Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Functional efficacy of revascularization |
Will be assessed as weighted average of the residual (12 month post-procedure) iFRs in coronary arteries that had at least one significant stenosis (>70% for CABG group, iFR = 0.89 for iFR-guided HCR) and diameter =1.5 mm at baseline. In case of proximal lesions of LAD, Cx, RCA, the coefficients 0.5; 0.25; 0.25 will be used, respectively. For other lesions Duke jeopardy scores will be used instead (for this scoring, the coronary tree is divided into 6 segments:1) LAD beyond the diagonal branch take-off, 2) major diagonal branch of the LAD, 3) major septal branch of the LAD, 4) Cx beyond the major obtuse margin branch take-off, 5) major obtuse margin branch, and 6) the posterior descending branch of the RCA. Each such segment is assigned 2 points with a possible maximum of 12/12. |
From baseline to 12 month |
|
| Secondary |
Between-group difference in the number of major cardiovascular and cerebral events (MACCE) |
The components of MACCE will be all-cause mortality, myocardial infarction (MI), stroke, and unplanned coronary revascularization |
From baseline to 12 months, 3, and 5 years |
|
| Secondary |
Between-group difference in the functional efficacy of the revascularization of non-LAD arteries |
Will be assessed as weighted average of the residual (12 month post-procedure) iFRs in all non-LAD coronary arteries with at least one significant stenosis (>70% for CABG group, iFR = 0.89 for iFR-guided HCR) and diameter =1.5 mm at baseline |
From baseline to 12 months |
|
| Secondary |
Between-group difference in the functional completeness of the revascularization |
The functional completeness will be assessed as the proportion of the coronary arteries with significant iFR at12 month post-procedure among the arteries with at least one significant stenosis (>70% for CABG group, iFR = 0.89 for iFR-guided HCR) and diameter =1.5 mm at baseline |
From baseline to 12 months |
|
| Secondary |
Between-group difference in the number of serious adverse events (other than MACCE) |
Any untoward medical occurrence that is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity |
From baseline to 12 months |
|
| Secondary |
Between-group difference in the frequency of serious adverse events in the peri-operative period |
Any untoward medical occurrence that is life-threatening, requires prolongation of existing hospitalization, results in persistent or significant disability/incapacity.
For HCR - a combination of the events during both surgical and endovascular stages (including stent thrombosis, dissections/ perforations/ruptures of coronary arteries, contrast nephropathy, pseudoaneurysms requiring surgical treatment) |
From the day of procedure to one week post-procedure |
|
| Secondary |
Between-group difference in the operation duration |
Duration of the operation in minutes |
From the time of intubation to the time of discharge from operating room assessed up to 24 hours |
|
| Secondary |
Between-group difference in the mechanical ventilation time |
A total inspiratory time when the tidal volume was delivered or the pressure was maintained |
From the intubation to complete withdrawal of ventilation support assessed up to 1 week |
|
| Secondary |
Between-group difference in ICU stay |
A total time spent in intensive care unit in hours |
From the time of discharge from operating room to the time of discharge from ICU assessed up to 30 days |
|
| Secondary |
Between-group difference in the number of patients who undergone re-operation for bleeding |
Repeat surgery needed for bleeding or cardiac tamponade either before hospital discharge or between hospital discharge and within 30 days of their index operation if discharged earlier than 30 days |
From the index operation to 30 days post-procedure |
|
| Secondary |
Between-group difference in the number of patients who received blood transfusion(s) |
Any transfusion of blood or blood products |
From the day of CABG to hospital discharge assessed up to 30 days |
|
| Secondary |
Between-group difference in the number of patients with wound infection |
Purulent discharge from the surgical site, wound or drain placed in the wound with at least one of the following signs/symptoms - pain or tenderness, localised swelling, or redness/heat |
From the end of surgery to hospital discharge assessed up to 30 days |
|
| Secondary |
Between-group difference in hospital stay |
A total number of days spent in hospital after surgery including PCI stage |
From the day of CABG to the discharge after PCI assessed up to 2 months |
|
| Secondary |
Between-group difference in the number of repeated revascularizations |
Any surgical or endovascular revascularization |
From baseline to 12 months |
|
| Secondary |
Between-group difference in the number of hospitalizations |
Any hospital stay longer than 24 hours |
From baseline to 12 months follow-up |
|
| Secondary |
Between-group difference in angina score |
Canadian Cardiovascular Society Classification |
12 months after the procedure |
|
| Secondary |
Between-group difference in the quality of life |
Will be assessed using EQ-5D instrument |
12 months after the procedure |
|
| Secondary |
Effect of proportion of coronary arteries with significant iFR 12 month post-procedure among the arteries with =1 significant stenosis and diameter =1.5 mm at baseline on probability of MACCE in patients with anatomically complete procedures |
Effect of functional completeness of revascularization on occurrence of MACCE evaluated by logistic regression model |
1, 3, and 5 years following randomization |
|
