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

Klok, Frederikus A.; Toenges, Gerrit; Ageno, Walter; Bouvaist, Hélène; Brodmann, Marianne; Cuccia, Claudio; Couturaud, Francis; Dellas, Claudia; Dimopoulos, Konstantinos; Duerschmied, Daniel; Empen, Klaus; Faggiano, Pompilio; Ferrari, Émile; Galiè, Nazzareno; Galvani, Marcello; Ghuysen, Alexandre; Giannakoulas, George; Huisman, Menno V.; Jiménez, David; Kozak, Matija; Lang, Irene; Lankeit, Mareike; Meneveau, Nicolas; Münzel, Thomas; Palazzini, Massimiliano; Petriş, Antoniu; Piovaccari, Giancarlo; Salvi, Aldo; Schellong, Sebastian; Schmidt, Kai‐Helge; Verschuren, Franck; Schmidtmann, Irene; Meyer, Guy; Konstantinides, Stavros; Antonio, Jaime; Freire, Abelaira; Akın, İbrahim; Anušić, Toni; Becker, Dorothea; Bertoletti, Laurent; Bettoni, Giuseppe; Binder, Harald; Carels, Regina; Pasquale, Giuseppe Di; Dürschmied, Daniel; Enea, Iolanda; Ficker, Joachim H.; Genth-Zotz, Sabine; Girard, Philippe; Gorbulev, Stanislav; Held, Matthias; Hobohm, Lukas; Kronfeld, Kai; Lehmacher, Walter; Miguel, Concepcion Patricia Lopez; Martin, N.; Mavromanoli, Anna C.; Parežnik, Roman; Quitzau, Kurt; Parepa, Irinel Raluca; Martin, Purificacion Ramirez; Righini, Marc; Todea, Silviu Bogdan; Torbicki, Adam; Valerio, Luca; Vanassche, Thomas; Vida-Simiti, L; Wolf-Pütz, Anamaria

doi:10.1016/s2352-3026(21)00203-9

Cited by 15 publications

(10 citation statements)

References 32 publications

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“…The levels of NT-proBNP were considered abnormal if being above the cut-off value of 125 pg/ml [14,15]. Statistical analysis was performed in the intention-to-treat population [10]. Categorical variables are reported with absolute and relative frequencies; continuous variables, with the corresponding median and interquartile range.…”

Section: Methodsmentioning

confidence: 99%

Recovery of right ventricular function after intermediate-risk pulmonary embolism: results from the multicentre Pulmonary Embolism International Trial (PEITHO)-2

et al. 2022

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Background Right ventricular (RV) function plays a critical role in the pathophysiology and acute prognosis of pulmonary embolism (PE). We analyzed the temporal changes of RV function in the cohort of a prospective multicentre study investigating if an early switch to oral anticoagulation in patients with intermediate-risk PE is effective and safe. Methods Echocardiographic and laboratory examinations were performed at baseline (PE diagnosis), 6 days and 6 months. Echocardiographic parameters were classified into categories representing RV size, RV free wall/tricuspid annulus motion, RV pressure overload and right atrial (RA)/central venous pressure. Results RV dysfunction based on any abnormal echocardiographic parameter was present in 84% of patients at baseline. RV dilatation was the most frequently abnormal finding (40.6%), followed by increased RA/central venous pressure (34.6%), RV pressure overload (32.1%), and reduced RV free wall/tricuspid annulus motion (20.9%). As early as day 6, RV size remained normal or improved in 260 patients (64.7%), RV free wall/tricuspid annulus motion in 301 (74.9%), RV pressure overload in 297 (73.9%), and RA/central venous pressure in 254 (63.2%). At day 180, the frequencies slightly increased. The median NT-proBNP level decreased from 1448 pg/ml at baseline to 256.5 on day 6 and 127 on day 180. Conclusion In the majority of patients with acute intermediate-risk PE switched early to a direct oral anticoagulant, echocardiographic parameters of RV function normalised within 6 days and remained normal throughout the first 6 months. Almost one in four patients, however, continued to have evidence of RV dysfunction over the long term. Graphical Abstract

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Section: Methodsmentioning

confidence: 99%

Recovery of right ventricular function after intermediate-risk pulmonary embolism: results from the multicentre Pulmonary Embolism International Trial (PEITHO)-2

et al. 2022

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“…The randomised controlled Pulmonary Embolism International THrOmbolysis (PEITHO) trial showed that 5.0% of initially anticoagulated patients suffered haemodynamic decompensation and/ or died, mostly within the first 72 hours after their admission, and required rescue reperfusion treatment 14 . Notably, this number was lower, at 1.4%, in the single-arm PEITHO-2 study 15 . Cohort data suggest that early mortality may reach 5-10% in initially normotensive Percutaneous treatment options for acute pulmonary embolism -a position paper patients with RVD and myocardial injury 16 .…”

