Prevalence and Clinical Outcomes of Discordant Lesions Between Fractional Flow Reserve and Nonhyperemic Pressure Ratios in Clinical Practice: The J-PRIDE Registry
Shoichi Kuramitsu, Yoshiaki Kawase, Tomohiro Shinozaki, Takenori Domei, Futoshi Yamanaka, Umihiko Kaneko, Tsunekazu Kakuta, Kazunori Horie, Hidenobu Terai, Hirohiko Ando, Yasutsugu Shiono, Toru Tagashira, Kazutaka Nogi, Takashi Kubo, Taku Asano, Jun Shiraishi, Hiromasa Otake, Akinori Sugano, Reo Anai, Atsushi Iwai, Yuetsu Kikuta, Hidetaka Nishina, Tsutomu Fujita, Tetsuya Amano, Masashi Iwabuchi, Hiroyoshi Yokoi, Takashi Akasaka, Hitoshi Matsuo, Nobuhiro Tanaka, Hirohiko Ando, Hirofumi Ohashi, Tetsuya Amano, Yuetsu Kikuta, Hitoshi Matsuo, Yoshiaki Kawase, Yuki Nakashima, Akinori Sugano, Jun Shiraishi, Hidenobu Terai, Yohei Yakuta, Shinichiro Yamada, Toru Tagashira, Hiromasa Otake, Takayoshi Toba, Takenori Domei, Toru Morofuji, Tomoaki Ito, Kazutaka Nogi, Atsushi Iwai, Shoichi Kuramitsu, Umihiko Kaneko, Kazunori Horie, Futoshi Yamanaka, Taku Asano, Kotaro Miyata, Nobuhiro Tanaka, Takashi Kubo, Tsunekazu Kakuta, Masahiro Hada, Hidetaka Nishina, Reo Anai, Yutaro Naka, Yasutsugu Shiono, Daisuke Higashioka
Abstract
BACKGROUND: Limited large-scale, real-world data exist on the prevalence and clinical impact of discordance between fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). METHODS: The J-PRIDE registry (Clinical Outcomes of Japanese Patients With Coronary Artery Disease Assessed by Resting Indices and Fractional Flow Reserve: A Prospective Multicenter Registry) prospectively enrolled 4304 lesions in 3200 patients from 20 Japanese centers. The lesions were classified into FFR+/NHPR−, FFR−/NHPR+, FFR+/NHPR+, or FFR−/NHPR groups according to cutoff values of 0.89 for NHPRs and 0.80 for FFR. The primary study end point was the cumulative 1-year incidence of target vessel failure (a composite of cardiac death, target vessel–related myocardial infarction, and clinically driven target vessel revascularization) on a lesion basis. RESULTS: An NHPR cutoff value of 0.89, determined using online software, predicted an FFR of 0.80 across various NHPR types. Discordance between FFR and NHPRs was observed in 20% of lesions (FFR+/NHPR−, 11.2%; FFR−/NHPRs+, 8.8%). Revascularization was deferred in 42.9% and 88.4% of the FFR+/NHPR− and FFR−/NHPR+ groups, respectively. In deferred vessels, the FFR+/NHPR− and FFR−/NHPR+ groups showed a higher 1-year incidence of target vessel failure compared with the FFR−/NHPR− group (7.9% versus 5.5% versus 1.7%; for FFR+/NHPR−, adjusted hazard ratio [aHR], 4.89 [95% CI, 2.68–8.91]; P <0.001; for FFR−/NHPR+, aHR, 2.64 [95% CI, 1.49–4.69]; P <0.001). In revascularized vessels, the 1-year target vessel failure rate was numerically higher in the FFR−/NHPR+ group than in the FFR+/NHPR+ group (9.6% versus 3.4%; aHR, 2.27 [95% CI, 0.70–7.34]; P =0.17), although with similar outcomes between the FFR+/NHPR− and FFR+/NHPR+ groups (2.3% versus 3.4%; aHR, 0.96 [95% CI, 0.37–2.38]; P =0.93). The FFR+/NHPR− group benefited from revascularization compared with medical treatment (aHR, 0.26 [95% CI, 0.08–0.86]; P =0.027); the FFR−/NHPR+ group did not (aHR, 2.39 [95% CI, 0.62–9.21]; P =0.20). CONCLUSIONS: Discordance between FFR and NHPRs was noted in 20% of lesions, and discordant deferred lesions resulted in worse outcomes than concordant negative lesions. Although the outcomes after deferring revascularization were comparable between the FFR+/NHPR− and FFR−/NHPR+ lesions, only FFR+/NHPR− lesions showed a benefit from revascularization compared with medical treatment, suggesting that an FFR-guided strategy is superior to an NHPR-guided strategy in discordant lesions. REGISTRATION: URL: https://www.umin.ac.jp ; Unique identifier: UMIN000038403.