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

February 17, 2022 updated by: Daniel Fernando Zazueta Salido, Instituto Nacional de Cardiologia Ignacio Chavez

Zotarolimus Eluting Stent Versus Sirolimus Eluting Stent in High Bleeding Risk Angioplasty

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Ciudad de México, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiología "Ignacio Chávez"
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Zotarolimus eluting stent

Size (diameter and length) will be chosen at operator's discretion aided by simple angiography, QCA, or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DES with an stent to artery ratio of 1.1. Post-dilatation will be performed when indicated. Device will be used by CE mark instructions.

All patients will receive DAPT as follows: After a loading dose (if necessary) of aspirin and a P2Y12 inhibitor, aspirin 100 mg and a P2Y12 inhibitor daily will be indicated for 1 month in both ACS and Chronic Coronary Syndrome (CCS). Patients with high ischemic risk could be extended to 3 months. After DAPT, SAPT will be continued with the drug of choice, preferably P2Y12 inhibitor. Patients requiring chronic anticoagulation will receive triple therapy only during hospitalization. At release, an oral anticoagulant (NOAC preferred over VKA) will be indicated along with 6 months of SAPT with a P2Y12 inhibitor.

Other Names:
  • Resolute Onyx, Zotarolimus eluting stent (Medtronic, Santa Rosa, CA, USA)
Experimental: 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.
Device: Sirolimus eluting stent

Size (diameter and length) will be chosen at operator's discretion aided by simple angiography, QCA, or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DES with an stent to artery ratio of 1.1. Post-dilatation will be performed when indicated. Device will be used in accordance with the CE mark instructions.

All patients will receive DAPT as follows: After a loading dose (if necessary) of aspirin and a P2Y12 inhibitor, aspirin 100 mg and a P2Y12 inhibitor daily will be indicated for 1 month in both ACS and CCS. Patients with high ischemic risk could be extended to 3 months. After DAPT, SAPT will be continued with the drug of choice, preferably P2Y12 inhibitor. Patients requiring chronic anticoagulation will receive triple therapy only during hospitalization. At release, an oral anticoagulant (NOAC preferred over VKA) will be indicated along with 6 months of SAPT with a P2Y12 inhibitor.

Other Names:
  • Ultimaster, Sirolimus eluting stent (Terumo; Tokyo, Japan)
  • Ultimaster Tansei, Sirolimus eluting stent (Terumo; Tokyo, Japan)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Bleeding
Time Frame: 12 months
Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater
12 months
Technical success
Time Frame: Periprocedural
Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a <30% residual stenosis.
Periprocedural
Cardiovascular death
Time Frame: 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.
12 months
Myocardial Infarction related to the treated vessel
Time Frame: 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.
12 months
Target Lesion Revascularization
Time Frame: 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.
12 months
Target Vessel Failure (TVF)
Time Frame: 12 months
Rate of TVF (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization)
12 months
Target Vessel Revascularization
Time Frame: 12 months
Rate of repeat percutaneous intervention or surgical bypass of any segment of the target vessel
12 months
Non-cardiovascular death
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

  • Study Director: Guering Eid-Lidt, MD, Instituto Nacional de Cardiología "Ignacio Chávez"
  • Principal Investigator: Daniel F Zazueta, MD, Instituto Nacional de Cardiología "Ignacio Chávez"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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