Section: Introductionmentioning

confidence: 77%

Percutaneous treatment options for acute pulmonary embolism: a clinical consensus statement by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function and the European Association of Percutaneous Cardiovascular Interventions

Pruszczyk¹,

Klok²,

Kucher³

et al. 2022

EuroIntervention

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There is a growing clinical and scientific interest in catheter-directed therapy (CDT) of acute pulmonary embolism (PE). Currently, CDT should be considered for patients with high-risk PE, in whom thrombolysis is contraindicated or has failed. Also, CDT is a treatment option for initially stable patients in whom anticoagulant treatment fails, i.e., those who experience haemodynamic deterioration despite adequately dosed anticoagulation. However, the definition of treatment failure (primary reperfusion therapy or anticoagulation alone) remains an important area of uncertainty. Moreover, several techniques for CDT are available without evidence supporting one over the other, and variation in practice with regard to periprocedural anticoagulation is considerable. The aim of this position paper is to describe the currently available CDT approaches in PE patients and to standardise patient selection, the timing and technique of the procedure itself as well as anticoagulation regimens during CDT. We discuss several clinical scenarios of the clinical evaluation of the "efficacy" of thrombolysis and anticoagulation, including treatment failure with haemodynamic deterioration and treatment failure based on a lack of improvement. This clinical consensus statement serves as a practical guide for CDT, complementary to the formal guidelines.

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“…An individual patient-level meta-analysis of 6 prospective cohort studies that included 2874 normotensive patients with PE reported that right ventricular dysfunction was associated with an increased risk of death, shock, or recurrent PE (OR, 2.28 [95% CI, 1.58-3.29) . A systematic review of 21 studies (11 prospective and 10 retrospective) that included 3111 patients reported that compared to the criterion standard of echocardiography, an increased right ventricular:left ventricular ratio greater than 1.0 had a sensitivity of 83% and a specificity of 75% for right ventricular dysfunction .…”

Section: Discussionmentioning

confidence: 99%

Acute Pulmonary Embolism

Freund

Cohen‐Aubart

Bloom

2022

JAMA

124

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ImportancePulmonary embolism (PE) is characterized by occlusion of blood flow in a pulmonary artery, typically due to a thrombus that travels from a vein in a lower limb. The incidence of PE is approximately 60 to 120 per 100 000 people per year. Approximately 60 000 to 100 000 patients die from PE each year in the US.ObservationsPE should be considered in patients presenting with acute chest pain, shortness of breath, or syncope. The diagnosis is determined by chest imaging. In patients with a systolic blood pressure of at least 90 mm Hg, the following 3 steps can be used to evaluate a patient with possible PE: assessment of the clinical probability of PE, D-dimer testing if indicated, and chest imaging if indicated. The clinical probability of PE can be assessed using a structured score or using clinical gestalt. In patients with a probability of PE that is less than 15%, the presence of 8 clinical characteristics (age &lt;50 years, heart rate &lt;100/min, an oxygen saturation level of &gt; 94%, no recent surgery or trauma, no prior venous thromboembolism event, no hemoptysis, no unilateral leg swelling, and no estrogen use) identifies patients at very low risk of PE in whom no further testing is needed. In patients with low or intermediate clinical probability, a D-dimer level of less than 500 ng/mL is associated with a posttest probability of PE less than 1.85%. In these patients, PE can be excluded without chest imaging. A further refinement of D-dimer threshold is possible in patients aged 50 years and older, and in patients with a low likelihood of PE. Patients with a high probability of PE (ie, &gt;40% probability) should undergo chest imaging, and D-dimer testing is not necessary. In patients with PE and a systolic blood pressure of 90 mm Hg or higher, compared with heparin combined with a vitamin K antagonist such as warfarin followed by warfarin alone, direct oral anticoagulants such as apixaban, edoxaban, rivaroxaban, or dabigatran, are noninferior for treating PE and have a 0.6% lower rate of bleeding. In patients with PE and systolic blood pressure lower than 90 mm Hg, systemic thrombolysis is recommended and is associated with an 1.6% absolute reduction of mortality (from 3.9% to 2.3%).Conclusions and RelevanceIn the US, PE affects approximately 370 000 patients per year and may cause approximately 60 000 to 100 000 deaths per year. First-line therapy consists of direct oral anticoagulants such as apixaban, edoxaban, rivaroxaban, or dabigatran, with thrombolysis reserved for patients with systolic blood pressure lower than 90 mm Hg.

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

Cited by 15 publications

References 32 publications

Recovery of right ventricular function after intermediate-risk pulmonary embolism: results from the multicentre Pulmonary Embolism International Trial (PEITHO)-2

Recovery of right ventricular function after intermediate-risk pulmonary embolism: results from the multicentre Pulmonary Embolism International Trial (PEITHO)-2

Percutaneous treatment options for acute pulmonary embolism: a clinical consensus statement by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function and the European Association of Percutaneous Cardiovascular Interventions

Acute Pulmonary Embolism

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