Revascularization With BVS or CABG in Patients With Advanced CAD
Revascularization With BVS or CABG in Patients With Advanced CAD
The purpose of the study is to investigate the extent of ischemia and left ventricular
 function in cardiovascular magnetic resonance (CMR), as well as patency of coronary arteries
 and grafts in coronary computed tomography angiography at 12 months follow up in patients
 with advanced coronary artery disease treated with percutaneous coronary intervention with
 the implantation of bioresorbable scaffolds or coronary artery bypass graft surgery.

 Additionally, the clinical results of the two methods of revascularization will be carried
 out annually up to 5 years.
Coronary artery disease (CAD) is the leading cause of death among adult population in
 developed countries. Optimal method of revascularization of patients with multivessel CAD is
 still the matter of debate. Currently, there are two recognized methods: percutaneous
 coronary intervention (PCI) and coronary artery bypass grafting (CABG). Both methods were
 compared in a number of studies, including several randomized trials. Most trials have left
 some doubts. First of all, none of them used functional evaluation of the stenosis. The
 decision regarding revascularization was based on angiographic results alone. The trials that
 have used fractional flow reserve (FFR) show no clear correlation between the degree of
 stenosis assessed angiographically, in the range of 50-90%, and its functional significance.
 In a randomized FAME trial, out of 1329 significant stenosis assessed anatomically, nearly
 40% revealed no functional significance. The study showed that coronary revascularization
 guided by FFR in multivessel stable CAD resulted in a smaller number of vessels stented, and
 hence fewer stent implantations. Such a strategy has improved patient clinical outcomes. In
 the group of patients undergoing revascularization based on fractional flow reserve
 significant reduction in major adverse cardiac events (MACE) was observed in 1- and 2-year
 follow up.

 Another weakness of former studies was the use of first-generation drug eluting stent (DES)
 showing an increased risk of restenosis and late and very late stent thrombosis. Many
 randomized studies documented superiority of new generation DES, with more biocompatible or
 bioresorbable polymer in terms of the incidence of MACE (SPIRIT, LEADERS). Recently, fully
 bioresorbable vascular scaffolds (BVS) have been introduced into routine clinical practice.
 Preliminary results of the ABSORB EXTEND trial demonstrated similar efficacy and safety of
 the Absorb BVS, as compared with the best-in-class its metallic counterpart XIENCE. Since the
 complete resorption of the scaffold requires two-three years, the greatest clinical benefit
 will be observed a couple of years after implantation. Total bioresorption of the scaffold
 not only allows to restore the physiological function of the vessel, but also eliminates a
 number of adverse events associated with the presence of permanent metallic prosthesis in the
 vessel wall, such as very late stent thrombosis and the neo-atherosclerosis development.

 Intravascular imaging with intravascular ultrasound (IVUS) or optical coherence tomography
 (OCT) is widely considered the gold standard for scaffold optimal implantation, although
 currently it is not routinely used. The use of intravascular imaging techniques before and
 after BVS implantation may help to avoid inadequate expansion and apposition of the scaffold
 struts. Subintimal calcifications detected with IVUS or OCT require adequate lesion
 preparation before stent deployment. This is particularly crucial for patients receiving BVS,
 where the goal of lesion preparation is to facilitate scaffold delivery, reduce plaque shift
 and to allow optimal scaffold expansion. OCT with its greater resolution enables to assess
 the scaffold integrity, apposition and the presence of thrombus or edge dissections.

 Based on the ABSORB EXTEND trial there are some suggestions for longer dual antiplatelet
 therapy duration and more potent agents than clopidogrel (i.e. ticagrelor) regardless of
 clinical presentation, particularly in the first months after BVS implantation. Ticagrelor in
 the PLATO trial has been shown to reduce the rate of a combined endpoint of cardio-vascular
 death, myocardial infarction, or stroke compared to clopidogrel. In patients treated with
 PCI, it also reduces the rate of stent thrombosis. Statins are the most widely used
 LDL-lowering drugs in high-risk patients. It is recommended to achieve a greater than 50%
 reduction in LDL levels. Treatment goal for fasting LDL-cholesterol is < 70 mg/dl (1.8
 mmol/l). In comparison with other lipid-lowering agents, rosuvastatin is the most potent
 agent to achieve the required reduction of LDL. Rosuvastatin in maximal tolerated dose is
 indicated to reduce the risk of myocardial infarction and revascularization procedures.

 RELEASE-BVS study is the first trial that takes into account all of the following important
 aspects:

 -  stable advanced coronary artery disease: 3-vessel disease or significant left main (LM)
 stenosis, suitable for either PCI or CABG with proven ischemia in stress CMR;

 -  coronary revascularization (PCI) guided by functional assessment of stenosis (iFR/FFR);

 -  the use of a bioresorbable everolimus-eluting scaffolds (Absorb) and PCI optimization
 with intracoronary imaging techniques (OCT);

 -  long-term post-procedural management with potent antiplatelet drug (ticagrelor) and
 optimal lipid-lowering therapy with maximal tolerated dose of rosuvastatin.
Inclusion Criteria:

 -  Patient age ≥18 years

 -  Patient with symptomatic stable CAD or silent ischemia, with 3-vessel disease and/or
 significant stenosis of left main coronary artery on angiography, with significant
 ischemia evaluated in stress CMR

 -  Patient suitable for both PCI or CABG after local heart team evaluation

 -  Patient understands and accepts the meaning and the aims of the study and is willing
 to sign written informed consent

 Exclusion Criteria:

 -  Prior CABG

 -  Concomitant valve disease requiring cardiac surgery

 -  Metal implants that may be the contraindication for CMR examination (e.g. peacemaker,
 ICD)

 -  Other contraindication for stress CMR or computed tomography (claustrophobia, asthma,
 a-v bloc, allergy to radiographic contrast or any prior anaphylaxis to contrast)

 -  Contraindication for 12 months dual antiplatelet therapy (DAPT) or known allergy to
 acetylsalicylic acid, clopidogrel or ticagrelor

 -  Female patient with child bearing potential

 -  Acute coronary syndrome within 2 weeks prior to revascularization

 -  Significant stenosis of any vessel, including LM if reference diameter > 4mm

 -  left ventricular ejection fraction (LVEF) <35%

 -  Life expectancy < 12 months

 -  Stroke or transient ischemic attack (TIA) within 3 months prior to revascularization

 -  Chronic kidney disease, estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2

 -  Planned surgery (other than CABG) within 12 months after randomization

 -  Diathesis, chronic oral anticoagulation therapy or history of bleeding

 -  Current participation in another trial or registry