Abstract | AIM: STUDY DESIGN: 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. CONCLUSION: 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.
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Authors | Nicola S Vos, Rene J van der Schaaf, Giovanni Amoroso, Jean-Paul R Herrman, Mark S Patterson, Ton Slagboom, Maarten A Vink |
Journal | Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
(Catheter Cardiovasc Interv)
Vol. 87
Issue 7
Pg. 1213-21
(Jun 2016)
ISSN: 1522-726X [Electronic] United States |
PMID | 26370515
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
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Copyright | © 2015 Wiley Periodicals, Inc. |
Chemical References |
- Cardiovascular Agents
- Coated Materials, Biocompatible
- Paclitaxel
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Topics |
- Angioplasty, Balloon, Coronary
(adverse effects, instrumentation, mortality)
- Cardiac Catheterization
- Cardiac Catheters
- Cardiovascular Agents
(administration & dosage, adverse effects)
- Clinical Protocols
- Coated Materials, Biocompatible
- Coronary Angiography
- Coronary Restenosis
(etiology)
- Drug-Eluting Stents
- Echocardiography
- Fractional Flow Reserve, Myocardial
- Humans
- Netherlands
- Paclitaxel
(administration & dosage, adverse effects)
- Prospective Studies
- Prosthesis Design
- Recurrence
- Research Design
- ST Elevation Myocardial Infarction
(diagnostic imaging, mortality, physiopathology, therapy)
- Time Factors
- Treatment Outcome
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