Drug-Eluting Balloon in Stable and Unstable Angina (DEBUT)

January 28, 2018 updated by: Tuomas Rissanen, North Karelia Central Hospital

Drug-Eluting Balloon in Stable and Unstable Angina: a Randomized Controlled Non-inferiority Trial

The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Stenting has reduced the need of revascularization procedures in stable CAD and ACS as compared to POBA. The use of stents is favored in stable CAD and in ACS according the the present ESC guidelines. However, especially in patients on warfarin or in patients at a high bleeding risk, stenting (and the use of DES in particular) is not recommended because of the longer DAPT required. In these patients, BMS may be used to shorten the duration of DAPT. However, there are problems associated with the treatment using BMS. First of all, a considerable high rate of restenosis is associated with stenting with BMS. Furthermore, stenting may be complicated by the "no-reflow" phenomenon, a coronary dissection or the closure of side branch during the treatment of bifurcation lesions. Implantation of a stent also exposes the patient to stent thrombosis. In contrast, these problems may be avoided by the use of DEB with the provisional BMS strategy.

The use of DEB has already been established in the treatment of ISR. Despite the lack of data of RCTs, DEB is already widely used in a variety of clinical situations in which stenting is not desirable. These situations include for example anticoagulation treatment, a high bleeding risk, poor compliance regarding medication, small vessels, bifurcation lesions, long and/or calcified lesions, in case of a marked variation in the vessel reference caliber, in long lesions and in patients with ACS. The all-comer registry data is promising but only hypothesis generating. Thus, it would be very important and ethical to test the efficacy of DEB in a wider patient population in a randomized controlled study.

Our hypothesis is that DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise having a high bleeding risk. Our study sheds light on the use of DEB in PCI of this challenging patient population. In most previous studies, BMS has been routinely added to the DEB treatment. This strategy seems not to yield any benefit but in contrast causes an increased risk of restenosis as compared to the DEB only strategy with provisional stenting. Finally, the current data on the use of DEB in patients with ACS is scarce and our study gives significant information also on this important issue.

Study Type

Interventional

Enrollment (Actual)

220

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

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital Heart Center
      • Joensuu, Finland, 80210
        • North Karelia Central Hospital
      • Kuopio, Finland, 70210
        • Kuopio University Hospital
      • Turku, Finland
        • Turku University Hospital

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:

  • Age ≥ 18 years
  • Informed written consent

  • At least one of the following

    1. Patient is using oral anticoagulation (warfarin, dabigatran or rivaroxaban)
    2. Anemia (hemoglobin below the threshold: < 117g/l in women and < 134 g/l in men) or thrombocytopenia (<100) detected <6 months prior the PCI
    3. Active malign disease (metastatic cancer or ongoing radio- or chemotherapy)
    4. Prior intracerebral hemorrhage or ischemic stroke
    5. Severe kidney or liver dysfunction (eGFR < 30ml/kg/min, liver cirrhosis, BIL >2x over threshold or ALAT >3x over threshold)
    6. Elective surgery planned < 12 months after the PCI
    7. General frailty for e.g. because of long corticosteroid treatment or generalized cachexia (BMI < 20 kg/m2)
    8. Age ≥ 80 years
    9. Inability or suspected inability to use DAPT for 12 months

  • Either of the following:

    10) Prior bleeding (BARC 2-5)

    1. Stable angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. Ischemia is documented by the pressure wire measurement (FFR) or by a non-invasive test such as stress ECG test or perfusion imaging
    2. ACS (UAP or NSTEMI): symptoms of heart ischemia ≥ 20 minutes and ≥ 0,5mm ST-depression or transient ST-elevation or T-wave inversion at least in two adjacent leads and/or a high sensitivity troponin (hs-tnt) rise at least one unit above the 99. percentile or at least 50% rise in hs-tnt between two samples taken 3 hours apart
  • ≥1 de novo lesions in native coronary arteries or bypass vein grafts
  • Reference diameter of the vessel is 2,5-4,0mm
  • Lesion or lesions are suitable for PCI

Exclusion Criteria:

  • Inability to give written consent
  • STEMI
  • Reference diameter of the vessel is <2,5mm or >4,0mm
  • Bifurcation lesion requiring the stenting of the side branch
  • Dissection affecting the flow (TIMI<3) or significant recoil (>30% in main branch, >50% in side branch) after predilatation
  • In-stent restenosis
  • Life expectancy < 12 months
  • Cardiogenic shock at the arrival to the coronary angiography
  • Uncertainty about neurological recovery e.g. after resuscitation
  • Unprotected left main (LM) lesion
  • Chronic total occlusion (CTO)

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)
Patients treated with drug-eluting balloon (DEB). Provisional stenting with BMS is permitted in case of a flow-limiting dissection or significant recoil (>30% in main branch and >50% side-branch), Includes both stable CAD and ACS patients.
Procedure: drug-eluting balloon (DEB)
The length of the DEB is chosen so that the lesion and 2mm from both ends are covered by the DEB. If needed, several DEBs can be used to cover the whole lesion. The diameter of the DEB and the pressure used is chosen so that the balloon-artery -ratio is 0.8-1.0. In case of a flow limiting dissection, significant recoil or coronary perforation, a provisional BMS is implanted (stent-artery -ratio 1.1) and the post dilatation is performed if indicated (the lesion length is >20mm or stent malapposition is suspected).
Other Names:
  • SeQuent Please (B Braun, Germany, diameter 2,5-4.0mm)
Active Comparator: bare-metal stent (BMS)
Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.
Procedure: bare-metal stent (BMS)
The BMS is implanted after predilatation (stent-artery -ratio 1.1) to cover the whole lesion and the postdilatation is performed if indicated (the lesion length >20mm or stent malapposition is suspected).
Other Names:
  • Integrity stent (Medtronic, USA, diameter 2,5-4,0mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR))
Time Frame: At 9 months
In stable patients, the evidence of ischemia is acquired either by non-invasive testing (for example stress ECG or perfusion imaging) or by pressure wire measurement (FFR) during coronary angiography.
At 9 months
ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Time Frame: at 36 months
at 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Time Frame: At 9 months
At 9 months
Failure to treat the lesion
Time Frame: During PCI
The failure to deliver the randomized treatment (DEB or BMS) to the target lesion is defined as a failure to treat the lesion.
During PCI

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Time Frame: at 36 months
at 36 months
Control angiography and OCT imaging
Time Frame: At 6 months
30 patients (15 from each group) will be randomly invited to a control angiography and OCT imaging to asses the rate of restenosis and endothelial healing.
At 6 months
MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR))
Time Frame: at 36 months
at 36 months

Collaborators and Investigators

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

Sponsor

North Karelia Central Hospital

Collaborators

Turku University Hospital
Kuopio University Hospital
University of Helsinki
Central Hospital of Lapland, Finland

Investigators

  • Principal Investigator: Tuomas Rissanen, MD, PhD, North Karelia Central Hospital
  • Principal Investigator: Antti Siljander, MD, North Karelia Central Hospital

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)

May 22, 2013

Primary Completion (Actual)

January 16, 2018

Study Completion (Actual)

January 16, 2018

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 28, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEBUT

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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