Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty (DEBORA)

October 19, 2021 updated by: Daniel Fernando Zazueta Salido, Instituto Nacional de Cardiologia Ignacio Chavez

Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk

Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing limus-eluting balloon vs. limus-eluting stents.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Drug Eluting Stents (DES) are the devices of choice for coronary angioplasty, including in patients with high-bleeding risk.

Different studies have been done to determine which strategy improves bleeding outcomes without risking the benefit of stenting. Different Double Anti-Platelet Therapy (DAPT) durations in different devices have shown that it is safe to reduce DAPT, with an increase in ischemic events but a better net clinical outcome.

Safety and efficacy of Drug Eluting Balloons (DEB) were proved when it was compared with Bare Metal Stents (BMS) in de-novo coronary lesions by presenting no events of target vessel closure after treatment.

Our hypothesis is that treating this group of high-bleeding risk patients with DEB will be no-inferior in terms of target vessel failure at 12 months when compared with DES for treatment of de-novo coronary lesions in high bleeding risk population, reducing incidence of significant bleeding events with DAPT reduction.

Study Type

Interventional

Enrollment (Actual)

5

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 Locations

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

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 a 2.5 - 4.0 mm reference diameter coronary artery suitable for elective 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 DEB or 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 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 while 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 Chronic Kidney Disease (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
  • Any ACS undergoing urgent PCI
  • Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
  • Unprotected left main lesion
  • Life expectancy < 12 months
  • Reference vessel diameter < 2.5 mm or > 4.0 mm
  • Bifurcation lesion requiring 2-stent technique
  • Chronic total occlusion
  • In-stent restenosis
  • Dissection affecting the flow (TIMI<3) or significant recoil (>30% in main branch, >50% in side branch) after predilatation
  • 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Eluting Balloon (DEB)
High Bleeding Risk patients treated with 2.5 - 4.0 mm drug-eluting balloons (DEB). Bailout stenting is permitted in case of a flow-limiting dissection or significant recoil (>30% in main branch and >50% side-branch), includes both stable coronary artery disease (SCAD) and acute coronary syndromes (ACS) patients undergoing elective Percutaneous Coronary Intervention (PCI).
Device: Drug Eluting Balloon (DEB)

Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DEB, and the diameter and pressure used aims a balloon to artery ratio of 1. In case of significant recoil (more than 30% for main vessels and 50% for side vessels), coronary perforation or flow limiting dissection, provisional stent will be implanted with a stent to artery ratio of 1.1 with stent post-dilatation when indicated. Device will be used in accordance with the CE mark instructions.

DAPT will be given for a month with aspirin and a P2Y12 inhibitor (clopidogrel will be favored). Single anti-platelet therapy (SAPT) with aspirin will be continued thereafter.

Other Names:
  • MagicTouch, Sirolimus coated balloon catheter, diameters 2.5 - 4.0 mm (Concept Medicals, Surat, India)
Active Comparator: Drug Eluting Stents (DES)
High Bleeding Risk patients treated with 2.5 - 4.0 mm drug-eluting stents (DES). Includes both stable CAD and ACS patients undergoing elective PCI.
Device: Drug Eluting Stents (DES)

Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (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. Devices will be used in accordance with the CE mark instructions.

DAPT will be indicated according to actual international guidelines.

Other Names:
  • Orsiro, Sirolimus eluting stent, diameters 2.5 - 4.0 mm (Biotronik AG, Bülach, Switzerland)
  • Resolute Onyx, Zotarolimus eluting stent, diameters 2.5 - 4.0 mm (Medtronic, Santa Rosa, CA, USA)
  • Xiencie Sierra, Everolimus eluting stent, diameters 2.5 - 4.0 mm (Abbott Vascular, Santa Clara, CA, USA)
  • Synergy, Everolimus eluting stent, diameters 2.5 - 4.0 mm (Boston Scientific, Natick, MA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 12 months
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
Cardiovascular death
Time Frame: 12 months

Rate of death resulting from cardiovascular causes in each group:

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) in each group: 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 in each group (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 repeated percutaneous intervention or surgical bypass of any segment of the target vessel in each group.
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 in each group:

  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
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
Subgroup analysis of target lesion failure
Time Frame: 12 months
Rate of TLF in treatment of bifurcations vs no bifurcation, by vessel size, in diabetes, by clinical Presentation (acute or chronic).
12 months
Subgroup analysis of major bleeding events
Time Frame: 12 months
Rate of BARC 3-5 bleeding events in patients with anticoagulation vs no anticoagulation, by DAPT duration, by inclusion criteria
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"

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)

April 20, 2021

Primary Completion (Actual)

September 29, 2021

Study Completion (Actual)

September 29, 2021

Study Registration Dates

First Submitted

May 8, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCAR-DG-DACEP-020-2021
  • 21-1223 (INCar Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individual patient data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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