Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/26430
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Spitzer, Ernest | - |
dc.contributor.author | McFadden, Eugene | - |
dc.contributor.author | VRANCKX, Pascal | - |
dc.contributor.author | de Vries, Ton | - |
dc.contributor.author | Ren, Ben | - |
dc.contributor.author | Collet, Carlos | - |
dc.contributor.author | Onuma, Yoshinobu | - |
dc.contributor.author | Garcia-Garcia, Hector M. | - |
dc.contributor.author | Lopes, Renato D. | - |
dc.contributor.author | Stone, Gregg W. | - |
dc.contributor.author | Cutlip, Donald E. | - |
dc.contributor.author | Serruys, Patrick W. | - |
dc.date.accessioned | 2018-07-26T12:44:09Z | - |
dc.date.available | 2018-07-26T12:44:09Z | - |
dc.date.issued | 2018 | - |
dc.identifier.citation | JACC-CARDIOVASCULAR INTERVENTIONS, 11(9), p. 823-832 | - |
dc.identifier.issn | 1936-8798 | - |
dc.identifier.uri | http://hdl.handle.net/1942/26430 | - |
dc.description.abstract | Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee. (c) 2018 by the American College of Cardiology Foundation. | - |
dc.description.sponsorship | Dr. Onuma has been a member of an advisory board for Abbott Vascular. Dr. Garcia-Garcia has served as a consultant for Tryton; has received speaker fees from Volcano/Philips; and has received institutional grants from Biotronik, Medtronic, Infraredx, and Neovasc. Dr. Lopes has received personal fees for consulting from Bayer, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck & Co., Inc., Pfizer, Portola Pharmaceuticals, and Boehringer Ingelheim; and has received institutional grant support from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, and Pfizer. Prof. Serruys has served as a consultant to Abbott, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sinomedical, Soc. Europa Dig. Publishing, Stentys, Svelte, Phillips/Volcano, St. Jude Medical, Qualimed, and Xeltis. Dr. Cutlip received research support from Celonova. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. | - |
dc.language.iso | en | - |
dc.rights | (C) 2018 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION | - |
dc.subject.other | clinical endpoint adjudication; clinical trial; coronary revascularization; staged procedure | - |
dc.title | Defining Staged Procedures for Percutaneous Coronary Intervention Trials A Guidance Document | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 832 | - |
dc.identifier.issue | 9 | - |
dc.identifier.spage | 823 | - |
dc.identifier.volume | 11 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Serruys, PW (reprint author), Imperial Coll London, NHLI, Int Ctr Circulatory Hlth, 59 North Wharf Rd, London W2 1LA, England. patrick.w.j.c.serruys@gmail.com | - |
local.type.refereed | Refereed | - |
local.type.specified | Review | - |
dc.identifier.doi | 10.1016/j.jcin.2018.03.044 | - |
dc.identifier.isi | 000432439600004 | - |
item.fullcitation | Spitzer, Ernest; McFadden, Eugene; VRANCKX, Pascal; de Vries, Ton; Ren, Ben; Collet, Carlos; Onuma, Yoshinobu; Garcia-Garcia, Hector M.; Lopes, Renato D.; Stone, Gregg W.; Cutlip, Donald E. & Serruys, Patrick W. (2018) Defining Staged Procedures for Percutaneous Coronary Intervention Trials A Guidance Document. In: JACC-CARDIOVASCULAR INTERVENTIONS, 11(9), p. 823-832. | - |
item.accessRights | Restricted Access | - |
item.fulltext | With Fulltext | - |
item.validation | ecoom 2019 | - |
item.contributor | Spitzer, Ernest | - |
item.contributor | McFadden, Eugene | - |
item.contributor | VRANCKX, Pascal | - |
item.contributor | de Vries, Ton | - |
item.contributor | Ren, Ben | - |
item.contributor | Collet, Carlos | - |
item.contributor | Onuma, Yoshinobu | - |
item.contributor | Garcia-Garcia, Hector M. | - |
item.contributor | Lopes, Renato D. | - |
item.contributor | Stone, Gregg W. | - |
item.contributor | Cutlip, Donald E. | - |
item.contributor | Serruys, Patrick W. | - |
crisitem.journal.issn | 1936-8798 | - |
crisitem.journal.eissn | 1876-7605 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
spitzer2018.pdf Restricted Access | Published version | 2.1 MB | Adobe PDF | View/Open Request a copy |
SCOPUSTM
Citations
3
checked on Sep 3, 2020
WEB OF SCIENCETM
Citations
16
checked on Aug 29, 2024
Page view(s)
22
checked on May 19, 2022
Download(s)
6
checked on May 19, 2022
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.