دورية أكاديمية
أعرض في EDS

Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.

التفاصيل البيبلوغرافية
العنوان: Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.
المؤلفون: De Filippo O; Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy ovidio.defilippo@gmail.com., Bianco M; Division of Cardiology, San Luigi Gonzaga University Hospital, Orbassano, Italy, Orbassano, Italy., Tebaldi M; Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy., Iannaccone M; Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy., Gaido L; Division of Cardiology, Maria Vittoria Hospital, Turin, Italy., Guiducci V; Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia, Italy., Santarelli A; Division of Cardiology, Department of Cardiovascular Diseases, AUSL Romagna, Degli Infermi Hospital, Rimini, Italy., Zaccaro L; Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy., Depaoli A; University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy., Vaudano P; Radiology Unit, San Giovanni Bosco Hospital, Turin, Italy., Quadri G; Cardiology Unit, Infermi Hospital, Rivoli, Italy., Gagnor A; Division of Cardiology, Maria Vittoria Hospital, Turin, Italy., Boccuzzi G; Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy., Solitro F; Radiology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy., Cortese G; Radiology, Maria Vittoria Hospital, Turin, Italy., Guarnaccia C; University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy., Tore D; University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy., Veltri A; Radiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Italy, Turin, Italy., Franchin L; Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy., Angelini F; Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy., Garbo R; Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy., Giammaria M; Division of Cardiology, Maria Vittoria Hospital, Turin, Italy., Varbella F; Cardiology Unit, Infermi Hospital, Rivoli, Italy., Marchisio F; Radiology Unit, Infermi Hospital, Rivoli, Italy., Fonio P; University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy., De Ferrari GM; Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy., Cerrato E; Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and Rivoli Infermi Hospital, RIvoli, Italy., Campo G; Division of Cardiology, Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara, Ferrara, Italy., D'Ascenzo F; Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
المصدر: Open heart [Open Heart] 2020 Oct; Vol. 7 (2).
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 101631219 Publication Model: Print Cited Medium: Print ISSN: 2053-3624 (Print) Linking ISSN: 20533624 NLM ISO Abbreviation: Open Heart Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group
مواضيع طبية MeSH: Computed Tomography Angiography* , Coronary Angiography* , Drug-Eluting Stents*, Coronary Artery Disease/*therapy , Percutaneous Coronary Intervention/*instrumentation, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/mortality ; Coronary Artery Disease/physiopathology ; Female ; Humans ; Italy ; Male ; Middle Aged ; Multicenter Studies as Topic ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/mortality ; Predictive Value of Tests ; Prospective Studies ; Randomized Controlled Trials as Topic ; Time Factors ; Treatment Outcome ; Young Adult
مستخلص: Background: The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.
Methods and Analysis: PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.
Trial Registration Number: NCT04144881.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: CT scanning; coronary angiography; coronary artery disease; coronary intervention (PCI)
سلسلة جزيئية: ClinicalTrials.gov NCT04144881
تواريخ الأحداث: Date Created: 20201030 Date Completed: 20201222 Latest Revision: 20240803
رمز التحديث: 20240803
مُعرف محوري في PubMed: PMC7597506
DOI: 10.1136/openhrt-2020-001253
PMID: 33122421
قاعدة البيانات: MEDLINE
الوصف
تدمد:2053-3624
DOI:10.1136/openhrt-2020-001253