Paclitaxel-coated balloon treatment for functionally nonsignificant residual coronary lesions after balloon angioplasty

Abstract

There is limited data on the efficacy of paclitaxel-coated balloon (PCB) compared to stents for de novo coronary lesions. The purpose of this study was to compare the efficacy of PCB treatment with stent implantation for de novo coronary lesions after successful plain old balloon angioplasty (POBA) guided by fractional flow reserve (FFR). In 200 patients scheduled for elective percutaneous coronary intervention (PCI) for de novo lesions, FFR was measured after POBA (POBA-FFR). If POBA-FFR was ≥ 0.75, patients were treated with PCB (PCB group, n = 78) or stent (Stent group, n = 73). If POBA-FFR was < 0.75, stent was implanted as planned (Reference group, n = 42). The primary endpoint was late lumen loss at 9 months and the secondary endpoint was adverse cardiac events (cardiac death, myocardial infarction, target lesion thrombosis, or repeat revascularization) at 12 months follow-up. There was no between-group differences in the POBA-FFR (0.87 ± 0.05 in PCB, 0.89 ± 0.06 in stent, p = 0.101). At 9 months, late lumen loss was significantly lower in the PCB group compared to the Stent group (0.05 ± 0.33 vs. 0.59 ± 0.76 mm, p < 0.001). Adverse cardiac events were not different between the PCB, Stent and Reference groups (2.6, 5.5, and 9.5% respectively; p = 0.430 for PCB vs. Stent group; p = 0.229 for the reference vs. both other groups). PCB treatment guided by POBA-FFR showed excellent 9 months angiographic and functional results, as well as comparable 12 months clinical outcomes, compared with stent implantation for de novo coronary lesions.

Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion

“…If these mismatch lesions were treated solely using angiography, as recommended by the German consensus group, all of them should be treated with stent implantation, since the residual DS was above 30%, even though the post-balloon FFR was > 0.75. Previous mid-and long-term follow-up studies in patients with an FFR after BA ≥ 0.75 showed comparable clinical outcomes between DCB and stent treatments [1,3,12]. Therefore, FFR-guided DCB treatment could safely reduce the number of unnecessary stent implantations in this mismatch population.…”

“…During the BA era, Bech et al [2] demonstrated that patients with a residual DS of  35% and an FFR value after BA of ≥ 0.90 had excellent clinical outcomes to 2-years. Further, in a previous study, it was demonstrated that DCB treatment after successful BA with a resultant FFR value ≥ 0.75 was safe and effective, without the additional risk of acute vessel closure [3].…”

“…The acceptable angiographic and functional criteria after BA to perform DCB treatment are TIMI grade 3 flow and FFR ≥ 0.75. In this FFR-guided DCB strategy, if the FFR after BA is ≥ 0.75, DCB treatment can be performed safely [3,12].…”

Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group

“…Recent European data also showed that the FFR-guided DCB-only approach of de novo lesions (cutoff value of FFR: 0.80) was feasible and safe in stable CAD, showing positive remodeling without lumen loss by OCT at 6 months [40]. Another study showed that the safety and efficacy of DCB was comparable with DES when the cut-off value of FFR was 0.75 after balloon angioplasty [41]. Recent Chinese data showed that DCB for de novo coronary lesions with diameters greater than 2.8 mm was safe and effective as for small vessel lesions [42].…”

Cardiovascular imaging 2018 in the International Journal of Cardiovascular Imaging

“…The purpose of the study by Her et al was to compare the efficacy of paclitaxel-coated balloon (PCB) treatment with stent implantation for de novo coronary lesions after successful plain old balloon angioplasty (POBA) guided by fractional flow reserve (FFR) [9]. 200 patients were included in the study and the primary endpoint was late lumen loss at 9 months.…”