Clinical trial NCT03805048: PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG
Official title: PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Dysfunctional venous bypass graft
Second generation DES
CABG
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either native vessel PCI or PCI of the venous bypass graft in a 1:1 fashion. Randomization will be performed using an interactive Web-based randomization system, Open Clinica
Primary purpose: TREATMENT

Brief summary: Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical indication for percutaneous coronary intervention and a dysfunctional graft on the target vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives: to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization. 1 year and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.

Detailed description: Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. The CT-substudy and the PROCTOR registry is planned to be conducted too (details included in the flow chart).

CCTA substudy Selected patients will be approached for participation in the CCTA substudy of the trial. Participation in this substudy is optional. After written informed consent is obtained patients will undergo a CCTA in an out-patient setting. The CCTA will be performed before the PCI procedure.

PROCTOR registry

Patients can be approached for the registry when :

* PCI have been deemed clinically indicated by the local hartteam, and
* both the lesions in the native vessel and the dysfunctional graft have been deemed technically feasible by the local hartteam,
* the patient does not meet the in- and exclusion criteria for the randomized PROCTOR study or declines to participate in the randomized study.

Patients will be approached for participation and will have one week to consider. Written informed consent is mandatory for participating in the registry. Patients will be followed by telephonic follow-up after 1, 3, and 5 years. No additional study procedures will be performed.

Study objectives:to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization.

1. PROCTOR main study

   - Investigate the clinical outcome of native vessel PCI vs. PCI of dysfunctional venous bypass graft with a clinical indication for revascularisation
2. CCTA substudy

   * Investigate prognostic value of CT-derived plaque characteristics for occurrence of MACE following bypass graft PCI
   * Investigate value of CCTA in guidance of CTO PCI procedures
3. PROCTOR Registry - Investigate long-term clinical outcomes in patients with dysfunctional venous bypass graft and an indication for PCI whom are not included in randomised main study.

All patients with a significant stenosis (\>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Patients will be eligible for inclusion if revascularization is deemed clinically indicated and technically feasible for PCI by the local heart team. The indication for revascularization will be based on symptoms and evidence of ischemia and viability in the target vessel territory. The lesion in the native vessel must be bypassed by a single venous graft or must be connected to a jump graft at the most distal anastomosis of that graft. In jump grafts, the lesion must be located distally to the second-to-last anastomosis. In case both the lesion in the native vessel and the lesion in the graft are deemed technically feasible for PCI, patients will be eligible for inclusion in the randomized study after consideration of in- and exclusion criteria. Patients who do not meet these criteria or decline to participate in the randomized study will be approached for inclusion in the registry. Subsequently patients will be approached for study participation. After being informed, patients will have at least 24 hours to consider participation. An independent physician will be available for extra information, if desired. After obtaining written informed consent, patients will be randomized to either native vessel PCI or PCI of the venous bypass graft. In case of PCI failure, a second attempt can be performed by the operator within one month.

If feasible, it is possible to perform a second attempt in another high-volume center. When successful PCI cannot be accomplished in one or two attempts, cross-over to the other treatment arm may be used as bailout strategy to restore myocardial blood flow to the distal vascular bed of the vessel. Randomization will be performed using an interactive Web-based randomization system, Open Clinica. After 1 and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.

Eligibility criteria: Inclusion Criteria:

* A significant stenosis (\>50% on angiography) in a venous bypass graft

  * The native lesion must be bypassed by a single graft or must be connected to a jump graft at the most distal anastomosis of that graft
  * In jumpgraft lesions, the lesion must be located distally to the second-to-last anastomosis
* Clinical indication for revascularization as determined by the local heart team (based on symptoms, documented ischemia, and viability).
* Both the native lesion and the venous graft lesion must be deemed suitable for PCI with a commercially available second generation DES.
* Informed consent must be obtained

Exclusion Criteria:

* \< 18 years of age
* Target vessel diameter \< 2.5 mm
* CABG performed less than 1 year prior to inclusion
* Diameter of the graft \> 5.5 mm
* Aneurysm formation in the bypass graft
* Heavy burden of thrombus in the bypass graft (\>50% of the bypass graft lumen in ≥2 out of 3 of the proximal, middle or distal third of the bypass graft).
* STEMI at presentation
* NSTEMI patients with ongoing ischemia
* Cardiogenic shock
* Severe kidney disease defined as an eGFR \< 30 ml/min.
* Pregnancy
* Estimated life expectancy \< 3 year
* Contraindications to PCI

Primary outcomes:
measure: Amount and type of Major Adverse Cardiac Events
timeFrame: 3 year follow up
Secondary outcomes:
measure: Amount and type of Major Adverse Cardiac Events
timeFrame: 1 and 5 year follow-up
measure: Amount of patients that have passed away
timeFrame: 1, 3 and 5 year follow-up
measure: Number of non-fatal myocardial infarctions
timeFrame: 1, 3 and 5 year follow-up
measure: Number of clinically driven target lesion revascularizations
timeFrame: 1, 3 and 5 year follow-up
measure: Number of target vessel revascularizations
timeFrame: 1, 3 and 5 year follow-up
measure: Number of target vessel failure.
timeFrame: 1, 3 and 5 year follow-up
measure: Number of non-fatal myocardial infarctions.
timeFrame: >48 hours after PCI
measure: Number of PCI-related myocardial infarctions.
timeFrame: 1, 3 and 5 year follow-up
measure: Specific angiographic outcome
timeFrame: 3-year follow up
measure: Quality of life assessed by SAQ
timeFrame: 1, 3 and 5 year follow-up
measure: Quality of life assessed by CCS
timeFrame: 1, 3 and 5 year follow-up
measure: Quality of life assessed by RDS
timeFrame: 1, 3 and 5 year follow-up
measure: Composite score of quality of life
timeFrame: 3-year follow-up
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital
state: Edegem
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bad Krozingen
country: Germany
facility: Universitäts Herzzentrum
city: Amsterdam
country: Netherlands
facility: Universitair Medische Centra
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum (Radboud UMC)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum
city: Warsaw
country: Poland
facility: Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy
city: Basildon
country: United Kingdom
facility: Basildon & Thurrock University Hospitals (Essex CTC)
city: Belfast
country: United Kingdom
facility: Health and Social Care Trust
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: UH Bristol NHS Trust, Bristol Heart Institute
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust, Wythenshawe Hospital
Study officials:
affiliation: Amsterdam UMC
name: Paul Knaapen
role: PRINCIPAL_INVESTIGATOR
References: