Functional comparison between the BuMA Supreme biodegradable polymer sirolimus-eluting stent and a durable polymer zotarolimus-eluting coronary stent using quantitative flow ratio: PIONEER QFR substudy

Abstract

Quantitative flow assessment nine months after stenting did not differ between B-SES and R-ZES, despite a significant difference in in-stent late lumen loss.

Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold

“…Although serial 2D‐QCA (e.g., LLL) has been used and benchmarked as a surrogate to assess the efficacy of coronary devices, 1 a recent meta‐analysis indicated that LLL may no longer reflect device efficacy in the current DES era 18 . In this meta‐analysis, the best cut‐off value of LLL for predicting TLR was 0.50 mm; below this threshold, LLL may not always correlate in a linear manner with TLR, 18 and a higher LLL may be associated with lower clinical TLR rates as demonstrated with the BuMA stent compared to the resolute DES 12 . QFR may be considered the new standard in evaluating coronary device performance over time.…”

“…Our results are similar to prior retrospective series. In a sub‐study of the SYNTAX II trial, 341 out of 1,177 lesions (29%) were not analyzable by QFR, 11 and the retrospective PIONEER QFR sub‐study showed that QFR was not feasible in 13% of lesions 12 . When QFR is planned in a prospective manner, previous reports indicated that it is feasible in almost all cases 13 …”

“…Recently, the ORBITA trial showed that 29% to 32% of patients with stable coronary artery disease who were indicated for PCI on anatomical angiographic assessment did not have significant ischemia by FFR or instantaneous wave‐free ratio in a double‐blinded randomized setting 15 . The PIONEER QFR sub‐study also included 30% target vessels with QFR >0.80 at baseline 12 . The proportion of patients that were candidate for PCI on an anatomical basis but without significant ischemia on functional indices is consistent across clinical trials and warrants the systematic use of functional evaluation (whether FFR, instantaneous wave‐free ratio or QFR) in device trials.…”

“…These decrease in QFR following Fantom BRS implantation are in line with the decline in FFR (0.007 per year) observed in serial FFR assessment of non‐intervened coronary segments “as a natural history.” 17 One post‐hoc analysis of the PIONEER randomized trial that compared a novel sirolimus‐eluting BuMA Supreme stent (SINOMED, Tianjin, China) with zotarolimus‐eluting Resolute stent (Medtronic, Minneapolis, MN) using serial QFR values reported 0.72 ± 0.15, 0.92 ± 0.05, and 0.89 ± 0.10 versus 0.73 ± 0.13, 0.93 ± 0.05, and 0.89 ± 0.11 at baseline, post‐PCI, and 9‐month follow‐up (all p values for BuMA vs. Resolute stent >.05) (Table S2). 12 While comparisons to the Fantom BRS cannot be made, serial QFR measures represent a significant advance in a more clinically relevant surrogate of revascularization than 2D‐QCA in the evaluation of coronary device performance overtime. Although serial 2D‐QCA (e.g., LLL) has been used and benchmarked as a surrogate to assess the efficacy of coronary devices, 1 a recent meta‐analysis indicated that LLL may no longer reflect device efficacy in the current DES era 18 .…”

Clinical expert consensus document on quantitative coronary angiography from the Japanese Association of Cardiovascular Intervention and Therapeutics

“…For a surrogate marker of stent efficacy, the potential applicability of the angiography-derived FFR as a new-generation QCA was reported [79]. A patient-level meta-analysis reported that even a statistically significant difference in angiographic late lumen loss within the low value range did not have a clinical impact [80].…”