FUNctional eFficacy of Hybrid coronAry REvascularization
FUNctional eFficacy of Hybrid coronAry REvascularization
The purpose of the study is to compare iFR-guided hybrid coronary revascularization (HCR) and
 traditional coronary artery bypass grafting (CABG) in terms of a functional efficacy of
 revascularization assessed by weighted average of iFRs measured 12 month post-procedure in
 the qualified coronary arteries (all arteries with at least one significant lesion and
 diameter >1.5 mm at baseline). The true significance of coronary artery disease (CAD) is
 reflected by the pressure gradients in coronary arteries showing the actual drop in
 myocardial perfusion whereas the degree of anatomical narrowing in fact only indicates a
 potential for hemodynamical changes that also depend on vessel compliance, distal vascular
 resistance, and collateral circulation. Then, the true effect of myocardial revascularization
 as treatment of CAD should be likewise assessed by measuring residual pressure gradients in
 coronary arteries remaining after revascularization, i.e. as the functional efficacy in
 analogy to the functional significance of CAD.
New generation of drug eluting stents (DES) have been shown to have better long-term patency
 rates than the vein grafts utilized in conventional CABG. Then, it may be expected that
 hybrid coronary revascularization (HCR) combining minimally invasive direct coronary artery
 bypass (MIDCAB) grafting of left anterior descending (LAD) artery by left internal mammary
 artery (LIMA) and stenting of non-LAD coronary arteries with the new generation DESs may have
 superior efficacy and safety compared to conventional CABG in patients with multivessel
 coronary artery disease (CAD). The true significance of CAD is reflected by the pressure
 gradients in coronary arteries that show actual changes in coronary blood flow and myocardial
 perfusion whereas the degree of anatomical narrowing only indicates a potential for the
 hemodynamical changes that also depend on vessel compliance, distal vascular resistance, and
 collateral circulation. Then, the true effect of myocardial revascularization as treatment of
 CAD should be likewise assessed by measuring residual pressure gradients in coronary arteries
 after revascularization, i.e. as the functional efficacy in analogy to the functional
 significance of CAD. For multi-vessel disease the summary hemodynamic effectiveness of
 revascularization may be captured either by continuous variable, e.g. averaged magnitude of
 the post-procedural pressure gradients in the qualified arteries or by categorical index,
 e.g. a relative proportion of the arteries with significant post-procedural pressure
 gradients among the qualified arteries both preferably weighted for their significance in
 myocardial blood supply. For comprehensive comparison of the revascularization strategies the
 qualified arteries should include all arteries/branches that had significant disease at
 baseline and were amenable to treatment with at least one of the revascularization methods,
 e.g. with at least one stenosis >70% and diameter >1.5 mm. The categorical measure of the
 functional efficacy may also be considered a measure of the functional completeness of
 revascularization in analogy to the conventional anatomical completeness. This functional
 completeness in terms of removal of all significant pressure gradients in coronary arteries
 is expected to be superior to anatomical completeness for assessing the procedural success of
 the intervention because the successful grafting/stent implantation does not guarantee the
 permanent removal of the pressure gradients, which may still persist due to development of
 intimal hyperplasia along the suture line of surgical anastomosis or stent
 underexpansion/edge dissection.

 The primary purpose of the study is to assess whether iFR -guided HCR done as the staged
 procedure with LIMA-LAD MIDCAB at first stage, and percutaneous coronary intervention (PCI)
 of non-LAD arteries at the second stage, is superior to conventional CABG in terms of the
 functional efficacy of revascularization assessed by the weighted average of iFRs measured 12
 month post-procedure in all 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. For proximal
 lesions in major coronary arteries - LAD, circumflex (Cx), and right coronary artery (RCA) -
 the simple weights 0.5, 0.25, 0.25 will be used, respectively. For other lesions the Duke
 jeopardy scores will be used instead. Measurement of functional efficacy at 12 month
 post-procedure will allow assessment of the final result of the intervention after complete
 vessel healing, endothelialization of the stents, on stable antithrombotic treatment, etc.
 Also, this study will assess whether achieving the functional completeness of
 revascularization described above in addition to the anatomical completeness of the procedure
 may further improve the treatment outcomes in patients with multivessel CAD. Specifically,
 the investigators will assess the relationship between the functional completeness of the
 revascularization and the occurrence of the MACCE over 1, 3, and 5 years following
 randomization in the patients with anatomically complete procedures. Finally, the hypothesis
 will be tested that iFR-guided HCR has better overall safety than CABG. Whereas, compared to
 CABG HCR is associated with less frequent perioperative complications, blood transfusions,
 shorter ICU and hospital stays, these benefits of less invasive treatment may be overridden
 by the additional complications of stenting, e.g. acute stent thrombosis, dissection,
 arterial perforation/rupture and others. With iFR guidance of the HCR these additional
 complications of PCI are expected to be less frequent and the whole procedure - more safe.
Inclusion Criteria:

 -  Signed written informed consent

 -  Stenosis ≥70% of the LAD and/or ≥50% of left main coronary artery in combination with
 at least one stenosis ≥70% of the Cx or RCA, suitable for revascularization (decided
 by a heart team)

 -  SYNTAX value ≥22.

 -  Clinical indications for coronary revascularization (angina refractory to optimal
 medical treatment, ischemia on non-invasive tests, reduced left ventricular ejection
 fraction)

 Exclusion Criteria:

 -  Previous heart surgery of any kind, including CABG

 -  Previous surgery involving the left pleural space

 -  The need for concomitant vascular or other cardiac surgery during index procedure
 (valve surgery, aortic surgery, left ventricular aneurysmectomy, endarterectomy, etc.)

 -  Chronic lung disease

 -  Chronic kidney disease determined as eGFR<60 ml/min/sq.m

 -  Failure to give informed consent.

 -  Life expectancy due to non-heart disease is less than 1 year.