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61. Effect of evolocumab on saphenous vein graft patency after coronary artery bypass surgery (NEWTON-CABG CardioLink-5): an international, randomised, double-blind, placebo-controlled trial.
作者: Subodh Verma.;Lawrence A Leiter.;Hwee Teoh.;G B John Mancini.;Adrian Quan.;Randi Elituv.;Meena Verma.;Elizabeth Misner.;Michael Szarek.;Kevin E Thorpe.;Tarit Saha.;Richard P Whitlock.;Bobby Yanagawa.;Béla Merkely.;Peter Jüni.;Michael J Koren.;Stephen J Nicholls.;Deepak L Bhatt.;C David Mazer.
来源: Lancet. 2025年406卷10509期1223-1234页
Saphenous vein graft (SVG) failure remains a substantial challenge after coronary artery bypass graft (CABG). LDL cholesterol (LDL-C) is a causal risk factor for atherosclerosis, but its role in SVG failure is not well established. We evaluated whether early initiation of intensive LDL-C lowering with evolocumab could reduce SVG failure.
62. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial.
作者: Mårten Falkenberg.;Stefan James.;Manne Andersson.;Mattias Andersson.;Martin Delle.;Jan Engström.;Torbjörn Fransson.;Peter Gillgren.;Anna Hilbertson.;Tal M Hörer.;Eva Jacobsson.;Björn Kragsterman.;Johan Lindbäck.;Hans Lindgren.;Karin Ludwigs.;Stefan Mellander.;Olle Nelzén.;Robert Olin.;Birgitta Sigvant.;Per Skoog.;Joachim Starck.;Gustaf Tegler.;Knut Thorbjørnsen.;Maria Truedson.;Carl-Magnus Wahlgren.;Jonas Wallinder.;Andreas Öjersjö.;Joakim Nordanstig.; .
来源: Lancet. 2025年406卷10508期1103-1114页
Drug-coated devices are frequently used in coronary and peripheral interventions, but their effect on amputation risk in peripheral artery disease is unclear. We assessed whether drug-coated devices affect the rate of above-ankle amputation in patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation.
63. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial.
作者: Joakim Nordanstig.;Stefan James.;Manne Andersson.;Mattias Andersson.;Martin Delle.;Jan Engström.;Torbjörn Fransson.;Peter Gillgren.;Anna Hilbertson.;Tal M Hörer.;Eva Jacobsson.;Björn Kragsterman.;Johan Lindbäck.;Hans Lindgren.;Karin Ludwigs.;Stefan Mellander.;Olle Nelzén.;Robert Olin.;Birgitta Sigvant.;Per Skoog.;Joachim Starck.;Gustaf Tegler.;Knut Thorbjørnsen.;Maria Truedson.;Carl-Magnus Wahlgren.;Jonas Wallinder.;Andreas Öjersjö.;Mårten Falkenberg.; .
来源: Lancet. 2025年406卷10508期1115-1127页
Drug-coated devices are widely used to reduce restenosis after lower limb revascularisation in patients with peripheral artery disease, but their effect on patient-centred outcomes remains unclear. We assessed the effect of paclitaxel-coated devices on clinically important outcomes in patients with intermittent claudication undergoing infrainguinal endovascular revascularisation.
64. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial.
作者: Min Chul Kim.;Joon Ho Ahn.;Dae Young Hyun.;Yongwhan Lim.;Kyung Hoon Cho.;Seung Hun Lee.;Seongho Park.;Seok Oh.;Doo Sun Sim.;Young Joon Hong.;Ju Han Kim.;Myung Ho Jeong.;Jang Hyun Cho.;Sang-Rok Lee.;Dong Oh Kang.;Jin-Yong Hwang.;Young Jin Youn.;Jung-Hee Lee.;Young-Hoon Jeong.;Jong-Hwa Ahn.;Dong-Bin Kim.;Eun Ho Choo.;Chan Joon Kim.;Weon Kim.;Jay Young Rhew.;Jong-Il Park.;Sang-Yong Yoo.;Youngkeun Ahn.; .
