Objective
to investigate whether drug coated balloon-only treatment (with possibility to bailout stenting) was safe and effective compared to PCI with bare metal stents
Study
investigator-initiated randomised single blind multicentre non-inferiority trial (margin 3% difference)
Population
risk factors for bleeding: use oral anticoagulants, age >80 years, anaemia, thrombocytopenia, malignancy, previous stroke or bleeding, severe renal dysfunction, hepatic failure, planned surgery, substantial frailty, previous significant bleeding included patients with stable angina or ACS with expected simple PCI procedure
Endpoints
MACE at 9 months
Conclusion
treatment of simple coronary lesions with drug-coated balloon was superior to bare metal stents in patients at a high-bleeding risk
Rissanen et al. Lancet. 2019;394:230-9