued:

Those with a contraindication for anticoagulant treatment: consider a superior vena cava filter (Grade 2C)

Acute upper-extremity DVT (long-term treatment)

VKA therapy (Grade 1C+) (for duration of treatment, see recommendations for acute DVT)

Persistent edema and pain Elastic bandages, for symptomatic relief (Grade 2C)