来源: Lancet. 2025年406卷10507期1032-1043页
The optimal timing of complete revascularisation for patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear. We aimed to assess whether immediate complete revascularisation was non-inferior to staged complete revascularisation during the index admission.
65. Vericiguat in patients with chronic heart failure and reduced ejection fraction (VICTOR): a double-blind, placebo-controlled, randomised, phase 3 trial.
作者: Javed Butler.;Ciaran J McMullan.;Kevin J Anstrom.;Irina Barash.;Marc P Bonaca.;Maria Borentain.;Stefano Corda.;Justin A Ezekowitz.;G Michael Felker.;Davis Gates.;Carolyn S P Lam.;Eldrin F Lewis.;JoAnn Lindenfeld.;Robert J Mentz.;Christopher M O'Connor.;Piotr Ponikowski.;Yogesh N V Reddy.;Giuseppe M C Rosano.;Clara Saldarriaga.;Michele Senni.;Lilin She.;Pedro Pinto Teixeira.;James Udelson.;Alessia Urbinati.;Vanja Vlajnic.;Adriaan A Voors.;Aiwen Xing.;Mahesh J Patel.;Faiez Zannad.; .
来源: Lancet. 2025年406卷10510期1341-1350页
Vericiguat is indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with heart failure and reduced ejection fraction (HFrEF) following a recent worsening event. The aim of the VICTOR trial was to assess the effect of vericiguat in patients with HFrEF without recent heart failure worsening.
66. Vericiguat for patients with heart failure and reduced ejection fraction across the risk spectrum: an individual participant data analysis of the VICTORIA and VICTOR trials.
作者: Faiez Zannad.;Christopher M O'Connor.;Javed Butler.;Ciaran J McMullan.;Kevin J Anstrom.;Irina Barash.;Marc P Bonaca.;Maria Borentain.;Stefano Corda.;Davis Gates.;Justin A Ezekowitz.;Adrian F Hernandez.;Carolyn S P Lam.;Eldrin F Lewis.;JoAnn Lindenfeld.;Robert J Mentz.;Piotr Ponikowski.;Yogesh N V Reddy.;Giuseppe M C Rosano.;Clara Saldarriaga.;Michele Senni.;Pedro P Teixeira.;James Udelson.;Alessia Urbinati.;Vanja Vlajnic.;Adriaan A Voors.;Aiwen Xing.;Mahesh J Patel.;Paul W Armstrong.; .
来源: Lancet. 2025年406卷10510期1351-1362页
Following completion of the VICTORIA trial, vericiguat was approved for the treatment of worsening heart failure with reduced ejection fraction (HFrEF) and received a class IIb recommendation in European and North American guidelines. The subsequent VICTOR trial evaluated the use of vericiguat in patients with HFrEF and no recent worsening. We aimed to assess the effect of vericiguat on clinical endpoints through pooled analyses of patient-level data from the VICTORIA and VICTOR trials.
67. Influenza vaccination to improve outcomes for patients with acute heart failure (PANDA II): a multiregional, seasonal, hospital-based, cluster-randomised, controlled trial in China.
作者: Craig S Anderson.;Chang Hua.;Zhiyan Wang.;Chi Wang.;Chao Jiang.;Rong Liu.;Rong Han.;Qiang Li.;Sana Shan.;Laurent Billot.;C Raina Macintyre.;Anushka Patel.;Hongjia Zhang.;Changsheng Ma.;Jianzeng Dong.;Xin Du.
来源: Lancet. 2025年406卷10507期1020-1031页
Influenza vaccination is widely recommended to prevent death and serious illness in vulnerable people, including those with heart failure. However, the randomised evidence to support this practice is limited and few people are vaccinated in many parts of the world. We aimed to determine whether influenza vaccination can improve the outcome of patients after an episode of acute heart failure requiring admission to hospital in China.
68. The clinical effectiveness of clarithromycin versus endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps (MACRO): a pragmatic, multicentre, three-arm, randomised, placebo-controlled phase 4 trial.
作者: Carl Philpott.;David J Beard.;Elnaz Saeedi.;Jonathan A Cook.;Stephen Jones.;Caroline S Clarke.;Lucinda Teoh.;Mike Thomas.;Paul Little.;Jane Vennik.;Valerie Lund.;Anne G M Schilder.;Fei Long.;Stephen Durham.;James Boardman.;Claire Hopkins.; .; .
