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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Coronary Stenosis Treated With Implant of Bioresorbable Devices

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary stenosis treated with Absorb

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.

Coronary angioplasty with implant of bioresorbable device

Intervention Type DEVICE

Percutaneous coronary intervention

Interventions

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Coronary angioplasty with implant of bioresorbable device

Percutaneous coronary intervention

Intervention Type DEVICE

Eligibility Criteria

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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.