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

Coronary Artery Disease Clinical Trial

— PROCTOR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03805048
• Other study ID #: Amsterdam UMC
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: June 30, 2027

Study information

• Verified date: September 2021
• Source: VU University Medical Center
• Contact: Paul Knaapen, Prof
• Phone: +31 20 4440123
• Email: p.knaapen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 584
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital	Antwerp	Edegem
Belgium	Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim	Antwerpen
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	UZ Leuven	Leuven
Germany	Universitäts Herzzentrum	Bad Krozingen
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Universitair Medische Centra	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
Poland	Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount and type of Major Adverse Cardiac Events	The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).	3 year follow up
Secondary	Amount and type of Major Adverse Cardiac Events	The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).	1 and 5 year follow-up
Secondary	Amount of patients that have passed away	Mortality score, all-cause mortality	1, 3 and 5 year follow-up
Secondary	Number of non-fatal myocardial infarctions	Any non-fatal myocardial infarction noticed	1, 3 and 5 year follow-up
Secondary	Number of clinically driven target lesion revascularizations	Any clinically driven target lesion revascularization noticed	1, 3 and 5 year follow-up
Secondary	Number of target vessel revascularizations	Any target vessel revascularization noticed.	1, 3 and 5 year follow-up
Secondary	Number of target vessel failure.	Any target vessel failure noticed	1, 3 and 5 year follow-up
Secondary	Number of non-fatal myocardial infarctions.	Any non-fatal myocardial infarction noticed.	>48 hours after PCI
Secondary	Number of PCI-related myocardial infarctions.	Any PCI-related myocardial infarction noticed.	1, 3 and 5 year follow-up
Secondary	Specific angiographic outcome	Any of the following outcomes: Late lumen loss; In-stent binary restenosis (=50%); In-stent re-occlusion; Difference in in-stent diameter stenosis between index procedure at inclusion, and at 3-year follow-up	3-year follow up
Secondary	Quality of life assessed by SAQ	The Seattle Angina Questionnaire is a self-assessment questionnaire where patients' physical limitations caused by angina are quantified, as well as the frequency of and changes in their symptoms, their satisfaction with treatment and how they perceive their Quality of Life. Each scale is transformed to a 0-100 scale. the higher the score, the better the patients functions/the higher the Quality of Life.	1, 3 and 5 year follow-up
Secondary	Quality of life assessed by CCS	Canadian Cardiovascular Society (CCS) Grading Scale measures whether patient have angina pectoris complaints, and to what extent patients experienced this. It uses a scale of 1-4 where 1 means angina pectoris (chest pain) only occurs with streneous, rapid or prolonged exertion, and 4 means angina is present during little physical effort or even during rest.	1, 3 and 5 year follow-up
Secondary	Quality of life assessed by RDS	Rose dyspnea scale questionnaire (RDS) measures dyspnea complaints, or shortness of breath. It consists of 4 questions about dysnpea complaints in the everyday life of patients. For every patient, a score is compiled of the highest limitation in daily life, resulting in a score of 0-4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort.; The scores from these questionnaires will be combined by summing the total scores.	1, 3 and 5 year follow-up
Secondary	Composite score of quality of life	Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score	3-year follow-up