来源: Lancet. 2025年406卷10506期926-939页
A paucity of evidence regarding use of endoscopic sinus surgery and antibiotics in managing chronic rhinosinusitis has contributed to a five-times variation in endoscopic sinus surgery rates, as well as variation in the use of antibiotics. The main aim of the present trial was to compare the clinical effectiveness of endoscopic sinus surgery or 3 months of clarithromycin treatment alongside intranasal medication in adults with chronic rhinosinusitis with or without nasal polyps.
69. Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up.
作者: Maud Robert.;Tigran Poghosyan.;Nicolas Romain-Scelle.;Sebastien Czernichow.;Dominique Delaunay.;Adrien Sterkers.;Litavan Khamphommala.;Andrea Lazzati.;Claire Blanchard.;Robert Caiazzo.;François Pattou.;Emmanuel Disse.; .
来源: Lancet. 2025年406卷10505期846-859页
Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.
70. Building community capacity in mental health care with the Strong Minds-Strong Communities programme: a randomised controlled trial in the USA.
作者: Margarita Alegría.;Gabriela Livas Stein.;Mario Cruz-Gonzalez.;Irene Falgas-Bague.;Sheri Lapatin Markle.;Kari M Eddington.;Andrew Supple.;Larimar Fuentes.;Claire Poindexter.;Patrick E Shrout.
来源: Lancet. 2025年406卷10505期832-845页
Provider shortages and lack of culturally responsive care limit mental health services in reaching multicultural populations worldwide. We examined the effectiveness of a psychoeducational intervention aimed at building community capacity to address depression and anxiety among racial, ethnic, and linguistic minoritised adults.
71. Antisense oligonucleotide DGAT-2 inhibitor, ION224, for metabolic dysfunction-associated steatohepatitis (ION224-CS2): results of a 51-week, multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
作者: Rohit Loomba.;Erin Morgan.;Keyvan Yousefi.;Dan Li.;Richard Geary.;Sanjay Bhanot.;Naim Alkhouri.; .
来源: Lancet. 2025年406卷10505期821-831页
ION224, a liver-directed antisense inhibitor of diacylglycerol O-acyltransferase 2 (DGAT2), suppresses de novo lipogenesis, an important metabolic pathway associated with lipotoxicity and the underlying inflammation, hepatocellular injury, and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH). This study aimed to prospectively assess the safety and efficacy of ION224 in patients with MASH and fibrosis.
72. Safety and efficacy of once-weekly efruxifermin versus placebo in metabolic dysfunction-associated steatohepatitis (HARMONY): 96-week results from a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial.
作者: Mazen Noureddin.;Juan P Frias.;Guy W Neff.;K Jean Lucas.;Cynthia Behling.;Pierre Bedossa.;Julie Dubourg.;Doreen Chan.;Mark Burch.;Erica Fong.;Brittany de Temple.;Matt Minerva.;Kim Barrett.;Reshma Shringarpure.;Erik J Tillman.;Timothy Rolph.;Andrew Cheng.;Kitty Yale.
来源: Lancet. 2025年406卷10504期719-730页
Efruxifermin is a bivalent fibroblast growth factor 21 analogue in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This trial aimed to prospectively assess the safety and efficacy of efruxifermin administration for 96 weeks in individuals with MASH and moderate (stage 2; F2) or severe (stage 3; F3) fibrosis.
73. Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, double-blind, randomised, placebo-controlled trial and updated meta-analysis.
作者: Patrick Rossignol.;Faiez Zannad.;Ziad Massy.;Michel Azizi.;Fatima Chorfa.;Julien Coadic.;João Pedro Ferreira.;Francisca Saraiva.;Dominique Mottier.;Francis Guillemin.;Willy Ngueyon Sime.;Sanae Bouali.;Bénédicte Rossignol.;Joëlle Nortier.;Isabelle Simon.;Christophe Robino.;Manuela Davin.;Pierre M Bataille.;François Chantrel.;Nelly Castin.;Vincent Esnault.;Isabelle Kazes.;Thierry Hannedouche.;Nassim Kamar.;Jean-Michel Achard.;Caroline Fenerol.;Carine Achard-Hottelart.;Yves Dimitrov.;Nicolas Girerd.;Delphine Maucort-Boulch.;Luc Frimat.; .
来源: Lancet. 2025年406卷10504期705-718页
No pharmacological therapy has been shown with certainty to improve the cardiovascular prognosis in patients with kidney failure on chronic haemodialysis. We aimed to investigate the effects of the steroidal mineralocorticoid receptor antagonist spironolactone on cardiovascular outcomes in patients on haemodialysis who are at high risk of cardiovascular events.
74. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial.
作者: Michael Walsh.;David Collister.;Martin Gallagher.;Patrick B Mark.;Janak R de Zoysa.;Jessica Tyrwhitt.;Karthik Tennankore.;Gilmar Reis.;Denis Xavier.;Wen J Liu.;Li Zuo.;Amanda Y Wang.;Camilo Félix.;Laura Sola.;Mustafa Arici.;Russell Villanueva.;Vivekanand Jha.;Dalton Précoma.;Christian G Rabbat.;Sheik Sulthan Alavudeen.;Atiya R Faruqui.;Mavel López-Flecher.;Lonnie Pyne.;Ron Wald.;Fei Yuan.;Kumar Balasubramanian.;Shun Fu Lee.;Alena Kuptsova.;Courtney Christou.;P J Devereaux.; .
来源: Lancet. 2025年406卷10504期695-704页
Patients undergoing maintenance dialysis for kidney failure are at substantial risk of cardiovascular morbidity and mortality. We aimed to establish if spironolactone reduces heart failure and cardiovascular deaths in these patients.
75. Post-exposure prophylaxis regimen of rabies monoclonal antibody and vaccine in category 3 potential exposure patients: a phase 4, open-label, randomised, active-controlled trial.
作者: Prasad S Kulkarni.;Anirudha Vyankatesh Potey.;Dhananjay Kapse.;Chetanraj Bhamare.;Avinash Gawande.;Renuka Munshi.;Sudhir Pawar.;Nithya J Gogtay.;Anurag Agarwal.;Muralidhar Tambe.;Sushama Thakre.;Clarence J Samuel.;Shahzada Mohmed Salim Khan.;Ravish H S.;Devang Rana.;Neha Singh.;Veena Kamath.;Hira Lal Bhalla.;Cyrus S Poonawalla.;Reeta S Mani.;Bhagwat Gunale.; .
来源: Lancet. 2025年406卷10503期627-635页
Rabies is almost invariably fatal. A rabies monoclonal antibody (RmAb) was approved in India in 2016 for passive prophylaxis. This post-marketing study aimed to evaluate the long-term safety, immunogenicity, and efficacy of a post-exposure prophylaxis (PEP) regimen containing RmAb.
76. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial.
作者: Fabrice Barlesi.;Wenxiu Yao.;Michaël Duruisseaux.;Ludovic Doucet.;Aitor Azkárate Martínez.;Vanesa Gregorc.;Oscar Juan-Vidal.;Shun Lu.;Charlotte De Bondt.;Filippo de Marinis.;Helena Linardou.;Young-Chul Kim.;Robert Jotte.;Enriqueta Felip.;Giuseppe Lo Russo.;Martin Reck.;Mary F Michenzie.;Wenjing Yang.;Julie N Meade.;Beata Korytowsky.;Tony S K Mok.; .
来源: Lancet. 2025年406卷10503期615-626页
Adagrasib is a KRASG12C inhibitor that demonstrated promising activity against KRASG12C-mutated advanced non-small-cell lung cancer (NSCLC) in a phase 2 trial. Here we aimed to compare the efficacy and safety of adagrasib versus docetaxel in patients with KRASG12C-mutated advanced NSCLC previously treated with chemotherapy and immunotherapy.
77. Adjuvant chemotherapy and hormonotherapy versus adjuvant hormonotherapy alone for women aged 70 years and older with high-risk breast cancer based on the genomic grade index (ASTER 70s): a randomised phase 3 trial.
