Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI

National Institute of Cardiology, Warsaw, Poland74 enrolled

Overview

The ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Beyond the patient-oriented outcomes, the influence of the studied CTO PCI strategies on the stress levels among interventional cardiologists will be explored. The main questions it aims to answer are as follows: * What is the difference between ADR versus retrograde strategy with regard to total procedure time, the rates of successful guidewire crossing and periprocedural complications as well as stress levels experienced by interventional cardiologists? * Is retrograde approach associated with higher rates of myocardial injury/infarction based on cardiac troponin/cardiac magnetic resonance (CMR) as compared with ADR? Participants will undergo pre- and postprocedural laboratory testing (cardiac troponin, CK-MB), CMR for late gadolinium enhancement and health status assessment. Subjects undergoing successful CTO PCI using antegrade wiring strategy will be included in the observational arm.

The ADRENALINE trial is planned as a multicenter, prospective randomized research experiment in patients with clinical indication for PCI of CTO. The target population will comprise patients with at least difficult CTO (J-CTO score ≥2) and angiographic equipoise for either ADR or the retrograde CTO recanalization strategy as evaluated by 2 independent CTO PCI operators. The pre-procedural assessment will comprise cardiac magnetic resonance (CMR) for late gadolinium enhancement, laboratory testing (cardiac troponin, creatine kinase-MB) and health status assessed by the Seattle angina questionnaire (SAQ) and the Rose Dyspnea Scale. Subsequently patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or the retrograde CTO crossing strategy (n=74), while subjects undergoing successful antegrade wiring will be included in the observational arm (n=47). After CTO PCI, the cardiac troponin and creatine kinase-MB will be measured at 12 hours intervals (at least up to 24 hours), while CMR with late gadolinium enhancement will be repeated within 5 days post-procedure (including the observational arm). The health status of the study participants (SAQ and the Rose Dyspnea Scale) will be re-assessed at 3-months post-CTO PCI. In addition, to investigate the effect of the studied CTO PCI strategies on the occupational hazard of interventional cardiologists, the physical and mental stress levels experienced by CTO operators will be continuously monitored during the procedure. The co-primary endpoint is defined as: 1) total procedure time and 2) successful guidewire crossing through CTO. The secondary endpoints include: time of successful guidewire crossing through CTO, final technical success of CTO PCI, radiation dose, contrast volume, equipment cost, procedural complications, rate of periprocedural myocardial injury, rate of new myocardial infarction on CMR, quality of life, target lesion failure (cardiac death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization) at 3 months follow-up, and stress indices experienced by physicians during the procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability) * at least difficult native CTO lesion with J-CTO difficulty score ≥2 points on invasive angiography * angiographic suitability for both ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators * informed consent for participation in the study Exclusion Criteria: * \<18 years of age * acute myocardial infarction * cardiogenic shock * severe valvular disease * estimated life expectancy \<1 year * contraindication to PCI * contrast allergy * positive pregnancy test or breast-feeding * native CTO lesion with easy or intermediate difficulty score on invasive angiography (J-CTO score \<2 points) * lack of angiographic equipoise between the ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators

Outcomes

Primary Outcomes

Total procedure time

Total procedure time in minutes.

Time frame: procedural (1 day)

Successful guidewire crossing through CTO

Rate of successful guidewire crossing through CTO.

Time frame: procedural (1 day)

Secondary Outcomes

Technical success

Achievement of Thrombolysis In Myocardial Infarction grade 3 flow in all ≥2.5-mm distal branches with \<30% residual stenosis.

Time frame: procedural (1 day)

Time of successful guidewire crossing

Time of successful guidewire crossing through CTO in minutes defined as the time from starting ADR or the retrograde approach to the time of successful CTO recanalization using any technique.

Time frame: procedural (1 day)

Fluoroscopy time

Fluoroscopy time in minutes.

Time frame: procedural (1 day)

Radiation dose

Total radiation dose in Gy and mGycm2.

Time frame: procedural (1 day)

Contrast volume

Total contrast volume in mL.

Time frame: procedural (1 day)

Cost of CTO PCI

Total cost of CTO PCI procedure in PLN.

Time frame: procedural (1 day)

Number and type of procedural complications

Total number and specification of procedural complications (death, non-fatal myocardial infarction, cardiac tamponade requiring pericardiocentesis, coronary perforation, stroke, major bleeding according to Bleeding Academic Research Consortium).

Time frame: procedural (1 day)

Periprocedural myocardial injury

Any periprocedural myocardial injury based on the dynamics of cardiac troponin.

Time frame: in-hospital (2-5 days)

Periprocedural myocardial infarction

Any periprocedural myocardial infarction based on the dynamics of creatine kinase-MB/cardiac troponin and according to Fourth universal definition of myocardial infarction.

Time frame: in-hospital (2-5 days)

Myocardial infarction on CMR

Any new myocardial infarction as assessed on serial CMR with late gadolinium enhancement.

Time frame: in-hospital (2-5 days)

Target lesion failure

Total number of cardiac death, target vessel-related myocardial infarction or clinically-driven target lesion revascularization.

Time frame: 3-months

All-cause death

Any death observed.

Time frame: 3-months

Cardiac death

Any cardiac death observed.

Time frame: 3-months

Target vessel-related myocardial infarction

Any target vessel-related myocardial infarction observed.

Time frame: 3-months

Clinically-driven target lesion revascularization

Any clinically-driven target lesion revascularization observed.

Time frame: 3-months

CCS class

Quality of life assessed by the Canadian Cardiovascular Society (CCS) grading scale measuring the severity of exertional angina (it uses a scale from 1 to 4 where 1 means angina only occurs with strenuous, rapid or prolonged exertion, and 4 means angina is present at rest).

Time frame: 3-months

SAQ score

Quality of life assessed by the Seattle Angina Questionnaire comprising a 19-item questionnaire categorized into five scales (angina frequency, angina stability, physical limitations, treatment satisfaction, and disease-specific quality of life) with each scale transformed to a 0-100 score (the higher the score, the better the quality of life).

Time frame: 3-months

Dyspnea severity on the Rose Dyspnea Scale

Quality of life assessed by the Rose dyspnea scale questionnaire measuring dyspnea complaints or shortness of breath (it consists of a score from 0 to 4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort).

Time frame: 3-months

Heart rate

Mean heart rate of the first CTO operator throughout CTO PCI.