Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice (REPARA-QALY)

Sección Hemodinamica y Cardiologia Intervencionista

Status: Unknown

Conditions: Coronary Stenosis Treated With Implant of Bioresorbable Devices

Treatments: Device: Coronary angioplasty with implant of bioresorbable device

Study type: Observational

Funder types: Other

Identifiers

NCT02854007

COR-BVS-2016-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Coronary stenosis treated with Absorb

Description:

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.

Treatment:

Device: Coronary angioplasty with implant of bioresorbable device