دورية أكاديمية
Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study.
| العنوان: | Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study. |
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| المؤلفون: | Gonsalves CF; Thomas Jefferson University Hospital, Philadelphia, PA., Gibson CM; Beth Israel Deaconess Medical Center, Boston, MA., Stortecky S; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: stortecky@gmx.at., Alvarez RA; Cleveland Clinic Florida, Weston, FL., Beam DM; Indiana University Health University Hospital, Indianapolis, IN., Horowitz JM; NYU Langone Health, New York, NY., Silver MJ; OhioHealth Heart and Vascular Physicians, Columbus, OH., Toma C; University of Pittsburgh Medical Center, Pittsburgh, PA., Rundback JH; Advanced Interventional & Vascular Services, LLP, Teaneck, NJ., Rosenberg SP; Inari Medical, Irvine, CA., Markovitz CD; Inari Medical, Irvine, CA., Tu T; Inari Medical, Irvine, CA., Jaber WA; Emory University Hospital, Atlanta, GA. |
| المصدر: | American heart journal [Am Heart J] 2023 Dec; Vol. 266, pp. 128-137. Date of Electronic Publication: 2023 Sep 12. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: St. Louis, MO : Mosby |
| مواضيع طبية MeSH: | Thrombolytic Therapy*/methods , Pulmonary Embolism*/drug therapy, Humans ; Treatment Outcome ; Fibrinolytic Agents ; Hemorrhage/chemically induced ; Catheters ; Thrombectomy/adverse effects |
| مستخلص: | Background: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. Methods: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. Implications: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted. Competing Interests: Disclosures C.F. Gonsalves reports receiving consulting fees from Inari Medical. C.M. Gibson reports receiving research grant support from Angel Medical Corporation, Bayer Corp, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson Corporation, and Portola Pharmaceuticals; and has received consulting monies from Amarin Pharma, Amgen, Arena Pharmaceuticals, Bayer Corporation, Boehringer Ingelheim, Boston Clinical Research Institute, Cardiovascular Research Foundation, Chiesi, CSL Behring, Eli Lilly, Gilead Sciences, Inc, Inari Medical, Janssen Pharmaceuticals, Johnson & Johnson Corporation, The Medicines Company, Merck & Co, Inc, Novo Nordisk, Pfizer, Pharma Mar, Portola Pharmaceuticals, Sanofi, Somahlution, St Francis Hospital, Verson Corporation, and Web MD. S. Stortecky reports receiving research grants to the institution from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; consulting fees from Boston Scientific and Teleflex, as well as honoraria for lectures from Boston Scientific. R.A. Alvarez reports receiving consulting fees from United Therapeutics Corporation. D.M. Beam reports receiving consulting fees from Inari Medical and Janssen Pharmaceuticals. J.M. Horowitz reports receiving consulting fees from Inari Medical and Penumbra. M.J. Silver reports receiving consulting fees from Medtronic, Boston Scientific, WL Gore and Associates, Cook Medical, Contego Medical, and Inari Medical, as well as speakers’ bureau for Bristol Myers Squibb, Astra Zeneca, and Pfizer. C. Toma reports receiving consulting fees from Medtronic, Neptune Medical and Philips. J.H. Rundback reports being a consultant or advisory board member for Inari Medical, Philips, AngioDynamics, Boston Scientific, Abbott, Medtronic, Truvic, and Aveera Medical; has stocks/options in Protexa, Aveera, and Kalgaro Medical; is a board member of Protexa Medical and the CLI Global Society; is the site or national PI and receives institutional research support from Abbott, 4S, Terumo, Reflow Medical and AngioDynamics. S.P. Rosenberg, C.D. Markovitz, and T. Tu are employees of Inari Medical and own stock and/or have stock options in the company. W.A. Jaber reports receiving consulting fees from Medtronic and Inari Medical. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT05111613 |
| المشرفين على المادة: | 0 (Fibrinolytic Agents) |
| تواريخ الأحداث: | Date Created: 20230913 Date Completed: 20231120 Latest Revision: 20231120 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.ahj.2023.09.002 |
| PMID: | 37703948 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1097-6744 |
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| DOI: | 10.1016/j.ahj.2023.09.002 |