Clinical trial NCT02486068: ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
Official title: ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Lesion
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
First posted: 2015-07-01
Enrollment: 1670
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this trial are:

In patients at high-risk for restenosis,

* To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
* To assess superiority of the BRS to the EES in TLF between 3 and 7 years


Eligibility criteria: Inclusion Criteria:

Patients (18-75 years old) with at least one of the followings:

* High-risk characteristics for restenosis

  * Medically treated Diabetes (oral medication or insulin)
  * Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent
* Complex target lesion

  * Single de-novo target lesion satisfying at least one of the following:
  * Lesion length \>28 mm
  * Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm
  * Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
  * Bifurcation with single stent strategy

Exclusion Criteria:

* Patients are excluded from this study if they have:
* Age \<18 years or \>75 years
* Known comorbidities which make patients unable to complete 7-years follow-up
* Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
* Pregnant woman
* Breastfeeding woman
* Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
* Cardiogenic Shock (Killip \>2)
* PCI with implantation of stents/scaffolds within previous 30 days.
* Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
* Renal insufficiency (GFR \<45 ml/min)
* Life expectancy \< 7 years
* Known non-adherence to DAPT
* Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)
* LVEF \<30%
* Patients at high bleeding risk who are not suitable for long-term DAPT
* Following lesion characteristics:

  * Target lesion reference vessel diameter (RVD) \< 2.5 and \> 4 mm
  * STEMI with RVD of \>3.5mm of the culprit target lesion
  * Target lesion with in-stent/scaffold thrombosis
  * Graft lesions as target lesions
  * Aorto-ostial lesion(s)
  * Left main lesion
  * Severe tortuosity of target vessel
  * In-scaffold restenosis
  * Bifurcation target lesion with intended 2 stent/scaffold strategy
* Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)

Primary outcomes:
measure: non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
timeFrame: 1 year
Secondary outcomes:
measure: superiority of the Absorb to the Xience in TLF between 3 and 7 years
timeFrame: 5 years
measure: Superiority of the Absorb to the Xience in TLF at 7 years
timeFrame: 7 years
measure: Superiority of the Absorb to the XIence in cumulative angina rate at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Cardiovascular Center Aalst OLV
city: Leuven
country: Belgium
facility: CHR Citadelle
city: Leuven
country: Belgium
facility: UZ Leuven
city: Brno
country: Czechia
facility: University Hospital Brno
city: Prague
country: Czechia
facility: Cardiocentre, University Hospital Kralovske
city: Prague
country: Czechia
facility: Central Military Hospital
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Elisabethkrankenhaus Essen
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Universität Leipzig - Herzzentrum
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: München
country: Germany
facility: Klinikum der Universität München
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu
city: Castelfranco Veneto
country: Italy
facility: Ospedale San Giacomo
city: Catanzaro
country: Italy
facility: Università degli studi Magna Graecia
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Arnas Civico Palermo
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Eindhoven
country: Netherlands
facility: Catherina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
city: Chrzanów
country: Poland
facility: American Heart of Poland
city: Krakow
country: Poland
facility: University Hospital Krakow
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia SA
city: Tychy
country: Poland
facility: American Heart of Poland
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Maastad hospital
name: Pieter Smits, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kocka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.