IDEAL MANAGEMENT OF PULMONARY EMBOLISM DISCLOSURES
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1 IDEAL MANAGEMENT OF PULMONARY EMBOLISM Samuel Z. Goldhaber, MD Section Head, Vascular Medicine Director, Thrombosis Research Group Cardiovascular Division Brigham and Women s Hospital Professor of Medicine Harvard Medical School December 19, 2015 DISCLOSURES Research Support: BiO 2 Medical; Boehringer- Ingelheim; BMS; BTG EKOS; Daiichi; Janssen; NHLBI; Thrombosis Research Institute Consultant: Bayer; Boehringer-Ingelheim; BMS; Daiichi; Janssen; Portola 1
2 LEARNING OBJECTIVES 1) Epidemiology 2) Pathophysiology: inflammation 3) Align management to risk level 4) Anticoagulation + advanced Rx 5) Optimal duration of anticoagulation 6) Psychosocial and family concerns AHA 2015 STATISTICS: PE IS THE #3 CAUSE OF CV DEATH Up to180,000 PE deaths/year PE MI Stroke STROKE (Circulation 2015; 131: e29-e322) 2
3 MI, PE, AND STROKE: EPIDEMIOLOGY MI: #1, but rate is plummeting; women are catching up to men. Stroke: #2, rate has plateaued. Women have less AF than men but more stroke from AF than men. PE/ DVT: #3, rate is increasing in both men and women. VTE INCIDENCE: INCREASING First-Time Occurrence Annual Event Rate, per 100, /86/88/89 // VTE DVT PE (Huang W. Am J Med 2014; 127: ) 3
4 DECLINING PE MORTALITY, HIGH READMISSION RATES (Minges KE. Am J Cardiol 2015; epubl) CARDIOVASCULAR RISK FACTORS AND VTE (N=63,552 meta-analysis) RF RR Obesity 2.3 Hypertension 1.5 Diabetes 1.4 Cigarettes 1.2 High Cholesterol 1.2 (Ageno W. Circulation 2008; 117: ) 4
5 HYPERCOAGULABILITY WORKUP Antiphospholipid Antibody Syndrome Predisposes to MI, Stroke, PE Predicts high risk of a recurrent event if anticoagulation is discontinued Lupus Anticoagulant Anticardiolipin Antibodies Beta-2-Glycoprotein Antiprothrombin PE: FILLED WITH WBCs and PLATELETS INFLAMMATION (Savchenko AS. J Thromb Haemostas 2014; 12: ) 5
6 COMMON PATHOPHYSIOLOGY: VTE AND ATHEROSCLEROSIS Obesity Hypertension Tobacco use Dyslipidemia Shared Risk Factors Diabetes Diet Stress Estrogen Therapy (Piazza, Goldhaber. Circulation 2010;121: 2146) A PANVASCULAR SYNDROME: SHARED RISK FACTORS/ PATHOPHYSIOLOGY: Lump, Don t Split VTE Myocardial Infarction VTE Myocardial Infarction Stroke Stroke 6
7 ANTICOAGULATION: THE FOUNDATION OF PE TREATMENT EVOLVING ANTICOAGULATION STRATEGIES Overlapping LMWH/ Warfarin Bridge UFH/ Warfarin Bridge Switching LMWH to Dabigatran (RE-COVER I,II) LMWH to Edoxaban (HOKUSAI) Oral Monotherapy Rivaroxaban (3 week loading dose) (EINSTEIN) Apixaban (1 week loading dose) (AMPLIFY) (Goldhaber SZ, Bounameaux H. Lancet 2012; 379: ) 7
8 ACUTE VTE TREATMENT: NOAC EFFICACY All 4 NOACs are noninferior to LMWH/ warfarin for efficacy, regardless of weight, PE vs. DVT, CKD, and cancer. Edoxaban: prespecified submassive PE subgroup showed superiority. (van Es N, et al. Blood 2014; 124: ) ACUTE VTE TREATMENT: NOAC SAFETY Meta-analysis (N=27,235): 39% lower major bleeding, 64% lower fatal bleeding, 63% less ICH than LMWH/ warfarin (van Es N, et al. Blood 2014; 124: ) 8
9 ANTIDOTES IN DEVELOPMENT Idarucizumab (BI ) Target: Dabigatran Structure: Humanized antibody fragment (FAb) to dabigatran Andexanet alpha Target: FXa inhibitors Structure: FXa decoy, lacking catalytic & binding activity ADVANCED MANAGEMENT OF PE: WHEN ANTICOAGULATION ALONE MIGHT NOT SUFFICE 9
10 RISK STRATIFY TO GUIDE MANAGEMENT STRATEGY 5% 10% 15% 70% High Risk Intermediate High: RVD+Tn Reperfuse: Lysis/ Embolectomy Reperfuse, Or Watch And Wait Intermediate Low Risk Low: RVD or Tn Hospitalize, Anticoagulate? Early Discharge; Anticoagulate (ESC Guidelines. European Heart J 2014; 35: ) ADVANCED PE THERAPIES 1. Systemic full-dose thrombolysis: 100 mg/2h TPA (FDA: 1990) Tenecteplase (PEITHO): (NEJM 2014) 2. Catheter-directed, Ultrasoundfacilitated thrombolysis 24 mg TPA (ULTIMA: Circulation 2014; 129: 479) (SEATTLE: JACC CV Intervent 2015) 3. Open surgical embolectomy 4. IVC Filter 10
