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Issue 41

The recent edition of PERTinent updates brought to you by
The PERT Consortium® Education Committee.

This edition features four impactful papers in PE management from 2021 selected by our 7^th Annual Symposium Course Directors.
Exclusive insights from each of the lead authors accompany the articles.

Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2): a multinational, multicentre, single-arm, phase 4 trial.

Klok FA, Toenges G, Mavromanoli AC, Barco S, Ageno W, Bouvaist H, Brodmann M, Cuccia C, Couturaud F, Dellas C, Dimopoulos K, Duerschmied D, Empen K, Faggiano P, Ferrari E, Galiè N, Galvani M, Ghuysen A, Giannakoulas G, Huisman MV, Jiménez D, Kozak M, Lang IM, Lankeit M, Meneveau N, Münzel T, Palazzini M, Petris AO, Piovaccari G, Salvi A, Schellong S, Schmidt KH, Verschuren F, Schmidtmann I, Meyer G, Konstantinides SV; PEITHO-2 investigators. 
Lancet Haematol. 2021 Sep;8(9):e627-e636.
doi: 10.1016/S2352-3026(21)00203-9. Epub 2021 Aug 4.
PMID: 34363769.

Comments from Erik Klok, MD, PhD:
“The PEITHO-2 study was a unique study performed by the international PEITHO consortium led by Professor Stavros Konstantinides. It evaluated the strategy of initial parenteral anticoagulation in patients admitted to the hospital because of intermediate-risk acute pulmonary embolism, with an early switch to oral treatment upon clinical confirmation of hemodynamic and respiratory stabilisation. This standardized clinical assessment of stabilisation was performed after 72 hours. Of the 402 study patients, 70% had intermediate-high risk pulmonary embolism. The strategy proofed safe, with a 2% 6-month incidence of recurrent venous thromboembolism, and a 0.5% 6-month incidence of fatal pulmonary embolism. The results of the PEITHO-2 study will help refining guideline recommendations for the initial treatment of acute intermediate-risk pulmonary embolism, allowing for standardising treatment of this specific patient group including earlier discharge from the hospital than current practice.”

Randomised controlled trial of a prognostic assessment and management pathway to reduce the length of hospital stay in normotensive patients with acute pulmonary embolism. 

Jiménez D, Rodríguez C, León F, Jara-Palomares L, López-Reyes R, Ruiz-Artacho P, Elías T, Otero R, García-Ortega A, Rivas-Guerrero A, Abelaira J, Jiménez S, Muriel A, Morillo R, Barrios D, Le Mao R, Yusen RD, Bikdeli B, Monreal M, Lobo JL; IPEP investigators.
Eur Respir J. 2021 Aug 12:2100412.
doi: 10.1183/13993003.00412-2021. Epub ahead of print. 
PMID: 34385269.

Comments from David Jiménez, MD, PhD, FERS:
“Large variations exist among hospitals in the use of treatment resources for pulmonary embolism. Lack of a common approach to the prognostication and treatment of pulmonary embolism has been cited as an explanation for these variations. We evaluated the safety and effectiveness of a critical pathway for the management of acute stable pulmonary embolism by means of a randomized controlled trial. In this study, implementation of a critical pathway reduced the length of hospital stay without causing harm to patients.”

Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial.

Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. 
Eur Heart J. 2021 Aug 31;42(33):3146-3157. 
doi: 10.1093/eurheartj/ehab373. .
PMID: 34363386; PMCID: PMC8408662.

Comments from Pierre-Marie Roy, MD, PhD:
“The main results of HOME-PE trial show that a triaging strategy based on the Hestia rule or based on sPESI had similar safety and effectiveness, and, with both triage rules, more than a third of patients were treated at home with a low rate of complications. Two other important features may help to enhance PE management. First, physicians, in their decision making for home treatment, do not used only PE severity criteria but also possible concomitant illness, social condition and patient’s opinion, criteria that are formally addressed in the Hestia rule, but that require an informal overruling of sPESI, thus impairing its applicability in everyday practice. Second, to ensure that patients had adequate medical support at discharge, participating hospitals had to create a dedicated patient pathway, prior to the start of the study. This organization, based on local expertise, is a key element of the Pulmonary Embolism Response Team, helping in the decision-making and timely follow-up of PE patients treated at home.”

Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.

Avgerinos ED, Jaber W, Lacomis J, Markel K, McDaniel M, Rivera-Lebron BN, Ross CB, Sechrist J, Toma C, Chaer R; SUNSET sPE Collaborators. 
JACC Cardiovasc Interv. 2021 Jun 28;14(12):1364-1373. 
doi: 10.1016/j.jcin.2021.04.049. Erratum in: JACC Cardiovasc Interv. 2021 Oct 11;14(19):2194.
PMID: 34167677.

Comments from Efthymios D. Avgerinos, MD:
“The SUNSET sPE was an investigator-initiated trial coming out of the University of Pittsburgh Medical Center in collaboration with Emory University and Piedmont Heart institute in Atlanta. Catheter interventions and catheter thrombolysis in particular has been increasingly used over the past 7-8 years in submassive PE. While Ultrasound assisted thrombolysis (USAT) has been the major thrombolytic procedure reported and used, it is unproved and controversial whether it is superior to standard CDT (SCDT) using traditional multi-sidehole catheters in the treatment of patients with submassive PE. In an era of increasing focus on quality and cost consciousness, the preferential use of USAT over SCDT needed to be rigorously studied.

The SUNSET sPE trial confirmed high safety and efficacy of contemporary catheter thrombolysis in the management of sPE patients. Patients with sPE undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic dose and duration of lysis. While the true potential value-add of USAT may be shortening the dose/duration of fibrinolytic drug infusion, this remains to be proven. Till then, the main impact of our study is the potential to change practice towards a cost saving alternative.”