title: REVascularization with paclitaxEL-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarcTION-A randomized controlled trial: Rationale and design of the REVELATION trial.
abstract: OBJECTIVE
  In primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI), stenting has proved to reduce the need for repeat revascularization compared with balloon angioplasty alone. The incidence of cardiac death or recurrent myocardial infarction, though, is not reduced by stenting. This is in part attributable to stent-related complications like stent thrombosis which may occur even years after implantation. A strategy of drug coated balloon (DCB) angioplasty without stenting would abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. Our aim is to evaluate the efficacy and safety of a DCB only strategy versus drug-eluting stents (DES) in PPCI for STEMI.
  
  
  METHODS
  The REVELATION trial is a prospective, single center, randomized study, in which 120 patients presenting with STEMI will be allocated to treatment with a DCB versus DES. Appertaining to the established prognostic value of fractional flow reserve (FFR) rather than angiographic lesion severity, the functional assessment of the infarct-related lesion by FFR at 9 months after initial treatment is the primary end point. Assuming an FFR value of 0.90 after stenting and an increased risk of adverse events if post-PCI FFR <0.85, we decided to accept an FFR value of ≥0.85 after DCB only at follow-up as noninferiority margin. Secondary end points include major adverse cardiac events up to 5-year follow-up.
  
  
  CONCLUSIONS
  Our trial will address the efficacy and safety of DCB angioplasty versus DES in the setting of PPCI for STEMI. The REVELATION trial will introduce the recognized prognostic significance of physiologic assessment of the infarct-related lesion by FFR at 9 months follow-up as primary end point. © 2015 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Nicola S
authors.initials: NS
authors.lastname: Vos
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Rene J
authors.initials: RJ
authors.lastname: van der Schaaf
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Amoroso
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Jean-Paul R
authors.initials: JP
authors.lastname: Herrman
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Patterson
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Maarten A
authors.initials: MA
authors.lastname: Vink
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006328:Cardiac Catheterization; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents; D004452:Echocardiography; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D009426:Netherlands; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012107:Research Design; D000072657:ST Elevation Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: ST-segment elevation myocardial infarction; drug-coated balloon; fractional flow reserve; primary percutaneous coronary intervention