Article Impact Level: HIGH Data Quality: STRONG Summary of JACC: Cardiovascular Interventions, 16(9), 1054–1061. https://doi.org/10.1016/j.jcin.2023.02.011 Dr. Bernardo Cortese et al.
Points
- The PICCOLETO II study compared the performance of paclitaxel drug-coated balloons (DCBs) with everolimus-eluting stents (DESs) in patients with de novo lesions in small coronary vessels.
- The 3-year clinical follow-up data showed that the rates of all-cause death, cardiac death, myocardial infarction, and target lesion revascularization did not significantly differ between the DCB and DES groups.
- However, the DES group had a higher incidence of major adverse cardiac events (MACEs) and acute vessel occlusion than the DCB group.
- MACEs occurred in 20.8% of the DES group compared to 10.8% in the DCB group, while acute vessel occlusion was observed in 4% of the DES group and 0% in the DCB group.
- The findings suggest a higher risk of MACEs in patients with de novo lesions in small coronary vessels treated with current-generation DESs compared to new-generation paclitaxel DCBs.
Summary
In this research paper, the authors conducted a study to compare the short- and long-term performance of paclitaxel drug-coated balloons (DCBs) with everolimus-eluting stents (DESs) in patients with de novo lesions in small coronary vessels. The study, PICCOLETO II, was a randomized clinical trial involving 232 patients, with 118 patients allocated to the DCB group and 114 patients to the DES group.
The initial findings showed that DCBs were superior to DESs regarding in-lesion late lumen loss at the six-month mark. Building upon these results, the researchers now report the final 3-year clinical follow-up, focusing on major adverse cardiac events (MACEs), which include cardiac death, nonfatal myocardial infarction, target lesion revascularization, and their components.
The 3-year clinical follow-up data revealed that the cumulative rates of all-cause death (4% vs. 3.9%), cardiac death (1% vs. 1.9%), myocardial infarction (6.9% vs. 2%), and target lesion revascularization (14.8% vs. 8.8%) did not show significant differences between the DCB and DES groups. However, when considering MACEs and acute vessel occlusion, the DES group had higher frequencies than the DCB group (20.8% vs. 10.8% and 4% vs. 0%, respectively). These differences were statistically significant, indicating a higher risk of MACEs in patients with de novo lesions in small vessel disease when treated with the current-generation DES compared with the new-generation paclitaxel DCB.
In conclusion, the long-term clinical follow-up of the PICCOLETO II randomized clinical trial demonstrates that patients with de novo lesions in small coronary vessels treated with paclitaxel DCBs had a lower risk of MACEs compared to those treated with everolimus-eluting stents. These findings support using DCBs over DESs in managing native vessel coronary artery disease. The results contribute to the existing knowledge in interventional cardiology and may have implications for clinical practice.
Link to the article: https://www.sciencedirect.com/science/article/abs/pii/S193687982300482X
References Cortese, B., Testa, G., Rivero, F., Erriquez, A., & Alfonso, F. (2023). Long-term outcome of drug-coated balloon vs drug-eluting stent for small coronary vessels. JACC: Cardiovascular Interventions, 16(9), 1054–1061. https://doi.org/10.1016/j.jcin.2023.02.011
