Coronary Artery Disease Clinical Trial
Official title:
Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.
Rationale: 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-coated balloon (DCB) 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.
Objective: This randomized controlled, non-inferiority trial is mainly designed to
prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only
strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction
(STEMI).
Rationale: 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-coated balloon (DCB) 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.
Objective: This randomized controlled, non-inferiority trial is mainly designed to
prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only
strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction
(STEMI).
Study design: This is a prospective, single center, non-inferiority, randomized controlled
trial.
Study population: All patients presenting with STEMI and suitable for PPCI.
Intervention: PPCI will be performed according to current guidelines. After thrombus
aspiration and pre-dilatation, randomization between a DCB only strategy (with bail-out
stenting if indicated) and DES will be done by 1:1 ratio. Concomitant medication will be
administered according current standards. Control coronary angiography, including
measurement of the fractional flow reserve (FFR) of the treated lesion(s), will be performed
after 9 months.
Main study parameters/endpoints: The main study parameter is the fractional flow reserve at
9 months follow-up. Secondary study parameters include cardiac death, recurrent myocardial
infarction in the target vessel area and ischemia driven target lesion revascularisation at
9 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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