PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG

NCT ID: NCT03805048

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2028-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Native Vessel PCI

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. Percutaneous coronary intervention of the native vessel will be performed according to current standard. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using four complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation and retrograde dissection reentry.

Group Type: OTHER

Percutaneous coronary intervention

Intervention Type: PROCEDURE

PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.

Graft PCI

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. Percutaneous coronary intervention of the bypass graft will be performed following current standards and at the discretion of the operating interventional cardiologist. Only commercially available second generation DES will be used in the treatment of bypass grafts. The second generation DES used in this study will be the XIENCE Sierra stent. The use of a filter-wire during the procedure will be left at the discretion of the operator.

Group Type: OTHER

Percutaneous coronary intervention

Intervention Type: PROCEDURE

PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.

Interventions

Percutaneous coronary intervention

PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Paul Knaapen

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Knaapen

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

University Hospital

Antwerp, Edegem, Belgium

Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim

Antwerp, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

UZ Leuven

Leuven, , Belgium

Universitäts Herzzentrum

Bad Krozingen, , Germany

Universitair Medische Centra

Amsterdam, , Netherlands

Academic Medical Center

Amsterdam, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Radboud Universitair Medisch Centrum (Radboud UMC)

Nijmegen, , Netherlands

Universitair Medisch Centrum

Utrecht, , Netherlands

Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy

Warsaw, , Poland

Basildon & Thurrock University Hospitals (Essex CTC)

Basildon, , United Kingdom

Health and Social Care Trust

Belfast, , United Kingdom

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust

Bournemouth, , United Kingdom

UH Bristol NHS Trust, Bristol Heart Institute

Bristol, , United Kingdom

Golden Jubilee National Hospital

Glasgow, , United Kingdom

St George's University Hospitals NHS Foundation Trust

London, , United Kingdom

Manchester University NHS Foundation Trust, Wythenshawe Hospital

Manchester, , United Kingdom

Countries

Belgium; Germany; Netherlands; Poland; United Kingdom

References

de Winter RW, Hoek R, Walsh SJ, Hanratty CG, Sprengers RW, Twisk JWR, Vegting I, Schumacher SP, Bom MJ, Verouden NJ, Henriques JP, Wilgenhof A, Viscusi MM, Teeuwen K, Opolski MP, Wolny R, Agostoni P, van Kuijk JP, Scholzel BE, Kraaijeveld AO, van Geuns RM, Dirksen MT, Heestermans AACM, Dens J, Bennett J, Haine SEF, Delewi R, Nap A, Spratt JC, Knaapen P; PROCTOR Trial Investigators. PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial. J Am Coll Cardiol. 2025 Oct 28:S0735-1097(25)09477-X. doi: 10.1016/j.jacc.2025.09.1577. Online ahead of print.

Reference Type: DERIVED

PMID: 41159978 (View on PubMed)

Other Identifiers

Amsterdam UMC

Identifier Type: -

Identifier Source: org_study_id