{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T14:14:12Z","timestamp":1774534452989,"version":"3.50.1"},"reference-count":46,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2015,9,15]],"date-time":"2015-09-15T00:00:00Z","timestamp":1442275200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>In primary percutaneous coronary intervention (PPCI) for ST\u2010elevation 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\u2010related 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\u2010eluting stents (DES) in PPCI for STEMI.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study design<\/jats:title><jats:p>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\u2010related 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\u2010PCI FFR &lt;0.85, we decided to accept an FFR value of \u22650.85 after DCB only at follow\u2010up as noninferiority margin. Secondary end points include major adverse cardiac events up to 5\u2010year follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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\u2010related lesion by FFR at 9 months follow\u2010up as primary end point. \u00a9 2015 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.26241","type":"journal-article","created":{"date-parts":[[2015,9,15]],"date-time":"2015-09-15T05:59:06Z","timestamp":1442296746000},"page":"1213-1221","source":"Crossref","is-referenced-by-count":11,"title":["<scp>REV<\/scp>ascularization with paclitax<scp>EL<\/scp>\u2010coated balloon angioplasty versus drug\u2010eluting stenting in acute myocardial infarc<scp>TION<\/scp>\u2014A randomized controlled trial: Rationale and design of the <scp>REVELATION<\/scp> trial"],"prefix":"10.1002","volume":"87","author":[{"given":"Nicola S.","family":"Vos","sequence":"first","affiliation":[{"name":"Department of Cardiology Onze Lieve Vrouwe Gasthuis Amsterdam The 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