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241. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.
作者: Andreas Baumbach.;Niels van Royen.;Ignacio J Amat-Santos.;Martin Hudec.;Matjaz Bunc.;Alexander Ijsselmuiden.;Peep Laanmets.;Daniel Unic.;Bela Merkely.;Renicus S Hermanides.;Vlasis Ninios.;Marcin Protasiewicz.;Benno J W M Rensing.;Pedro L Martin.;Fausto Feres.;Manuel De Sousa Almeida.;Eric van Belle.;Axel Linke.;Alfonso Ielasi.;Matteo Montorfano.;Mark Webster.;Konstantinos Toutouzas.;Emmanuel Teiger.;Francesco Bedogni.;Michiel Voskuil.;Manuel Pan.;Oskar Angerås.;Won-Keun Kim.;Jürgen Rothe.;Ivica Kristić.;Vicente Peral.;Scot Garg.;Hesham Elzomor.;Akihiro Tobe.;Marie-Claude Morice.;Yoshinobu Onuma.;Osama Soliman.;Patrick W Serruys.; .
来源: Lancet. 2024年403卷10445期2695-2708页
Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA).
242. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials.
作者: Alexa B Kimball.;Gregor B E Jemec.;Christopher J Sayed.;Joslyn S Kirby.;Errol Prens.;John R Ingram.;Amit Garg.;Alice B Gottlieb.;Jacek C Szepietowski.;Falk G Bechara.;Evangelos J Giamarellos-Bourboulis.;Hideki Fujita.;Robert Rolleri.;Paulatsya Joshi.;Pratiksha Dokhe.;Edward Muller.;Luke Peterson.;Cynthia Madden.;Muhammad Bari.;Christos C Zouboulis.
来源: Lancet. 2024年403卷10443期2504-2519页
Patients with hidradenitis suppurativa have substantial unmet clinical needs and scarce therapeutic options. We aimed to assess the efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with moderate-to-severe hidradenitis suppurativa.
243. Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial.
作者: Suhaniya N S Samarasinghe.;Bianca Leca.;Shahd Alabdulkader.;Georgios K Dimitriadis.;Allan Davasgaium.;Puja Thadani.;Kate Parry.;Migena Luli.;Karen O'Donnell.;Brett Johnson.;Ali Abbara.;Florian Seyfried.;Rachel Morman.;Ahmed R Ahmed.;Sherif Hakky.;Christos Tsironis.;Sanjay Purkayastha.;Carel W le Roux.;Stephen Franks.;Vinod Menon.;Harpal Randeva.;Alexander D Miras.
来源: Lancet. 2024年403卷10443期2489-2503页
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea.
244. Post-trial monitoring of a randomised controlled trial of intensive glycaemic control in type 2 diabetes extended from 10 years to 24 years (UKPDS 91).
作者: Amanda I Adler.;Ruth L Coleman.;Jose Leal.;William N Whiteley.;Philip Clarke.;Rury R Holman.
来源: Lancet. 2024年404卷10448期145-155页
The 20-year UK Prospective Diabetes Study showed major clinical benefits for people with newly diagnosed type 2 diabetes randomly allocated to intensive glycaemic control with sulfonylurea or insulin therapy or metformin therapy, compared with conventional glycaemic control. 10-year post-trial follow-up identified enduring and emerging glycaemic and metformin legacy treatment effects. We aimed to determine whether these effects would wane by extending follow-up for another 14 years.
245. Tenecteplase versus standard of care for minor ischaemic stroke with proven occlusion (TEMPO-2): a randomised, open label, phase 3 superiority trial.
作者: Shelagh B Coutts.;Sandeep Ankolekar.;Ramana Appireddy.;Juan F Arenillas.;Zarina Assis.;Peter Bailey.;Philip A Barber.;Rodrigo Bazan.;Brian H Buck.;Ken S Butcher.;Marie-Christine Camden.;Bruce C V Campbell.;Leanne K Casaubon.;Luciana Catanese.;Kausik Chatterjee.;Philip M C Choi.;Brian Clarke.;Dar Dowlatshahi.;Julia Ferrari.;Thalia S Field.;Aravind Ganesh.;Darshan Ghia.;Mayank Goyal.;Stefan Greisenegger.;Omid Halse.;Mackenzie Horn.;Gary Hunter.;Oje Imoukhuede.;Peter J Kelly.;James Kennedy.;Carol Kenney.;Timothy J Kleinig.;Kailash Krishnan.;Fabricio Lima.;Jennifer L Mandzia.;Martha Marko.;Sheila O Martins.;George Medvedev.;Bijoy K Menon.;Sachin M Mishra.;Carlos Molina.;Aimen Moussaddy.;Keith W Muir.;Mark W Parsons.;Andrew M W Penn.;Arthur Pille.;Octávio M Pontes-Neto.;Christine Roffe.;Joaquin Serena.;Robert Simister.;Nishita Singh.;Neil Spratt.;Daniel Strbian.;Carol H Tham.;M Ivan Wiggam.;David J Williams.;Mark R Willmot.;Teddy Wu.;Amy Y X Yu.;George Zachariah.;Atif Zafar.;Charlotte Zerna.;Michael D Hill.; .
