The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study

N/AActive Not RecruitingNCT02973529

Aarhus University Hospital Skejby120 enrolled

Overview

Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.

BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions. BRS are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time. The aim of this study is to compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS. Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS. Methods: Prospective, open label, single blind, randomized, feasibility and safety pilot study with inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month follow-up by OCT and follow-up for clinical endpoints until 10 years. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the BRS. The patients are assessed by optical coherence tomography (OCT) before, during and after implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month follow-up, or before if they are readmitted with a possible target lesion failure. The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before performing final OCT. Results are reported as clinical safety at 6 months (myocardial infarction, revascularization, death) and stent healing index by OCT including malapposition, stent coverage, side branch ostial area late loss, fracture and evaginations.

Study Type

Conditions

Coronary Artery Disease

Interventions

AbsorbDEVICE

Randomization to implantation of Absorb BVS in bifurcation lesion

DesolveDEVICE

Randomization to implantation of Desolve BRS in bifurcation lesion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable angina pectoris * Age \> 18 years * Stabilized non-ST elevation myocardial infarction * Silent angina * De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch * All Medina classes except Medina x.x.1 * Diameter of side branch ≥ 2.5 mm * Signed informed consent Exclusion Criteria: * ST-elevation infarction within 48 hours * Expected survival \< 1 year * Severe heart failure (NYHA≥III) * S-creatinine \> 120 µmol/L * Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus * Unable to cover main vessel lesion with one scaffold * Severe tortuosity * Severe calcification

Locations (4)

Aarhus University Hospital

Aarhus N, Denmark

Odense University Hospital

Odense, Denmark

Zealand University Hospital, Roskilde

Roskilde, Denmark

Latvian Heart Center

Riga, Latvia

Outcomes

Primary Outcomes

Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.

Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.

Time frame: 6 months

Index of adverse vessel wall features

Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain

Time frame: 6 months

Secondary Outcomes

Optical coherence tomography endpoint: acute malapposition

Time frame: Baseline

Optical coherence tomography endpoint: acquired malapposition

Time frame: 6 and 24 months

Optical coherence tomography endpoint: persistent malapposition

Time frame: 6 and 24 months

Optical coherence tomography endpoint: Coverage of jailing struts

Time frame: 6 and 24 months

Optical coherence tomography endpoint: Extra stent lumen (including evaginations)

Time frame: Baseline, 6 and 24 months

Optical coherence tomography endpoint: Late stent recoil

Time frame: 6 and 24 months

Data from ClinicalTrials.gov

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