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

• Conditions: Coronary Stenosis Treated With Implant of Bioresorbable Devices
• Interventions: Device: Coronary angioplasty with implant of bioresorbable device

• 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

Arm && Interventions

Group	Intervention	Description
Coronary stenosis treated with Absorb	Coronary angioplasty with implant of bioresorbable device	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.

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