Research grants

The aim of the study is to compare contemporary methods of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). The study hypothesis is the non-inferiority of PCI compared to CABG in terms of the primary composite endpoint (death, myocardial infarction, stroke).
The study will include patients with multivessel coronary artery disease, left main coronary artery disease, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS), who are eligible for early invasive treatment, have a Syntax Score below 33, and for whom both PCI and CABG are deemed feasible with the possibility of achieving complete revascularization, as assessed by the “Heart Team” consisting of an interventional cardiologist and a cardiac surgeon. For centers without a cardiac surgery department, “Heart Team” consultations will be conducted via videoconference, and imaging records will be transferred using the TeleDICOM system.

Main exclusion criteria include qualification for conservative treatment, procedures other than CABG due to structural heart defects, STEMI, stable coronary artery disease, or immediate need for PCI.
After meeting inclusion criteria and none of the exclusion criteria, the patient will be randomized in a 1:1 ratio to PCI or CABG.
PCI procedures will be performed after hemodynamic assessment of all lesions using modern techniques (iFR, QFR), with implantation of contemporary drug-eluting stents, and optimized using intravascular imaging.
CABG procedures will be performed according to the experience of the individual center, including the OPCAB technique, and the internal mammary artery will be used in all cases.

The primary endpoint of the study is a composite of all-cause death, myocardial infarction, and stroke at 1-year follow-up.
To prove the study hypothesis with 80% power, a 5% alpha error, and a 5% loss to follow-up rate, 500 patients per group must be included.
Secondary endpoints will include ischemia-driven repeat revascularization, left ventricular ejection fraction, major and minor bleeding, new-onset atrial fibrillation, de novo heart failure, unplanned rehospitalization, quality of life, and cost-effectiveness.
After discharge, patients will follow strict secondary prevention protocols, including both cardiac and surgical rehabilitation, and attend four scheduled follow-up specialist visits including echocardiography and exercise testing at designated time points.

Positive results from this study will confirm the safety and effectiveness of PCI in this patient population, which may enhance access to treatment and broaden therapeutic options for a large group of patients. The findings may also lead to the revision and development of new international clinical guidelines. Furthermore, the study will support decision-making processes in centers without on-site cardiac surgery facilities.

The study is designed as a randomized, blinded, and multicenter clinical trial. A total of 110 patients diagnosed with HFpEF will be included. Fifty-five patients will be randomly assigned to each study arm based on the 2021 European Society of Cardiology (ESC) definition of HFpEF.
Each eligible patient will undergo an exercise test on a bicycle cardiopulmonary ergospirometer, as well as laboratory tests including both a basic panel and measurements of selected adipokines and inflammatory markers in the blood serum. Quality of life will also be assessed, and coronary angiography with evaluation of coronary microcirculation will be performed. Based on the ergospirometry test results, an individual training load will be established for the home rehabilitation period.
Subsequently, a bicycle ergometer and a set of sensors for telerehabilitation will be delivered to the patient’s home, and the participant will be trained in their use. Over the following 12 weeks, the intervention group will perform supervised home-based rehabilitation sessions four times a week via remote monitoring. The control group, consisting of 55 patients, will receive standard care.

After 12 weeks, all participants will undergo a follow-up ergospirometry exercise test, a repeat of the initial laboratory tests, quality of life assessment, and a follow-up coronary angiography with coronary microcirculation evaluation. Every adverse event will be assessed for home rehabilitation safety by an independent team.
Primary endpoints of the study will include evaluation of physical capacity parameters obtained from cardiopulmonary exercise testing, left ventricular filling parameters, and patients’ quality of life.

We hypothesize that properly conducted home rehabilitation can significantly improve the physical performance of patients with HFpEF as assessed by the exercise test. Furthermore, parameters of left ventricular filling may also improve. Improvement in these parameters has been proven to reduce the risk of mortality, decrease hospitalization rates, and enhance the quality of life in patients with HFpEF.

Project co-financed under the Operational Program Innovative Economy 2007-2013, Priority Axis IV. Investments in innovative undertakings, Measure 4.5. Support for investments of great importance for the economy, Sub-measure 4.5.2. Support for investments in the modern services sector.