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Journal club: trials highlighted for appraisal
90 recent trials from NEJM, JAMA, the Lancet and other journals. Each PDF is the full paper with the appraisal done on it: every important sentence is highlighted, and a numbered note in the margin says whether it protects or weakens the trial.
The first page of each PDF sums up the appraisal: PICO, a risk-of-bias table (RoB 2), the effect sizes recomputed from the raw counts (RR, absolute difference, NNT), what the paper does not tell you, and the bottom line. Log in with Google to download any 10 trials free. Any SolvedPGSS subscription unlocks all of them, together with Solved Papers, Landmark Trials and free PPT Bank decks.
- Question (PICO)
- Risk of bias
- Results
- Conclusions & spin
- Applicability
Cardiology 35
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A-CLOSE trial · Clopidogrel alone vs DAPT in high ischaemic risk
Noninferior on the net end point only by trading fewer bleeds for more ischaemic events and deaths.
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ACACIA-HCM trial · Aficamten in nonobstructive hypertrophic cardiomyopathy
Symptom and VO2 gains were smaller than the trial was designed to detect; LVEF fell below 50% in 1 in 10.
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ACASA-TAVI trial · NOAC vs antiplatelet monotherapy after TAVI
A NOAC cut valve thickening on CT (NNT 9), but a margin set for three times the event rate leaves safety unproven.
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AIR-STEMI trial · Angiography-derived physiology to guide complete revascularisation in STEMI
Cut death, MI, stroke or repeat revascularisation from 13.7% to 8.9%, mainly through fewer MIs, with fewer stents.
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AMUNDSEN trial · Evolocumab before PCI for acute MI
Doubled the share at LDL target at 1 year, but did not reduce death or cardiovascular hospitalisation.
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CARDIO-TTRansform trial · Eplontersen for transthyretin amyloid cardiomyopathy
Cut TTR by about three-quarters but did not reduce CV death and events; a trustworthy negative trial.
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CMR GUIDE trial · CMR scar to guide ICDs in LVEF 36-50%
An ICD did not reduce sudden death or serious arrhythmia in scarred hearts with mildly reduced EF; total deaths were equal.
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COBRRA trial · Apixaban vs rivaroxaban bleeding in acute VTE
Clinically relevant bleeding 3.3% vs 7.1% over 3 months, favouring apixaban; open label, but the effect is large.
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DECAF trial · Coffee vs abstinence after cardioversion for AF
Carrying on with coffee led to less AF recurrence than abstinence (47 vs 64 of 100); small and open label.
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DKCRUSH VIII trial · IVUS vs angiography guidance for complex bifurcation PCI
IVUS guidance cut 1-year target vessel failure from 14.7% to 6.1% (NNT 12), through fewer MIs and repeat procedures.
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ES-BempedACS trial · Triple vs dual lipid lowering early after ACS
Adding bempedoic acid to statin plus ezetimibe did not raise the share reaching LDL below 55 mg/dL at 8 weeks.
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IMPACTS-BP trial · Team-based hypertension control in low-income US clinics
Cluster RCT: team-based package cut systolic BP a further 6.4 mm Hg at 18 months; open label, post-randomisation recruitment, and no cardiovascular event outcomes.
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LOSE-AF trial · Weight loss in older patients with persistent AF
A low-calorie programme cut weight by 9.7% but did not change AF symptoms or burden; primary outcome was switched.
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NOTION-4 trial · Short-term DOAC and leaflet thickening after TAVR
Three months of a DOAC cut leaflet thickening while taken, but the difference was gone by 12 months.
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PRAGUE-26 trial · Catheter-directed thrombolysis in intermediate-high-risk PE
The 7-day composite fell from 6.8% to 0.7%, but outcome judges were not blinded and 2 intracranial bleeds occurred.
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REVELUTION trial · Coronary plaque after androgen deprivation therapy
Leuprolide was followed by more plaque growth than relugolix, in a small open-label trial with a post hoc model.
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SINGLE-AF trial · DOACs for AF with intermediate stroke risk
DOACs cut the composite from 13 to 4 events, but only 17 primary events and a mid-trial end-point change make it fragile.
