Clinical Validation of a Novel Pressure Microcatheter‐Based Nonhyperemic Pressure Ratio (SUPREME II Study)
Year: 2026
Type: article
Abstract: Background The constant resistance ratio (cRR) is a novel nonhyperemic pressure ratio based on piezoresistive pressure microcatheter (PMC) measurements. With repeated measurements in randomized order of PMC and pressure wire techniques, this study aimed primarily to validate the diagnostic performance of cRR compared with fractional flow reserve (FFR) in coronary lesions of 30% to 90% diameter stenosis. Methods SUPREME II (Sensor‐Equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements) was a multicenter, prospective study that included 466 patients (483 vessels) from 11 centers. All target vessels were assessed using both pressure wire and PMC separately in randomized order under resting and hyperemic conditions. The primary end point was the diagnostic accuracy of the cRR using a PMC‐based FFR of ≤0.80 as the reference standard. Secondary end points included the cRR “gray zone” of the cRR–FFR hybrid strategy and the proportion of patients in whom diagnosed was achieved without vasodilator use. Results The optimal cRR cutoff was 0.89, which correctly classified 82.8% of the patients, with a sensitivity and specificity of 87.0% and 80.1%, respectively, and achieved an area under the curve of 0.92 with FFR PMC as reference (area under the curve 0.90 with FFR pressure wire as reference). If FFR was added for decision‐making in cases of cRR values between 0.85 and 0.91, a cRR–‐FFR hybrid strategy achieved a 95.3% agreement with the FFR‐only strategy and allowed 68.5% of the patients to not require using vasodilator. Conclusions In coronary stenosis of 30% to 90% diameter stenosis, cRR measurements were highly feasible. The diagnostic accuracy of cRR with FFR PMC as reference was excellent. Further, a cRR–FFR hybrid strategy may reduce vasodilator use without compromising diagnostic accuracy. Registration URL: https://clinicaltrials.gov/study/NCT05417763 ; Unique Identifier: NCT05417763.
Institutions: Zhongshan Hospital, Guangdong Provincial People's Hospital, Zunyi Medical University, Peking University Third Hospital, Xiamen University, Shandong Provincial Hospital, The Affiliated Yongchuan Hospital of Chongqing Medical University, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Xinjiang Medical University, Sir Run Run Shaw Hospital, First Affiliated Hospital of Harbin Medical University, Johannes Gutenberg University Mainz
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,810
OpenAlex ID: W7135238279