Management of Intermediate-Risk Pulmonary Embolism
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1 Management of Intermediate-Risk Pulmonary Embolism Stavros V. Konstantinides, MD, PhD, FESC Professor, Clinical Trials in Antithrombotic Therapy Center for Thrombosis und Hemostasis, University of Mainz, Germany Professor of Cardiology Democritus University of Thrace, Greece
2 Disclosures Advisory boards / Lecture fees (moderate): Boehringer Ingelheim Bayer HealthCare Pfizer Bristol-Myers Squibb Daiichi Sankyo
3 Management of intermediate risk: the questions 1) What options do we have to treat PE? 2) What is intermediate-risk PE? 3) What is the recommended evidence-based treatment for intermediate-risk PE?
4 Systemic thrombolysis for PE Recommendation Class Level Thrombolytic therapy in patients with high-risk PE presenting with cardiogenic shock and/or persistent arterial hypotension Surgical pulmonary embolectomy if thrombolysis is absolutely contraindicated or has failed Catheter embolectomy or fragmentation of proximal pulmonary arterial clots may be an alternative to surgical treatment I I IIb A C C
5 Thrombolysis for PE: recent epidemiological data Nationwide Inpatient Sample USA ,110,320 patients discharged with diagnosis of PE (ICD-9-CM) 72,230 (3.4%) unstable (shock, ventilated) 21,390 (30%) received thrombolytics In patients who received thrombolysis: All-cause mortality: RR, 0.31 ( ) PE-related death: RR, 0.20 ( ) PD Stein. Am J Med. 2012;125: Epub 2012 Feb 10.
6 Interventions for PE Ekosonic Control Unit Ekosonic Mach4 Endovascular Device Trials in patients with non-high-risk PE: NCT in Europe (randomized) NCT in the US (single-arm) 5 fr Intelligent side-hole drug delivery catheter ACC.13: Saturday, March 9, 3:15 p.m. Ultrasound MicroSonic Core Courtesy Prof. Nils Kucher, Bern, CH
7 Anticoagulation for pulmonary embolism: NOAC Current standard of care LMWH or Fonda s.c.* VKA Day 1 Day 5 11 At least 3 months RE-COVER (published) HOKUSAI-VTE (NCT ongoing) Switching LMWH s.c. dabigatran bid / edoxaban od Day 1 Day 5 11 At least 3 months Single oral drug EINSTEIN-DVT/PE (published) rivaroxaban 15 mg bid for 3 weeks, then 20 od AMPLIFY (NCT ongoing) apixaban 10 mg bid for 1 week, then 5 bid Day 1 At least 3 months *Or UFH or fondaparinux S Konstantinides and SZ Goldhaber. Eur Heart J 2012; in press
8 Phase III trial Setting Comparator Status (Jan 2013) Dabigatran RECOVER VTE treatment Parenteral anticoagulant RECOVER II (NCT ) RE-SONATE (NCT ) RE-MEDY (NCT ) VTE treatment VTE long-term prevention after 6-18 months of VKA VTE long-term treatment after 3-6 months of A/C Parenteral anticoagulant Placebo VKA (doubleblind) Rivaroxaban EINSTEIN-DVT DVT treatment Enoxaparin/VKA (open-label) Apixaban Edoxaban EINSTEIN-PE PE + symptomatic DVT treatment EINSTEIN-EXT VTE prevention after 6-12 mo. rivaroxaban or VKA AMPLIFY (NCT ) AMPLIFY-EXT HOKUSAI-VTE (NCT ) Published 2009 presented; publication pending presented; publication pending presented; publication pending Published 2010 Enoxaparin/VKA Published 2012 (open-label) Placebo Published 2010 VTE treatment Enoxaparin/VKA Recr. completed; results expected VTE prevention after completed intended treatment for DVT or PE Two doses of apixaban versus placebo Published 2012 DVT and/or PE treatment LMWH Recr. completed; results expected S Konstantinides and M Lankeit. Haemostaseol 2013 [Epub ahead of press]
9 Single drug approach for severe PE as well? Anatomical extent of PE Rivaroxaban n=2,419 N (%) Standard Tx n=2,413 Limited: <25% of vasculature of a single lobe 309 (12.8) 299 (12.4) Intermediate 1392 (57.5) 1424 (59.0) Extensive: multiple lobes and >25% of entire pulmonary vasculature 597 (24.7) 576 (23.9) Not assessable 121 (5.0) 114 (4.7) HR Büller for the EINSTEIN Investigators. N Engl J Med 2012; published online March 26
10 Management of intermediate risk: the questions 1) What options do we have to treat PE? 2) What is intermediate-risk PE? 3) What is the recommended evidence-based treatment for intermediate-risk PE?
