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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Emil N Holck, MD
+45 31419472
eh@clin.au.dk
Evald Christiansen, MD PhD
+45 78452028
evald.christiansen@dadlnet.dk
Heart Diseases Myocardial Ischemia Coronary Artery Disease Ischemia
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Study design
Prospective randomized open labeled multicenter study
Hypotheses
1. In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events).
2. In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months.
Inclusion Criteria
* CTO in native coronary artery
* Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
* Age ≥18 yrs.
* Able to provide written Informed consent and willing to comply with the specified follow-up contacts
* Target artery ≥ 2.5 mm
Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:
Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO
Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO
Cohort C: patients enrolled but not randomized in cohort A or B
Exclusion criteria (for both cohort A and B)
* NSTEMI or STEMI within 1 month
* Coronary anatomy not suitable for CTO-procedure
* Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference
* Life expectancy \< 2 years
* Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
* Contraindication to dual anti-platelet therapy
* Pregnancy
* eGFR \< 30 mL/min/1.73 m2
* In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
* Severe valvular heart disease
Primary endpoint
Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization\*), hospitalization for heart failure or incidence of malignant arrhythmias.
\*CCS class ≥ 2 and/or QoL score \< 60. Same criteria used as for allocation to Cohort B
Cohort B: SAQ Quality of Life Assessment after 6 months.
Number of patients
1,560 (1200 in cohort A/360 in cohort B
Follow up time
Cohort A: 5 years Cohort B: 6 months
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028. No abstract available."; "34238552"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Evald Christiansen, MD PhD
+45 78452028
evald.christiansen@dadlnet.dk
Emil N Holck, MD
+45 31419472
eh@clin.au.dk
The study is sponsored by Aarhus University Hospital Skejby
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
