Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk

Not Applicable

Recruiting

• Conditions: Percutaneous Coronary Intervention; High Bleeding Risk; Coronary Artery Disease
• Interventions: Device: Sirolimus eluting stent; Device: Zotarolimus eluting stent

• Registration Number: NCT05240781
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-29
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04
• Primary Completion: 2024-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus Eluting Stent	Sirolimus eluting stent	High Bleeding Risk patients to be treated with drug-eluting stents (DES). Includes both stable CAD and ACS patients undergoing elective PCI.
Zotarolimus Eluting Stent	Zotarolimus eluting stent	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.

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	Rate of composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Myocardial Infarction related to the treated vessel	12 months	Rate of myocardial infarction related to the treated vessel (according to the 4th international definition of myocardial infarction): detection of an increase or decrease in cardiac troponin values with at least 1 of the values above the upper reference limit of the 99th percentile and at least 1 of the following conditions : Symptoms of acute myocardial ischemia. New ischemic changes in the electrocardiogram. Appearance of pathological Q waves. Imaging evidence of loss of viable myocardium or new regional abnormalities in myocardial wall mobility following a pattern compatible with ischemic etiology.; Identification of a coronary thrombus by angiography with intracoronary imaging or by autopsy Any MI that cannot be clearly attributed to a vessel other than the revascularized one will be considered as MI related to the treated vessel.
Target Vessel Revascularization	12 months	Rate of repeat percutaneous intervention or surgical bypass of any segment of the target vessel
Non-cardiovascular death	12 months	Rate of any death that is not thought to be the result of a cardiovascular cause: 1. Death resulting from malignancy; 2. Death resulting from pulmonary causes; 3. Death caused by infection (includes sepsis); 4. Death resulting from gastrointestinal causes; 5. Death resulting from accident/trauma; 6. Death caused by other noncardiovascular organ failure 7. Death resulting from other noncardiovascular cause
Major Bleeding	12 months	Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater
Target Vessel Failure (TVF)	12 months	Rate of TVF (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization)
Cardiovascular death	12 months	Rate of death resulting from cardiovascular causes: Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage Death resulting from other cardiovascular cause Any MI not clearly attributable to a non- target vessel will be considered as target-vessel MI.; Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.
Target Lesion Revascularization	12 months	Rate of repeated percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Technical success	Periprocedural	Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a \<30% residual stenosis.

Trial Locations

Locations (1)

Instituto Nacional de Cardiología "Ignacio Chávez"; 🇲🇽 Ciudad de México, Mexico