DECLARATION OF CONFLICT OF INTEREST

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1 DECLARATION OF CONFLICT OF INTEREST

2 IDENTIFYING LOW-RISK PULMONARY EMBOLISM CLINICAL SCORES David Jiménez, MD, PhD Respiratory Department Ramón y Cajal Hospital Madrid, Spain

3 Potential Conflicts of Interest Financial conflicts of interest None related to this topic

4 Presentation objectives To review the usefulness of clinical prognostic models for identifying low-risk patients with acute PE To discuss their role in the prognostication algorithm

5 Prognosis in PE patients All PE patients should undergo rapid risk stratification (grade 1C) Kearon C. Chest 2008

6 Cardiac biomarkers Torbicki A, Eur Heart J 2008

7 AHA scientific statement Jaff MR, Circulation 2011

8 Wood KE. Chest 2002 High-risk patients Definition based on one single clinical variable (i.e., systolic blood pressure) Indication for escalated therapy No RCTs demonstrating survival advantage for thrombolysis in this scenario PPV 14% NPV 99%

9 Methodological issues Muerte: RR 0.9 (95% CI: ) Recurrencia: RR 0.6 (95% CI ) Sangrado: RR 1.49 (95% CI ) Muerte y recurrencia: RR 0.55 (95% CI ) Torbicki A, Eur Heart J 2008

10 Methodological issues MAPPET: 10% in-hospital death; 94% due to PE ICOPER: 11% 2-weeks death; 45% due to PE RIETE: 61% of early deaths due to PE Konstantinides S. Circulation 1997 Goldhaber SZ. Lancet 1999 Conget F. Thromb Haemost 2008

11 Etiologies and time to death of 1,291 patients with acute PE 10 5 PE-related death Time, days Non PE-related death Sánchez D, JTH 2011 (press)

12 Etiologies and time to death of 1,291 patients with acute PE 10 spesi OR 5.97* OR 8.79* *P < 0.05 Sánchez D, JTH 2011 (press)

13 Etiologies and time to death of 1,291 patients with acute PE 10 ctni OR 1.34 OR 2.39* *P < 0.05 Sánchez D, JTH 2011 (press)

14 not being at high- or intermediate-risk for PE-related death does not mean being at lowrisk for all-cause mortality and viceversa Not published, and probably unpublishable

15 Geneva score: derivation 296 outpatients from a single centre Cancer Heart failure Previous deep vein thrombosis po2 < 8 kpa SBP < 100 mm Hg Deep vein thrombosis (US) 2 points 1 point 1 point 1 point 2 points 1 point < 2 points: low-risk > 2 points: high-risk Wicki J. Thromb Haemost 2000

16 Geneva score: validation 199 patients from 3 centres Recurrent VTE, death or major bleeding 3-month follow-up Low-risk: 79.9% Adverse events: 5% (95% CI, ) Nendaz MR. Thromb Haemost 2004

17 Pulmonary Embolism Severity Index Aujesky D, AJRCCM 2005

18 PESI: validation 367 patients from 117 European emergency departments 90-day all-cause mortality: 6.3% Low-risk: 44.7% Negative predictive value: 99.4% (CI 95%: %) Aujesky D. Eur Heart J 2006

19 PESI and Geneva score Jiménez D, Chest 2007

20 Reproducibility 302 PE patients All-cause 30-day mortality: 3% Kappa: 0.69 Chan CM, JTH 2010

21 PESI score Validated Transportable Reproducible Tested in a RCT (OTPE) Donze J. Thromb Haemost 2008

22 Simplified PESI 995 patients from a single centre Age > 80 1,0 1 point Cancer 0,8 1 point Original PESI Simplified PESI Cardiopulmonary disease HB > 110/min Sensitivity 0,6 0,4 1 point 1 point SBP < 100 mm Hg 0,2 1 point O 2 saturation < 90% 0,0 0,0 0,2 0,4 0,6 1 point 1 - Specificity 0,8 1,0 Jiménez D. Arch Intern Med 2010

23 RIETE registry 7,106 patients Low-risk group: 36.2% Negative predictive value*: 98.9% (CI 95%: %) *30-day all-cause mortality Jiménez D. Arch Intern Med 2010

24 spesi: validation 369 patients from 18 hospitals (SWIVTER) 30-day all-cause mortality: 4.3% Low-risk: 28.7% Negative predictive value: 100% Spirk D. Thromb Haemost 2011 (press)

25 spesi vs. shock index 1,206 patients from a single centre 1/ /2009. Simplified PESI Shock index Low risk 31% 85% NPV 98.4% 91.7% NPV* 97.8% 96.7% *Non fatal recurrent VTE or non fatal major bleeding Sam A. Eur Respir J 2011

26 PESI vs. spesi Original PESI derivation dataset (n = 15,531) PESI spesi Low risk 40.9% 36.8% NPV* 97.7% 97.3% *30-day all-cause mortality Venetz C, Thromb Haemost 2011 (press)

27 PESI vs. spesi 357 PE patients from a RCT PESI spesi Low risk 52.1% 46.2% NPV* 99.4% 99.4% *30-day all-cause mortality Righini M, J Thromb Haemost 2011 (press)

28 PESI vs. spesi 847 normotensive patients from the PROTECT study Simplified PESI PESI Low risk 35.8% 40.7% NPV* 99.7% ( ) 98.8% ( ) *30-day all-cause mortality PROTECT investigators, unpublished

29 PESI vs. ESC 510 patients from a single center PESI ESC Low risk 31% 40% NPV* 97.2% ( ) 97.4% ( ) *In-hospital mortality: 8% Vanni S, JTH 2011 (press)

30 spesi vs. ESC 526 patients from a single center spesi ESC Low risk 31% 39% NPV* 100% 96.6% ( ) *30-day mortality: 7.6% Lankeit M, Chest 2011 (press)

31 Early discharge 304 PESI III patients from a single centre PESI Simplified PESI Reclassified 27.3% 12.5% NPV* 98.8% 100% * 30-day all-cause mortality Jiménez, unpublished

32 Summary Risk stratification models are useful spesi is accurate and easy to use For identifying low-risk patients, prognostication of PE is not just a matter of the heart