Back to resultsDrug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty (DEBORA)
Primary Purpose
High Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Drug Eluting Balloon (DEB)
Drug Eluting Stents (DES)
Sponsored by
About this trial
This is an interventional treatment trial for High Bleeding Risk focused on measuring Drug Eluting Balloon (DEB), Drug Eluting Stent (DES), High bleeding risk (HBR), High hemorrhagic risk, Dual anti-platelet therapy (DAPT)
Eligibility Criteria
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:
- Anticipated use of long-term oral anticoagulation
- Severe or end-stage CKD (eGFR <30 mL/min)
- Hemoglobin < 11 g/dL
- Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
- Moderate or severe baseline thrombocytopenia (<100,000/uL)
- Chronic bleeding diathesis
- Liver cirrhosis with portal hypertension
- Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
- Previous spontaneous intracranial hemorrhage
- Previous traumatic intracranial hemorrhage within the past 12 months
- Presence of Brain arteriovenous malformation (AVM)
- Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
- Non deferrable major surgery while on DAPT
- Recent major surgery or major trauma within 30 days before PCI
Minor Criteria:
- Age 75 years old and older
- Moderate Chronic Kidney Disease (CKD) (eGFR 30-59 mL/min)
- Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
- Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
- Long term use of NSAIDs or steroids
- 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
Sites / Locations
- Instituto Nacional de Cardiologia "Ignacio Chávez"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Drug Eluting Balloon (DEB)
Drug Eluting Stents (DES)
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Target Lesion Failure (TLF)
Composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization
Secondary Outcome Measures
Cardiovascular death
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.
Myocardial Infarction related to the treated vessel
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.
Target Lesion Revascularization
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
Target Vessel Failure (TVF)
Rate of TVF in each group (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization)
Target Vessel Revascularization
Rate of repeated percutaneous intervention or surgical bypass of any segment of the target vessel in each group.
Non-cardiovascular death
Rate of any death that is not thought to be the result of a cardiovascular cause in each group:
Death resulting from malignancy
Death resulting from pulmonary causes
Death caused by infection (includes sepsis)
Death resulting from gastrointestinal causes
Death resulting from accident/trauma
Death caused by other noncardiovascular organ failure
Death resulting from other noncardiovascular cause
Major Bleeding
Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater
Technical success
Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a <30% residual stenosis.
Subgroup analysis of target lesion failure
Rate of TLF in treatment of bifurcations vs no bifurcation, by vessel size, in diabetes, by clinical Presentation (acute or chronic).
Subgroup analysis of major bleeding events
Rate of BARC 3-5 bleeding events in patients with anticoagulation vs no anticoagulation, by DAPT duration, by inclusion criteria
Full Information
NCT ID
NCT04885816
First Posted
May 8, 2021
Last Updated
October 19, 2021
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
1. Study Identification
Unique Protocol Identification Number
NCT04885816
Brief Title
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
Acronym
DEBORA
Official Title
Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 undergoing elective coronary percutaneous intervention comparing limus-eluting balloon vs. limus-eluting stents.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Keywords
Drug Eluting Balloon (DEB), Drug Eluting Stent (DES), High bleeding risk (HBR), High hemorrhagic risk, Dual anti-platelet therapy (DAPT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-blind, non-inferiority clinical trial enrolling high bleeding risk patients 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.
Masking
Participant
Masking Description
Randomized treatment will not be revealed to patient at any time during procedure or afterwards until follow-up is done.
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug Eluting Balloon (DEB)
Arm Type
Experimental
Arm Description
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).
Arm Title
Drug Eluting Stents (DES)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Drug Eluting Balloon (DEB)
Other Intervention Name(s)
MagicTouch, Sirolimus coated balloon catheter, diameters 2.5 - 4.0 mm (Concept Medicals, Surat, India)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Drug Eluting Stents (DES)
Other Intervention Name(s)
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)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Description
Composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiovascular death
Description
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.
Time Frame
12 months
Title
Myocardial Infarction related to the treated vessel
Description
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.
Time Frame
12 months
Title
Target Lesion Revascularization
Description
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
Time Frame
12 months
Title
Target Vessel Failure (TVF)
Description
Rate of TVF in each group (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization)
Time Frame
12 months
Title
Target Vessel Revascularization
Description
Rate of repeated percutaneous intervention or surgical bypass of any segment of the target vessel in each group.
Time Frame
12 months
Title
Non-cardiovascular death
Description
Rate of any death that is not thought to be the result of a cardiovascular cause in each group:
Death resulting from malignancy
Death resulting from pulmonary causes
Death caused by infection (includes sepsis)
Death resulting from gastrointestinal causes
Death resulting from accident/trauma
Death caused by other noncardiovascular organ failure
Death resulting from other noncardiovascular cause
Time Frame
12 months
Title
Major Bleeding
Description
Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater
Time Frame
12 months
Title
Technical success
Description
Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a <30% residual stenosis.
Time Frame
Periprocedural
Title
Subgroup analysis of target lesion failure
Description
Rate of TLF in treatment of bifurcations vs no bifurcation, by vessel size, in diabetes, by clinical Presentation (acute or chronic).
Time Frame
12 months
Title
Subgroup analysis of major bleeding events
Description
Rate of BARC 3-5 bleeding events in patients with anticoagulation vs no anticoagulation, by DAPT duration, by inclusion criteria
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Anticipated use of long-term oral anticoagulation
Severe or end-stage CKD (eGFR <30 mL/min)
Hemoglobin < 11 g/dL
Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
Moderate or severe baseline thrombocytopenia (<100,000/uL)
Chronic bleeding diathesis
Liver cirrhosis with portal hypertension
Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
Previous spontaneous intracranial hemorrhage
Previous traumatic intracranial hemorrhage within the past 12 months
Presence of Brain arteriovenous malformation (AVM)
Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
Non deferrable major surgery while on DAPT
Recent major surgery or major trauma within 30 days before PCI
Minor Criteria:
Age 75 years old and older
Moderate Chronic Kidney Disease (CKD) (eGFR 30-59 mL/min)
Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
Long term use of NSAIDs or steroids
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guering Eid-Lidt, MD
Organizational Affiliation
Instituto Nacional de Cardiología "Ignacio Chávez"
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Nacional de Cardiologia "Ignacio Chávez"
City
Ciudad de México
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual patient data will not be shared with other researchers.
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Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
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