New England Journal of Medicine最新文献

{"title":"Working at Cross-PURPOSEs to Ending HIV.","authors":"Glenda E Gray, W D Francois Venter","doi":"10.1056/NEJMe2414709","DOIUrl":"https://doi.org/10.1056/NEJMe2414709","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 13","pages":"1344-1345"},"PeriodicalIF":96.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Letter of Recommendation Regarding Impersonal Personal Statements.","authors":"Matthew J Farrell, Trudy C Wu, Ann C Raldow","doi":"10.1056/NEJMp2414494","DOIUrl":"10.1056/NEJMp2414494","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1257-1259"},"PeriodicalIF":96.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ménétrier's Disease.","authors":"Xing Wang, Haifeng Liu","doi":"10.1056/NEJMicm2415138","DOIUrl":"10.1056/NEJMicm2415138","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1334"},"PeriodicalIF":96.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Left Atrial Appendage Closure after Ablation for Atrial Fibrillation.","authors":"Oussama M Wazni, Walid I Saliba, Devi G Nair, Eloi Marijon, Boris Schmidt, Troy Hounshell, Henning Ebelt, Carsten Skurk, Saumil Oza, Chinmay Patel, Arvindh Kanagasundram, Ashish Sadhu, Sri Sundaram, Jose Osorio, George Mark, Madhukar Gupta, David B DeLurgio, Jeffrey Olson, Jens Erik Nielsen-Kudsk, Lucas V A Boersma, Jeff S Healey, Karen P Phillips, Federico M Asch, Katherine Wolski, Kristine Roy, Thomas Christen, Brad S Sutton, Kenneth M Stein, Vivek Y Reddy","doi":"10.1056/NEJMoa2408308","DOIUrl":"10.1056/NEJMoa2408308","url":null,"abstract":"<p><strong>Background: </strong>Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking.</p><p><strong>Methods: </strong>We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated score (≥2 in men and ≥3 in women) on the CHA₂DS₂-VASc scale (range, 0 to 9, with higher scores indicating a greater risk of stroke) and who underwent catheter ablation. Patients were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive oral anticoagulation. The primary safety end point, tested for superiority, was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months. The secondary end point, tested for noninferiority, was major bleeding, including procedure-related bleeding, through 36 months.</p><p><strong>Results: </strong>A total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA₂DS₂-VASc score was 3.5±1.3. At 36 months, a primary safety end-point event had occurred in 65 patients (8.5%) in the left atrial appendage closure group (device group) and in 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority); a primary efficacy end-point event had occurred in 41 patients (5.3%) and 44 patients (5.8%), respectively (P<0.001 for noninferiority); and a secondary end-point event had occurred in 3.9% and 5.0% (P<0.001 for noninferiority). Complications related to the appendage closure device or procedure occurred in 23 patients.</p><p><strong>Conclusions: </strong>Among patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1277-1287"},"PeriodicalIF":96.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cervical Cancer. Reply.","authors":"Krishnansu S Tewari","doi":"10.1056/NEJMc2501310","DOIUrl":"https://doi.org/10.1056/NEJMc2501310","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 13","pages":"1351"},"PeriodicalIF":96.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modest Blood Pressure Increase with Age in Adults with Down's Syndrome.","authors":"Andrea Kelly, Meghan Shirley Bezerra, Kate Fitzpatrick, Kat Adams, Ahtish Arputhan, Rachel Walega, Patricia Y Chu, John Cockcroft, Raymond R Townsend","doi":"10.1056/NEJMc2412190","DOIUrl":"https://doi.org/10.1056/NEJMc2412190","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 13","pages":"1346-1348"},"PeriodicalIF":96.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis.","authors":"Daniel Blockmans, Sara K Penn, Arathi R Setty, Wolfgang A Schmidt, Andrea Rubbert-Roth, Ellen M Hauge, Helen I Keen, Tomonori Ishii, Nader Khalidi, Christian Dejaco, Maria C Cid, Bernhard Hellmich, Meng Liu, Weihan Zhao, Ivan Lagunes, Ana B Romero, Peter K Wung, Peter A Merkel","doi":"10.1056/NEJMoa2413449","DOIUrl":"https://doi.org/10.1056/NEJMoa2413449","url":null,"abstract":"<p><strong>Background: </strong>Giant-cell arteritis is a systemic vasculitis with limited treatment options. The efficacy and safety of upadacitinib - a selective Janus kinase (JAK) inhibitor that blocks the signaling of several cytokines, including interleukin-6 and interferon-γ - are unknown in patients with giant-cell arteritis.