Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels

Treatment of lesions allocated in small or mid-sized coronary vessels still
represents a challenge for interventional cardiologists and remains an
independent predictor for angiographic restenosis, even after the introduction
of drug-eluting stents (DES). Several studies have demonstrated the good
clinical outcomes of DES, in this particular setting. however even the latest
generations of DES are still associated with a higher
incidence of restenosis, vessel thrombosis and myocardial infarction in this
setting; without reaching a plateau of adverse events. Lately drug-coated
balloons (DCB) have emerged as an attractive alternative for the treatment of
coronary de-novo lesions. In the last years, several new generation DCB have
been developed, with the aim of improving the trackability and deliverability
of these devices, along with an improvement of drug release, especially in
tortuous and small vessels. Until 2016, only paclitaxel-eluting DCB were
marketed, due to the specific lipophilic
properties of paclitaxel, that render this drug particularly appealing for
local delivery.

However, currently available DES all elute sirolimus or analogue drugs (the so
called "- limus" class) due to the improved outcome shown when compared to
paclitaxel-eluting stents, that were abandoned almost a decade ago due to
reduced efficacy and increased thrombotic risk. Despite no specific issues were
raised for currently available paclitaxel-eluting DCB used for coronary
applications, sirolimus has well recognized
antiproliferative properties and a wider therapeutic window. The main issue
with this drug delivered locally without prosthesis implantation is related to
its intrinsic lower lipophilia (thus, the ability of penetrating into tissues),
that could hamper its ability to exert local antirestenotic effects.

In 2016, the first sirolimus-coated DCB obtained the CE mark and was marketed
in Europe and Asia (Magic Touch, Concept Medical, FL, USA); this balloon elutes
sirolimus, a powerful cell growth-inhibitory drug, characterized by a low
lipophilicity. This device has been studies in several lesion settings till
date, but not by means of a study adequately powered for clinical endpoints.

To observe and evaluate the efficacy, of Magic Touch SCB compared to one of the
gold standard treatment for native vessel disease, (everolimus-eluting stent,
EES).

The main OCT subanalysis endpoints are:
- Acute mean and minimum lumen cross-sectional area (CSA) gain between pre- and
post-PCI in the SCB and DES groups;
- Late mean and minimum lumen CSA loss from post-PCI to 9 months;
- Change in lumen area stenosis across all timepoints (pre-PCI, post-PCI, and 9
months)
- A series of detailed analyses aiming to evaluate the extension and severity
of balloon and stent-induced vascular injury will be performed

International, multicentric, prospective, investigator-driven, open-label,
randomized (1:1) clinical trial.

The included patients will undergo a Percutaneous Coronary Intervention (PCI)
with either Magic Touch Sirolimus Coated Balloon or an Everolimus-eluting stent

Generally, all patients will receive a higher degree of telephone and clinical
follow-up than he/she would outside of the study environment and have a
dedicated clinical study team following his/her progress. It is hoped that
through this study, information gained on the safety and efficacy of the
devices used will help in the management of future patients with similar
conditions.

The complications associated with the use of the SCB are the same associated to
any intervention of coronary angioplasty (with or without stent)
during the first hours after intervention: occlusion of the vessel with the
need for new intervention; risk of coronary perforation; risk of spontaneous
bleeding or bleeding from the vascular access, or related to the concomitant
use of anti-thrombotic drugs; damage to other vessels from the catheter transit
and/or arterial thrombosis; allergic reaction to the iodinated contrast medium;
contrast induced nephropathy.

The long-term risks are potentially lower with DCB than with DES: with such
devices there is no risk of late or very late stent thrombosis; the shorter
duration of dual antiplatelet therapy (usually 1 month) can reduce the risk of
bleeding events compared with a duration of 6-12 months with the drug-eluting
stent; the risk of a new PCI, because of restenosis, is instead comparable to
that of drug-eluting stents, but lower compared to bare-metal stents. The
absence of exclusion criteria regaring the sickness of the patient (need for
surgery, anemia, high bleeding risk) may render this study unique in assessing
the role of DCB vs DES in such populations