来源: Lancet. 2024年403卷10444期2597-2605页
Individuals with minor ischaemic stroke and intracranial occlusion are at increased risk of poor outcomes. Intravenous thrombolysis with tenecteplase might improve outcomes in this population. We aimed to test the superiority of intravenous tenecteplase over non-thrombolytic standard of care in patients with minor ischaemic stroke and intracranial occlusion or focal perfusion abnormality.
246. Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial.
作者: Chris C Parker.;Noel W Clarke.;Adrian D Cook.;Howard Kynaston.;Charles N Catton.;William R Cross.;Peter M Petersen.;Rajendra A Persad.;Fred Saad.;Lorna C Bower.;John Logue.;Heather Payne.;Silvia Forcat.;Cindy Goldstein.;Claire Murphy.;Juliette Anderson.;Maroie Barkati.;David M Bottomley.;Jennifer Branagan.;Ananya Choudhury.;Peter W M Chung.;Lyn Cogley.;Chee L Goh.;Peter Hoskin.;Vincent Khoo.;Shawn C Malone.;Lindsey Masters.;Stephen L Morris.;Abdenour Nabid.;Aldrich D Ong.;Rakesh Raman.;Kathryn L Tarver.;Alison C Tree.;Jane Worlding.;James P Wylie.;Anjali M Zarkar.;Wendy R Parulekar.;Mahesh K B Parmar.;Matthew R Sydes.; .
来源: Lancet. 2024年403卷10442期2405-2415页
Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear.
247. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.
作者: Chris C Parker.;Howard Kynaston.;Adrian D Cook.;Noel W Clarke.;Charles N Catton.;William R Cross.;Peter M Petersen.;Rajendra A Persad.;Cheryl A Pugh.;Fred Saad.;John Logue.;Heather Payne.;Lorna C Bower.;Chris Brawley.;Mary Rauchenberger.;Maroie Barkati.;David M Bottomley.;Klaus Brasso.;Hans T Chung.;Peter W M Chung.;Ruth Conroy.;Alison Falconer.;Vicky Ford.;Chee L Goh.;Catherine M Heath.;Nicholas D James.;Charmaine Kim-Sing.;Ravi Kodavatiganti.;Shawn C Malone.;Stephen L Morris.;Abdenour Nabid.;Aldrich D Ong.;Rakesh Raman.;Sree Rodda.;Paula Wells.;Jane Worlding.;Wendy R Parulekar.;Mahesh K B Parmar.;Matthew R Sydes.; .
来源: Lancet. 2024年403卷10442期2416-2425页
Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain.
248. Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial.
作者: Jürgen Beck.;Christian Fung.;Daniel Strbian.;Lukas Bütikofer.;Werner J Z'Graggen.;Matthias F Lang.;Seraina Beyeler.;Jan Gralla.;Florian Ringel.;Karl Schaller.;Nikolaus Plesnila.;Marcel Arnold.;Werner Hacke.;Peter Jüni.;Alexander David Mendelow.;Christian Stapf.;Rustam Al-Shahi Salman.;Jenny Bressan.;Stefanie Lerch.;Arsany Hakim.;Nicolas Martinez-Majander.;Anna Piippo-Karjalainen.;Peter Vajkoczy.;Stefan Wolf.;Gerrit A Schubert.;Anke Höllig.;Michael Veldeman.;Roland Roelz.;Andreas Gruber.;Philip Rauch.;Dorothee Mielke.;Veit Rohde.;Thomas Kerz.;Eberhard Uhl.;Enea Thanasi.;Hagen B Huttner.;Bernd Kallmünzer.;L Jaap Kappelle.;Wolfgang Deinsberger.;Christian Roth.;Robin Lemmens.;Jan Leppert.;Jose L Sanmillan.;Jonathan M Coutinho.;Katharina A M Hackenberg.;Gernot Reimann.;Mikael Mazighi.;Claudio L A Bassetti.;Heinrich P Mattle.;Andreas Raabe.;Urs Fischer.; .
