The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.
Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known. Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
546
SeQuent Please (BBraun) + tailored antithrombotic regimen: 1. Stable patients without OAC: perioperative SAPT (preferably) or perioperative DAPT followed by lifelong SAPT 2. Stable patients with OAC: perioperative SAPT (preferably) or perioperative DAPT and lifelong OAC 3. ACS patients without OAC: 1-month DAPT followed by lifelong SAPT 4. ACS patients with OAC: perioperative DAPT followed by 1-month SAPT and lifelong OAC
Biofreedom (Biosensors), Synergy (Boston Scientific), Ultimaster Tansei (Terumo) and Integrity Onyx (Medtronic), Xience Pro S (Abbott) or Promus Elite (Boston Scientific) or any other DES can also be used provided that it has a CE mark for 1-month DAPT, combined with tailored antithrombotic regimen: 1. Stable patients without OAC: 1-month DAPT followed by lifelong SAPT 2. Stable patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and life-long OAC 3. ACS patients without OAC: 3-month DAPT followed by lifelong SAPT 4. ACS patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and lifelong OAC
Central Hospital of Central Finland
Jyväskylä, Central Finland, Finland
NOT_YET_RECRUITINGCentral Hospital of Lapland
Rovaniemi, Lapland, Finland
The composite of MACE and BARC type 2-5 bleeding episodes
Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR). BARC = Bleeding academic research consortium. 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.
Time frame: 12 months
The composite of MACE and BARC2-5 bleedings
Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR). BARC = Bleeding academic research consortium. 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.
Time frame: 24 and 36 months
MACE
Composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)
Time frame: 12, 24 and 36 months
BARC2-5 bleedings
BARC = Bleeding academic research consortium
Time frame: 12, 24 and 36 months
BARC3-5 bleedings
BARC = Bleeding academic research consortium
Time frame: 12, 24 and 36 months
Total mortality
All-cause mortality
Time frame: 12, 24 and 36 months
Cardiovascular mortality
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Kuopio University Hospital
Kuopio, Northern Savonia, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Southwest Finland, Finland
NOT_YET_RECRUITINGHelsinki University Hospital
Helsinki, Uusimaa, Finland
NOT_YET_RECRUITINGNorth Karelia Central Hospital
Joensuu, Finland
RECRUITINGCentral Hospital of Päijät-Häme
Lahti, Finland
RECRUITINGOulu university hospital
Oulu, Finland
NOT_YET_RECRUITINGSatakunta Central Hospital
Pori, Finland
NOT_YET_RECRUITINGTampere Heart Hospital
Tampere, Finland
NOT_YET_RECRUITING...and 4 more locations
Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: 1. Death caused by acute MI 2. Death caused by sudden cardiac, including unwitnessed, death 3. Death resulting from heart failure 4. Death caused by stroke 5. Death caused by cardiovascular procedures 6. Death resulting from cardiovascular hemorrhage 7. Death resulting from other cardiovascular cause
Time frame: 12, 24 and 36 months
TVF
Target-vessel failure
Time frame: 12, 24 and 36 months
TLR
Target-lesion revascularization
Time frame: 12, 24 and 36 months
TLF
Target-lesion failure
Time frame: 12, 24 and 36 months
Myocardial infarction
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
Time frame: 12, 24 and 36 months
The composite of TVF (Target-vessel failure) and BARC2-5 bleedings
Target-vessel failure. BARC = Bleeding academic research consortium.
Time frame: 12, 24 and 36 months
The composite of TLF (Target-lesion failure) and BARC2-5 bleedings
Target-lesion failure. BARC = Bleeding academic research consortium.
Time frame: 12, 24 and 36 months
The composite of TLR (Target-lesion revascularization) and BARC2-5 bleedings
Target-lesion revascularization. BARC = Bleeding academic research consortium.
Time frame: 12, 24 and 36 months
The composite of TLR (Target-lesion revascularization) and BARC3-5 bleedings
Target-lesion revascularization. BARC = Bleeding academic research consortium.
Time frame: 12, 24 and 36 months
Acute vessel closure as defined by the international consensus criteria for definite/probable stent thrombosis
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
Time frame: 12, 24 and 36 months
Hospitalization for urgent revascularization
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
Time frame: 12, 24 and 36 months
Stroke (ischemic or hemorrhagic) or TIA
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
Time frame: 12, 24 and 36 months