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SWITCH-SWEDEHEART trial · Prasugrel vs ticagrelor as the regional default in ACS
No difference in death, MI or stroke at 1 year in a huge registry trial that randomised only 3 clusters.
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TAVI PCI trial · Timing of PCI around TAVI
TAVI first and PCI after was noninferior to PCI first at 1 year (22.2% vs 24.2%), with blinded adjudication.
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ALPACA trial · Lepodisiran, a long-acting siRNA against lipoprotein(a)
One injection cut Lp(a) by about 94% for around a year, a lab result that says nothing yet about heart attacks.
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AQUATIC trial · Adding aspirin to anticoagulation in chronic coronary syndrome
Aspirin added to an anticoagulant raised death and major bleeding, and the trial stopped early for harm.
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ASPREE-XT trial · Aspirin in healthy older adults, extended follow-up
Over 8.3 years aspirin gave no fewer cardiovascular events but more major bleeding (about 1 extra per 82 people).
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BaxHTN trial · Baxdrostat for uncontrolled and resistant hypertension
Baxdrostat cut office SBP 9-10 mm Hg more than placebo at 12 weeks; BP surrogate only, and 7.9% on 2 mg needed treatment for hyperkalaemia.
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BROADWAY trial · Obicetrapib (CETP inhibitor) added to maximum lipid therapy in high-risk patients
Cut LDL 32.6 points more than placebo at day 84 with placebo-like side effects; surrogate end point, effect waned by one year, not powered for events.
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DIGIT-HF trial · Digitoxin in HF with reduced ejection fraction
Death or HF admission fell from 44.1% to 39.5% (HR 0.82), in a trial that reached only about half its planned size.
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FRESH-UP trial · Liberal fluid intake vs restriction in chronic HF
A 1.5-litre fluid limit did not improve health status and left patients thirstier; too small to exclude harm.
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Launch-HTN trial · Lorundrostat for uncontrolled and resistant hypertension
Lorundrostat 50 mg cut office systolic BP 9.1 mm Hg more than placebo at 6 weeks; only 12 weeks, no MRA comparator, more hyperkalaemia and eGFR falls.
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LOT-MDR trial · Loop dose increase vs added thiazide for diuretic resistance in acute HF
One dose of IV chlorothiazide raised urine sodium more than a 2.5-fold loop dose; a surrogate after a single dose.
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OCEAN trial · Rivaroxaban vs aspirin after successful AF ablation
Stroke or covert stroke was rare with either drug (5 vs 9 events); rivaroxaban caused more nonmajor bleeding. Stopped early and badly underpowered.
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ODYSSEY-HCM trial · Mavacamten for symptomatic nonobstructive hypertrophic cardiomyopathy
Mavacamten did not improve peak VO2 or KCCQ over placebo at 48 weeks despite lower NT-proBNP; LVEF drops and heart-failure events were more common.
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REBOOT trial · Beta-blockers after MI with LVEF above 40%
Beta-blockers did not reduce death, reinfarction or heart-failure admission (HR 1.04); open label with about a quarter crossing over by 4 years.
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RIVAWAR trial · Rivaroxaban vs warfarin for LV thrombus after MI
Clot resolution was similar (95.8% vs 96.6%), but per-protocol analysis and a wide margin weaken the noninferiority claim.
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CLEAR trial · Colchicine after acute myocardial infarction
Colchicine for a median 3 years after MI did not cut CV events (9.1% vs 9.3%); well blinded, but 25% stopped the drug.
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OCEANIC-AF trial · Asundexian vs apixaban for stroke prevention in AF
Factor XIa inhibitor asundexian 50 mg tripled stroke or embolism versus apixaban (1.3% vs 0.4%) despite less bleeding; stopped early after median 155 days.
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OPTION trial · Left atrial appendage closure vs anticoagulation after AF ablation
Closure cut non-procedural bleeding (8.5% vs 18.1%) with similar death/stroke; open-label, sponsor-run, benefit mostly from minor bleeds.
