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The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design

The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design
The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design
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.

0002-8703
910-916
Perera, D.
8bf4808b-cdc8-4792-9ca7-58a5abf56754
Stables, R.
6aaefe18-cce7-42a8-a160-5bcd8763554b
Booth, J.
1a0f7357-ea6e-43f7-87c8-40cb97c4d070
Thomas, M.
f5239f6a-49f5-4645-9f1c-37ae8fbcd0d5
Redwood, S.
9b1b8333-41ca-46ce-b500-2561c6608096
Curzen, N.
70f3ea49-51b1-418f-8e56-8210aef1abf4
Perera, D.
8bf4808b-cdc8-4792-9ca7-58a5abf56754
Stables, R.
6aaefe18-cce7-42a8-a160-5bcd8763554b
Booth, J.
1a0f7357-ea6e-43f7-87c8-40cb97c4d070
Thomas, M.
f5239f6a-49f5-4645-9f1c-37ae8fbcd0d5
Redwood, S.
9b1b8333-41ca-46ce-b500-2561c6608096
Curzen, N.
70f3ea49-51b1-418f-8e56-8210aef1abf4

Perera, D., Stables, R., Booth, J., Thomas, M., Redwood, S. and Curzen, N. (2009) The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design. American Heart Journal, 158 (6), 910-916. (doi:10.1016/j.ahj.2009.09.015). (PMID:19958856)

Record type: Article

Abstract

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.

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More information

Published date: 2009
Organisations: Human Development & Health

Identifiers

Local EPrints ID: 355193
URI: http://eprints.soton.ac.uk/id/eprint/355193
ISSN: 0002-8703
PURE UUID: 695d1e20-d673-4e65-9b23-610294deaff3
ORCID for N. Curzen: ORCID iD orcid.org/0000-0001-9651-7829

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Date deposited: 13 Aug 2013 14:26
Last modified: 15 Mar 2024 03:23

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Contributors

Author: D. Perera
Author: R. Stables
Author: J. Booth
Author: M. Thomas
Author: S. Redwood
Author: N. Curzen ORCID iD

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