Author + information
- Received February 4, 2019
- Revision received April 2, 2019
- Accepted April 9, 2019
- Published online May 21, 2019.
- Nicola S. Vos, MD,
- Nick D. Fagel, MD,
- Giovanni Amoroso, MD, PhD,
- Jean-Paul R. Herrman, MD, PhD,
- Mark S. Patterson, MD, PhD,
- Lieuwe H. Piers, MD, PhD,
- René J. van der Schaaf, MD, PhD,
- Ton Slagboom, MD and
- Maarten A. Vink, MD, PhD∗ ()
- ↵∗Address for correspondence:
Dr. Maarten A. Vink, Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis Hospital, Oosterpark 9, 1091 AC, Amsterdam, the Netherlands.
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)
- drug-coated balloon
- fractional flow reserve
- primary percutaneous coronary intervention
- ST-segment elevation myocardial infarction
This trial was funded by BV Cardioresearch OLVG. All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 4, 2019.
- Revision received April 2, 2019.
- Accepted April 9, 2019.
- 2019 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.