Document Detail


The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design.
MedLine Citation:
PMID:  19958856     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Several observational studies have suggested that mortality and major complications after high-risk percutaneous coronary intervention (PCI) can be reduced by elective insertion of an intra-aortic balloon pump (IABP). However, to date, this assertion has never been tested in a randomized trial, and as such, international guidelines do not provide formal recommendations for IABP use in this setting. The BCIS-1 is a randomized trial that addresses the hypothesis that elective IABP insertion before high-risk PCI will reduce major adverse cardiac and cerebrovascular events (MACCEs) at hospital discharge or 28 days after index PCI, whichever occurs sooner. High risk is defined by the presence of severe left ventricular dysfunction as well as a large amount of myocardium at risk. Patients who are in cardiogenic shock, have a class I indication for IABP use, or have an absolute contraindication to IABP use will be excluded. Three hundred eligible patients will be randomized to receive elective IABP insertion or no planned IABP insertion. The findings of BCIS-1 are expected to define the role of balloon counterpulsation in high-risk PCI. Confirmation of the efficacy of elective IABP use may prompt review of the international guidelines, which are currently very restricted. In contrast, a neutral or adverse outcome with elective counterpulsation in these high-risk patients will allow evidence-based rationalization of the current disparity between guidelines and the frequent real-world use of elective IABP support.
Authors:
Divaka Perera; Rodney Stables; Jean Booth; Martyn Thomas; Simon Redwood;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  158     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-04     Completed Date:  2010-01-06     Revised Date:  2010-03-03    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  910-916.e2     Citation Subset:  AIM; IM    
Affiliation:
Cardiovascular Division, Rayne Institute, St Thomas' Hospital, London SE1 7EH, United Kingdom.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00910481; ISRCTN/ISRCTN40553718
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Transluminal, Percutaneous Coronary*
Humans
Intra-Aortic Balloon Pumping*
Research Design*
Investigator
Investigator/Affiliation:
Divaka Perera / ; Simon Redwood / ; Rodney Stables / ; Martyn Thomas / ; Jean Booth / ; Peter Ludman / ; Gerard Stansby / ; Chris Palmer / ; Michael Roughton / ; Winston Banya / ; James Cotton / ; Nick Curzen / ; Adam de Belder / ; David Roberts / ; Jean Booth / ; Fiona Nugara / ; Marcus Flather / ; Charlotte Gillam / ; Michael Roughton / ; Winston Banya / ; Michael Pitt / ; Jerome Ment / ; Nadia Elgaylani / ; Joanne Pitt / ; Juliet Hulse / ; Melissa Reeve / ; Adam de Belder / ; David Hildick-Smith / ; Stephen Holmberg / ; Nick Pegge / ; Rob Hatrick / ; Elaine Joyce / ; Ailie Mackenzie / ; Nina Cooter / ; Fraser Witherow / ; Pauline Chambers / ; Sally Breakspear / ; Tony Gershlick / ; Gayle Richardson / ; Mohsin Farooq / ; Kathryn Fairbrother / ; Pat Desouza / ; Simon Redwood / ; Divaka Pererac / ; Martyn Thomas / ; James Coutts / ; Brian Clapp / ; Sundip Patel / ; Aldo Rinaldi / ; Balwinder Wasan / ; Lucy Woodhead / ; Karen Wilson / ; Matthew Allen / ; Martyn Thomas / ; Phillip Maccarthy / ; Jonathan Hill / ; Michelle Andrews / ; Jayne Damm / ; Joanne Gregory / ; Daniel Blackman / ; Jonathan Blaxill / ; Philip Batin / ; John Greenwood / ; Maurice Pye / ; Stephen Wheatcroft / ; Claire Priestly / ; Kathryn Somers / ; Rodney Stables / ; Joe Mills / ; Nicholas Palmer / ; Heather Rogers / ; Claire Prince / ; Douglas Fraser / ; Faz Ordoubadi / ; Karen Palmer / ; Robert Henderson / ; Kamran Baig / ; Leong Lee / ; William Smith / ; Jane Burton / ; Rosie Swallow / ; Peter O'Kane / ; Suneel Talwar / ; Terry Levy / ; Nicki Lakeman / ; Priscilla Ryder / ; David Roberts / ; Simon Eccleshall / ; Lesley Hutt / ; Lesley Helliwell / ; James Cotton / ; Michael Norell / ; Michael Cusack / ; Saib Khogali / ; Andrew Smallwood / ; Stephen Brecker / ; Charles Pumphrey / ; Sue Brown / ; Jo Ann Multaney / ; Nick Curzen / ; Alison Calver / ; Keith Dawkins / ; Zoe Nicholas / ; Sue Kitt / ; Jim Nolan / ; Mark Gunning / ; Julie Machin / ; Keith Oldroyd / ; Colin Petrie / ; Colin Berry / ; Stephen Robb / ; John Boyle / ; Joanne Kelly / ; Fiona Stevenson /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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