Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice

• Conditions: Coronary Stenosis Treated With Implant of Bioresorbable Devices

• Registration Number: NCT02854007
• Lead Sponsor: Sección Hemodinamica y Cardiologia Intervencionista

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).

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)	1 year follow-up	To construct QALYs, the EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension. If a patient dies, the value of EQ-5D is 0 from the date of death.

Secondary Outcome Measures

Name	Time	Method
"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.	1 year follow-up

Trial Locations

Locations (1)

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain