Don't Just Read the Abstract

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On this episode, Pip and Rich discuss HI-PEITHO, a randomised controlled trial of catheter-directed fibrinolysis in patients presenting with intermediate risk PE. This was an industry-sponsored trial. Patients could be included if they had a ratio of RV:LV end diastolic diameter of ≥1.0 and an elevated troponin level + at least two of SBP ≤110 mm Hg, HR ≥100 bpm, or a respiratory rate of >20 breaths per minute.

The primary outcome was a composite of pulmonary embolism–related death, cardiorespiratory decompensation or collapse or symptomatic recurrence of pulmonary embolism within 7 days.

After randomising 544 patients, a primary-outcome event occurred in 11 patients in the intervention group and 28 in the usual care arm (relative risk, 0.39; 95% CI, 0.20 to 0.77; P=0.005). So, is this a slam dunk? Should we roll out this intervention? Here we discuss the nuances of the primary outcome finding that it was mostly driven by number of patients who had a NEWS score of 9 or more, 24 hours after randomisation. Pip and Rich debate the meaning of this outcome and much more. This is most definitely a study where reading beyond the abstract is 100% necessary!

Novo Nordisk has provided sponsorship to HaemSTAR to cover the costs of the development of Don’t Just Read the Abstract initiative. Novo Nordisk has had no influence over the creation, development, or content of any of the materials available

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In this episode, Pip and Rich discuss the C-TRACT trial: Vedantham et al. Endovascular Therapy for Post-Thrombotic Syndrome — A Randomized Trial. 2026

N Engl J Med 2026;394:2293-2304

C-TRACT (Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy) was a phase 3, publicly funded, multicentre, open-label, assessor-blinded RCT published in NEJM that randomised 225 patients with moderate-to-severe post-thrombotic syndrome (PTS) and imaging-confirmed iliac-vein obstruction to endovascular therapy (iliac-vein stenting + enhanced antithrombotic therapy) plus standard care versus standard care alone.

Key Results

At 6 months, the endovascular group had a statistically significant reduction in PTS severity by the Venous Clinical Severity Score (VCSS: 8.1 vs. 10.0, adjusted difference −2.0 points; P=0.001). Quality-of-life scores also improved with a 14.5-point improvement in venous disease–specific QoL (VEINES-QOL) and a 6.1-point improvement in the SF-36 physical component summary with the intervention.

However, bleeding was significantly higher in the intervention group (11.6% vs. 3.6%; P=0.03).

In the episode, Pip and Rich discuss key critical appraisal points including:

• Modest primary endpoint difference. The 2-point VCSS difference, while statistically significant, is relatively small on a 0–30 scale. The clinical meaningfulness of this difference at the individual patient level is debatable, though the authors argue that many patients shifted to lower severity categories.
• Open-label design. The trial was open-label, which is a significant limitation for patient-reported outcomes like quality of life. While the primary outcome (VCSS) was assessed by blinded evaluators, the large QoL differences (which are the most compelling results) are susceptible to expectation and performance bias - a limitation the authors themselves acknowledge.
• Short follow-up. Results are reported at only 6 months. Stent patency, durability of benefit, and long-term safety (including stent-related complications and the consequences of enhanced antithrombotic therapy) remain unknown.
• The relevance of enhanced antithrombotic therapy which confounds the intervention. The endovascular arm received both stenting and additional antithrombotic therapy, making it impossible to disentangle the contribution of each component and likely explaining the higher bleeding rate.
• Generalisability. The trial was limited to patients with iliac-vein obstruction and moderate-to-severe PTS, a specific subset of the broader PTS population. Results should not be extrapolated to milder disease or non-iliac obstruction.

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On this episode, Pip and Rich chat to Consultant Haematologist, Dr Kate Musgrave and Thrombosis Nurse Specialist, Vicky Marr about how they developed and implemented a natural language processing model that identifies cases of hospital acquired thrombosis. Implementing this strategy in their hospital in Newcastle-Upon-Tyne has led to saving thousands of hours of manually trawling radiology reports - enabling them to focus on what matters - interacting with patients. The tool is now available for implementation across the NHS. This is a must-listen for anyone wanting to improve efficiency in their hospital.

Read more about the project here.

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Following its recent US FDA approval, on this episode, Pip and Rich discuss mitapivat, an allosteric activator of red-cell pyruvate kinase. They focus on ENERGIZE, a randomised controlled trial of mitapivat vs placebo (2:1) randomisation in people living with transfusion dependent thalassaemia. It met its primary endpoint of achieving significantly more patients reaching a haemoglobin rise of at least 1 g/L. However, Pip and Rich discuss the relevance of this surrogate endpoint as well as the small effects on fatigue and quality of life.

Taher et al. Mitapivat in adults with non-transfusion-dependent α-thalassaemia or β-thalassaemia (ENERGIZE): a phase 3, international, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Jul 5;406(10498):33-42. doi: 10.1016/S0140-6736(25)00635-X.

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On this episode, Pip and Rich VAY-HIT2, a trial recently published in the New England Journal of Medicine. This study randomised patients with relapsed/refractory ITP after first line corticosteroids to eltrombopag + ianalumab or placebo.

As the thrombopoietin receptor agonists such as eltrombopag are often given for extensive periods, there's a lot of interest in giving additional treatment that can result in a relatively short course of treatment. Ianalumab is an anti-B-Cell Activating Factor (BAFF) Receptor monoclonal antibody.

VAY-HIT2 was a phase 3, randomised, double-blind trial, assigning, in a 1:1:1 ratio, adults with primary ITP and an insufficient response or a relapse after first-line glucocorticoid therapy to receive eltrombopag + ianalumab at a dose of 9 mg or 3 mg per kilogram of body weight or placebo once monthly for 4 months.

The trial did meet its primary endpoint but there's a lot to discuss, most importantly the quality of life end points - and the interpretation is not straight forward!

Conflict of interest disclosure here: Pip has received travel expenses and payment for attending an advisory board for Novartis. Pip is also leading a Novartis-sponsored UK audit of the treatment of warm autoimmune haemolytic anaemia on behalf of HaemSTAR (www.haemstar.org/TRUTH).

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