The Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery

A Partially Randomized Patient Preference Trial to Assess the Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting: the MICS-CABG PRPP Trial

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 after surgery and the overall patency rate of the grafts within 14 days 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Minimally Invasive Cardiac Surgery
• Intervention / Treatment: Procedure: MICS-CABG; Procedure: sternotomy CABG

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yichen Gong, Doctor; Phone Number: 8618611693463; Email: 18611693463@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 >75%) 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:(A patient will be excluded from the study if they meet any of the following criteria)

① Unstable preoperative hemodynamic status (vasoactive drugs such as dopamine, epinephrine or norepinephrine to maintain blood pressure, or an intra-aortic balloon pump [IABP] is implanted preoperatively) or requiring emergency surgery. ② Severe emphysema, hypoxemia [postbronchodilator 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. ③ Old extensive myocardial infarction without a 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). ④ Severe pleural adhesion, chest deformity, or previous thoracic radiotherapy. ⑤Previous thoracotomy surgery. ⑥ Simultaneous valve or other cardiac surgery. ⑦Planned cardiopulmonary bypass surgery. ⑧Poor condition of the distal coronary artery (diffuse stenosis, chronic total obstructive lesion with severe calcification or inability to match the graft due to a small diameter (<1.0 mm). ⑨Intolerance to surgery in combination with the following complications: Terminal cancer, uncontrolled infection, bleeding, severe brain injury, infarction or bleeding, multiple organ failure and other major organ dysfunction such as severe liver dysfunction or severe congestive heart failure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MICS-CABG; Patients undergoing MICS-CABG.	Procedure: MICS-CABG; Off-pump multi-vessel coronary artery bypass grafting via left thoracotomy under minimally invasive conditions.
Active Comparator: sternotomy CABG; Patients undergoing thoracotomy OPCABG.	Procedure: sternotomy CABG; Off-pump multi-vessel coronary artery bypass grafting with conventional thoracotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 PCS score	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.	30 days after surgery
Overall patency rate of the grafts	the patency rates of the LIMA, RIMA, saphenous vein graft (SVG) and radial artery (RA) will be evaluated by the Fitzgibbon A+B grade	within 14 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 PCS scores	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.	7 days, 3 months, 6 months and 1 year after surgery
SF-36 MCS scores	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.	7 days, 3 months, 6 months and 1 year after surgery
Patency rate of the different material grafts	the patency rates of the LIMA, RIMA, saphenous vein graft (SVG) and radial artery (RA) will be evaluated by the Fitzgibbon A+B grade	14 days and 1 year after surgery
Length of incubation	the time of assisted respiratory ventilation after surgery	within 7 days after surgery
Hospitalization cost	total hospitalization cost of each patient	within 7 days after surgery
Length of postoperative hospitalization time	total postoperative hospitalization time of the patients	within 7 days after surgery
Bypass surgical variation index	The actual graft number is compared with the preoperative strategy. If the actual number of grafts is less than that in the preoperative plan, the results will be recorded.	within 7 days after surgery
Intrahospital RBC transfusion volume	the amount of red blood cells (U) to be transfused during hospitalization. Indications for blood transfusion include hemoglobin less than 90 g/L, severe intraoperative or postoperative active bleeding, or other blood transfusion considered necessary by the surgeons.	within 7 days after surgery
Wound infection rate	wound dehiscence, effusion and secondary debridement and suture	within 3 months after surgery
Number of Participants with re-exploration for bleeding or other causes (not including wound-related causes)	the requirement to return to the operating room for reopening of sternotomy or MICS CABG incision for any reason, such as bleeding, postoperative acute myocardial ischemia and unexplained circulatory instability. Debridement for DSWI or infection of anterior-lateral wounds will be excluded.	within 1 year after surgery
Major adverse cardiac and cerebrovascular events (MACCEs)	Composite endpoint of all-cause death, nonfatal myocardial infarction, stroke, and target vessel ischemia-driven repeated revascularization (TVR).	1, 6, 12, 24, 36, and 60 months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Yunpeng Ling, Peking University Third Hospital; Principal Investigator: Yichen Gong, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2021
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PKU MICS-CABG PRPP Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No