Author + information
- Received December 5, 2017
- Revision received March 7, 2018
- Accepted March 13, 2018
- Published online May 2, 2018.
- Ernest Spitzer, MDa,b,
- Eugène McFadden, MDa,c,
- Pascal Vranckx, MD, PhDd,
- Ton de Vries, MSca,
- Ben Ren, MD, PhDa,b,
- Carlos Collet, MDe,
- Yoshinobu Onuma, MD, PhDa,
- Hector M. Garcia-Garcia, MD, PhDf,
- Renato D. Lopes, MD, PhDg,
- Gregg W. Stone, MDh,
- Donald E. Cutlip, MDi,j and
- Patrick W. Serruys, MD, PhDk,∗ ()
- aCardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands
- bDepartment of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands
- cDepartment of Cardiology, Cork University Hospital, Cork, Ireland
- dDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium
- eDepartment of Cardiology, Academic Medical Center, Amsterdam, the Netherlands
- fDepartment of Cardiology, MedStar Washington Hospital Center, Washington, DC
- gDivision of Cardiology, Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina
- hClinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, New York
- iBaim Institute for Clinical Research, Boston, Massachusetts
- jBeth Israel Deaconess Medical Center, Boston, Massachusetts
- kInternational Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom
- ↵∗Address for correspondence:
Prof. Patrick W. Serruys, International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59 North Wharf Road, London W2 1LA, United Kingdom.
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.
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.
- Received December 5, 2017.
- Revision received March 7, 2018.
- Accepted March 13, 2018.
- 2018 American College of Cardiology Foundation
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