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.
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 Type
OBSERVATIONAL
Enrollment
1,000
Percutaneous coronary intervention
Hospital 12 de Octubre
Madrid, Madrid, Spain
RECRUITINGQuality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)
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.
Time frame: 1 year follow-up
"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.
Time frame: 1 year follow-up
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