Randomised controlled trial
Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels
- Randomised controlled trial
- academic
- international
- investigator-driven
- multicentre
- open-label
Authors' conclusion
The long-term clinical follow-up of the PICCOLETO II randomized clinical trial shows a higher risk of MACEs in patients with de novo lesions in small vessel disease when they are treated with the current-generation DES compared with the new-generation paclitaxel DCB.
Study context
- Population
- Patients with de novo lesions in small coronary vessel disease102 vs 101 with 3-year follow-up
- Participants
- 118 vs 114
- Comparison
- Paclitaxel DCB vs everolimus-eluting DES
- DCBn = 118
- DESn = 114reference
- Primary endpoint
- MACE (cardiac death, nonfatal MI, target lesion revascularization) and its individual components (final clinical follow-up)
- Follow-up
- 3 years
Primary result
As reported in the abstract
MACE
P = 0.046
Further findings
All-cause death, cardiac death, MI, target lesion revascularization · 3 years
All-cause death
Cardiac death
MI
Target lesion revascularization
- All-cause death, cardiac death, MI, target lesion revascularization: all-cause death P = 0.98
- All-cause death, cardiac death, MI, target lesion revascularization: cardiac death P = 0.56
- All-cause death, cardiac death, MI, target lesion revascularization: MI P = 0.14
- All-cause death, cardiac death, MI, target lesion revascularization: target lesion revascularization P = 0.18
All-cause death, cardiac death, MI, target lesion revascularization · 3 years
- No significant difference between DCB and DES
Safety
Acute vessel occlusion · 3 years
P = 0.042
Original publication
Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels. JACC Cardiovasc Interv. Published 19 April 2023. doi:10.1016/j.jcin.2023.02.011
Summarised from the published abstract; every number is checked against it