11:21 Update on the ORBITA - CTO trial John Davies (Basildon - UK) _____________________________________________ PARALLEL SESSION Cto & Chip Regitries & Trials Auditorium Zubin Mehta - Friday 11:00 - 12:00 Chairpersons: Paul Knaapen (Amsterdam - NL), Gennaro Sardella (Rome) Discussants: Björn Billmann (Wolfenbuettel - D), Laurent Drogul (Nice - F), Sergey Furkalo (Kiev - UA), Maciej Lesiak (Poznan - PL) ___________________________________________ 15th Experts Live CTO, EUROCTO Club meeting in partnership with the GISE CTO meeting. September 8th - 9th, 2023 Florence, Italy

1. Dr John Davies
ORBITA-CTO Pilot study
A randomised placebo-controlled trial of
CTO PCI vs placebo with optimal medical
therapy: Design & Protocol

2. ORBITA-CTO Pilot: A randomised placebo-controlled trial of CTO PCI vs placebo with
optimal medical therapy
On behalf of ORBITA-CTO Pilot Investigators: Sarosh Khan MBBS, Samer Fawaz BMBS, Rupert Simpson
MBChB, Craig Robertson BSc, Paul Kelly MD, Shah Mohdnazri MD, Kare Tang MBBS, Christopher M
Cook PhD, Sean Gallagher MD, Peter O’Kane PhD, James C Spratt PhD, Emmanouil Brilakis PhD,
Grigoris V Karamasis MD, Rasha Al-Lamee PhD, Thomas R Keeble MD, John R Davies PhD

3. Disclosures
Nature of Financial Relationship Ineligible Company
Grant/Research Support Abbott
All Relevant Financial Relationships have been mitigated.
Faculty disclosure information can be found on the app

4. Background
No blinded assessment of symptoms
2018 Guidelines do not include DECISION-CTO trial

5. Hypothesis
• CTO PCI results in a clinically and
statistically significant improvement in
anginal symptoms and reduction in the use
of anti-anginal medication.
• Feasibility of double-blind placebo
controlled trial in CTO
Design
• Randomised
• Placebo-controlled
• Pilot (n=50)
• Multi-centre, UK
 Essex CTC (rec)
 Royal Bournemouth (rec)
 St George’s London
 Cardiff, Wales

6. Primary Feasibility Outcome
Fidelity of blinding using Bang’s blinding index (BI)
Protocol adherence
Primary Efficacy Outcome
Change in daily angina ordinal clinical outcome scale

7. Secondary outcomes
Change in SAQ physical limitation, angina frequency, angina stability, treatment satisfaction
and quality of life scores
Change in SAQ summary score
Quality of life as measured by EQ-5D-5L
Change in Rose dyspnea scale
Cost of treatment
Change in peak VO2 and VO2 at AT
Change in other cardiovascular CPET parameters (eg oxygen pulse, ΔVO2/ΔWR and
ΔO2 pulse/ΔWR)

8. Inclusion Criteria
1. Accepted for CTO PCI procedure by a
specialist CTO operator.
2. Patients with symptoms related to a single
vessel CTO.
Symptoms defined as:
a) Typical exertional angina
b) Angina symptoms at rest (including decubitus
angina and post-prandial angina).
c) Shortness of breath on exertion considered to
be angina equivalent.
3. Clinical evidence of ischaemia in CTO territory
4. Evidence of viability
5. J-CTO score ≤ 3.

9. Exclusion Criteria
1. Acute coronary syndrome within 4 weeks.
2. PCI to non-CTO lesion in prior 4 weeks as part
of ACS or elective PCI.
3. Non-revascularised clinically important
non-CTO vessel.
4. Proven ischaemia (invasive or non-invasive) in
non-culprit territory.
5. Contraindications to PCI or drug-eluting stent
(DES) implantation.
6. Inability to tolerate or contraindication to DAPT.
7. Severe valvular heart disease.
8. Severe chronic pulmonary disease (FEV1
<30%
of predicted value).
9. Severe musculoskeletal disease resulting in
immobility.
10. Life expectancy <2years.
11. Pregnancy.
12. Age <18years.
13. Inability to consent

10. Angina Symptom Assessment Online App

11. From Nowbar et al. ORBITA-2; EuroIntervention
Ordinal Clinical Outcome Scale for Angina
Comprised of:
Daily symptom assessment via online app
Units of antianginal medication
High-level category overrides
- Unblinding due to intolerable angina
- Acute coronary syndrome
- Death

12. Study Phases

13. Post successful CTO PCI
Patients randomised to CTO PCI have CTO vessel physiology performed immediately after
successful CTO PCI including:
• Resting indices
• Hyperaemic & Non-hyperaemic indices
• Bolus thermodilution
• Continuous thermodilution
• Secondary analysis of patients allocated to CTO PCI: coronary physiology correlation to change
in symptoms

14. ORBITA-CTO Pilot Funding
Abbott provided funding for study expenses i.e overnight stay
No involvement in study design, steering, data analysis or reporting

15. Optimising placebo
DAY WARD
CATHLAB
WARD
Ward Handover
Discharge Letter
60 min
Placebo
Report
IV ADENOSINE
2 min

16. ORBITA-CTO Pilot
Summary & Progress
• DESIGN: UK multi-center prospective,
randomised, placebo-controlled clinical
pilot study of CTO PCI vs placebo
• OBJECTIVE: Assess feasibility and signal of
efficacy
• TARGET: 50 total participants
• COMPLETION: Recruitment June 2024
Final: December 2024
• PRINCIPAL INVESTIGATOR
John Davies, Essex Cardiothoracic Centre
Screened (n=247)
at CTO MDT
Enrolled (n= 31)
Eligible (n= 45)
Completed (n= 15)
Randomised (n= 23)
Excluded (162)
Inclusion unmet
•48% asymptomatic
•26% JCTO>3
•23% no ischaemia
Exclusion unmet
•30% bystander
disease/ischaemia
Declined (14)
Excluded on table (7)
•6 recanalized CTO
•1 bystander disease

17. Thank you
ORBITA-CTO Pilot
clinicaltrials.org
ORBITA-CTO Pilot: Study Design & Protocol