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Navvus血流储备分数降低造影剂用量、成本及辐射(CONTRACT)研究;使用RXi快速交换血流储备分数装置进行单中心临床和经济学评估的见解

Navvus FFR to reduce CONTRAst, Cost and radiaTion (CONTRACT); insights from a single-centre clinical and economical evaluation with the RXi Rapid-Exchange FFR device.

作者信息

Masdjedi Kaneshka, Van Mieghem Nicolas M, Diletti Roberto, van Geuns Robert-Jan, de Jaegere Peter, Regar Evelyn, Zijlstra Felix, van Domburg Ron T, Daemen Joost

机构信息

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.

出版信息

Int J Cardiol. 2017 Apr 15;233:80-84. doi: 10.1016/j.ijcard.2017.01.019. Epub 2017 Jan 4.

Abstract

OBJECTIVES

To assess whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention.

BACKGROUND

FFR is the mainstay of functional hemodynamic assessment of coronary artery lesions. The RXi Navvus system (ACIST Medical Systems, Eden Prairie, MN) is a monorail microcatheter with FFR-measurement capability through optical pressure sensor technology.

METHODS

This is an investigator-initiated, prospective, single-center, observational cohort study. A total of 238 patients were enrolled, 97 patients with Navvus and 141 with conventional pressure-wire based FFR (PW-FFR). Final analyses were performed on the cohort in which only 1 device was used (82 Navvus procedures vs. 136 PW-FFR procedures).

RESULTS

No significant differences were found in the total amount of contrast used (150±77 vs 147±79ml; p=0.81), radiation use (6200±4601 vs. 5076±4655 centiG∗cm; p=0.09) or costs (€1994,- vs. €1930,-; p=0.32) in the Navvus vs. PW-FFR groups respectively.

CONCLUSIONS

No significant differences were found in the amount of contrast used, total procedural costs or radiation when the Navvus system was used as compared to conventional FFR wires.

CONDENSED ABSTRACT

CONTRACT is an investigator-initiated, prospective, single-center, observational cohort study that evaluated whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. Use of the RXi Navvus system was associated with comparable procedural costs, amount of radiation and contrast used as compared to PW-FFR systems.

摘要

目的

评估与使用标准血流储备分数(FFR)导丝相比,RXi Navvus系统在接受冠状动脉造影或经皮冠状动脉介入治疗的真实患者群体中是否能减少总造影剂用量、辐射量及总体研究成本。

背景

FFR是冠状动脉病变功能血流动力学评估的主要方法。RXi Navvus系统(ACIST Medical Systems,明尼苏达州伊甸草原)是一种单轨微导管,通过光学压力传感器技术具备FFR测量能力。

方法

这是一项由研究者发起的前瞻性、单中心观察性队列研究。共纳入238例患者,97例使用Navvus系统,141例使用基于传统压力导丝的FFR(PW-FFR)。对仅使用一种设备的队列进行最终分析(82例Navvus操作与136例PW-FFR操作)。

结果

Navvus组与PW-FFR组在总造影剂用量(150±77 vs 147±79ml;p=0.81)、辐射量(6200±4601 vs. 5076±4655厘戈瑞*厘米;p=0.09)或成本(1994欧元 vs. 1930欧元;p=0.32)方面均未发现显著差异。

结论

与传统FFR导丝相比,使用Navvus系统时在造影剂用量、总操作成本或辐射量方面未发现显著差异。

摘要

CONTRACT是一项由研究者发起的前瞻性、单中心观察性队列研究,评估与使用标准血流储备分数(FFR)导丝相比,RXi Navvus系统在接受冠状动脉造影或经皮冠状动脉介入治疗的真实患者群体中是否能减少总造影剂用量、辐射量及总体研究成本。与PW-FFR系统相比,使用RXi Navvus系统时的操作成本、辐射量及造影剂用量相当。

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