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Page 8 of 12 Onea et al. Vessel Plus 2023;7:13 https://dx.doi.org/10.20517/2574-1209.2023.11

P = 0.058), but the rates of TLF and TLR were higher in patients with DM (5.36% vs. 2.77%; OR, 1.991,
[40]
95%CI: 1.077 - 3.681, P = 0.025; 4.15% vs. 1.90%; OR, 2.233, 95%CI: 1.083 - 4.602, P = 0.026) .
More recently, the prospective multicentre HYPER study evaluated the safety and efficacy of a novel
paclitaxel-DCB (Restore DCB, Cardionovum GmbH, Germany) in conjunction with a current-era DES on
lesions ≥ 28 mm in 100 patients. DCB was used on the distal lesion or the side branch. Dr Ielasi presented
the results during EuroPCR 2022. The primary endpoint of the study was a device-oriented composite
endpoint of cardiac death, target-vessel MI and ischemia-driven TLR in the DES- or DCB-treated segments.
At 1 year, a low event rate of 3.7% was reported, mostly linked to TLR at the DCB level, while there were no
recorded thrombotic events . The HYPER II study is awaited to confirm these optimistic results.
[41]

Yang et al. conducted a recent large-scale multicentre prospective study comparing DCB alone or as part of
a hybrid strategy with DES in treating long and diffuse coronary lesions (in the DCB arm, mean lesion
length = 43.5 mm and mean vessel diameter = 2.47 mm). SeQuent Please DCB was used in a hybrid manner
in 60% of cases. Both MLD immediately after PCI and LLL were significantly lower in the DCB group (1.79
± 0.46 mm vs. 2.38 ± 0.54 mm, P < 0.001; 0.06 ± 0.61 mm vs. 0.41 ± 0.64 mm, P < 0.001). Interestingly, in
46.3% of cases, the lesions displayed LLE. At the 3-year follow-up [Figure 4], DCB-angioplasty was similar
to DES regarding the primary endpoint of the study (TLR: 7.3% vs. 8.3%; log-rank P = 0.636). Moreover,
similar results were observed in cases of MACE (11.3% vs. 13.7%; log-rank P = 0.324) and cardiac death
(1.7% vs. 2.1%; log-rank P = 0.82), while no thrombotic events were registered among the DCB-treated
patients (0 vs. 4; log-rank P = 0.193). In addition, when comparing DCB-only with the blended strategy,
TLR and MACE rates were again similar (6.4% vs. 8.0%, log-rank P = 0.651; 11.4% vs. 11.2%, log-rank P =
0.884) .
[42]

A recent retrospective study on the value and relevance of DCB in 254 patients with multivessel CAD was
published. Patients were assigned to either a DCB ± DES or a DES-only strategy. The primary endpoint was
MACE (a composite of cardiac death, MI, stroke, ST, TVR and major bleeding). After 2 years of follow-up,
DCB were associated with a lower frequency of MACE compared to the DES group (3.9% vs. 11.0%;
P = 0.002). The data remained consistent for cardiac death, TVR and major bleeding rates as well (0.4% vs.
2.4%; 3.1% vs. 6.3%; 0.4% vs. 2.8%) .
[43]

Noteworthy, a meta-analysis conducted by Giacoppo et al. has shown that with respect to ISR treatment,
although DCB are superior to DES in cases of focal lesions, the primary endpoint of all-cause death, MI, or
target-lesion thrombosis was comparable between groups in case of diffuse-ISR . Thus, the benefit of
[44]
DCB-PCI seems to be influenced by lesion length not only in de-novo CAD, but also in cases of ISR.
Moreover, for the overall ISR population, at 3 years of follow-up, the rate of the primary endpoint was again
similar between groups (HR 0.80, 95%CI: 0.58 - 1.09; P = 0.152), while TLR was higher following DCB
treatment, compared with DES (HR 1.32, 95%CI: 1.02 - 1.70; P = 0.035; number-needed-to-harm 28.5).

LIMITATIONS
A special mention should be given to the need for randomization in clinical studies comparing DCB and
DES, especially in complex lesion subsets, as in daily practice, DES are more likely to be used in those
settings. Also, certain high-risk scenarios, such as large thrombus burden, residual stenosis or significant
dissection after lesion preparation, could also determine a selection bias, and are usually excluded from
DCB treatment. Current information on the outcomes of DCB (small mechanistic RCT, propensity-
matched studies, and large registries) are useful, but some ongoing and future RCT will need to have clinical
primary and secondary endpoints before we can allow for a diffusive use of DCB instead of stents in many