Revascularization with paclitaxel-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarction - a randomized controlled trial

Compared with balloon angioplasty, implantation of bare metal stents (BMS) and
drug eluting stents (DES) have shown to reduce repeat target lesion
revascularization in primary percutaneous coronary intervention (PPCI).
However, this did not result in a reduction of mortality or recurrent
myocardial infarction. Furthermore, there are concerns of the occurrence of
stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of
using a drug-eluting balloon (DEB) only strategy in PPCI, showed good short-
and long-term clinical results, with sustained safety and efficacy at 12 months
follow-up. To date little is known about the long-term effects of this
treatment modality in STEMI. Besides, angiographic follow-up is of great
clinical importance by giving insight on the treated infarct lesion and to
assess the functional angioplasty result.

This randomized controlled trial is designed to prospectively assess the safety
and efficacy of a CE-marked paclitaxel-eluting balloon only strategy versus
third generation DES in the setting of a STEMI. This inferiority design serves
to demonstrate this comparison in terms of fractional flow reserve at 9 months
angiographic follow-up, as a functional assessment of the angioplasty result.

This study is a prospective, single center, randomized controlled trial. A
group of 120 patients will be enrolled in this study. Randomization will be
done by 1:1 ratio. No cross-over between the 2 arms will be accepted.

All procedures will be performed by an interventional cardiologist. The use of
thrombectomy or thrombosuction devices is recommended as a standard procedure
in STEMI. Predilatation with a balloon is mandatory. Overall it is recommended
to achieve an optimal lumen diameter by predilatation.
In case of randomization to the DEB only strategy, the DEB is deployed at low
pressure (max 10 atm) for at least 60 seconds, and the diameter has a 1:1
balloon-to-artery ratio. As current standard of care, provisional stenting in
case of a DEB only strategy is at the discretion of the operator and advised
only in case of:
• Residual minimal luminal diameter of the treated lesion < 50% after balloon
dilatation(s) with sufficiently large balloon;
• Dissections >= type C, leading to (threatening) vessel closure
In case of additional stenting, a BMS must be used.
DES implantation following current guidelines.
The use of medication is according current guidelines, including one year of
dual anti-platelet therapy for all patients.

The initial procedure en hospitalization will be performed according to
accepted guidelines and current standard of care. No benefits or additional
risks are expected. The burden for the control coronary angiography is limited.
Patients need to come to the hospital on an outpatient basis for one day. Costs
for travelling to the hospital will be compensated. The patient will be
accompanied by one of the research nurses during all investigations. Besides
this, the patient will be contacted by telephone only 5 times during 5 year of
follow-up. These conversations will be around 10 minutes and wil contain
questions about his/her medical status.
The main risk and complications of the study are associated with the control
coronary angiography. These are all discussed with the patient at the time of
recruitment. The risk of a severe complication at cardiac catheterisation is
around 0.03%.