MInithoraCotomy vs Sternotomy for Multivessel Coronary Artery Bypass Grafting: A Partially Randomized Patient Preference Trial Assessing Quality of Life and Patency Outcomes
This trial will address essential questions of the efficacy and safety of MICS-CABG in addition to the quality of life and patency rate of the grafts. The study will also address the impact of patients' preferences on external validity and internal validity. In this study, patients with a preference will be allocated to treatment strategies accordingly, whereas only those patients without a distinct preference will be randomized. The randomized trial is a 248-patient controlled, randomized, investigator-blinded trial. It is designed to compare whether treatment with MICS-CABG is beneficial in comparison to CABG. This study is aimed to establish the superiority hypothesis for the physical component summary (PCS) accompanied by the noninferiority hypothesis for overall graft patency. Patients with no treatment preference will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoints are the PCS score at 30 days (1 month) after surgery and the overall patency rate of the grafts within 14 days ( before discharge) after surgery. Secondary outcome measures include the PCS score and patency rate at different time points. Safety endpoints include major adverse cardiac and cerebrovascular events, complications, bleeding, wound infection, death, etc.
Eligibility
Sex
ALL
Min age
25 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:(A patient will be included in the study when the following criteria and requirements are met)
① Patient age of ≥25 years but ≤85 years, and patients with CAD who require multivessel coronary bypass surgery. ② Angina that affects daily life and work and is uncontrollable with conservative treatment. ③ Significant stenosis in the left main (LM) coronary artery, left anterior descending (LAD) branch or left circumflex (LCX) branch \>70%. ④ Severe stenosis (stenosis degree \>70%) of three main branches of the coronary artery (anterior descending branch, circumflex branch, right coronary artery) with the need to undergo off-pump coronary artery bypass surgery.
Exclusion Criteria:
* Unstable preoperative hemodynamic status requiring emergency surgery
* Severe emphysema, hypoxemia \[post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC)\<70% and FEV1%predicted\<50% or partial pressure of oxygen (pO2)\<60 mmHg or partial pressure of carbon dioxide (pCO2)\>40 mmHg without oxygen therapy\]
* Old large area myocardial infarction, no viable myocardium based on isotope and echocardiography examination, significant cardiac enlargement, cardiothoracic ratio\>0.75, EF\<30%, left ventricular diastolic diameter (LVDd)\>60 mm, left ventricular aneurysm or severe arrhythmia, prone to experience unstable preoperative hemodynamic status during surgery
* Severe pleural adhesion, chest deformity, or previous thoracic radiotherapy
* Previous open heart surgery
* Simultaneous valve or other cardiac surgery
* Planned cardiopulmonary bypass surgery
* Poor condition of myocardial infarction (MI), extensive lesion, distal or entire diffuse stenosis, or inability to match lumen due to small diameter (\<1.0 mm) or severe calcification
* Others: Terminal cancer, uncontrolled infection, bleeding, progressive degenerative systemic disease, severe brain injury, multiple organ failure and other major organ dysfunction such as severe liver dysfunction, severe heart failure or cardiogenic shock, intolerance to surgery, and other contraindications of CABG
Primary outcome measure(s)
SF-36 PCS score (Physical component summary of medical outcomes study-short form 36-item scores) at 30 days (1month) after surgery — 30 days (1 month) after surgery The SF-36 is a concise health test that features Physical Functioning (PF), Roe-Physical (RP), Bodily Pain, General Health (GH), Vitality (VT), Social Functioning (SF), Roe-Emotional (Emotional) and Mental Health (MH) functioning and comprehensively summarizes the quality of life of the respondents across 8 aspects. The PCS and mental component summary (MCS) can be calculated from the eight abovementioned indicators with different weights. The PCS and the MCS each range from 0 to 50, with a lower score indicating worse quality of life (QoL) and a higher score indicating better QoL.
Overall patency rate of the grafts — within 14 days after surgery (before discharge) the patency rates of the LIMA, RIMA, saphenous vein graft (SVG) and radial artery (RA) will be evaluated by the Fitzgibbon A+B grade
Trial sites (1)
Facility
City
Region
Status
Peking University Third Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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