Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation

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.

• Supraflex Cruz Sirolimus-eluting Stent (Device): PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.

Primary outcomes

• 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 outcomes

• 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.
• MACE (Major Adverse Cardiac Events) [6 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.
• TLF (Target Lesion Failure) [6 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
• Death [6 months]: To assess the occurrence of Death
• Acute Myocardial Infarction (AMI) [12 months]: To assess the occurrence of AMI
• Acute Myocardial Infarction (AMI) [6 months]: To assess the occurrence of AMI
• Stroke [12 months]: To assess the occurrence of Stroke
• Stroke [6 months]: To assess the occurrence of Stroke
• Target vessel revascularization (TVR) [12 months]: To assess the occurrence of TVR
• Target vessel revascularization (TVR) [6 months]: To assess the occurrence of TVR

Sex: All, ages: 18 Years to any

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 exclusion criteria

* Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included.
* Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s).
* Patients treatment for restenosis or stent thrombosis.
* Patients presentation in cardiogenic shock or after cardiorespiratory arrest.
* Patients with allergy to any of the components of the stent to be used.
* Patients with impossibility for follow-up.
* Patients with life expectancy less than 1 year.

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