来源: Lancet. 2024年403卷10442期2395-2404页
It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone.
249. Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.
作者: Victor Tumukunde.;Melissa M Medvedev.;Cally J Tann.;Ivan Mambule.;Catherine Pitt.;Charles Opondo.;Ayoub Kakande.;Ruth Canter.;Yiga Haroon.;Charity Kirabo-Nagemi.;Andrew Abaasa.;Wilson Okot.;Fredrick Katongole.;Raymond Ssenyonga.;Natalia Niombi.;Carol Nanyunja.;Diana Elbourne.;Giulia Greco.;Elizabeth Ekirapa-Kiracho.;Moffat Nyirenda.;Elizabeth Allen.;Peter Waiswa.;Joy E Lawn.; .
来源: Lancet. 2024年403卷10443期2520-2532页
Preterm birth is the leading cause of death in children younger than 5 years worldwide. WHO recommends kangaroo mother care (KMC); however, its effects on mortality in sub-Saharan Africa and its relative costs remain unclear. We aimed to compare the effectiveness, safety, costs, and cost-effectiveness of KMC initiated before clinical stabilisation versus standard care in neonates weighing up to 2000 g.
250. Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND): a multicentre, parallel, randomised controlled trial in the UK.
作者: Rebecca L Gould.;Christopher J McDermott.;Benjamin J Thompson.;Charlotte V Rawlinson.;Matt Bursnall.;Mike Bradburn.;Pavithra Kumar.;Emily J Turton.;David A White.;Marc A Serfaty.;Christopher D Graham.;Lance M McCracken.;Laura H Goldstein.;Ammar Al-Chalabi.;Richard W Orrell.;Tim Williams.;Rupert Noad.;Idris Baker.;Christina Faull.;Thomas Lambert.;Suresh K Chhetri.;John Ealing.;Anthony Hanratty.;Aleksandar Radunovic.;Nushan Gunawardana.;Gail Meadows.;George H Gorrie.;Tracey Young.;Vanessa Lawrence.;Cindy Cooper.;Pamela J Shaw.;Robert J Howard.; .
来源: Lancet. 2024年403卷10442期2381-2394页
Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Acceptance and Commitment Therapy (ACT) is a psychological therapy incorporating acceptance, mindfulness, and behaviour change techniques. We aimed to evaluate the effectiveness of ACT plus usual care, compared with usual care alone, for improving quality of life in people with motor neuron disease.
251. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network.
作者: Martin Dreyling.;Jeanette Doorduijn.;Eva Giné.;Mats Jerkeman.;Jan Walewski.;Martin Hutchings.;Ulrich Mey.;Jon Riise.;Marek Trneny.;Vibeke Vergote.;Ofer Shpilberg.;Maria Gomes da Silva.;Sirpa Leppä.;Linmiao Jiang.;Stephan Stilgenbauer.;Andrea Kerkhoff.;Ron D Jachimowicz.;Melania Celli.;Georg Hess.;Luca Arcaini.;Carlo Visco.;Tom van Meerten.;Stefan Wirths.;Pier Luigi Zinzani.;Urban Novak.;Peter Herhaus.;Fabio Benedetti.;Kristina Sonnevi.;Christine Hanoun.;Matthias Hänel.;Judith Dierlamm.;Christiane Pott.;Wolfram Klapper.;Döndü Gözel.;Christian Schmidt.;Michael Unterhalt.;Marco Ladetto.;Eva Hoster.
来源: Lancet. 2024年403卷10441期2293-2306页
Adding ibrutinib to standard immunochemotherapy might improve outcomes and challenge autologous stem-cell transplantation (ASCT) in younger (aged 65 years or younger) mantle cell lymphoma patients. This trial aimed to investigate whether the addition of ibrutinib results in a superior clinical outcome compared with the pre-trial immunochemotherapy standard with ASCT or an ibrutinib-containing treatment without ASCT. We also investigated whether standard treatment with ASCT is superior to a treatment adding ibrutinib but without ASCT.
252. Extended optical treatment versus early patching with an intensive patching regimen in children with amblyopia in Europe (EuPatch): a multicentre, randomised controlled trial.