Stroke & neurology 10
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EMPHASIS trial · Minocycline in acute ischaemic stroke
Excellent recovery rose from 47.4% to 52.6% (NNT 20), smaller than planned and resting on borderline statistics.
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Magnesium in SAH trial · Targeted magnesium to prevent vasospasm after aneurysmal SAH
No effect on vasospasm, delayed ischaemia or outcome; no sample size or registration was reported.
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OCEANIC-STROKE trial · Asundexian for secondary stroke prevention
The factor XIa inhibitor cut ischaemic stroke from 8.4% to 6.2% (NNT 47) without a clear rise in major bleeding.
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rrAD trial · Exercise and vascular risk reduction for cognition in older adults
Neither exercise nor intensive BP and LDL lowering changed cognition over 2 years compared with usual care.
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TRIDENT trial · Low-dose triple antihypertensive pill after ICH
Recurrent stroke fell from 7.4% to 4.6% (HR 0.61), mostly repeat bleeds, in patients who tolerated a run-in.
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CREST-2 trial · Stenting or endarterectomy plus intensive medical therapy for asymptomatic carotid stenosis
Stenting cut the 4-year composite from 6.0% to 2.8%; endarterectomy not significant. Stenting result is fragile (3-4 events) and open-label.
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EMPROTECT trial · Particle MMA embolization after surgery for chronic subdural haematoma
Post-operative particle embolization cut 6-month recurrence 21.0% to 14.8%, not significant; underpowered, open label, reoperation decided by unblinded surgeons.
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ESCAS trial · Speech therapy plus Cerebrolysin for nonfluent aphasia
Aphasia scores rose about 15 points more than placebo, in a two-centre pilot with an overstated discussion.
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HOPE trial · Alteplase for ischaemic stroke at 4.5 to 24 hours
With perfusion selection, excellent recovery rose (NNT 8) at the cost of more symptomatic bleeds (NNH 31).
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ICHADAPT-2 trial · Intensive BP lowering and ischaemic lesions after ICH
New lesions 31% vs 38% on MRI, but half the patients had no primary scan, so safety is not proven.
Critical care & anaesthesia 12
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ACTiVE trial · Automated closed-loop vs protocolised conventional ventilation in ICU adults
Closed-loop ventilation did not increase ventilator-free days (16.7 vs 16.3); caveat: open label, 21% of randomised patients removed for lacking deferred consent.
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ARISE FLUIDS trial · Early vasopressors vs fluids in septic shock
Days alive and out of hospital were identical (76 vs 76) despite a 1.1-litre difference in fluid.
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ARISS trial · Albumin replacement in septic shock
90-day mortality 43.3% vs 45.9%, not significant; with 440 of 1662 planned patients the answer is 'not shown'.
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ImmunoSep trial · Biomarker-guided anakinra or interferon gamma in sepsis
Precision immunotherapy doubled SOFA responders at day 9 (35.1% vs 17.9%), but the end point is a surrogate and 28- and 90-day mortality did not differ.
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R2D2-ICU trial · Low-use vs high-use wrist restraints in ventilated ICU patients
Avoiding routine wrist straps did not change coma- or delirium-free days or self-extubation, but about 30% non-adherence per arm and open-label scoring blur the contrast.
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RSI trial · Ketamine vs etomidate for intubating critically ill adults
No difference in 28-day death (28.1% vs 29.1%) in a large, well-concealed trial with a hard end point.
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SNaPP trial · Sugammadex vs neostigmine for pulmonary complications
A 2.5-point fall driven by atelectasis; pneumonia and death did not differ and the CI touches no effect.
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ADAPT-Sepsis trial · Procalcitonin or CRP-guided antibiotic stopping in ICU sepsis
Daily PCT-guided advice cut antibiotic days by 0.88 and CRP did not; PCT mortality non-inferiority rests on a wide 5.4-point margin, barely met.
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ANDROMEDA-SHOCK-2 trial · Capillary refill time-targeted personalised resuscitation in septic shock
CRT-guided protocol won on the hierarchical composite (win ratio 1.16) via shorter vital support; mortality unchanged, and support-stopping decisions were unblinded.