11 The large group of normotensive PE patients >95%
12 Echocardiographic findings in acute PE Echo criteria RV dilatation (RV>LV, or RVEDD >30 mm) RV free wall hypokinesia Paradoxical septal wall Pulmonary hypertension (RV-RA gradient >30 mm Hg, or pulmonary acceleration time <80 ms) S Konstantinides. Curr Opin Cardiol 2005; N Engl J Med 2008
13 Incidence Echo alone probably does not indicate poor prognosis 30% Alteplase (n=118) Placebo (n=138) P= (23.2%) 20% 10% P=0.7 4 (3.4%) 3 (2.2%) 0 P=0.2 1 (0.7%) P= (2.5%) 8 (5.8%) P= (2.5%) 3 (2.2%) 9 (7.6%) 0 Death CPR Shock Intubation Emergency Thrombolysis S Konstantinides. N Engl J Med 2002;347:1143
14 Imaging of RV dysfunction on CT: similar information Prospective multicenter validation (457 pts with PE): RV dilatation: RV:LV >0.9 present in 66% of patients sensitivity, 92%; NPV, 100% Independent predictor of adverse outcome: HR, 3.5; 95% CI, ; P= C Becattini, S Konstantinides. Eur Heart J 2011;32:
15 Troponins in PE: LOW positive predictive value Author Pts (n) Marker Ref. value* Positive (%) NPV (%) PPV (%) Giannitsis, 2000 Konstantinides, 2002 Konstantinides, Trop T Trop I Trop T Janata, Trop T Pruszczyk, Trop T * in ng/ml N Kucher. Circulation 2003;108:2191
16 BNP, probnp in PE: LOW positive predictive value Author Pts (n) Marker ten Wolde, BNP Kucher, BNP Krüger, BNP Kucher, NT-proBNP Pruszczyk, NT-proBNP Binder, NT-proBNP Ref. value 21.7 pmol/l 50 pg/ml 90 pg/ml 500 pg/ml pg/ml 1,000 pg/ml Positive (%) NPV (%) PPV (%) N Kucher. Circulation 2003;108:2191
17 Tools for risk stratification of PE: a critical look S Konstantinides and SZ Goldhaber. Eur Heart J 2012
18 Combine biomarkers with imaging? Parameter RV Dysfunction +? Myocardial injury Tests / Findings RV dilatation, hypokinesis or pressure overload on echocardiography RV dilatation on spiral CT [BNP or NT-proBNP elevation] [ right heart pressures at RHC] Cardiac troponin T or I positive [H-FABP] [Myoglobin]
19 Biomarkers combined with imaging: early evidence Patient group Complication risk (OR, 95% CI) Troponin T-negative (<0.04 ng/ml) Troponin-positive, echo-negative Troponin-negative, echo-positive Both troponin- and echo-positive ~ 15% of all PE patients 3.70 ( ) P= ( ) P= ( ) P=0.004 L Binder, S Konstantinides. Circulation 2005;112:
20 Biomarkers combined with imaging: additive value Echo + GDF-15 Echo + H-FABP M Lankeit., S Konstantinides. Am J Respir Crit Care Med 2008;177: C Dellas, S Konstantinides. J Am Coll Cardiol 2010;55:2150
21 Further determinants of an adverse early outcome Preexisting cardiovascular disease Acute pressure overload (RV dysfunction) Other serious comorbidity (cancer) Recurrent PE (residual DVT) Presence of a PFO Poor prognosis
22 Pulmonary Embolism Severity Index (PESI) Low-risk, 0 points (30 to 36% of patients) High-risk, 1 or more points D Jiménez. Arch Intern Med 2010;170:1383
23 Cardiac troponins on top of spesi (Swiss registry) Multicentre prospective registry: 369 unselected patients Combined endpoint: death or recurrent PE at 30-days D Spirk. Thromb Haemost 2011;Epub ahead of print
24 Cardiac troponins on top of spesi (Swiss registry) Additive value of the combination with troponin testing D Spirk. Thromb Haemost 2011;Epub ahead of print
25 Management of intermediate risk: the questions 1) What options do we have to treat PE? 2) What is intermediate-risk PE? 3) What is the recommended evidence-based treatment for intermediate-risk PE?
