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Page 10 of 12 Onea et al. Vessel Plus 2023;7:13 https://dx.doi.org/10.20517/2574-1209.2023.11

The aforementioned HYPER II study (ClinicalTrials.gov Identifier: NCT05650450) aims at assessing the
feasibility and outcome of a blended DCB (Restore DCB)/ DES approach in treating diffuse CAD, defined
as lesion length > 38 mm in 500 patients. The primary endpoint of the study, TLF, as well as its individual
components (cardiac death, any target-vessel MI excluding peri-procedural MI, TLR), will be available at 12
up to 24 months.

Following the same direction, another study will randomize patients to either a hybrid DCB (SeQuent
Please)/DES or DES strategy. A longer follow-up period of up to 3 years is expected, taking into account
both device- and patient-related cardiovascular clinical endpoints (ClinicalTrials.gov Identifier:
NCT03589157).

On the other hand, D-Lesion Long (ClinicalTrials.gov Identifier: NCT03155971) and GINGER
(ClinicalTrials.gov Identifier: NCT05471245) studies will evaluate the performance of a DCB-only strategy
using SeQuent Please or Magic Touch by means of 9-month angiographic LLL.

RENOVATE study will randomize over 1,600 patients with complex coronary features, including long
lesions (cutoff ≥ 38 mm). Intravascular imaging guidance will be compared to angiography-guided PCI
using current-generation DES or DCB while TVF (a composite of cardiac death, MI, and clinically-driven
TVR) will be assessed at 1 year (ClinicalTrials.gov Identifier: NCT03381872).

PICCOLETO III is another randomized clinical trial evaluating the efficacy of either a paclitaxel- or a
sirolimus-DCB in comparison to DES, foreseeing a long follow-up of up to 5 years. Various complex
settings will be addressed, including very-long lesions.

TRANSFORM II trial will compare the Magic Touch DCB with EES in the setting of CAD with lesions up
to 50 mm, in vessels between 2 - 3 mm. Co-primary endpoints are TLF and net adverse clinical events at 12
months.

CONCLUSION
With increasingly higher rates of diffuse coronary lesions to be treated by means of PCI, and still
suboptimal long-term results using the current DES, the need for a new modern approach to these lesions
represents an important research activity. In this context, the use of DCB, which has demonstrated its safety
and efficacy in a wide spectrum of complex scenarios, including native vessel disease, could become a valid
alternative to long stenting, which has been demonstrated to be associated with poorer outcomes. Even
though data is still scarce, this approach has become of great interest in daily practice, but large randomized
clinical trials are needed to confirm the results reported in current studies.

DECLARATIONS
Authors’ contributions
Conceived and designed the analysis, collected the data, and wrote the paper: Onea HL, Lazar FL
Conceived and designed the analysis, collected the data, and revised the paper: Olinic DM
Conceived and designed the analysis, collected the data, wrote the paper, and revised the paper: Cortese B
All authors read and approved the final version of the manuscript.

Availability of data and materials
Not applicable.