Drug-Coated Balloon Angioplasty for De Novo Lesions on the Left Anterior Descending Artery

Abstract

BACKGROUND: Drug-coated balloons (DCB) are an emerging tool for modern percutaneous coronary intervention (PCI), but evidence on their use for de novo lesions on large vessels is limited. METHODS: Consecutive patients undergoing DCB-based PCI on the left anterior descending artery in 2 Italian centers from 2018 to 2022 were retrospectively enrolled and compared with patients who received left anterior descending PCI with contemporary drug-eluting stents (DES). In-stent restenosis was excluded. The DCB group included both patients undergoing DCB-only PCI and those receiving hybrid PCI with DCB and DES combined. The primary end point was target lesion failure at 2 years, defined as the composite of target lesion revascularization, cardiac death, and target vessel myocardial infarction. RESULTS: We included 147 consecutive patients undergoing DCB-based treatment on the left anterior descending artery and compared them to 701 patients who received conventional PCI with DES. In the DCB group, 43 patients (29.2%) were treated with DCB only and 104 (70.8%) with a hybrid approach; DCB length was greater than stent length in 55.1% of cases. Total treated length was higher in the DCB group (65 [40–82] versus 56 [46–66] mm; P =0.002), while longer DESs were implanted (38 [24–62] versus 56 [46–66] mm; P <0.001) and a higher rate of large vessels were treated (76.2% versus 83.5%; P =0.036) in the DES cohort. The cumulative 2-year target lesion failure incidence was not significantly different between the 2 groups (DCB, 4.1% versus DES, 9.8%; hazard ratio, 0.51 [95% CI, 0.20–1.27]; P =0.15). After a 1:1 propensity score matching resulting in 139 matched pairs, the DCB-based treatment was associated with a lower risk for target lesion failure at 2 years compared with DES-only PCI (hazard ratio, 0.2 [95% CI, 0.07–0.58]; P =0.003), mainly driven by less target lesion revascularization. CONCLUSIONS: A DCB-based treatment approach for left anterior descending revascularization allows a significantly reduced stent burden, thereby potentially limiting target lesion failure risk at midterm follow-up.

Drug-Coated Balloon Versus Drug-Eluting Stent for Treating De Novo Large Vessel Coronary Artery Disease: A Systematic Review and Meta-Analysis of 13 Studies Involving 2,888 Patients

“…Twelve studies reported clinical follow-up data on CVD, MI and TLR. 13–24 No differences were found between DCB and DES for the risk of CVD [1.1% vs 3.2%; RR: 0.49 (95% CI: 0.23 - 1.03; p=0.06; I 2 =0%] ( Figure 2 ); MI [0.3% vs 1.5%; RR: 0.48 (95% CI: 0.16 - 1.45; p=0.89; I 2 =0%] ( Figure 3 ), and TLR [3.7% vs 6.1%; RR: 0.73 (95% CI: 0.40 - 1.34; p=0.32; I 2 =27%] ( Figure 4 ). Eight studies reported data on ACD 14,16–20,24,25 .…”

“…13–24 No differences were found between DCB and DES for the risk of CVD [1.1% vs 3.2%; RR: 0.49 (95% CI: 0.23 - 1.03; p=0.06; I 2 =0%] ( Figure 2 ); MI [0.3% vs 1.5%; RR: 0.48 (95% CI: 0.16 - 1.45; p=0.89; I 2 =0%] ( Figure 3 ), and TLR [3.7% vs 6.1%; RR: 0.73 (95% CI: 0.40 - 1.34; p=0.32; I 2 =27%] ( Figure 4 ). Eight studies reported data on ACD 14,16–20,24,25 . At follow-up, no differences were found between DCB and DES for the risk of ACD [5.5% vs 7.8%; RR: 0.78 (95% CI: 0.57 - 1.07; p=0.12; I 2 =0%] ( Figure 5 ).…”

“…This finding is consistent with the results of our meta-analysis, where this outcome is close to significance (p=0.06), hypothesizing an advantage of the “metal-free” approach. 24…”

Research progress of drug eluting balloon in arterial circulatory system

“…It can occur in distal coronary arteries, descending branches, side branches, and bifurcations, and its complexity results in a poorer outcome compared with focal lesions. The use of DES alone not only has long-term metal irritation and a higher risk of late thrombosis, but also the placement of long DES stents (≥60 mm) can lead to an increased incidence of adverse events, resulting in poorer outcomes in diffuse coronary artery disease, whereas the combination of DEB and DES can limit the length of the stent to a certain extent, reduce stent loading, and decrease the incidence of the aforementioned adverse events, providing a favorable treatment for diffuse coronary artery disease ( 82 , 83 ).…”

A New Frontier for Drug-Coated Balloons: Treatment of “De Novo” Stenosis in Large Vessel Coronary Artery Disease

“…Most of the feasibility data of DCB PCI in large vessels come from sub-analysis of larger observational retrospective or prospective studies with few dedicated studies. Data obtained from observational studies [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ] are summarized in Table 1 , whereas randomized studies comparing DCB and stent are presented in Table 2 and Table 3 [ 32 , 33 , 34 , 35 , 36 , 37 , 38 ].…”