Clinical trial NCT03857906: Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery
Official title: Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Cardiomyopathy
Heart Failure
Keywords: intra-aortic balloon pump
coronary artery bypass graft
preoperative
Lead sponsor: CMN "20 de Noviembre"
Sponsor class: OTHER
Collaborators: name: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
First posted: 2019-02-28
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac surgery were assessed for the inclusion/exclusion criteria, provided signed informed consent, and were allocated to one of two treatments: IABP insertion before skin incision (IABP group) or no IABP insertion (control group). In all cases, the decision of the IABP insertion was generated in a previous Heart Team session, this team was integrated by a Clinical Cardiologist, Cardiac Interventionist, Cardiothoracic Surgeon and Anesthesiologist, in base on the personal risk/benefit of each patient. There was no blinding for patients or physicians in aware of the Heart Team decisions. Outcome assessors were unaware of the assigned treatment.

Brief summary: Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.

Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.

Detailed description: Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).

Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p \<0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0

Eligibility criteria: Inclusion Criteria:

* All patients greater than 18 years
* Scheduled for coronary artery bypass graft (CABG) surgery were eligible
* Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (\>50%)
* Written informed consent provided

Exclusion Criteria:

* Prior cardiogenic shock,
* Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
* Previous IABP use
* AMI mechanical complications
* Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
* Tachyarrhythmia
* Other aortic procedures
* Other non-CABG surgical procedures
* Massive pulmonary embolism
* Older than 90 years of age
* Any coagulopathy
* Severe concomitant disease associated with a life expectancy of less than 6 months.

Primary outcomes:
measure: 30-Day All-Cause Mortality
timeFrame: 30 days
measure: 30-Day Postoperative Myocardial Infarction
timeFrame: 30 days
Secondary outcomes:
measure: 30-day occurrence rate of PCI
timeFrame: 30 days
measure: Requirement of mechanical ventilation
timeFrame: 30 days
measure: acute kidney injury
timeFrame: 30 days
measure: Need for renal replacement therapy
timeFrame: 30 days
measure: ICU length of stay
timeFrame: 30 days
measure: Postoperative use of inotropes and vasopressors
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: CMN "20 de Noviembre"
name: Juán Antonio Suárez-Cuenca
role: PRINCIPAL_INVESTIGATOR
References: