Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels

Abstract

We retrospectively examined the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo stenosis in large coronary vessels (LV; pre-or postprocedural reference vessel diameter !2.75 mm) in comparison with placement of drug-eluting stents (DESs).Consecutive de novo stenotic lesions in the LV electively and successfully treated with either PCB (n = 73) or DESs (n = 81) from January 2016 to December 2018 at our center were included. The primary endpoint was the incidence of target lesion failure (TLF), including cardiac death, nonfatal myocardial infarction, and target vessel revascularization. The impact of PCB on TLF was examined using Cox proportional hazards models by including 39 variables. The secondary endpoint, angiographic restenosis, defined as a follow-up percent diameter stenosis > 50, was examined in angiographic follow-up lesions after PCB angioplasty (n = 56) and DES placement (n = 53). This retrospective investigation was conducted in July 2022.The mean PCB size and length were 3.23 ± 0.42 and 18.4 ± 4.3 mm, respectively. The TLF frequency in the PCB group (6.8% during the mean observational interval of 1536 ± 538 days) was not significantly different from that in the DES group (14.6%, 1344 ± 606 days, P = 0.097). PCB was not a significant predictor of TLF in the univariate analysis (hazard ratio: 0.424; 95%CI: 0.15-1.21; P = 0.108). There was no angiographic restenosis after PCB angioplasty.The present observational single-center study showed that PCB for de novo stenosis in the LV had no significant adverse impact on TLF and had favorable angiographic outcomes.

Cardiovascular Outcomes after Paclitaxel-Coated Balloon Angioplasty versus Drug-Eluting Stent Placement for Acute Coronary Syndrome: A Systematic Review and Meta-Analysis

“…Second, PCB angioplasty showed good angiographic outcomes at chronic phase represented in small LLL ( Table 4 ). The small (less than 0.10 mm) mean magnitudes of LLL after PCB angioplasty were consistent in the cases of CCS by the elective procedures regardless of vessel sizes [ 1 , 19 , 20 , 21 , 22 ]. A small LLL gave low incidences of TLR including TVR; those in turn, contributed to the low and statistically equivalent frequencies of composite MACE compared to DES ( Figure 2 , Figure 3 and Figure 4 ).…”

“…This unique angiographic phenomenon at chronic phase after PCB angioplasty, LLE, was also observed in cases of ACS [ 13 , 15 , 24 , 25 , 26 ] ( Table 4 ). Similarly, LLE was observed in approximately half of the angiographic followed-up lesions after PCB angioplasty for ACS ( Table 4 ) as with after for CCS [ 20 , 21 , 22 , 23 ]. Greater lumen enlargement in ACS compared to CCS with the significant increase in the vessel and lumen area, and significant decrease in the plaque area [ 24 ] was reported.…”

“…A small LLL gave low incidences of TLR including TVR; those in turn, contributed to the low and statistically equivalent frequencies of composite MACE compared to DES ( Figure 2 , Figure 3 and Figure 4 ). In cases of CCS, a net small LLL was composed by approximately half of minus LLL [ 20 , 21 , 22 , 23 , 24 ], i.e., late lumen enlargement (LLE). We previously reported a potential mechanism for LLE in cases of CCS [ 21 ], with the following four factors: (I) balloon angioplasty enlarged the lumen and vessel areas (vessel enlargement); (II) the distribution of paclitaxel suppressed the plaque and induced its regression; (III) minor dissections formed at any step further facilitated the diffusion of paclitaxel into the plaques; and (IV) almost all minor dissections formed peri-operatively were sealed in the chronic phase without LLL.…”

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][14][15][16][17][18][19][20][21][22][23][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][17][18][19][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).…”