International journal of cardiology
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Randomized Controlled Trial
Short- and long-term functional results following drug-coated balloons versus drug- eluting stents in small coronary vessels: The RESTORE quantitative flow ratio study.
Background Immediate and long-term functional outcomes after percutaneous treatment of small vessel disease (SVD) with drug-coated balloon (DCB) versus drug-eluting stent (DES) remain unknown. The study sought to investigate whether treatment of de novo SVD with DCB yields similar functional results compared with DES, as judged with angiography-based quantitative flow ratio (QFR). Methods and results QFR was measured at pre-procedural, post-procedural and 9-month angiography in all available subjects from the non-inferiority RESTORE SVD China trial, in which patients were randomized to Restore DCB (n = 116) or Resolute DES (n = 114) study arms. ⋯ Conclusions Treatment of coronary SVD with DCB resulted in similar 9-month functional results compared with DES. This study provides evidences to the value of QFR as a mean of evaluating device performance after coronary revascularization. Clinical trial registration URL: https://www.clinicaltrials.gov; ClinicalTrial.gov: Identifier: NCT02946307.