11 LYSIS IN SUBMASSIVE PE: MORTALITY META-ANALYSIS (JAMA 2014; 311: ) L CEREBELLAR BLEED: after 50 mg of a planned 100 mg/2h TPA IV systemically 11
12 TPA 24 mg = total TPA dose TPA 12 mg TPA 12 mg 12
13 OVERCOMING THE HURDLE OF INTRACRANIAL HEMORRHAGE Study ICH (Fibrinolysis) ICOPER (Goldhaber SZ, Lancet 1999) PEITHO (Meyer G, NEJM 2014) ULTIMA (Kucher N, Circulation 2014) SEATTLE II (Piazza G, Goldhaber SZ. JACC Cardiovasc Intervention; August 2015) 9/304 (3.0%) 10/506 (2.4%) 0/30 (0%) 0/150 (0%) 13
14 PE RESPONSE TEAM (PERT) PERT Team Ac6va6on via Paging System PERT Evalua6on by On- Call Physician Web- Based Video Conference Vascular Medicine Echocardiography Interven6onal Cardiology Discussion and Consensus Cardiothoracic Surgery Pulmonary Cri6cal Care Radiology Op6ons and Recommenda6ons Presented to the Pa6ent, Family, and Care Team ACTION (Dudzinski D and Piazza G. Circulation 2015; in press) 14
15 OPTIMAL DURATION OF ANTICOAGULATION MANAGING VTE AS A CHRONIC ILLNESS VTE: mostly a chronic inflammatory illness, not a one-shot event cured with 3-6 months of anticoagulation. Extended duration anticoagulation is often needed. As soon as extended duration anticoagulation is discontinued, the rate of new PE/ DVT increases. 15
16 UK REGISTRY: RECURRENT VTE (Martinez C. Thromb Haemost 2014; 112: ) RE-SONATE: Dabigatran 150 mg BID vs. placebo 92% Less VTE (NEJM; : ) 16
17 THROMBIN- INDUCED INFLAMMATION LEADS TO THROMBOSIS (Croce K, Libby P. Intertwining of thrombosis and inflammation in atherosclerosis. Curr Opin Hematol 2007;14: 55) Aspirin LOW-DOSE ASPIRIN: 35% LESS VTE Effects of aspirin treatment on recurrent venous thromboembolism and other outcomes after adjustment for baseline characteristics: age (<50 years, 50 65, 65), sex (male vs female), qualifying event (deep-vein thrombosis only vs pulmonary embolism with or without deepvein thrombosis), body mass index (normal, overweight, obese) and duration of anticoagulation (<6, 6 9, 9 months). Simes J et al. Circulation. 2014;130: (Circulation 2014; 130: ) Copyright American Heart Association, Inc. All rights reserved. 17
18 PE AND DVT: PSYCHOLOGICAL IMPACT AND LACK OF PUBLIC AWARENESS RX OF ANTIPSYCHOTIC, ANXIOLYTIC, SEDATIVE, AND ANTIDEPRESSANT DRUGS TO VTE PATIENTS (Hojen AA. Thrombosis Research 2015; 135: ) 18
19 THEMES FROM OUR PE SUPPORT GROUP (patients regionally referred) Anger at delay in diagnosis Feeling well, looking well, yet harboring a major illness Yearning for an answer to why me? Protection of family members Optimal duration of anticoagulation NOAC versus VKA PUBLIC AWARENESS: DVT/ PE (J Thromb Haemostasis 2015; 13: ) 19
20 20
21 PHASES OF TREATMENT FOR VTE Initiation (5-21 days) UFH, LMWH, Fonda Rivaroxaban 15 mg BID Apixaban 10 mg BID Early Maintenance (3-6 months) Warfarin (INR ) Rivaroxaban 20 mg Daily Apixaban 5 mg BID Dabigatran 150 mg BID Edoxaban 60 mg Daily Extension (up to indefinite) Warfarin (INR ) Rivaroxaban 20 mg Daily Apixaban 2.5 mg BID Dabigatran 150 mg BID Warfarin (INR ) Aspirin 81 mg Daily Sulodexide 500 U BID (Blondon M, Bounameaux H. Circulation 2015; epubl Sept 25) TAKE HOME MESSAGES 1. Risk stratify; align Rx to prognosis 2. NOACs: less bleeding than warfarin 3. Low-dose aspirin: effective for secondary prevention of VTE, but not as effective as anticoagulants 4. PE: a chronic inflammatory illness 5. Ask patients about their emotions. 21
Disclosures. Objectives
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