ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO

Condition(s) studied

Investigational drug(s) / intervention(s)

Percuteneous Coronary Intervention: PCI of Chronic Total Occlusions

Optimal Medical Therapy: Initiation and titration of optimal medical therapy in the control arm.

Study summary

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

Eligibility

Primary outcome measure(s)

• Major Adverse Cerebral and Cardiovascular Events — 5 Year
  Primary outcome in the Cohort A.
• Quality of life - Seattle Angina Questionnaire — 6 months
  Primary outome in the Cohort B

Trial sites (27)

More Aarhus University Hospital Skejby trials in Spain

Other trials for the same condition