Nutzenbewertung

Regadenoson

(neues Anwendungsgebiet: Messung der fraktionellen Flussreserve der Stenose)

Verfahrensstand

Beginn des Verfahrens beim G-BA:

01.03.2019

Veröffentlichung der Nutzenbewertung und Beginn des schriftlichen Stellungnahmeverfahrens:

03.06.2019

Fristende zur Abgabe einer schriftlichen Stellungnahme:

24.06.2019

Beschlussfassung beim G-BA:

Mitte August 2019

Verfahrensstatus:

Beschlussfassung wird vorbereitet

Grundlegende Informationen

Wirkstoff:

Regadenoson

Handelsname:

Rapiscan®

Therapeutisches Gebiet:

Messung der fraktionellen Flussreserve der Stenose (Sonstiges)

Pharmazeutischer Unternehmer:

GE Healthcare Buchler GmbH & Co. KG


Studienergebnisse

Intravenous regadenoson with aminophylline reversal is safe and equivalent to intravenous adenosine infusion for fractional flow reserve measurements

BACKGROUND: Small studies have shown that adenosine is equivalent to regadenoson when obtaining coronary fractional flow reserve (FFR) measurements. A study that also evaluates time and safety of aminophylline reversal of regadenoson effects has not been presented.

HYPOTHESIS: Reversal of regadenoson with aminophylline is safe and equivalent to adenosine for FFR measurements.

METHODS: Forty-six consecutive patients who underwent clinically indicated FFRs at the time of coronary angiography were enrolled between 4/2012 and 5/2014. Each patient had FFR measured using adenosine 140 mcg/kg/min IV, and following return to baseline, FFR was measured using regadenoson 400 mcg IV, which then was reversed with aminophylline 150 mg IV. Time to baseline hemodynamics was measured. Agreement between the two assessments was compared using linear regression.

ClinicalTrials.gov-Kennung (NCT-Nummer): NCT01482169

Kurzbeschreibung der Studie

BACKGROUND: Small studies have shown that adenosine is equivalent to regadenoson when obtaining coronary fractional flow reserve (FFR) measurements. A study that also evaluates time and safety of aminophylline reversal of regadenoson effects has not been presented.

HYPOTHESIS: Reversal of regadenoson with aminophylline is safe and equivalent to adenosine for FFR measurements.

METHODS: Forty-six consecutive patients who underwent clinically indicated FFRs at the time of coronary angiography were enrolled between 4/2012 and 5/2014. Each patient had FFR measured using adenosine 140 mcg/kg/min IV, and following return to baseline, FFR was measured using regadenoson 400 mcg IV, which then was reversed with aminophylline 150 mg IV. Time to baseline hemodynamics was measured. Agreement between the two assessments was compared using linear regression.

ClinicalTrials.gov-Kennung (NCT-Nummer): NCT01482169

Ergebnisse der Studie in der Übersicht

FFR results were similar with both agents (R2 = 0.935, P < 0.0001). Also, using the 0.80 cutoff for significantly depressed FFR, there was no divergence regarding studies' significance. After aminophylline reversal of regadenoson, hemodynamics returned to baseline in 111 ± 71 seconds. There were no unexpected side effects or complications.


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