Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Chronic oral anticoagulation, Ultrathin-strut stent, Biodegradable polymer, High-bleeding risk, Percutaneous Coronary Intervention
Brief summary
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
Detailed description
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
Interventions
PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all inclusion criteria: * Patients with Signed informed consent and * Patients with \>=18 years old and * Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and * Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used
Exclusion criteria
Patients do not have to meet any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACE (Net Adverse Clinical Events) | 12 month | Combined endpoint of Cardiac Death, Acute Myocardial Infarction, Stroke, Need for new Treated Vessel Revascularization (TVR) and BARC (Bleeding Academic Research Consortium) 3-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE (Major Adverse Cardiac Events) | 12 months | To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer. |
| TLF (Target Lesion Failure) | 12 months | To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation. |
| Death | 12 months | To assess the occurrence of Death |
| Acute Myocardial Infarction (AMI) | 12 months | To assess the occurrence of AMI |
| Stroke | 12 months | To assess the occurrence of Stroke |
| Target vessel revascularization (TVR) | 12 months | To assess the occurrence of TVR |
Countries
Spain
Contacts
CONTACTJuan Gabriel Córdoba Soriano, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed