Comparison of a Paclitaxel-Coated Balloon Without Stent Implantation Against a Drug-Eluting Bioresorbable Scaffold for Treatment of Stable Coronary Artery Disease: A Prospective Randomized Study Using Optical Coherence Tomography
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Angiographic NLG
Study Overview
Brief Summary
This prospective randomized clinical trial aims to compare two different "metal-free" strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).
Detailed Description
Background:
Coronary artery disease (CAD) accounts for most deaths in the industrialized countries due to its high prevalence of 6-8%. CAD is mainly treated by percutaneous coronary interventions (PCI), which currently involve in over 90% of cases the implantation of metallic stents, mostly as drug-eluting devices(DES). Despite continuous technological advancement over the last decade, DES are still limited at long-term follow-up by restenosis and also by the risk of thrombosis, occurring in 5-20% and respectively 0.5-1.7% of cases. Therefore, two metal-free strategies are evaluated in order to overcome these intrinsic limitations of DES:
- Bioresorbable scaffolds (BRS) proved comparable safety and efficacy at 1 year compared to best-in-class DES comparators and also showed in small substudies very promising 5-year results with restoration of vasomotricity and positive vessel remodeling. Optical coherence tomography (OCT) is the new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. OCT is currently recommended for both guidance of implantation and for assessment of long-term results of BRS.
- Drug-coated balloons (DCB) were mainly employed to treat restenosis in metallic stents, but newer reports advocate their potential to be used as stand-alone treatment of de-novo stenoses without stenting, especially when fractional flow reserve (FFR) measurements are additionally used to assess PCI results.
This clinical trial evaluates the FFR-guided DCB-only (experimental arm: SeQuent Please™, B Braun Melsungen GmBH) PCI against the OCT-guided BRS implantation (comparator arm: Absorb™, Abbott Vascular) for treatment of stable CAD. The trial is designed as a non-inferiority, nationally conducted, multicenter, open-labeled, controlled study using a 1:1 block randomization and am invasive 6-9 month follow-up (f/u) by quantitative coronary angiography (QCA) and OCT.
Beyond the pre-specified endpoints the study mainly looking at suppression of neointimal proliferation, we will also investigate the patterns of healing and neointimal proliferation, the plaque morphology and neoatherosclerosis f/u using OCT at 6-9 months. Clinically, we attempt to record the major adverse cardiovascular events (MACE: acute myocardial infarction, cardiac death, TLR) up to 5 years after the index procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •written consent
- •indication for elective PCI of a de novo coronary stenosis in a native vessel
- •coronary multivessel disease with clinically proven indication for repeating coronary angiography at 6-9 months (staged PCI strategy)
Exclusion Criteria
- •pregnancy, lactation, women of childbearing age w/o reliable contraception
- •life expectance < 50 % at 1 year
- •major surgery planned within 6 months
- •participation in other clinical trials or impossibility to give written consent
- •acute coronary syndrome or cardiogenic shock within the last 4 weeks
- •stent thrombosis, defined as "probable" or "definite" by ARC
- •contraindication against dual antiplatelet therapy
- •allergy against mTOR-inhibitors or taxol derivates
- •target lesion situated in the left main coronary artery, in a bypass graft or a grafted vessel
- •reference luminal diameter of the target lesion > 3.75 mm or < 2.0 mm
- •lesion length > 30 mm, bifurcation lesion requiring intervention on a major side branch
Arms & Interventions
BRS
OCT-guided BRS implantation: implantation of a bioresorbable scaffold (BRS) under OCT guidance.
Note: Absorb™ from Abbott Vascular has been used as BRS until this product became unavailable in April 2017. Currently the recruitment is stopped due to this issue, until the use of another BRS gets final approval.
Intervention: OCT-guided BRS implantation (Device)
DCB-only
FFR-guided DCB-only PCI: PCI using DCB (SeQuent Please™, B Braun Melsungen GmBH) without stent implantation und FFR guidance
Intervention: FFR-guided DCB-only PCI (Device)
Outcomes
Primary Outcomes
Angiographic NLG
Time Frame: 6-9 months
Absolute net luminal diameter gain measured by QCA as minimal luminal diameter at f/u - minimal luminal diameter at baseline within the region of interest
Secondary Outcomes
- TLR(0-9 months)
- Volumetric NLG(6-9 months)
- Angiographic and volumetric LLL(6-9 months)
Investigators
Tudor C. Poerner, MD
PD Dr. med. Tudor C. Poerner
University of Jena