Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk (ZEVS-HBR)

National Institute of Cardiology Ignacio Chavez

Status: Enrolling

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; High Bleeding Risk

Treatments: Device: Sirolimus eluting stent; Device: Zotarolimus eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05240781

21-1277

Details and patient eligibility

About

Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous intervention with a zotarolimus eluting stent versus a sirolimus eluting stent and short Dual Antiplatelet Therapy (DAPT).

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients 18 years old or older with an ischemic de-novo lesion(s) in coronary artery or coronary bypass graft suitable for percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by DES, and has at least 1 major or 2 minor Academic Research Consortium High Bleeding Risk criteria:

Major criteria:

• 1. Anticipated use of long-term oral anticoagulation
• 2. Severe or end-stage Chronic Kidney Disease (CKD) (eGFR <30 mL/min)
• 3. Hemoglobin < 11 g/dL
• 4. Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
• 5. Moderate or severe baseline thrombocytopenia (<100,000/uL)
• 6. Chronic bleeding diathesis
• 7. Liver cirrhosis with portal hypertension
• 8. Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
• 9. Previous spontaneous intracranial hemorrhage
• 10. Previous traumatic intracranial hemorrhage within the past 12 months
• 11. Presence of Brain Arteriovenous malformation (AVM)
• 12. Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
• 13. Non-deferrable major surgery on DAPT
• 14. Recent major surgery or major trauma within 30 days before PCI

Minor Criteria:

• 1. Age 75 years old and older
• 2. Moderate CKD (eGFR 30-59 mL/min)
• 3. Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
• 4. Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
• 5. Long term use of NSAIDs or steroids
• 6. Any ischemic stroke at any time not meeting major criterion

Exclusion criteria

• STEMI undergoing primary PCI
• Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
• Unprotected left main lesion
• Reference diameter larger or shorter than available stents
• Life expectancy < 12 months
• In-stent restenosis o thrombosis of previous stent
• Inability to give written consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Zotarolimus Eluting Stent

Active Comparator group

Description:

High Bleeding Risk patients to be treated with drug-eluting stents (DES). Includes both stable Coronary Artery Disease (CAD) and Acute Coronary Syndrome (ACS) patients undergoing elective PCI.

Treatment:

Device: Zotarolimus eluting stent

Sirolimus Eluting Stent

Experimental group

Description:

High Bleeding Risk patients to be treated with drug-eluting stents (DES). Includes both stable CAD and ACS patients undergoing elective PCI.

Treatment:

Device: Sirolimus eluting stent