High-risk percutaneous coronary intervention with or without mechanical circulatory support: Will Impella show superiority in the PROTECT IV randomized trial?. (Record no. 14349)

MARC details
000 -LEADER
fixed length control field 04481nam a22006497a 4500
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20240807190551.0
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fixed length control field 240807s20242024 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1878-0938
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S1553-8389(24)00580-3 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
Transcribing agency whc
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 39013705
245 ## - TITLE STATEMENT
Title High-risk percutaneous coronary intervention with or without mechanical circulatory support: Will Impella show superiority in the PROTECT IV randomized trial?.
251 ## - Source
Source Cardiovascular Revascularization Medicine. 2024 Jul 14
252 ## - Abbreviated Source
Abbreviated source Cardiovasc Revasc Med. 2024 Jul 14
253 ## - Journal Name
Journal name Cardiovascular revascularization medicine : including molecular interventions
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2024
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2025
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Publication date 2024 Jul 14
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Medline status Publisher
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Date added to catalog 2024-08-07
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Date Medline record created 2024/07/16 21:58
501 ## - WITH NOTE
Local holdings Available in print through MWHC library: 2002 - present
520 ## - SUMMARY, ETC.
Abstract BACKGROUND: PROTECT IV is a current enrolling randomized controlled trial evaluating high-risk percutaneous coronary intervention (HR-PCI) with prophylactic Impella versus no Impella to reduce the composite primary endpoint of all-cause death, stroke, myocardial infarction (MI), or cardiovascular hospitalization. In a PROTECT IV-like cohort of patients who underwent HR-PCI without Impella, we aimed to report the rate of major adverse events to determine whether the trial is adequately powered.
520 ## - SUMMARY, ETC.
Abstract CONCLUSION: Therefore, PROTECT IV estimates that a sample size of 1252 patients is required for Impella to be declared superior to the non-Impella group. Using our observed 2-year outcome of 30.8 %, we estimate that PROTECT IV requires 1966 patients, demonstrating that PROTECT IV is probably underpowered. Copyright © 2024 Elsevier Inc. All rights reserved.
520 ## - SUMMARY, ETC.
Abstract METHODS AND RESULTS: A total of 700 patients meeting similar inclusion/exclusion criteria of PROTECT IV who underwent HR-PCI without Impella at a single tertiary center from 2008 to 2022 were included in the analysis. The composite rates of all-cause death, MI, target lesion revascularization, and target vessel revascularization at 1, 2, and 3 years were estimated using the Kaplan-Meier method, and the results were used to calculate the sample size under the constant hazard ratio assumption and expected number of events to be observed used in planning PROTECT IV. The primary endpoint occurred in 30.8 % of patients at 2 years. PROTECT IV assumes a hazard ratio of 0.75 using a multivariate Cox regression, which, under a 5 % level and 90 % power, yields 516 events. This implies a 2-year primary outcome rate of 50 % for the non-Impella arm.
546 ## - LANGUAGE NOTE
Language note English
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Topical term or geographic name entry element IN PROCESS -- NOT YET INDEXED
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Indexing Automated
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Institution MedStar Heart & Vascular Institute
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Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Advanced Cardiac Catheterization Research Fellowship
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Department Cardiovascular Disease Fellowship
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Department Interventional Cardiology Fellowship
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Abusnina, Waiel
Institution Code MWHC
Program Advanced Cardiac Catheterization Research Fellowship
Degree MBBCh
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Local Authors Ahmed, Shaan
Institution Code MWHC
Program Cardiovascular Disease Fellowship
Degree MD
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Banerjee, Avantika
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Ben-Dor, Itsik
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Bernardo, Nelson L
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Case, Brian C
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Chaturvedi, Abhishek
Institution Code MWHC
Program Advanced Cardiac Catheterization Research Fellowship
Degree MBBS
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Chitturi, Kalyan
Institution Code MWHC
Program Advanced Cardiac Catheterization Research Fellowship
Degree DO
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Haberman, Dan
Institution Code MWHC
Program Interventional Cardiology Fellowship
Degree MD
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Hashim, Hayder
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Lupu, Lior
Institution Code MWHC
Program Interventional Cardiology Fellowship
Degree MBA, MD
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Merdler, Ilan
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Reddy, Pavan
Institution Code MWHC
Program Advanced Cardiac Catheterization Research Fellowship
Degree MD
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Rogers, Toby
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Satler, Lowell F
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Sawant, Vaishnavi
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
Institution Code MHVI
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Zhang, Cheng
Institution Code MHVI
790 ## - Authors
All authors Chitturi KR, Zhang C, Abusnina W, Sawant V, Banerjee A, Ahmed S, Merdler I, Haberman D, Chaturvedi A, Lupu L, Reddy P, Case BC, Rogers T, Hashim HD, Ben-Dor I, Bernardo NL, Satler LF, Waksman R
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DOI <a href="https://dx.doi.org/10.1016/j.carrev.2024.07.003">https://dx.doi.org/10.1016/j.carrev.2024.07.003</a>
Public note https://dx.doi.org/10.1016/j.carrev.2024.07.003
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Source of classification or shelving scheme Dewey Decimal Classification
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              08/07/2024   39013705 08/07/2024 08/07/2024 Journal Article

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