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

• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• ID-TLR (Ischemia Driven Target Lesion Revascularisation) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  

• ID-TLR (Ischemia Driven Target Lesion Revascularisation) [ Time Frame: At 9 months ] [ Designated as safety issue: No ]
  
• Failure to treat the lesion [ Time Frame: During PCI ] [ Designated as safety issue: No ]
  The failure to deliver the randomized treatment (DEB or BMS) to the target lesion is defined as a failure to treat the lesion.
  
  

• Control angiography and OCT imaging [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  
• ID-TLR (Ischemia Driven Target Lesion Revascularisation) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  

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.