26 What did the guidelines say in 2008? Recommendation Class Level Anticoagulation should be initiated without delay in patients with high or intermediate clinical probability of PE while diagnostic workup is still ongoing I C LMW heparin or fondaparinux for most patients I A Thrombolysis generally NOT recommended (1B) may be considered in selected cases IIb B
27 Biomarkers + echo identify candidates for thrombolysis? Thrombolysis?
28 Primary Outcome, Secondary Outcomes Seconray Outomes, SAE Long-term Follow-up Confirmed acute symptomatic PE PEITHO - Design TNK Absence of hemodynamic collapse UFH infusion UFH, LMWH or Fondaparinux <2 h Confirmed RV dysfunction + myocardial injury DOUBLE BLIND R Placebo VKA UFH infusion UFH, LMWH or Fondaparinux UFH bolus i.v. VKA Day 2 Day 7 Day 30 Day 180 S Konstantinides for the PEITHO Steering Committee. Am Heart J 2012;163:33-38.e1
29 PEITHO FINAL Status (July 31, 2012) GLOBAL: cumulative ACC.13, Late-Breaking Trials: Monday, March 11, : a.m planned actual Jul Jun May Apr Mar Feb Jan 2012 Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan 2011 Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan 2010 Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan 2009 Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan 2008 Dec Nov
30 Intermediate-risk PE: Conclusions and outlook (1) Right ventricular dysfunction is an important - but not the only - determinant of prognosis in acute pulmonary embolism. In normotensive patients, echocardiographic and CT parameters, several biomarkers, and clinical parameters, have individually been correlated with poor prognosis. PEITHO, a large European randomized trial, will soon determine whether definition of intermediate-risk PE by imaging + biomarker may have implications for acute management, i.e. set the indication for early thrombolysis.
31 Intermediate-risk PE: Conclusions and outlook (2) Future risk stratification scores and strategies may need to include clinical data (comorbidity) and define a smaller proportion of patients at truly elevated risk for advanced early treatment (thrombolysis, intervention). It will need to be determined whether new oral anticoagulants can be given from the beginning also to patients with intermediate-risk PE.
32 EARLY DEATH RISK EARLY DEATH RATE Hypotension, instability Clinical RISK MARKERS Normotensive, high clinical risk (score?) Imaging/biochemical RV dysfunction (echo, CT) Positive biomarker (troponin, BNP) HIGH >15% (+) NON- HIGH PE classification update : like this? 8-10% % ACUTE TREATMENT Thrombolysis (intervention, surgery) Thrombolysis / Intervention Monitoring; initial A/C inhospital <1% - - (-) - Early discharge
33 Or perhaps as simple as this? EARLY DEATH RISK EARLY DEATH RATE Hypotension, instability Clinical RISK MARKERS Normotensive, high clinical risk (score?) Imaging/biochemical RV dysfunction (echo, CT) Positive biomarker (troponin, BNP) HIGH >15% (+) ACUTE TREATMENT Thrombolysis (intervention, surgery) NON- HIGH 1-8% - (+) Initial A/C inhospital <1% - - (-) - Early discharge
34 1st European Spring School 2013 The Science and Practice of Venous Thromboembolism
35 Thank you
36 EINSTEIN-PE: Primary efficacy outcome Rivaroxaban (n=2,419) Warfarin (n=2,413) n (%) n (%) First symptomatic recurrent VTE 50 (2.1%) 44 (1.8%) Recurrent DVT 18 (0.7%) 17 (0.7%) Non-fatal PE 22 (0.9%) 19 (0.8%) Fatal PE 2 1 Unexplained death where PE could not be ruled out 8 (0.3%) 5 (0.2%) Odds ratio 2.00 Rivaroxaban superior Rivaroxaban non-inferior Rivaroxaban inferior P=0.003 for non-inferiority HR Büller for the EINSTEIN Investigators. N Engl J Med 2012; published online March 26
37 AMPLIFY-EXT: two doses of apixaban Two doses of apixaban (2.5 mg and 5 mg, twice daily) versus placebo Pts with VTE who had completed 6-12 months of anticoagulation study drugs were given for 12 months 2482 pts included in ITT Primary EP: 8.8% in placebo vs. 1.7% in EACH apixaban dose 0.8% vs. 0.2% (2.5 mg) vs. 0.1% (5 mg) G Agnelli for the AMPLIFY Investigators. N Engl J Med. 2012; Epub ahead of print
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