Coronary Arteriosclerosis, Coronary Artery Disease of Significant Bypass Graft, Coronary Artery Disease Progression, Stent Restenosis, Stent Stenosis
Conditions
Keywords
Secondary revascularization, Repeat revascularization, Coronary revascularization, Coronary artery bypass graft
Brief summary
The study will evaluate patients with, at least, one previous procedure of coronary revascularization (surgical, percutaneous or both), that are referred for a new, clinically indicated, diagnostic coronary angiography, to describe their clinical characteristics, management, and prognosis, and will propose a prognosis-oriented classification.
Detailed description
Secondary or repeated revascularization refers to any repeated coronary intervention following an index coronary revascularization procedure, and represents a wide proportion of patients received in catheterization laboratories. These patients have an increased complexity and worse outcomes than patients without previous revascularization. Clinical investigation has focused in lesion-specific treatments when a single previous revascularization fails, but there is paucity of patient-level information including complex patients with multiple revascularizations. Other gaps in evidence addressed by this study are the absence of a a prognosis-oriented classification of previously revascularized patients and a clinical meaningful definition of revascularization failure. The registry as well intends to provide insights on how secondary revascularization decisions are taken and long term prognosis after secondary revascularization. The registry of secondary revascularization (in Spanish: Registro multicéntrico de reVAscularización SECundaria, REVASEC) is a multicenter, prospective, observational cohort study that incudes consecutive patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography, in different Spanish hospitals. The aims are describing the incidence, clinical profile, therapeutic management and prognosis of these patients.
Interventions
None listed
Sponsors
Laboratorios Farmacéuticos Rovi, S.A.
S&H MEDICAL SCIENCE SERVICE, S.L.
Hospital San Carlos, Madrid
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Previous successful coronary revascularization, either percutaneous or surgical, in at least one vessel with diameter ≥2 mm * Previous successful coronary revascularization must have been successful in at least one vessel and the patient must have been discharged after the previous revascularization * Clinically indicated diagnostic coronary angiography * Provide written informed consent
Exclusion criteria
* Inability or refusal to provide written informed consent * Patient included in any other clinical trial in which the revascularization device is blind to patient or investigator, or is not commercially available * Insufficient data about previous revascularizations * Previous revascularization only on vessels of less than 2 mm or which was not successful in any vessel * Previous percutaneous revascularization with simple plain old balloon angioplasty * Index coronary angiography indicated as scheduled repeated angiography, planned percutaneous coronary intervention, or pre-surgical angiography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented composite endpoint | 1 year | Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent angina (CCS class, patients reported) | 1 to 5 years | Describe the presence of recurrent angina (CCS class) and analyze its predictors |
| Rates of individual components of primary outcome | 1 to 5 years | Rates of individual components of primary outcomes: all-cause death, myocardial infarction or new unplanned revascularization |
| Composite endpoint at 2 to 5 years | 2 to 5 years | Composite endpoint including: all-cause death, any myocardial infarction or new unplanned revascularization |
| Rate of failure of previous revascularization | baseline (assessed at index catheterization) | Rate of failure of previous revascularization using the classical definition: \>50% stent restenosis or \>50% stenosis in a surgical graft |
| Feasibility of secondary revascularization | per protocol, 1 month after index catheterization | Define the rates of successful and complete revascularization |
Countries
Spain
Outcome results
None listed