Drug-Eluting Balloon in Stable and Unstable Angina

NCT ID: NCT01781546

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-22
• Study Completion Date: 2018-01-16

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

drug-eluting balloon (DEB)

Intervention Type: PROCEDURE

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).

bare-metal stent (BMS)

Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.

Group Type: ACTIVE_COMPARATOR

bare-metal stent (BMS)

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

Other Intervention Names

SeQuent Please (B Braun, Germany, diameter 2,5-4.0mm); Integrity stent (Medtronic, USA, diameter 2,5-4,0mm)

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Central Hospital of Lapland, Finland

UNKNOWN

Sponsor Role: collaborator

North Karelia Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tuomas Rissanen

Cardiologist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuomas Rissanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Karelia Central Hospital

Antti Siljander, MD

Role: PRINCIPAL_INVESTIGATOR

North Karelia Central Hospital

Locations

Helsinki University Hospital Heart Center

Helsinki, , Finland

North Karelia Central Hospital

Joensuu, , Finland

Kuopio University Hospital

Kuopio, , Finland

Turku University Hospital

Turku, , Finland

Countries

Finland

References

Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.

Reference Type: DERIVED

PMID: 31204115 (View on PubMed)

Other Identifiers

DEBUT

Identifier Type: -

Identifier Source: org_study_id