</p><p><strong>Methods: </strong>We randomly assigned patients with new-onset or relapsing giant-cell arteritis, in a 2:1:1 ratio, to receive upadacitinib at a dose of 15 mg or 7.5 mg orally once daily plus a 26-week glucocorticoid taper or placebo plus a 52-week glucocorticoid taper. The primary end point was sustained remission at week 52, defined by the absence of signs or symptoms of giant-cell arteritis from week 12 through week 52 and adherence to the protocol-specified glucocorticoid taper.</p><p><strong>Results: </strong>A total of 209 patients received upadacitinib at a dose of 15 mg, 107 received upadacitinib at a dose of 7.5 mg, and 112 received placebo; 70% of the patients had new-onset giant-cell arteritis. Upadacitinib at a dose of 15 mg showed superiority over placebo with respect to the primary end point (46.4% [95% confidence interval {CI}, 39.6 to 53.2] vs. 29.0% [95% CI, 20.6 to 37.5]; P = 0.002). Upadacitinib at a dose of 15 mg was superior to placebo in the analysis of the hierarchically prespecified and multiplicity-controlled key secondary end points of sustained complete remission, time to a disease flare, cumulative glucocorticoid exposure, and patient-reported outcomes. Upadacitinib at a dose of 7.5 mg was not superior to placebo with respect to the primary end point (41.1% [95% CI, 31.8 to 50.4]). Safety outcomes during the treatment period of 52 weeks were similar in the upadacitinib and placebo groups. Although cardiovascular risk is a potential concern with a JAK inhibitor, no major adverse cardiovascular events occurred in the upadacitinib groups.</p><p><strong>Conclusions: </strong>In patients with giant-cell arteritis, upadacitinib at a dose of 15 mg - but not 7.5 mg - with a 26-week glucocorticoid taper showed efficacy superior to that of placebo with a 52-week glucocorticoid taper. (Funded by AbbVie; SELECT-GCA ClinicalTrials.gov number, NCT03725202.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death.","authors":"Marc Humbert, Vallerie V McLaughlin, David B Badesch, H Ardeschir Ghofrani, J Simon R Gibbs, Mardi Gomberg-Maitland, Ioana R Preston, Rogerio Souza, Aaron B Waxman, Victor M Moles, Laurent Savale, Carmine Dario Vizza, Stephan Rosenkranz, Yaru Shi, Barry Miller, Harald S Mackenzie, Samuel S Kim, Maria José Loureiro, Mahesh J Patel, Joerg Koglin, Alexandra G Cornell, Marius M Hoeper","doi":"10.1056/NEJMoa2415160","DOIUrl":"https://doi.org/10.1056/NEJMoa2415160","url":null,"abstract":"<p><strong>Background: </strong>Sotatercept improves exercise capacity and delays the time to clinical worsening in patients with World Health Organization (WHO) functional class II or III pulmonary arterial hypertension. The effects of add-on sotatercept in patients with advanced pulmonary arterial hypertension and a high risk of death are unclear.</p><p><strong>Methods: </strong>In this phase 3 trial, we randomly assigned patients with pulmonary arterial hypertension (WHO functional class III or IV) and a high 1-year risk of death (Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management Lite 2 risk score, ≥9) who were receiving the maximum tolerated dose of background therapy to receive add-on sotatercept (starting dose, 0.3 mg per kilogram of body weight; escalated to target dose, 0.7 mg per kilogram) or placebo every 3 weeks. The primary end point was a composite of death from any cause, lung transplantation, or hospitalization (≥24 hours) for worsening pulmonary arterial hypertension, assessed in a time-to-first-event analysis.</p><p><strong>Results: </strong>A total of 172 patients were included (86 each in the sotatercept and placebo groups). The trial was stopped early on the basis of the efficacy results of a prespecified interim analysis. At least one primary end-point event occurred in 15 patients (17.4%) in the sotatercept group and in 47 patients (54.7%) in the placebo group (hazard ratio, 0.24; 95% confidence interval, 0.13 to 0.43; P<0.001). Death from any cause occurred in 7 patients (8.1%) in the sotatercept group and in 13 patients (15.1%) in the placebo group; lung transplantation in 1 patient (1.2%) and 6 patients (7.0%), respectively; and hospitalization for worsening pulmonary arterial hypertension in 8 patients (9.3%) and 43 patients (50.0%). The most common adverse events with sotatercept were epistaxis and telangiectasia.