Lesion preparation strategy before paclitaxel-coated balloon angioplasty for in-stent restenosis: a multicenter real-world study
X Qian, C Yang, Y Zhang, C Guan, Y Sui, H Wang, J QianAbstract
Background
Paclitaxel-coated balloon (PCB) is an established treatment for coronary in-stent restenosis (ISR), yet the optimal lesion preparation strategy before PCB remains unclear.
Purpose
This study aimed to evaluate association between lesion preparation strategy and long-term clinical outcomes after PCB treatment for ISR.
Methods
This is a post-hoc analysis from the prospective, multicenter, real-world PEPCAD China registry which was to evaluate the efficacy and safety of PCB in the treatment of real world Chinese patients with coronary ISR. Patients were classified according to lesion preparation strategy: plain balloon angioplasty (PBA), scoring balloon angioplasty (SBA), or cutting balloon angioplasty (CBA). The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 5 years. Cox proportional hazards models were used to estimate HR and 95% CI for composite endpoint, , adjusting for confounding factors.
Results
Among 465 patients enrolled, 246 patients (52.9%), 54 patients (11.6%), and 165 patients (35.5%) were in PBA, SBA, and CBA groups, respectively. The mean age was more than 60 years and about one fifth of the patients were female in all three groups. The prevalence of diabetes mellitus was 36.2% in the PBA group, compared with 42.6% in the SBA group and 40.0% in the CBA group. At 5 years, the primary composite endpoint occurred in 11.0% of PBA group, 16.7% of SBA group, and 23.6% of CBA group (log-rank p=0.003). After adjustment, CBA group was associated with a significantly higher risk of composite endpoint compared to PBA (adjusted HR 1.38, 95% CI 1.05–1.81, p=0.020). However, no significant differences were observed between the other groups (SBA group vs. PBA group adjusted HR: 1.33, 95%CI: 0.55-3.25, p=0.525; CBA group vs. SBA group adjusted HR: 1.33, 95%CI: 0.60-2.92, p=0.483)).
Conclusion
In this real-world ISR registry, lesion preparation with CBA before PCB was associated with increased long-term adverse cardiac events compared to PBA, whereas SBA showed similar outcomes to PBA or CBA. These findings call into question the use of CBA for lesion modification prior to PCB in ISR.