作者: Frank A Proudlock.;Michael Hisaund.;Gail Maconachie.;Eleni Papageorgiou.;Ali Manouchehrinia.;Annegret Dahlmann-Noor.;Payal Khandelwal.;Jay Self.;Christina Beisse.;Irene Gottlob.; .
来源: Lancet. 2024年403卷10438期1766-1778页
Amblyopia, the most common visual impairment of childhood, is a public health concern. An extended period of optical treatment before patching is recommended by the clinical guidelines of several countries. The aim of this study was to compare an intensive patching regimen, with and without extended optical treatment (EOT), in a randomised controlled trial.
253. A measles and rubella vaccine microneedle patch in The Gambia: a phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial.
作者: Ikechukwu Adigweme.;Mohammed Yisa.;Michael Ooko.;Edem Akpalu.;Andrew Bruce.;Simon Donkor.;Lamin B Jarju.;Baba Danso.;Anthony Mendy.;David Jeffries.;Anne Segonds-Pichon.;Abdoulie Njie.;Stephen Crooke.;Elina El-Badry.;Hilary Johnstone.;Michael Royals.;James L Goodson.;Mark R Prausnitz.;Devin V McAllister.;Paul A Rota.;Sebastien Henry.;Ed Clarke.
来源: Lancet. 2024年403卷10439期1879-1892页
Microneedle patches (MNPs) have been ranked as the highest global priority innovation for overcoming immunisation barriers in low-income and middle-income countries. This trial aimed to provide the first data on the tolerability, safety, and immunogenicity of a measles and rubella vaccine (MRV)-MNP in children.
254. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial.
作者: Seung-Jung Park.;Jung-Min Ahn.;Do-Yoon Kang.;Sung-Cheol Yun.;Young-Keun Ahn.;Won-Jang Kim.;Chang-Wook Nam.;Jin-Ok Jeong.;In-Ho Chae.;Hiroki Shiomi.;Hsien-Li Kao.;Joo-Yong Hahn.;Sung-Ho Her.;Bong-Ki Lee.;Tae Hoon Ahn.;Ki-Yuk Chang.;Jei Keon Chae.;David Smyth.;Gary S Mintz.;Gregg W Stone.;Duk-Woo Park.; .
来源: Lancet. 2024年403卷10438期1753-1765页
Acute coronary syndrome and sudden cardiac death are often caused by rupture and thrombosis of lipid-rich atherosclerotic coronary plaques (known as vulnerable plaques), many of which are non-flow-limiting. The safety and effectiveness of focal preventive therapy with percutaneous coronary intervention of vulnerable plaques in reducing adverse cardiac events are unknown. We aimed to assess whether preventive percutaneous coronary intervention of non-flow-limiting vulnerable plaques improves clinical outcomes compared with optimal medical therapy alone.
255. Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial.
作者: Xiaobo Li.;Zhen Ge.;Jing Kan.;Muhammed Anjum.;Ping Xie.;Xiang Chen.;Hamid Sharif Khan.;Xiaomei Guo.;Tahir Saghir.;Jing Chen.;Badar Ul Ahad Gill.;Ning Guo.;Imad Sheiban.;Afsar Raza.;Yongyue Wei.;Feng Chen.;Gary S Mintz.;Jun-Jie Zhang.;Gregg W Stone.;Shao-Liang Chen.; .
来源: Lancet. 2024年403卷10439期1855-1865页
Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome.
256. Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial.
作者: Michael J Foley.;Christopher A Rajkumar.;Fiyyaz Ahmed-Jushuf.;Florentina A Simader.;Shayna Chotai.;Rachel H Pathimagaraj.;Muhammad Mohsin.;Ahmed Salih.;Danqi Wang.;Prithvi Dixit.;John R Davies.;Tom R Keeble.;Claudia Cosgrove.;James C Spratt.;Peter D O'Kane.;Ranil De Silva.;Jonathan M Hill.;Sukhjinder S Nijjer.;Sayan Sen.;Ricardo Petraco.;Ghada W Mikhail.;Ramzi Khamis.;Tushar Kotecha.;Frank E Harrell.;Peter Kellman.;Darrel P Francis.;James P Howard.;Graham D Cole.;Matthew J Shun-Shin.;Rasha K Al-Lamee.
来源: Lancet. 2024年403卷10436期1543-1553页
The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement.
257. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.
作者: Javed Butler.;Sanjiv J Shah.;Mark C Petrie.;Barry A Borlaug.;Steen Z Abildstrøm.;Melanie J Davies.;G Kees Hovingh.;Dalane W Kitzman.;Daniél Vega Møller.;Subodh Verma.;Mette Nygaard Einfeldt.;Marie L Lindegaard.;Søren Rasmussen.;Walter Abhayaratna.;Fozia Z Ahmed.;Tuvia Ben-Gal.;Vijay Chopra.;Justin A Ezekowitz.;Michael Fu.;Hiroshi Ito.;Małgorzata Lelonek.;Vojtěch Melenovský.;Bela Merkely.;Julio Núñez.;Eduardo Perna.;Morten Schou.;Michele Senni.;Kavita Sharma.;Peter van der Meer.;Dirk Von Lewinski.;Dennis Wolf.;Mikhail N Kosiborod.; .
来源: Lancet. 2024年403卷10437期1635-1648页
In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups.
258. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.
作者: Zhen Ge.;Jing Kan.;Xiaofei Gao.;Afsar Raza.;Jun-Jie Zhang.;Bilal S Mohydin.;Fentang Gao.;Yibing Shao.;Yan Wang.;Hesong Zeng.;Feng Li.;Hamid Sharif Khan.;Naeem Mengal.;Hongliang Cong.;Mingliang Wang.;Lianglong Chen.;Yongyue Wei.;Feng Chen.;Gregg W Stone.;Shao-Liang Chen.; .
来源: Lancet. 2024年403卷10439期1866-1878页
Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE).
259. Feasibility, safety, and impact of the RTS,S/AS01E malaria vaccine when implemented through national immunisation programmes: evaluation of cluster-randomised introduction of the vaccine in Ghana, Kenya, and Malawi.
作者: Kwaku Poku Asante.;Don P Mathanga.;Paul Milligan.;Samuel Akech.;Abraham Oduro.;Victor Mwapasa.;Kerryn A Moore.;Titus K Kwambai.;Mary J Hamel.;Thomas Gyan.;Nelli Westercamp.;Atupele Kapito-Tembo.;Patricia Njuguna.;Daniel Ansong.;Simon Kariuki.;Tisungane Mvalo.;Paul Snell.;David Schellenberg.;Paul Welega.;Lucas Otieno.;Alfred Chimala.;Edwin A Afari.;Philip Bejon.;Kenneth Maleta.;Tsiri Agbenyega.;Robert W Snow.;Madaliso Zulu.;Jobiba Chinkhumba.;Aaron M Samuels.; .
来源: Lancet. 2024年403卷10437期1660-1670页
The RTS,S/AS01E malaria vaccine (RTS,S) was introduced by national immunisation programmes in Ghana, Kenya, and Malawi in 2019 in large-scale pilot schemes. We aimed to address questions about feasibility and impact, and to assess safety signals that had been observed in the phase 3 trial that included an excess of meningitis and cerebral malaria cases in RTS,S recipients, and the possibility of an excess of deaths among girls who received RTS,S than in controls, to inform decisions about wider use.
260. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial.
作者: José Manuel Pérez-García.;Javier Cortés.;Manuel Ruiz-Borrego.;Marco Colleoni.;Agostina Stradella.;Begoña Bermejo.;Florence Dalenc.;Santiago Escrivá-de-Romaní.;Lourdes Calvo Martínez.;Nuria Ribelles.;Frederik Marmé.;Alfonso Cortés.;Cinta Albacar.;Geraldine Gebhart.;Aleix Prat.;Khaldoun Kerrou.;Peter Schmid.;Sofia Braga.;Serena Di Cosimo.;Maria Gion.;Gabriele Antonarelli.;Crina Popa.;Emilia Szostak.;Daniel Alcalá-López.;Petra Gener.;Jose Rodríguez-Morató.;Leonardo Mina.;Miguel Sampayo-Cordero.;Antonio Llombart-Cussac.; .
来源: Lancet. 2024年403卷10437期1649-1659页
PHERGain was designed to assess the feasibility, safety, and efficacy of a chemotherapy-free treatment based on a dual human epidermal growth factor receptor 2 (HER2) blockade with trastuzumab and pertuzumab in patients with HER2-positive early breast cancer (EBC). It used an 18fluorine-fluorodeoxyglucose-PET-based, pathological complete response (pCR)-adapted strategy.
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