Clinical trial NCT02854007: Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice
Official title: REgistry of PAtients Treated With bioabsoRbable Devices in dAily Clinical Practice: Costs, Effectiveness, QALYs, and Efficiency. REPARA-QALY Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Stenosis Treated With Implant of Bioresorbable Devices
Keywords: Coronary artery disease
Angioplasty
Bioresorbable coronary device
QALY (Quality-Adjusted Life Years)
Lead sponsor: Sección Hemodinamica y Cardiologia Intervencionista
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 sites.

Brief summary: A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. A before-after comparative analysis will be performed, so that each patient will act as his/her own control.

Detailed description: Economical evaluation study of the efficiency of Absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with Absorb based on the criteria established according to standard clinical practice. A comparison group without Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own control, and a before-after comparison will be done. This is therefore a prospective, observational cohort study with concurrent data collection.

Primary objective:

* To assess utility (QALYs gained) in patients implanted Absorb in standard clinical practice conditions.

Secondary objectives:

* To assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with Absorb implantation.
* To assess costs (direct and indirect) derived from coronary revascularization with Absorb implantation.
* To assess efficiency in terms of cost/utility (cost per QALY gained) and cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).

Eligibility criteria: Inclusion Criteria:

* Age ranging from 18 and 95 years.
* Both sexes.
* Coronary revascularization with Absorb for any of the following lesions: de novo, restenosis, segment ST elevation myocardial infarction (STEMI), chronic total occlusion (CTO), trunk, venous graft, or bifurcations.
* Informed consent signed before participation in the study is started.

Exclusion Criteria:

* Pregnant or nursing woman..
* Cardiogenic shock.
* Refusal to participate in the study.

Primary outcomes:
measure: Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)
timeFrame: 1 year follow-up
Secondary outcomes:
measure: "Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
affiliation: Hospital 12 de Octubre, Madrid
name: Felipe Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: