Drug-Coated Balloons versus Drug-Eluting Stents for Treatment of De-Novo Coronary Artery Lesions in Patients with Stable Coronary Artery Disease - the COATED Trial.

Stenting has significantly reduced the need for revascularization procedures as
compared to plain old balloon angioplasty. Additionally, drug-eluting stents
(DES) have significantly decreased in-stent restenosis compared to bare-metal
stents and its use is recommended in current guidelines. Nevertheless, using
DES carries te risk of in-stent restenosis and stent thrombosis, and requires
the use of dual antiplatelet therapy during an extensive period of time. With
the use of drug-coated balloons (DCB), all these problems can be either avoided
or attenuated, while maintaining the anti-proliferative properties of DES.
However, data on the use of DCB for treatment in a general population of
patients with stable coronary artery disease (CAD) is currently lacking.

The aim of the study is to investigate the value of DCB treatment of single
de-novo coronary artery lesions in patients with stable coronary artery
disease, as compared to treatment with DES in a randomized fashion.

This is an investigator-initiated, randomized,open-label, single-center,
non-inferiority clinical trial. Patients with a single de-novo lesion in a
native coronary artery and accepted for percutaneous intervention (PCI) will be
randomized in a 1:1 ratio to treatment with DCB or DES. Patients in DES group
receive DAPT for 6 months (clopidogrel + aspirin), followed by life-long
treatment with a single platelet inhibitor (aspirin). Patients in DCB group
receive DAPT for 3 months, followed by life-long treatment with a single
platelet inhibitor.

After inclusion, patients will be randomized (1:1) to treatment with DCB or
DES. Patients in DES group receive DAPT for 6 months (clopidogrel + aspirin),
followed by life-long treatment with a single platelet inhibitor (aspirin).
Patients in DCB group receive DAPT for 3 months, followed by life-long
treatment with a single platelet inhibitor.

All patients included in the trial will have a clinical indication for
percutaneous revascularization. Since there are no randomized controlled trials
which advocate the use of either DES or DCB over one another in this setting,
patients will not be exposed to extra risk due to randomization in the trial.
Contemporary native vessel PCI is associated with low in-hospital events rates,
i.e. in- hospital mortality of 0.9%, vascular complication in 0.7%, procedural
complications in 4.7% and bleeding requiring transfusion in 3.3%.
All patients will undergo coronary angiography after 1 year follow-up and will
thus be exposed to the risks of invasive coronary angiography. Coronary
angiography is characterized by a low complication rate (<0.5%) of e.g.
bleeding, stroke, coronary dissection, myocardial infarction, or death (<0.1%).
Radiation exposure of a repeat coronary angiography is estimated at 5-10 mSv.
Patients participating in the CCTA substudy will be exposed to an effective
dose equivalent ~2.1 mSv. Impact CT Dosimetry software package version 1.04 was
used to calculate the radiation dosage. Furthermore, ionized contrast agents
will be used during CCTA, which can be nefrotoxic and may elicit allergic
reactions.
Expected benefit of this study:
Using DCB for the treatment of single de novo coronary artery lesions may
obviate the use of DES, and therefore reduce the risk on in-stent restenosis
and stent thrombosis and shorten the use of dual antiplatelet therapy. However,
data on the use of DCB for treatment in a general population of patients with
stable coronary artery disease is currently lacking. This trial could provide
this data and therefore influence current guidelines on the application of DCBs
in patients with stable coronary artery disease.