Comparison of Short- and Mid-term Outcomes of Off-pump and On-pump Coronary Artery Bypass Grafting (CABG) surgery in Patients With 3-vessel Coronary Artery Disease: A Randomized Clinical Trial

Comparison of short-term and medium-term complications of on-pump vs. off-pump coronary artery bypass grafting

the randomized trial, phase 4, randomized by the method of blocks of 4 in two equal parallel groups (off-pump and on-pump) of 274 patients.

All surgeries were performed at the Tehran Heart Center by a high-experienced surgeon in both methods with and without the use of a cardiopulmonary pump device. Due to the nature of the intervention (type of surgery), blinding of the intervention was done for the patients, post-operative follow-up doctors, and data analysts.

inclusion criteria: patients with three vessels coronary disease requiring coronary artery bypass grafting surgery. exclusion criteria: Patients with Single-vessel CAD and/or other concomitant cardiac surgery such as valve replacement, aorta reconstruction, or other additional cardiovascular disease necessitating concomitant surgery were excluded.

The first group: patients who undergo coronary artery bypass surgery using the on-pump method. The second group: patients who undergo coronary artery bypass surgery by the off-pump method.

major adverse cardiovascular events (MACE) including all-cause mortality, acute coronary syndrome, stroke or transient ischemic attack, and the need for repeat revascularization (percutaneous coronary intervention or redo-CABG).

Randomization will be done by the method of "limited randomization" and using the method of blocks of equal size (each block of four patients). By convention, we assign two letters A and B to each type of surgery (off-pump and on-pump). In each block, we will have different permutations of A and B, but an equal number of each intervention (2 to A and 2 to B). In this way, we will have six blocks. Then the sequence of these blocks will be made randomly by the random sequence generation software "Random Allocation Software", which according to the sample size of 272, we will have 68 blocks. Then, in order to hide the random allocation, the "central randomization" method will be used. In this method, sequence information will be provided to someone outside of the study process in the research center, and researchers will be informed of the type of intervention assigned to that patient by phone call based on the order of patients entering the study. This process will continue until the last patient.

According to the contract, one of the letters A and B is assigned to each type of surgery (Off-pump and On-pump) before the start of the study. Due to the nature of the intervention (type of surgery), which cannot be blinded for the surgeon and the main staff of the surgical team, blinding of the intervention is done for the patients, doctors, and those responsible for collecting the data of the outcome of the post-surgery study and the data analyst, and these people They will not know about the type of intervention assigned to groups A and B, and in the information available to these people, the type of intervention is indicated by the letters mentioned.

All clinical information of patients without personal information after patient de-identification

Six months after the publication of the results

All biological science researchers

For inclusion in review studies or referring to result of current study in publications

The data will be accessible by sending an official request to mmd.forouzan@gmail.com

Requests will be accessible to the requester by sending the data file via email after being reviewed by the Tehran Heart Center Research Council