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FLUID trial · Hospital-wide lactated Ringer's vs normal saline
Switching a whole hospital's fluid did not change death or readmission at 90 days (20.3% vs 21.4%).
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GAP trial · Gabapentin for pain after major surgery
Did not shorten hospital stay or cut serious adverse events; pain fell by under 1 point on a 10-point scale.
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Oesophageal pressure ventilation trial · Oesophageal-pressure-guided ventilation in pancreatitis ARDS
Oxygenation improved, but the paper's own counts do not support its mortality P value: a spot-the-error paper.
Diabetes, obesity & metabolism 9
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SURPASS-EARLY trial · Tirzepatide vs intensified usual care in early type 2 diabetes
HbA1c and weight fell more with tirzepatide, but the open-label arms were titrated unevenly.
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CAPDCA trial · Personalised education model and glucose control
HbA1c 1 point lower at 18 months, but only 3 centres per arm and an analysis that ignores clustering.
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DEAN trial · Dapagliflozin for biopsy-proven MASH
Dapagliflozin raised 48-week histological MASH improvement from 30% to 53% vs placebo; biopsy surrogates only, 19% missing end biopsies, mostly young men.
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OASIS 4 trial · Oral semaglutide 25 mg for obesity
13.6% vs 2.2% weight loss over 64 weeks, with nausea in about half; the paper contradicts itself on completion.
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REDEFINE 1 trial · Cagrilintide plus semaglutide (CagriSema) for obesity
CagriSema cut weight 20.4% vs 3.0% on placebo and 5.5 points more than semaglutide; surrogate end point, sponsor-run, and GI events in 80%.
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SOUL trial · Oral semaglutide and cardiovascular outcomes in type 2 diabetes
MACE fell from 13.8% to 12.0% (HR 0.86), mainly nonfatal MI; cardiovascular and all-cause death did not clearly fall.
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STRIDE trial · Semaglutide and walking capacity in peripheral artery disease
Maximum walking distance rose about 13% more than placebo; the authors' 'prioritise semaglutide' is overstated.
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SURMOUNT-1 (3 years) trial · Tirzepatide for obesity and diabetes prevention
New diabetes 1.3% vs 13.3% (NNT 9), but one third did not finish and dropout was higher on placebo.
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SURPASS-CVOT trial · Tirzepatide vs dulaglutide for CV outcomes in type 2 diabetes
Tirzepatide was non-inferior to dulaglutide for CV death, MI or stroke (HR 0.92) but not superior; only modified ITT shown, no per-protocol analysis.
Kidney 4
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FINE-ONE trial · Finerenone in type 1 diabetes with CKD
Albuminuria fell 25% more than placebo over 6 months in a well-run trial; albuminuria is a surrogate.
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EMPA-KIDNEY (long term) trial · Empagliflozin in CKD, post-trial follow-up
Kidney progression or CV death fell from 30.3% to 26.2% (NNT 25), with benefit lasting about a year after stopping.
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SWEETSTONE trial · Empagliflozin for calcium and uric acid kidney stones
Lowered one urine supersaturation measure per stone type over 2 weeks; a surrogate, not stone events.
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VISIONARY trial · Sibeprenlimab (anti-APRIL) in IgA nephropathy: interim phase 3 analysis
Sibeprenlimab cut 9-month proteinuria 51% more than placebo; caveat: interim surrogate result, eGFR and long-term safety still unreported.
Infection, oncology & other 20
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ADHERE-ASCVD trial · Digital reminders to improve statin refills
One message raised 14-day refills from 12.0% to 14.4% (NNT 43); switching channels added nothing.
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GALE CRUSTED trial · Double-dose ivermectin with permethrin for severe scabies
Doubling ivermectin did not raise cure (75% vs 82%), and about a quarter of the primary data were missing.
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GLISTEN trial · Linerixibat for itch in primary biliary cholangitis
Itch fell 0.72 points more than placebo, far below a meaningful change, while diarrhoea hit 61% (NNH 3).
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No OUCH trial · Paracetamol or hydromorphone added to ibuprofen for children's limb injury
Neither add-on lowered 60-minute pain versus ibuprofen alone; hydromorphone quadrupled adverse events; caveat: families chose trial, results pooled.
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RepurpSS-II trial · Leflunomide plus hydroxychloroquine in Sjögren's disease
ESSDAI fell about 4 points more than placebo, but one third of the active arm did not complete 24 weeks.
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SCOUT trial · Short antibiotic courses vs single-dose fosfomycin for UTI in women
Nitrofurantoin for 5 days beat single-dose fosfomycin at day 7 (74% vs 59%, NNT 7); open label, stopped at 69%.
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Tucidinostat + R-CHOP trial · Tucidinostat with R-CHOP in double-expressor DLBCL
2-year event-free survival 60.3% vs 50.5%; appraised from JAMA's 2-page research summary only.
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BREAKWATER trial · Encorafenib + cetuximab + mFOLFOX6 for first-line BRAF V600E colorectal cancer
Doubled median survival (30.3 vs 15.1 months) over chemotherapy; open-label, sponsor-analysed, interim OS look, more grade 3/4 toxicity.
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DeLLphi-304 trial · Tarlatamab vs chemotherapy in relapsed small-cell lung cancer
Tarlatamab improved overall survival over second-line chemotherapy (13.6 vs 8.3 months, HR 0.60); caveat: open label, interim stop, 11-month follow-up.
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EMERALD-1 trial · Durvalumab with or without bevacizumab plus TACE in unresectable HCC
Durvalumab plus bevacizumab with TACE extended PFS (HR 0.77), durvalumab alone did not; primary comparison switched mid-trial and survival data not yet shown.
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ERSPC (23 years) trial · European prostate cancer screening at 23 years
Inviting 456 men to PSA screening prevented 1 prostate cancer death, at the cost of 12 extra diagnoses per death averted.
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MajesTEC-3 trial · Teclistamab plus daratumumab vs DPd/DVd in relapsed myeloma
Tec-Dara cut progression or death by 83% (HR 0.17) and improved survival; caveat: open label, more fatal infections early (13 vs 4).
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NSABP B-51 trial · Omitting nodal irradiation after nodes clear with neoadjuvant chemotherapy
Nodal RT did not reduce invasive recurrence in ypN0 patients (HR 0.88, 0.60-1.28); early time-driven analysis with 109 of 172 planned events.
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PALM007 trial · Tecovirimat vs placebo for clade I mpox in the DRC
Tecovirimat did not speed lesion healing (7 vs 8 days, CI crossing 1) or viral clearance; caveat: subjective end point, hospitalised clade I patients only.
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SELECT-GCA trial · Upadacitinib with a 26-week steroid taper for giant-cell arteritis
Upadacitinib 15 mg raised 52-week sustained remission (46% vs 29%); drug and shorter taper were tested together, and 30% did not complete.
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SONIA trial · Oral steroids for community-acquired pneumonia in Kenya
30-day death 26.0% vs 22.6% (HR 0.84), about 1 death prevented per 30, but a crude comparison just crosses no effect.
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VERITAS trial · Navigational bronchoscopy vs CT-guided needle biopsy for 10-30 mm lung nodules
Bronchoscopy non-inferior for diagnostic accuracy (79.0% vs 73.6%) with far fewer pneumothoraces; unblinded, unequal post-randomisation exclusions, comparator underperformed.
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AALL1731 trial · Blinatumomab added to chemo in standard-risk childhood B-ALL
Two blinatumomab cycles raised 3-year DFS from 87.9% to 96.0%; open-label, stopped early at 42% of events, more sepsis in average-risk children.
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BALANCE trial · 7 vs 14 days of antibiotics for bloodstream infection
7 days was non-inferior to 14 days for 90-day death (14.5% vs 16.1%); open-label, S. aureus excluded, 7-day arm often ran longer.
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CABINET trial · Cabozantinib vs placebo in previously treated advanced NET
Cabozantinib lengthened PFS (8.4 vs 3.9 months epNET; 13.8 vs 4.4 pNET) with no survival gain yet; stopped early, heavy toxicity.