</p><p><strong>Conclusions: </strong>Among high-risk adults with pulmonary arterial hypertension who were receiving the maximum tolerated dose of background therapy, treatment with sotatercept resulted in a lower risk of a composite of death from any cause, lung transplantation, or hospitalization (≥24 hours) for worsening pulmonary arterial hypertension than placebo. (Funded by Merck Sharp and Dohme, a subsidiary of Merck [Rahway, NJ]; ZENITH ClinicalTrials.gov number, NCT04896008.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation.","authors":"Tobias Reichlin, Thomas Kueffer, Patrick Badertscher, Peter Jüni, Sven Knecht, Gregor Thalmann, Nikola Kozhuharov, Philipp Krisai, Corinne Jufer, Jens Maurhofer, Dik Heg, Tiago V Pereira, Felix Mahfoud, Helge Servatius, Hildegard Tanner, Michael Kühne, Laurent Roten, Christian Sticherling","doi":"10.1056/NEJMoa2502280","DOIUrl":"https://doi.org/10.1056/NEJMoa2502280","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary-vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation (PFA) is a nonthermal ablation method with few adverse effects beyond the myocardium. Data are lacking on outcomes after PFA as compared with cryoballoon ablation as assessed with continuous rhythm monitoring.</p><p><strong>Methods: </strong>In this randomized noninferiority trial in Switzerland, we randomly assigned patients with symptomatic paroxysmal atrial fibrillation in a 1:1 ratio to undergo PFA or cryoablation. All the patients received an implantable cardiac monitor to detect atrial tachyarrhythmias. The primary end point was the first recurrence of an atrial tachyarrhythmia between day 91 and day 365 after ablation. We assessed noninferiority using a margin of 20 percentage points for the difference in the cumulative incidence of recurrence. The safety end point was a composite of procedure-related complications.</p><p><strong>Results: </strong>A total of 105 patients were assigned to undergo PFA, and 105 were assigned to undergo cryoablation. A recurrence of atrial tachyarrhythmia was observed between day 91 and day 365 in 39 patients in the PFA group and in 53 patients in the cryoablation group (Kaplan-Meier cumulative incidence, 37.1% and 50.7%, respectively; between-group difference, -13.6 percentage points; 95% confidence interval, -26.9 to -0.3; P<0.001 for noninferiority, P = 0.046 for superiority). The safety end point occurred in 1 patient (1.0%) with PFA and in 2 patients (1.9%) with cryoablation.</p><p><strong>Conclusions: </strong>Among patients with symptomatic paroxysmal atrial fibrillation, PFA was noninferior to cryoballoon ablation with respect to the incidence of a first recurrence of atrial tachyarrhythmia, as assessed by continuous rhythm monitoring. (Funded by Inselspital and others; SINGLE SHOT CHAMPION ClinicalTrials.gov number, NCT05534581.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation.","authors":"Rajesh K Kharbanda, James Kennedy, Zahra Jamal, Matthew Dodd, Richard Evans, Kiran K Bal, Alexander D Perkins, Daniel J Blackman, David Hildick-Smith, Adrian P Banning, Andreas Baumbach, Peter Ludman, Stephen Palmer, Rodney H Stables, Robert Henderson, Clare Appleby, James Cotton, Nick Curzen, Muhiddin Ozkor, Jonathan Byrne, Rajesh Aggarwal, Rajiv Das, Sagar Doshi, Stuart Watkins, Douglas F Muir, Richard Anderson, Saqib Chowdhary, Richard Varcoe, Stephen Dorman, Sam Firoozi, Raj Chelliah, Colum Owens, Simon Redwood, Bernard Prendergast, Javaid Iqbal, Karim Ratib, Ciprian Dospinescu, Venkatesan Suresh, Nicholas Cruden, Thirumaran Rajathurai, Iqbal S Malik, Andrew Wiper, Charis Costopoulos, Ayush Khurana, Amerjeet Banning, Tim Clayton","doi":"10.1056/NEJMoa2415120","DOIUrl":"https://doi.org/10.1056/NEJMoa2415120","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke.</p><p><strong>Methods: </strong>We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner).</p><p><strong>Results: </strong>A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, -0.02 percentage points; 95% confidence interval, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group.</p><p><strong>Conclusions: </strong>Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}