Trial Outcomes & Findings for Balloon Pump Assisted Coronary Intervention Study (NCT NCT00910481)

NCT ID: NCT00910481

Last Updated: 2024-08-07

Results Overview

(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 301 participants
• Primary outcome timeframe: Hospital discharge or 28 days following PCI, whichever occurs sooner
• Results posted on: 2024-08-07

Participant Flow

Participant milestones

Measure	Elective IABP Insertion Intra-Aortic Balloon Pump: Elective IABP insertion before PCI	No Planned IABP Insertion
Overall Study STARTED	151	150
Overall Study COMPLETED	151	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Balloon Pump Assisted Coronary Intervention Study

Baseline characteristics by cohort

Measure	Elective IABP Insertion n=151 Participants Left ventricular ejection fraction was 23.6% (SD, 5.2%) in the elective IABP group	No Planned IABP Insertion n=150 Participants Left ventricular ejection fraction was 23.6% (SD, 5.5%) in the no planned IABP group	Total n=301 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	33 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	125 Participants n=5 Participants	117 Participants n=7 Participants	242 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	117 Participants n=7 Participants	239 Participants n=5 Participants

PRIMARY outcome

Timeframe: Hospital discharge or 28 days following PCI, whichever occurs sooner

Population: All

(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

Outcome measures

Measure	Elective IABP Insertion n=151 Participants Intra-Aortic Balloon Pump: Elective IABP insertion before PCI	No Planned IABP Insertion n=150 Participants
Major Adverse Cardiac and Cerebrovascular Events	23 Participants	24 Participants

SECONDARY outcome

Timeframe: 6-months following randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of PCI procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital Discharge or 28 days following PCI (whichever occurs sooner)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital Discharge or 28 days following PCI (whichever occurs sooner)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital Discharge or 28 days following PCI (whichever occurs sooner)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital Discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of PCI procedure

Outcome measures

Outcome data not reported

Adverse Events

Elective IABP Insertion

Serious events: 2 serious events

Other events: 2 other events

Deaths: 3 deaths

No Planned IABP Insertion

Serious events: 0 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Measure	Elective IABP Insertion n=151 participants at risk Intra-Aortic Balloon Pump: Elective IABP insertion before PCI	No Planned IABP Insertion n=150 participants at risk
Nervous system disorders CVA	1.3% 2/151	0.00% 0/150

Other adverse events

Measure	Elective IABP Insertion n=151 participants at risk Intra-Aortic Balloon Pump: Elective IABP insertion before PCI	No Planned IABP Insertion n=150 participants at risk
Cardiac disorders Procedural Complications	1.3% 2/151	10.7% 16/150

Additional Information

Professor Divaka Perera

King's College London

Phone: 02071887188

Email: divaka.perera@kcl.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place