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Updated: Jan 24, 2026

Acute Myocardial Infarction in Rats
Published on: February 16, 2011
Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION
Nicola S Vos1, Nick D Fagel1, Giovanni Amoroso1
1Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.
Insights
Drug-coated balloons (DCB) are as effective as drug-eluting stents (DES) for treating ST-segment elevation myocardial infarction (STEMI). This DCB strategy is a safe and feasible alternative for primary percutaneous coronary intervention in STEMI patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Drug-eluting stents (DES) improve outcomes in ST-segment elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI) regarding repeat revascularization but not mortality.
- Drug-coated balloons (DCB) offer a potential alternative to DES, aiming to reduce restenosis seen with plain balloon angioplasty without the drawbacks of stenting.
Purpose of the Study:
- To compare the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary PCI for STEMI.
Main Methods:
- The prospective, randomized REVELATION trial enrolled 120 patients with STEMI undergoing primary PCI.
- Patients with nonseverely calcified culprit lesions were randomized to DCB or DES after pre-dilatation.
- The primary endpoint was fractional flow reserve (FFR) at 9 months.
Main Results:
- At 9 months, mean FFR was 0.92 ± 0.05 in the DCB group (n=35) and 0.91 ± 0.06 in the DES group (n=38) (p=0.27), demonstrating noninferiority.
- One case of abrupt vessel closure occurred in the DCB group.
- Two patients (one in each group) required target lesion revascularization by 9 months.
Conclusions:
- In STEMI, a DCB strategy is noninferior to DES regarding FFR at 9 months.
- The DCB approach appears to be a safe and feasible treatment option for primary PCI in STEMI.
Objectives:
This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).
Background:
In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty.
Methods:
In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion.
Results:
A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group).
Conclusions:
In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802).
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