{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T16:44:24Z","timestamp":1791996264190,"version":"4.4.0"},"reference-count":13,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"\n Importance<\/jats:title>\n For patients presenting with symptomatic prosthetic valve thrombosis (PVT) after mechanical heart valve replacement, thrombolytic therapy with alteplase is accepted as a first-line therapeutic alternative. The utility of tenecteplase compared with conventional regimens remains unstudied, to the authors\u2019 knowledge, in this patient population.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the relative safety and efficacy of tenecteplase compared with standard infusions of alteplase in patients with PVT.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting and Participants<\/jats:title>\n This was an open-label, parallel-group, non-inferiority randomized clinical trial among consecutive adult patients presenting with obstructive PVT of a mechanical prosthetic valve over the study period from October 2022 to August 2024 to a single tertiary care center in India.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients received thrombolytic therapy with a low-dose slow infusion alteplase or weight-based bolus doses of tenecteplase.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcomes were to determine the rates of complete thrombolytic success and the incidence of major complications.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 83 patients (mean [SD] age, 39.6\u2009[12.4] years, 42 male [50.6%]) were randomized to receive alteplase (n\u2009=\u200943) or tenecteplase (n\u2009=\u200940). The rates of the primary efficacy end point (complete thrombolytic success) were significantly higher (risk ratio, 1.18; 95% CI, 1.03-1.39;\n P<\/jats:italic>\n \u2009=\u2009.02 for noninferiority) in the tenecteplase group (39 patients [97.5%]) compared with the alteplase group (35 patients [81.5%]). Additionally, patients treated with tenecteplase had higher rates of complete success with the first administered dose and a shorter duration of hospital stay (median [IQR], 4.1 [3.2-5.1] days vs 6.5 [4.3-9.2] days;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). The rates of major and minor adverse events were similar.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Tenecteplase may be a safe and effective alternative to alteplase in patients presenting with obstructive PVT. Patients treated with tenecteplase in our study had higher rates of complete thrombolytic success and a shorter duration of hospital stay. Furthermore, the relative ease of drug administration with tenecteplase may translate to greater clinical benefit in a real-world setting.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Clinical Trials Registry of India:\n CTRI\/2022\/10\/046127<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamacardio.2025.4369","type":"journal-article","created":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T16:00:42Z","timestamp":1764777642000},"page":"84","source":"Crossref","is-referenced-by-count":10,"title":["Tenecteplase vs Alteplase in Mechanical Prosthetic Heart Valve Thrombosis"],"prefix":"10.1001","volume":"11","author":[{"given":"Gautam","family":"Sharma","sequence":"first","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krishna Prasad","family":"Akkineni","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nayani","family":"Makkar","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asmita","family":"Shukla","sequence":"additional","affiliation":[{"name":"Centre for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Partha","family":"Haldar","sequence":"additional","affiliation":[{"name":"Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devagourou","family":"Velayoudam","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic & Vascular Surgery, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamal","family":"Kamal","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjeev","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Cardiac Vascular Radiology & Endovascular Interventions, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nitish","family":"Naik","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ambuj","family":"Roy","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Seth","sequence":"additional","affiliation":[{"name":"Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Department of Neurology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"3","key":"hbr250018r1","doi-asserted-by":"publisher","first-page":"932","DOI":"10.1016\/S0003-4975(96)00531-0","article-title":"Guidelines for reporting morbidity and mortality after cardiac valvular operations: the