作者: Etienne Brain.;Olivier Mir.;Emmanuelle Bourbouloux.;Olivier Rigal.;Jean-Marc Ferrero.;Sylvie Kirscher.;Djelila Allouache.;Véronique D'Hondt.;Aude-Marie Savoye.;Xavier Durando.;Francois P Duhoux.;Laurence Venat-Bouvet.;Emmanuel Blot.;Jean-Luc Canon.;Florence Rollot-Trad.;Hervé Bonnefoi.;Telma Roque.;Jérôme Lemonnier.;Aurélien Latouche.;Julie Henriques.;Magali Lacroix-Triki.;Dewi Vernerey.; .
来源: Lancet. 2025年406卷10502期489-500页
For women aged 70 years or older with oestrogen receptor-positive HER2-negative invasive breast cancer, hormonotherapy is a standard adjuvant treatment, while the role of chemotherapy is debated. We aimed to assess the effect of adjuvant chemotherapy on overall survival in these older patients with high-risk tumours according to a prognostic genomic signature.
78. Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi.
作者: Sitara Swarna Rao Ajjampur.;Kumudha Aruldas.;Kristjana H Ásbjörnsdóttir.;Euripide Avokpaho.;Robin Bailey.;Gilles Cottrell.;Sean R Galagan.;Katherine E Halliday.;Parfait Houngbégnon.;Moudachirou Ibikounlé.;Gideon John Israel.;Saravanakumar Puthupalayam Kaliappan.;Khumbo Kalua.;Hugo Legge.;D Timothy J Littlewood.;Adrian J F Luty.;Malathi Manuel.;Achille Massougbodji.;Arianna Rubin Means.;William E Oswald.;Nils Pilotte.;Rachel Pullan.;Rohan Michael Ramesh.;Lyson Samikwa.;James Simwanza.;Katherine K Thomas.;Steven A Williams.;Stefan Witek-McManus.;Judd L Walson.; .
来源: Lancet. 2025年406卷10502期475-488页
Soil-transmitted helminths are targeted for elimination as a public health problem. This study assessed whether, with high coverage, community-wide mass drug administration (MDA) could lead to transmission interruption.
79. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.
作者: Remo Panaccione.;Brian G Feagan.;Anita Afzali.;David T Rubin.;Walter Reinisch.;Julián Panés.;Silvio Danese.;Tadakazu Hisamatsu.;Natalie A Terry.;Leonardo Salese.;Rian Van Rampelbergh.;Aparna Sahoo.;Marion L Vetter.;Jacqueline Yee.;Chenglong Han.;Mary Ellen Frustaci.;Kitty Y Y Wan.;Zijiang Yang.;Jewel Johanns.;Jane M Andrews.;Geert R D'Haens.;Bruce E Sands.; .
来源: Lancet. 2025年406卷10501期358-375页
Despite the availability of biological therapies, suboptimal disease control remains a problem for patients with Crohn's disease. We report the results of the GALAXI-2 and GALAXI-3 studies, which aimed to assess the efficacy and safety of intravenous induction followed by subcutaneous maintenance therapy with guselkumab over 48 weeks in adults with moderately to severely active Crohn's disease.
80. Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial.
作者: Neeraj Agarwal.;Arun A Azad.;Joan Carles.;André P Fay.;Nobuaki Matsubara.;Cezary Szczylik.;Ugo De Giorgi.;Jae Young Joung.;Peter C C Fong.;Eric Voog.;Robert J Jones.;Neal D Shore.;Fred Saad.;Curtis Dunshee.;Stefanie Zschäbitz.;Jan Oldenburg.;Xun Lin.;Cynthia G Healy.;Matko Kalac.;Dana Kennedy.;Karim Fizazi.
来源: Lancet. 2025年406卷10502期447-460页
The primary analysis of this phase 3 trial combining talazoparib with enzalutamide demonstrated significantly improved radiographic progression-free survival (rPFS) versus enzalutamide plus placebo in patients with metastatic castration-resistant prostate cancer unselected for homologous recombination repair (HRR) gene alterations. Overall survival data were immature at that time. Here we report the final prespecified overall survival analysis, an updated descriptive analysis of rPFS, and safety in the cohort unselected for HRR gene alterations.
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