Comparing PCI and medical therapy for chronic total occlusion in heart disease

International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions With Myocardial Ischemia - ISCHEMIA-CTO Trial

This study is testing whether a new heart procedure using special stents can help people with blocked arteries feel better and have fewer heart problems compared to just taking medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1560 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aarhus University Hospital Skejby (other)
• Locations: 27 sites (Aarhus N and 26 other locations)
• Trial ID: NCT03563417 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Percutaneous Coronary Intervention (PCI) using the latest drug-eluting stents compared to optimal medical therapy (OMT) in patients with chronic total occlusion (CTO) of coronary arteries. It is a prospective randomized open-label multicenter study that includes both asymptomatic and symptomatic patients with varying degrees of myocardial ischemia. Patients will undergo three months of OMT before being randomized into treatment groups, with outcomes measured in terms of major adverse cardiovascular events and quality of life improvements. The study aims to provide clearer evidence on the benefits of PCI in managing CTO.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic total occlusion in a native coronary artery and evidence of myocardial ischemia.

Not a fit: Patients with recent heart attacks or unsuitable coronary anatomy for PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence that PCI is more effective than medical therapy in improving outcomes for patients with chronic total occlusion.

How similar studies have performed: Previous studies on similar topics have faced challenges, with some failing to demonstrate clear benefits, indicating that this approach is still under investigation.

Eligibility criteria

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 assess by nuclear imaging.

Cohort C: Screening population not eligible for randomization in cohort A or B

Exclusion Criteria:

* NSTEMI or STEMI within 1 month
* Coronary anatomy not suitable for CTO-procedure
* Coronary 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

Where this trial is running

Aarhus N and 26 other locations

• Aarhus University Hospital — Aarhus N, Denmark (RECRUITING)
• Rigshospitalet — Copenhagen, Denmark (RECRUITING)
• Gentofte Hospital — Hellerup, Denmark (RECRUITING)
• Odense University Hospital — Odense, Denmark (RECRUITING)
• Zealand University Hospital — Roskilde, Denmark (RECRUITING)
• North-Estonia Medical Centre — Tallinn, Estonia (RECRUITING)
• Helsinki University Central Hospital — Helsinki, Finland (ACTIVE_NOT_RECRUITING)
• Kuopio University Hospital — Kuopio, Finland (ACTIVE_NOT_RECRUITING)
• Heart Hospital Tampere — Tampere, Finland (RECRUITING)
• Turku University Hospital — Turku, Finland (RECRUITING)
• Clinique Louis Pasteur — Essey-lès-Nancy, France (ACTIVE_NOT_RECRUITING)
• Cardiovascular Institute, Groupe Hospitalier Mutualiste — Grenoble, France (RECRUITING)
• Hospital Germans Trias I Pujol — Badalona, Barcelona, Spain (ACTIVE_NOT_RECRUITING)
• Hospital Galdakao — Galdakao, Bizkaia, Spain (RECRUITING)
• Hospital Vall de Hebron — Barcelona, Spain (ACTIVE_NOT_RECRUITING)
• Hospital Clinic — Barcelona, Spain (RECRUITING)
• Hospital de Bellvitge — Barcelona, Spain (ACTIVE_NOT_RECRUITING)
• Hospital Universitario Clinico San Carlos — Madrid, Spain (RECRUITING)
• Hospital la Paz — Madrid, Spain (ACTIVE_NOT_RECRUITING)
• Hospital Universitari de Tarragona Joan XXIII — Tarragona, Spain (RECRUITING)
• Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
• Skaane University Hospital (Lund) — Lund, Sweden (ACTIVE_NOT_RECRUITING)
• Stockholm South Central Hospital (Södersjukhuset) — Stockholm, Sweden (ACTIVE_NOT_RECRUITING)
• Belfast Health and Social Care Trust, Department of Cardiology — Belfast, United Kingdom (ACTIVE_NOT_RECRUITING)
• University Hospital Bristol — Bristol, United Kingdom (ACTIVE_NOT_RECRUITING)
• Barts Health NHS — London, United Kingdom (ACTIVE_NOT_RECRUITING)
• St George's University Hospital — London, United Kingdom (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Evald Christiansen, MD PhD — Aarhus University Hospital
• Study coordinator: Evald Christiansen, MD PhD

Conditions: Ischemic Heart Disease, Chronic Total Occlusion of Coronary Artery