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经皮冠状动脉介入治疗后血管造影引导与生理引导对比的随机研究:EASY-PREDICT研究

Randomized Study Comparing Angiography Guidance With Physiology Guidance After PCI: The EASY-PREDICT Study.

作者信息

Ulacia Flores Paola, Cieza Tomas, Ouarrak Safia, Ruhl Andrés, Mengi Siddharta, De Larochellière Robert, Garcia-Labbé David, Déry Jean-Pierre, Poulin Anthony, Larose Éric, Noël Bernard, Nguyen Can Manh, Paradis Jean-Michel, Bertrand Olivier F

机构信息

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec City, Canada.

出版信息

Circ Cardiovasc Interv. 2025 Jul;18(7):e015165. doi: 10.1161/CIRCINTERVENTIONS.125.015165. Epub 2025 May 21.

DOI:10.1161/CIRCINTERVENTIONS.125.015165
PMID:40400236
Abstract

BACKGROUND

Physiology assessment of coronary lesion prepercutaneous coronary intervention (PCI) using hyperemic and nonhyperemic pressure ratios is useful to determine if a lesion requires treatment. Whether the physiology after PCI is superior to angiography guidance only is unknown. The study sought to investigate whether post-PCI physiology improves clinical outcomes compared with standard angiographic guidance.

METHODS

All-comers patients referred for diagnostic angiography and possible PCI were recruited in a high-volume tertiary care hospital. After uncomplicated PCI, patients were randomized to angiography guidance or target vessel physiology, including nonhyperemic pressure ratio (resting distal coronary pressure to aortic pressure ratio and diastolic pressure ratio) and fractional flow reserve. The primary outcome was the rate of target vessel failure, including cardiac death, myocardial infarction, and target vessel revascularization at 18 months post-PCI. Angina score, medications, and quality of life were also assessed.

RESULTS

Two hundred twenty-one patients were randomized in the angiography group (110 patients, 166 lesions) and the physiology group (111 patients, 159 lesions). Immediate post-PCI physiology results were deemed suboptimal in 22 (17%) cases, and operators performed further optimization steps. Final post-PCI results were resting distal coronary pressure to aortic pressure ratio of 0.95±0.04, the diastolic pressure ratio of 0.94±0.06, and the fractional flow reserve of 0.90±0.07. Ultimately, 9 lesions (7%) remained with fractional flow reserve values ≤0.80. At 18-month follow-up, target vessel failure was 17.4% in the angiography group and 18% in the physiology group (=0.88). Rates of cardiac death (1% versus 0%; =0.32), myocardial infarction (13% versus 11%; =0.66), and target vessel revascularization (4% versus 7%; =0.24) remained similar in both groups. No difference in angina score, medication, or quality of life was found.

CONCLUSIONS

In all-comers patients undergoing uncomplicated PCI, routine post-PCI physiology assessment was not associated with clinical benefit compared with standard angiographic guidance. Further study is required to determine how post-PCI physiology guidance can be helpful in selected lesions.

REGISTRATION

URL: https://clinicaltrials.gov/; Unique identifier: NCT04929496.

摘要

背景

使用充血和非充血压力比值对经皮冠状动脉介入治疗(PCI)前的冠状动脉病变进行生理学评估,有助于确定病变是否需要治疗。PCI术后的生理学评估是否优于单纯血管造影引导尚不清楚。本研究旨在探讨PCI术后生理学评估与标准血管造影引导相比是否能改善临床结局。

方法

在一家大型三级护理医院招募所有因诊断性血管造影和可能的PCI前来就诊的患者。在无并发症的PCI术后,患者被随机分为血管造影引导组或靶血管生理学评估组,后者包括非充血压力比值(静息时冠状动脉远端压力与主动脉压力比值及舒张压比值)和血流储备分数。主要结局是靶血管失败率,包括PCI术后18个月时的心源性死亡、心肌梗死和靶血管血运重建。还评估了心绞痛评分、用药情况和生活质量。

结果

221例患者被随机分为血管造影组(110例患者,166处病变)和生理学组(111例患者,159处病变)。22例(17%)患者PCI术后即刻生理学评估结果不理想,术者采取了进一步优化措施。PCI术后最终结果为冠状动脉远端静息压力与主动脉压力比值为0.95±0.04,舒张压比值为0.94±0.06,血流储备分数为0.90±0.07。最终,9处病变(7%)的血流储备分数值≤0.80。在18个月的随访中,血管造影组的靶血管失败率为17.4%,生理学组为18%(P=0.88)。两组的心源性死亡(1%对0%;P=0.32)、心肌梗死(13%对11%;P=0.66)和靶血管血运重建(4%对7%;P=0.24)发生率相似。心绞痛评分、用药情况或生活质量方面未发现差异。

结论

在接受无并发症PCI的所有患者中,与标准血管造影引导相比,常规PCI术后生理学评估未显示出临床获益。需要进一步研究以确定PCI术后生理学评估如何对特定病变有帮助。

注册信息

网址:https://clinicaltrials.gov/;唯一标识符:NCT04929496。

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