Condition category
Circulatory System
Date applied
13/09/2006
Date assigned
13/02/2007
Last edited
18/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rodney Stables

ORCID ID

Contact details

Liverpool Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00910481

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BCIS-1

Study hypothesis

Elective use of Intra-Aortic Balloon Pump (IABP) in high risk Percutaneous Coronary Intervention (PCI) patients will reduce the rate of in-hospital major adverse cardiovascular events compared to patients who are managed with no planned insertion of IABP.

Ethics approval

Approval received from the UK MREC for Scotland on the 28th April 2005 (ref. no.: 05/MRE00/43).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Multi-vessel coronary artery disease

Intervention

In brief patients in the elective group will have the IABP inserted at the start of the procedure, before coronary intervention. Unless prolonged use is clinically indicated, the IABP will be removed four to 24 hours following PCI. An intravenous (iv) heparin infusion will be commenced on completion of the Abciximab infusion, with a target Activited Partial Thromboplastin Time (APTT) ratio between 1.5 and 2.5. When it is felt appropriate to remove the IABP, the heparin infusion will be discontinued and the balloon catheter removed when the Activated Clotting Time (ACT) falls below 160 seconds. Manual pressure haemostasis is recommended.

In the No Planned group, bailout IABP insertion is at the discretion of the operator and would be considered acceptable if the following conditions occur during PCI:
1. Prolonged hypotension (relative to initial BP)
2. Refractory VT/VF
3. Pulmonary oedema

Bailout IABP insertion will be recorded as a secondary outcome event and not as cross-over between treatment assignments, if inserted in the context of the above conditions.

Intervention type

Drug

Phase

Not Specified

Drug names

Heparin, abciximab

Primary outcome measures

Comparison of Major Adverse Cardiovascular Events (MACE) at hospital discharge or 28 days whichever is sooner. MACE includes death, myocardial infarction, cerebrovascular accident and repeat revascularisation.

Secondary outcome measures

1. Mortality at six months
2. Procedural success
3. Procedural complications
4. Bleeding complications
5. Access site complications
6. Transient ischaemic attacks
7. Length of hospital stay

Overall trial start date

01/12/2005

Overall trial end date

30/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients at least 18 years of age
2. Proposed single or multi-vessel percutaneous intervention to native coronary arteries or coronary bypass grafts
3. Presence of BOTH the following high risk features:
3.1. Impaired Left Ventricular (LV) function: Ejection Fraction (EF) less than 30% (quantified by echocardiography or LV angiography)
3.2. Large area of myocardium at risk, either unprotected left main stem target lesion or Jeopardy Score more than or equal to eight, or target vessel provides collateral supply to an occluded second vessel which supplies more than 40% of myocardium
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Shock (systolic Blood Pressure [BP] less than 85 mmHg despite correction of hypovolaemia)
2. Acute myocardial infarction within previous 48 hours defined as:
2.1. chest pain or equivalent symptoms consistent with acute myocardial infarction, and
2.2. New ST segment elevation of at least 1 mm in two or more contiguous Electrocardiogram (ECG) leads, persisting for more than 15 minutes, or new left bundle branch block on ECG persisting for more than 15 minutes
3. Planned staged intervention procedure within 28 days of index PCI
4. Ventricular Septal Defect (VSD)/Mitral Regurgitation (MR) or intractable Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) post Myocardial Infarction (MI)
5. Thoracic/abdominal aortic disease
6. Significant ilio-femoral artery disease (documented on Doppler studies or ilio-femoral angiography or absent femoral pulses bilaterally), the presence of clinical signs of acute leg ischaemia and previous bilateral femoral bypass graft surgery
7. More than mild aortic regurgitation on echocardiography
8. Bleeding diathesis or Warfarin therapy with International Normalised Ratio (INR) more than 2.5
9. Active internal bleeding (except menstruation)
10. Allergy to aspirin, clopidogrel, heparin or Glycoprotein (GP) IIb/IIIa inhibitors
11. Thrombocytopenia (platelet count less than 100,000 cells/mm^3)
12. Women who are pregnant
13. Patients who have previously been enrolled in this study

Recruitment start date

01/12/2005

Recruitment end date

30/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool Cardiothoracic Centre
Liverpool
L14 3PE
United Kingdom

Sponsor information

Organisation

British Cardiovascular Interventional Society (UK)

Sponsor details

Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Research organisation

Website

http://www.bcis.org.uk/

Funders

Funder type

Industry

Funder name

Datascope (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cordis - a Johnson and Johnson Company (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eli Lilly and Company Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19958856
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20736470
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23224207

Publication citations

  1. Protocol

    Perera D, Stables R, Booth J, Thomas M, Redwood S, , The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design., Am. Heart J., 2009, 158, 6, 910-916.e2, doi: 10.1016/j.ahj.2009.09.015.

  2. Results

    Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, de Belder A, Redwood S, , Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial., JAMA, 2010, 304, 8, 867-874, doi: 10.1001/jama.2010.1190.

  3. Results

    Perera D, Stables R, Clayton T, De Silva K, Lumley M, Clack L, Thomas M, Redwood S, , 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, 127, 2, 207-212, doi: 10.1161/CIRCULATIONAHA.112.132209.

Additional files

Editorial Notes