Clinical trial NCT05240781: Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk
Official title: Zotarolimus Eluting Stent Versus Sirolimus Eluting Stent in High Bleeding Risk Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Bleeding Risk
Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: Short DAPT
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, non-inferiority clinical trial enrolling eligible subjects with high bleeding risk and coronary artery disease to be treated by percutaneous coronary intervention at the National Institute of Cardiology "Ignacio Chávez" in México. Included patients will have follow-up at the outpatient clinic through 1 year, until death or study exit, whichever comes first.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 12 months
measure: Myocardial Infarction related to the treated vessel
timeFrame: 12 months
measure: Target Lesion Revascularization
timeFrame: 12 months
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
measure: Target Vessel Revascularization
timeFrame: 12 months
measure: Non-cardiovascular death
timeFrame: 12 months
measure: Major Bleeding
timeFrame: 12 months
measure: Technical success
timeFrame: Periprocedural
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Cardiología "Ignacio Chávez"
Study officials:
affiliation: Instituto Nacional de Cardiología "Ignacio Chávez"
name: Guering Eid-Lidt, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Cardiología "Ignacio Chavez"
name: Daniel F Zazueta, MD
role: PRINCIPAL_INVESTIGATOR
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