Balloon Pump Assisted Coronary Intervention Study

NCT00910481 — Not applicable, Completed, 301 participants, British Cardiovascular Intervention Society
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RegistryNCT00910481, acronym BCIS-1
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment301 (Actual)
SponsorBritish Cardiovascular Intervention Society (Other)
ConditionsCoronary Artery Disease, Left Ventricular Dysfunction
InterventionsIntra-Aortic Balloon Pump (Device)
Datesstart 2005-12-01, primary completion 2011-01-01, completion 2012-12-01, first posted 2009-05-29, last updated 2024-08-07
Locations1 site in United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Disease All trials for Left Ventricular Dysfunction All trials of Intra-Aortic Balloon Pump

-Summary

This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.

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+Arms and interventions

ArmTypeInterventionsDescription
Elective IABP InsertionExperimentalDevice: Intra-Aortic Balloon Pump
No Planned IABP InsertionNo intervention
  • Intra-Aortic Balloon Pump (Device): Elective IABP insertion before PCI

+Outcome measures

Primary outcomes

  • Major Adverse Cardiac and Cerebrovascular Events [Hospital discharge or 28 days following PCI, whichever occurs sooner]: (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

Secondary outcomes

  • All-cause Mortality [6-months following randomization]
  • Major Procedural Complications [Duration of PCI procedure]
  • Bleeding Complications (Major and Minor) [Hospital Discharge or 28 days following PCI (whichever occurs sooner)]
  • Access Site Complications [Hospital Discharge or 28 days following PCI (whichever occurs sooner)]
  • Transient Ischemic Attack [Hospital Discharge or 28 days following PCI (whichever occurs sooner)]
  • Length of Hospital Stay [Hospital Discharge]
  • Procedural Success [Duration of PCI procedure]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* impaired left ventricular function (Ejection Fraction < 30%)
* large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Exclusion Criteria:

* cardiogenic shock
* acute STEMI within previous 48 hours
* complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias)
* contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)

+Posted results

Participant flow

MilestoneElective IABP InsertionNo Planned IABP Insertion
Started151150
Completed151150
Not completed00

Outcome results

  • Major Adverse Cardiac and Cerebrovascular Events (Primary), Count of participants, Participants: Elective IABP Insertion 23; No Planned IABP Insertion 24
  • All-cause Mortality (Secondary)
  • Major Procedural Complications (Secondary)
  • Bleeding Complications (Major and Minor) (Secondary)
  • Access Site Complications (Secondary)
  • Transient Ischemic Attack (Secondary)
  • Length of Hospital Stay (Secondary)
  • Procedural Success (Secondary)

Adverse events

ArmDeathsSerious adverse eventsOther adverse events
Elective IABP Insertion3/151 (2.0%)2/151 (1.3%)2/151 (1.3%)
No Planned IABP Insertion1/150 (0.7%)0/150 (0.0%)16/150 (10.7%)

Serious adverse events by term

TermOrgan systemElective IABP InsertionNo Planned IABP Insertion
CVANervous system disorders2/1510/150

Other adverse events by term

TermOrgan systemElective IABP InsertionNo Planned IABP Insertion
Procedural ComplicationsCardiac disorders2/15116/150

+Locations (1)

FacilityCityCountryStatus
British Cardiovascular Intervention SocietyLondonUnited Kingdom

+Publications

  • Results publication: Perera D, Stables R, Clayton T, De Silva K, Lumley M, Clack L, Thomas M, Redwood S; BCIS-1 Investigators. Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention. Circulation. 2013 Jan 15;127(2):207-12. doi: 10.1161/CIRCULATIONAHA.112.132209. Epub 2012 Dec 6. PMID 23224207
  • Results publication: Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, de Belder A, Redwood S; BCIS-1 Investigators. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):867-74. doi: 10.1001/jama.2010.1190. PMID 20736470
  • Results publication: Perera D, Stables R, Booth J, Thomas M, Redwood S; BCIS-1 Investigators. The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design. Am Heart J. 2009 Dec;158(6):910-916.e2. doi: 10.1016/j.ahj.2009.09.015. PMID 19958856

+Investigators