Coronary Stenosis Treated With Implant of Bioresorbable Devices
Conditions
Keywords
Coronary artery disease, Angioplasty, Bioresorbable coronary device, QALY (Quality-Adjusted Life Years)
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).
Interventions
DEVICECoronary angioplasty with implant of bioresorbable device
Percutaneous coronary intervention
Sponsors
Sección Hemodinamica y Cardiologia Intervencionista
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Contacts
Primary ContactFelipe Hernandez, MD
Backup ContactMiriam Bascones, MD
Outcome results
None listed