Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.

Abstract

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).

• Authors: Nicola S Vos, Nick D Fagel, Giovanni Amoroso, Jean-Paul R Herrman, Mark S Patterson, Lieuwe H Piers, René J van der Schaaf, Ton Slagboom, Maarten A Vink
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 12 Issue 17 Pg. 1691-1699 (09 09 2019) ISSN: 1876-7605 [Electronic] United States
• PMID: 31126887 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Cardiovascular Agents
• Coated Materials, Biocompatible
• Paclitaxel

Topics

• Aged
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation, mortality)
• Cardiovascular Agents (administration & dosage, adverse effects)
• Coated Materials, Biocompatible
• Drug-Eluting Stents
• Female
• Fractional Flow Reserve, Myocardial
• Humans
• Male
• Middle Aged
• Netherlands
• Paclitaxel (administration & dosage, adverse effects)
• Prospective Studies
• Prosthesis Design
• ST Elevation Myocardial Infarction (diagnostic imaging, physiopathology, therapy)
• Time Factors
• Treatment Outcome