Effect of Paclitaxel-Coated Balloon Angioplasty on Side Branch Lesion and Cardiovascular Outcomes in Patients with De Novo True Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

Abstract

To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions. MethodsIn total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction and angina pectoris. ResultsThere were no differences in diameter, minimum lumen diameter (MLD) and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244-0.941, P = 0.033). ConclusionPCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.

Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis

“…Of these, 17 were further excluded for the reasons listed in Figure 1. Finally, seven studies [21][22][23][24][25][26][27] were included.…”

“…The study characteristics are summarized in Table 1 . Overall, four RCTs [ 22 , 24 , 25 , 27 ] and three NRCTs [ 21 , 23 , 26 ] were included in the meta-analysis, comprising 803 patients with CBLs treated with provisional stenting using DES. These studies were published between 2013 and 2021 and were performed in Spain [ 21 ] and China [ 22 – 27 ].…”

“…Overall, four RCTs [22,24,25,27] and three NRCTs [21,23,26] were included in the meta-analysis, comprising 803 patients with CBLs treated with provisional stenting using DES. Tese studies were published between 2013 and 2021 and were performed in Spain [21] and China [22][23][24][25][26][27]. Te sample size of the included studies varied between 42 and 222.…”

“…Besides, early case series have consistently shown that SB protection with DCB is safe and associated with favorable angiographic and short-term clinical outcomes [19,20]. Subsequently, some clinical studies were performed to compare the efects of DCBs and conventional uncoated balloon (UCB) for CBLs treated with provisional stenting using DES [21][22][23][24][25][26][27]. Although most of the studies showed that DCB is superior to UCB in improving the angiographic outcomes for the SB, the benefts of DCB with regard to the clinical outcomes were rarely reported [21][22][23][24][25][26][27], probably due to the limited sample sizes of the studies.…”

“…Subsequently, some clinical studies were performed to compare the efects of DCBs and conventional uncoated balloon (UCB) for CBLs treated with provisional stenting using DES [21][22][23][24][25][26][27]. Although most of the studies showed that DCB is superior to UCB in improving the angiographic outcomes for the SB, the benefts of DCB with regard to the clinical outcomes were rarely reported [21][22][23][24][25][26][27], probably due to the limited sample sizes of the studies. Terefore, in this study, we performed a meta-analysis of clinical studies to systematically evaluate the infuence of SB protection with DCB compared with UCB on angiographic and clinical outcomes in patients with CBLs treated with provisional stenting using DES.…”