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To assess the safety and efficacy of the DIORTM Paclitaxel Drug-Eluting Balloon in coronary bifurcations in combination with a BMS, with a specific focus on the side branch (SB) using the provisional T-stenting technique with final kissing balloons.

CONCLUSION

1. The use of DEB in bifurcation PCI is feasible
2. The pre-defined primary endpoint of 50% reduction in MB late loss has not been reached (due to better than expected BMS “angiographic” performance)
3. There is a strong trend showing a favorable outcome combining DEB with a BMS in MB and using a DEB in SB with regards to overall bifurcation binary restenosis rate
4. Concerning clinical endpoints, there is a consensual trend favoring DEB+BMS in terms of TLR and total MACE rates compared to BMS +POBA
5. The use of DEB+BMS in bifurcations with only 3 months of DAPT seems safe with 0% occurrence of stent thrombosis
6. The non-powered randomised comparison between all three arms shows a clear unfavorable outcome for the use of BMS+POBA in bifurcations