Clinical trial NCT01858077: Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial
Official title: Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA Trial): A Clinical Evaluation Comparing the Efficacy and Performance of ABSORB™ Everolimus Eluting Bioresorbable Vascular Scaffold Strategy Versus the XIENCE Family (XIENCE PRIME™ or XIENCE Xpedition™) Everolimus Eluting Coronary Stent Strategy in the Treatment of Coronary Lesions in Consecutive All-comers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 1845
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.

Detailed description: The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.

Eligibility criteria: Inclusion Criteria:

* Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family.
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
* Unsuccessful predilation of one or more of the planned lesion to be treated.
* Planned treatment of in-stent restenosis of a previously placed metallic stent.
* Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm.
* Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents.
* Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
* Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
* Subjects with a limited life expectancy less than one year.
* Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
* Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
* Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 2 years
Secondary outcomes:
measure: Device success
timeFrame: 1 day
measure: Procedural success
timeFrame: 1 day
measure: Target vessel failure (TVF)
timeFrame: 30 days, and 1, 3, 4 and 5 years
measure: Target lesion failure
timeFrame: 30 days, and 1, 2, 3, 4 and 5 years
measure: All revascularizations
timeFrame: 5 year
measure: Major adverse cardiac events
timeFrame: 30 days, and 1, 2, 3, 4 and 5 years
measure: All cause mortality
timeFrame: 30 days, 1 year, 2, 3, 4 and 5 years
measure: Myocardial Infarction
timeFrame: 30 days, 1, 2, 3, 4 and 5 years
measure: Target Lesion Revascularization (TLR)
timeFrame: 30 days, 1 year, 2, 3, 4 and 5 years
measure: Target Vessel Revascularization (TVR)
timeFrame: 30 days, 1 year, 2, 3, 4 and 5 years
measure: Non-Target Vessel Revascularization (NTVR)
timeFrame: 30 days, 1 year, 2, 3, 4 and 5 years
measure: Scaffold/Stent Thrombosis
timeFrame: 30 days, 1, 2, 3, 4 and 5 years
measure: Seattle Angina Questionnaire (SAQ)
timeFrame: 1 year and 2 years
measure: Quality of Life Questionnaire (QOL)
timeFrame: 1 year and 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Hilversum
country: Netherlands
facility: TerGooi Hospital
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Joanna Wykrzykowska, MD, PhD
role: STUDY_DIRECTOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Rob de Winter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan Piek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan Tijssen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jose Henriques, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woudstra P, Grundeken MJ, Kraak RP, Hassell ME, Arkenbout EK, Baan J Jr, Vis MM, Koch KT, Tijssen JG, Piek JJ, de Winter RJ, Henriques JP, Wykrzykowska JJ. Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design. Am Heart J. 2014 Feb;167(2):133-40. doi: 10.1016/j.ahj.2013.09.017. Epub 2013 Oct 17.
citation: Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, van der Schaaf RJ, Arkenbout EK, Weevers APJD, Garcia-Garcia HM, Kraak R, Piek JJ, Tijssen JGP, Henriques JPS, de Winter RJ, Wykrzykowska JJ. Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial. EuroIntervention. 2022 Mar 18;17(16):1340-1347. doi: 10.4244/EIJ-D-21-00419.
citation: Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJsselmuiden AJ, Elias J, van Dongen IM, Tijssen RYG, Koch KT, Baan J Jr, Vis MM, de Winter RJ, Piek JJ, Tijssen JGP, Henriques JPS; AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017 Jun 15;376(24):2319-2328. doi: 10.1056/NEJMoa1614954. Epub 2017 Mar 29.