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Onea et al. Vessel Plus 2023;7:13 https://dx.doi.org/10.20517/2574-1209.2023.11 Page 5 of 12

the DCB and DES groups, HR 0.99; 95%CI: 0.68 - 1.45; P = 0.95), once more highlighting the safety and
efficacy profile of DCB in the treatment of native small vessels disease. What is more, DCB was shown to
significantly reduce the rates of major bleeding in patients with chronic kidney disease (12 vs. 3, HR 0.26;
95%CI: 0.07 - 0.92; P = 0.037) [23,24] .

Another important randomized trial, PICCOLETO II, compared the efficacy of DCB (Elutax SV, AR Baltic,
Germany) with EES (Abbott Vascular, USA) in de-novo vessels < 2.75 mm, reporting significantly higher
late lumen loss (LLL) in the DES arm (0.17 ± 0.39 mm vs. 0.04 ± 0.28 mm; P = 0.03 for superiority) at the
[26]
[25]
6-month follow-up . The final follow-up of this study was recently published . After 3 years, the authors
reported a significant reduction in abrupt vessel closure and MACE in the DCB arm (10.8% vs. 20.8%;
P = 0.046).

Large native vessels disease
Based on the encouraging results reported for the use of DCB in small-vessel disease, continuous efforts
have been made to investigate the role of this promising technology in large native vessels. In consequence,
an important number of studies have recently reported data for this scenario as well.

Yu et al. enrolled 288 consecutive patients with RVD between 2.25 and 4.0 mm in a randomized clinical trial
which compared the performance of DCB (Sequent Please) with DES (Resolute Integrity, Medtronic; EES;
SYNERGY; Firehawk, MicroPort, China) in terms of LLL at 9-month angiographic follow-up and 12-month
MACE . The angiographic follow-up reported the excellent performance of the DCB, as minimal lumen
[27]
diameter (MLD) was significantly increased compared with post-intervention level (2.02 ± 0.62 mm vs. 1.83
± 0.44 mm; P < 0.001) only in the DCB group and LLL was -0.19 ± 0.49 with the DCB vs. 0.03 ± 0.64 mm
with the DES. Moreover, 12-month MACE was similar in the two groups (2.44% vs. 6.33%; P = 0.226).

In another study, Uskela et al. enrolled 463 patients with 562 lesions, most of them located in large coronary
vessels (79% > 2.75 mm) which were treated using paclitaxel-DCB. MACE rate at 12 months was 7.1% for
stable CAD and 12% for acute coronary syndromes (ACS); TLR occurred in 1.4% of stable CAD and in 2.8%
of ACS patients, with only one acute vessel closure occurring after this strategy .
[28]

Rosenberg et al. conducted a large-scale trial including 1,025 patients (more than 65% with de-novo CAD)
treated with a stentless strategy and, after 9 months of follow-up, reported lower TLR rates in the de-novo
group (2.3%) compared to DES-ISR (5.8%) (P = 0.049) . Moreover, when comparing small with large
[29]
vessels disease, no significant differences between the two groups regarding TLR (3.8% vs. 1%; P = 0.20) or
MACE (5.7% vs. 6.11%; P = 0.903) were observed, thus suggesting that the outcomes after a DCB-only
strategy for de-novo lesions may be independent of the vessel diameter .
[30]

With these encouraging results in mind, many experienced centers started using this strategy for large
native vessels disease, in order to limit the amount of implanted metal, especially in complex lesions
occurring in frail patients. Figures 2 and 3 illustrate the excellent immediate- and mid-term results of a
“leave nothing behind” strategy used for the treatment of diffuse large vessel disease. What is more, Figure 3
shows the important late lumen enlargement (LLE) obtained after the use of DCB at 5 months of follow-up.
This LLE phenomenon is related to paclitaxel-DCB, probably due to an effect of this drug at the level of
tunica adventitia and seems to be more pronounced in cases of types A and B dissections after DCB
angioplasty. The role of LLE with some DCB seems particularly appealing in cases of DCB usage for the
management of long lesions and diffuse disease .
[31]