American Association for Thoracic Surgery, Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity.","volume":"62","author":"Edmunds","year":"1996","journal-title":"Ann Thorac Surg"},{"issue":"2","key":"hbr250018r2","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1161\/01.CIR.89.2.635","article-title":"Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses.","volume":"89","author":"Cannegieter","year":"1994","journal-title":"Circulation"},{"issue":"10","key":"hbr250018r3","doi-asserted-by":"publisher","first-page":"977","DOI":"10.1016\/j.jacc.2021.12.027","article-title":"Thrombolysis or surgery in patients with obstructive mechanical valve thrombosis: the multicenter HATTUSHA study.","volume":"79","author":"\u00d6zkan","year":"2022","journal-title":"J Am Coll Cardiol"},{"issue":"19","key":"hbr250018r4","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.124.035143","article-title":"Surgery vs thrombolytic therapy for the management of left-sided prosthetic valve thrombosis without hemodynamic compromise: a systematic review and meta-analysis.","volume":"13","author":"Chopard","year":"2024","journal-title":"J Am Heart Assoc"},{"issue":"2","key":"hbr250018r5","doi-asserted-by":"publisher","first-page":"206","DOI":"10.1016\/j.jcmg.2012.10.016","article-title":"Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial.","volume":"6","author":"\u00d6zkan","year":"2013","journal-title":"JACC Cardiovasc Imaging"},{"issue":"2","key":"hbr250018r6","doi-asserted-by":"publisher","first-page":"409","DOI":"10.1016\/j.ahj.2015.04.025","article-title":"Ultraslow thrombolytic therapy: a novel strategy in the management of prosthetic mechanical valve thrombosis and the predictors of outcome: the ultra-slow PROMETEE trial.","volume":"170","author":"\u00d6zkan","year":"2015","journal-title":"Am Heart J"},{"issue":"17","key":"hbr250018r7","doi-asserted-by":"publisher","first-page":"1437","DOI":"10.1001\/jama.2024.14721","article-title":"Tenecteplase vs alteplase for patients with acute ischemic stroke: the ORIGINAL randomized clinical trial.","volume":"332","author":"Meng","year":"2024","journal-title":"JAMA"},{"issue":"4","key":"hbr250018r8","doi-asserted-by":"publisher","first-page":"506","DOI":"10.1016\/j.ihj.2017.10.014","article-title":"Tenecteplase vs streptokinase thrombolytic therapy in patients with mitral prosthetic valve thrombosis.","volume":"70","author":"Kathirvel","year":"2018","journal-title":"Indian Heart J"},{"issue":"3","key":"hbr250018r9","doi-asserted-by":"publisher","first-page":"365","DOI":"10.1016\/j.ihj.2021.02.005","article-title":"Clinical outcomes of patients with mitral prosthetic valve obstructive thrombosis treated with streptokinase or tenecteplase.","volume":"73","author":"Kiran","year":"2021","journal-title":"Indian Heart J"},{"issue":"3","key":"hbr250018r10","first-page":"268","article-title":"Predictors of the outcome of thrombolytic therapy in prosthetic mitral valve thrombosis: a study of 62 events.","volume":"18","author":"Nagy","year":"2009","journal-title":"J Heart Valve Dis"},{"issue":"9","key":"hbr250018r11","doi-asserted-by":"publisher","first-page":"3670","DOI":"10.1073\/pnas.91.9.3670","article-title":"A faster-acting and more potent form of tissue plasminogen activator.","volume":"91","author":"Keyt","year":"1994","journal-title":"Proc Natl Acad Sci U S A"},{"issue":"8","key":"hbr250018r12","doi-asserted-by":"publisher","first-page":"1218","DOI":"10.1111\/jth.12577","article-title":"Thrombolytic therapy or surgery for valve prosthesis thrombosis: systematic review and meta-analysis.","volume":"12","author":"Castilho","year":"2014","journal-title":"J Thromb Haemost"},{"issue":"21","key":"hbr250018r13","doi-asserted-by":"publisher","first-page":"1557","DOI":"10.1093\/eurheartj\/ehs486","article-title":"Urgent surgery compared with fibrinolytic therapy for the treatment of left-sided prosthetic heart valve thrombosis: a systematic review and meta-analysis of observational studies.","volume":"34","author":"Karthikeyan","year":"2013","journal-title":"Eur Heart J"}],"container-title":["JAMA Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamacardiology\/articlepdf\/2841756\/jamacardiology_sharma_2025_br_250018_1767980835.80476.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T16:01:00Z","timestamp":1768406460000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamacardiology\/fullarticle\/2841756"}},"subtitle":["The TENET Randomized Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2026,1,1]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamacardio.2025.4369","relation":{},"ISSN":["2380-6583"],"issn-type":[{"value":"2380-6583","type":"print"}],"subject":[],"published":{"date-parts":[[2026,1,1]]}}}