Study Finds Drug-Coated Balloon Strategy Non-Inferior to DES in STEMI

In the setting of STEMI, a drug-coated balloon strategy may be non-inferior to a drug-eluting stent (DES) in terms of fractional flow reserve (FFR) at nine months, according to results from the REVELATION trial presented May 21 at EuroPCR in Paris and simultaneously published in JACC: Cardiovascular Interventions.
Nicola S. Vos, MD, et al., analyzed 120 patients to assess the efficacy and safety of a drug-coated balloon strategy vs. DES in STEMI. Patients with a de novo, non-severely calcified culprit lesion in a native coronary artery and a residual stenosis of less than 50 percent after predilatation were randomized to treatment with either a drug-coated balloon or DES.
Results showed that at nine months after enrollment, the mean FFR value was 0.92 ± 0.05 in the drug-coated balloon group and 0.91 ± 0.55 in the DES group, respectively. Further, there was one abrupt vessel closure requiring treatment that occurred following treatment with a drug-coated balloon, there were two patients that required non-urgent target lesion revascularization (one in each group), and no deaths.
The researchers conclude that the drug-coated balloon strategy was "safe and feasible." They add that drug-coated balloon angioplasty "may represent a valuable alternative strategy by which the purpose of truly leaving nothing behind can be accomplished without compromising results."
In an accompanying editorial comment, Omeed Neghabat, BSc, and Niels Ramsing Holm, MD, note that "while these results are promising for use of drug-coated balloons, the findings should be interpreted with the necessary caution due to the high percentage of cases lost to follow-up both for FFR and event recording."
ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC, adds that due to the small sample size, a much larger study is needed to assess this question.
Clinical Topics: Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention
Keywords: Drug-Eluting Stents, Coronary Vessels, Myocardial Infarction, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Angioplasty, Balloon
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