Short- and long-term functional results following drug-coated balloons versus drug- eluting stents in small coronary vessels: The RESTORE quantitative flow ratio study. (15th March 2021)

• Record Type: Journal Article
• Authors: Li, Long; Guan, Changdong; Meng, Shuai; Bai, Yinxiao; Zhang, Zhihao; Zou, Kaiyuan; Ruan, Yang; Cao, Xiaojing; Jia, Ruofei; Guo, Caixia; Escaned, Javier; Jin, Zening; Xu, Bo
• Is Part Of: International journal of cardiology. Volume 327(2021)
• Page Start: 45
• Page End: 51
• Publication Date: 2021-03-15
• Subjects: Quantitative flow ratio -- Drug-coated balloon -- Drug-eluting stent -- Percentage diameter stenosis -- Small vessel disease; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2020.11.035
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: 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. Primary outcome of this analysis was 9-month QFR. Pre-procedural, post-procedural and 9-month QFR was performed in 84.8% (195/230), 83.0% (191/230) and 93.8% (181/193) cases, respectively. At 9 months, the QFR of DCB showed no significant difference to DES (0.88 ± 0.23 vs. 0.92 ± 0.12, p = 0.12). Both 9-month QFR and the QFR difference between post-procedure and 9-month follow-up were correlated with angiographic percentage of diameter stenosis and late loss, and predictive of 2-year clinical outcome. 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 . Highlights: Percutaneous revascularization in SVD with DCB resulted in a similar functional outcome with DES at 9-month follow-up. Performing QFR in small vessels is feasible and useful as a mean of evaluating device performance. Future studies may investigate QFR or QFR loss in combination with % diameter stenosis or late lumen loss as a surrogate endpoint.