Comparison of healing responses after treatment of complex bifurcation lesions with a dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System + Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb BVS: an optical coherence tomography (OCT) analysis.
This is a prospective single center randomized clinical trial with baseline OCT and clinical, angiographic and OCT follow-up at thirty months. Patients with true and complex coronary bifurcation lesions are randomly assigned to treatment with the dedicated Axxess biolimus-eluting bifurcation stent in the proximal main vessel (MV) and additional Absorb everolimus-eluting BVS in the branches versus a modified T technique using Absorb BVS only. The primary endpoint is changes in minimal luminal area assessed with OCT from baseline to 30 months in pre-specified bifurcation segments. The main aims are to assess acute performance and to compare long-term vessel healing with optical coherence tomography, and clinical and angiographic outcome after treatment of complex bifurcation lesions with a dedicated stent with additional Absorb Bioabsorbable scaffolds (BVS) versus a modified T stenting technique with Absorb BVS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
In one group, the coronary bifurcation lesion will be treated (Coronary bifurcation PCI) with the Axxess device + Absorb BVS. In the other group, the coronary bifurcation lesions will be treated(Coronary bifurcation PCI) by modified T stenting using Absorb BVS.
Department of Cardiovascular Disease, University Hospitals Leuven
Leuven, Belgium
Changes in minimal luminal area in 4 pre-specified bifurcation segments (Proximal mainbranch (MB) segment; Bifurcation segment; Ostial distal MB segment; Ostial side-branch (SB segment), assessed with OCT, from baseline to 30 months.
Time frame: 30 months
Acute strut apposition following index PCI (baseline OCT)
Time frame: 30 months
Cumulative major adverse cardiac events (MACE) rate (cardiac death, myocardial infarction, clinically driven TLR) at 1, 6 and 12 months and annually for 5 years from the procedure date.
Time frame: 1 month, 6 months, 1,2,3,4,5 years
Quantitative coronary angiography (QCA) Minimal Lumen Diameter before and after PCI, and at 30 months
Time frame: 24 hours and at 30 months
Device success, defined as deployment of the assigned stents without system failure or device-related complication
Time frame: 24 hours
Presence of thrombus on final OCT pullback following index PCI
Time frame: 24 hours
- Assessment of the integrity of the Absorb BVS following completion of index PCI using 3D OCT.
Time frame: 24 hours
Minimal lumen area at baseline and follow-up in the other 6 pre-specified bifurcation segments (Proximal edge segment; Proximal MB segment; Distal MB segment; Distal MB edge segment; SB segment: Distal SB edge segment)
Time frame: 24 hours and 30 months
Changes in minimal luminal area in all 10 pre-specified bifurcation segments, assessed with OCT, from baseline to 30 months.
Christophe Dubois, MD PhD
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Time frame: 24 hours and 30 months
Percent struts malapposed in the Axxess stent at 30 months post procedure
Time frame: 30 months
Percent struts uncovered in the Axxess stent at 30 months post procedure
Time frame: 30 months
Target vessel failure (TVF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR)
Time frame: 1 month, 6 months, 1,2,3,4,5 years
Stent thrombosis at 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Time frame: 1 month, 6 months, 1,2,3,4,5 years
Target lesion revascularisation (TLR) at 1, 6, 12 months and yearly thereafter (up to 5y)
Time frame: 1 month, 6 months, 1,2,3,4,5 years
Target vessel revascularisation (TVR) at at 1, 6, 12 months and yearly thereafter (up to 5y)
Time frame: 1 month, 6 months, 1,2,3,4,5 years
All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 months and yearly thereafter (up to 5y)
Time frame: 1 month, 6 months, 1,2,3,4,5 years
Acute gain following index PCI
Time frame: 24 hours
Late Lumen Loss (in-stent) at 30 months
Time frame: 30 months
Binary in-stent/scaffold restenosis at 30 months
Time frame: 30 months
Binary in-segment restenosis at 30 months
Time frame: 30 months
Binary in-bifurcation restenosis (stent and segment) at 30 months
Time frame: 30 months
Lesion success, defined as attainment of <50% residual stenosis of the target lesion using any percutaneous method
Time frame: 24 hours
Procedure success, defined as lesion success without the occurrence of MACE during the hospital stay.
Time frame: 24 hours
Analysis of the vasoreactivity (Vasomotor testing, using vasodilatory response to acetylcholine (Ach) in all patients) of the bifurcation segments previously stented/scaffolded.
Time frame: 30 months
Procedure duration from randomization to final angiogram (before final OCT)
Time frame: 24 hours
Contrast usage from randomization to final angiogram (before final OCT)
Time frame: 24 hours
Radiation from randomization to final angiogram (before final OCT)
Time frame: 24 hours