None listed
Conditions
Brief summary
There is currently no clear agreement on the best way to treat certain types of coronary artery narrowings that occur right at a branch point (known as Medina 0,0,1 and 0,1,0 lesions). Two main stenting methods are commonly used, each with pros and cons, but they have never been directly compared in a clinical trial. The PROST trial will, for the first time, compare these two approaches to determine which leads to better outcomes over two years. The results could help standardise treatment, improve patient outcomes, and provide clearer guidance for cardiologists managing this complex type of coronary disease.
Interventions
Patients with Medina 0,0,1 or 0,1,0 bifurcation disease (i.e. ostial disease within a coronary bifurcation) will be randomised to one of two treatment arms. Provisional/inverse provisional stenting (PS) or Focal Ostial Stenting (FOS). This technique is performed by interventional cardiologists and takes an average of approximately 30min. A Core Lab of imaging and the procedural report will be used to monitor adherence to the intervention protocol.
In the PS strategy:
- Both bifurcation arms a
Patients with Medina 0,0,1 or 0,1,0 bifurcation disease (i.e. ostial disease within a coronary bifurcation) will be randomised to one of two treatment arms. Provisional/inverse provisional stenting (PS) or Focal Ostial Stenting (FOS). This technique is performed by interventional cardiologists and takes an average of approximately 30min. A Core Lab of imaging and the procedural report will be used to monitor adherence to the intervention protocol. In the PS strategy: - Both bifurcation arms are wired with a standard coronary wire. - A stent is deployed from proximal main branch (PMB) into the Distal Main Branch or Sidebranch (DMB/SB). - Proximal Optimisation Technique (POT) is performed to expand the proximal aspect of the stent. - Kissing Balloon inflation is performed. - Repeat POT performed. - SB bailout performed at discretion of operator. - Repeat intra-vascular imaging at conclusion of procedure including entire stenting segment and 3mm distal and proximal if possible.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 18 years and older - Clinical indication for invasive coronary angiogram and PCI with stable angina or equivalent, acute coronary syndrome, ischaemia demonstrated on functional study, ventricular arrhythmias, cardiomyopathy, or valvular heart disease. - Able to provide informed consent. - Anatomical criteria: - De novo coronary disease - Medina 0,1,0 or 0,0,1 coronary bifurcation disease, with MLD located within 4mm of POB. - Lesion severity greater than or equal to 70% stenosis, positive pressure wire assessment (FFR less than or equal to 0.8; NHPR<0.9), positive functional assessment in territory being revascularised, or culprit lesion for STEMI or NSTEMI. - Ostial branch greater than or equal to 2.75mm with SB diameter greater than or equal to 2.25mm - greater than or equal to 73mm in length, or are responsible ischaemia for greater than or equal to 10% of the left ventricular (LV) mass, or stress echocardiogram positive in greater than or equal to 3 contiguous segments, or positive on CMR perfusion in greater than or equal to 2 contiguous segments. - Amenable to treatment using both PS and FOS strategy.
Exclusion criteria
- Age < 18 years - Cardiogenic Shock - Allergy/intolerance to anti-platelet medication - Less than 2 year expected survival - Anticipated difficulties in follow up - Active bleeding disorder/pre-disposition to bleeding - Functioning bypass graft on either main branch or side branch. - Chronic total occlusion (CTO) of MB or SB. - Unwilling or unable to provide informed consent. - Trifurcation - Not amenable to treatment using both PS and FOS strategy.
Outcome results
None listed