Head-to-Head Independent Study Shows Use of GE Healthcare's Visipaque™ (iodixanol) Leads to Better Image Quality of Coronary Stents During CT Angiography

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Head-to-Head Independent Study Shows Use of GE Healthcare's Visipaque iodixanol) Leads to Better Image Quality of Coronary Stents During CT Angiography

Visipaque Patients Also More Comfortable During Scans
March 05, 2014 04:00 AM Eastern Standard Time

CHALFONT ST. GILES, England--(BUSINESS WIRE)--GE Healthcare today announced results from an independent study, which showed that use of isosmolar contrast agent Visipaque™ 320 (iodixanol 320mg I/ml) provides better image quality of coronary stents during multi-detector CT coronary angiography (MDCT-CA) than use of Iomeron® 400 (iomeprol 400mg l/ml) when injected at the same flow rate (5.0 ml/s) and volume (80ml). Patients injected with Visipaque at 5.0 ml/s also experienced less heat sensation, fewer premature heart beats and their overall heart rate (HR) was less affected during scanning. The data were published online in Journal of Cardiovascular Computed Tomography.1

    "Although MDCT-CA is increasingly used as a non-invasive tool for evaluating coronary stents and bypass grafts, it was unknown until now, whether iodinated contrast medium characteristics affected diagnostic performance"

"Although MDCT-CA is increasingly used as a non-invasive tool for evaluating coronary stents and bypass grafts, it was unknown until now, whether iodinated contrast medium characteristics affected diagnostic performance" said Professor Daniele Andreini, lead author of the study, Centro Cardiologico Monzino, Milan, Italy.

About the Study

This study evaluated 254 patients undergoing MDCT-CA coronary stent follow-up with Iomeron 400 at 5.0 ml/s flow rate (group 1, n=83), Visipaque 320 at 6.2 ml/s flow rate (group 2, n=87) and Visipaque 320 at 5.0 ml/s flow rate (group 3, n=84). Heart rate (HR) immediately before and at the end of scanning, HR variation, premature heart beats (PHB) and heat sensation by visual analog scale (VAS) after scanning were recorded.

The study found overall stent evaluability was significantly higher in patients who received Visipaque 320 at 5.0 ml/s than those who received Visipaque 320 6.2 ml/s (98% vs. 91%) or Iomeron 400 5.0 ml/s (98% vs. 92%) due to a lower number of severe artifacts in group 3 (n=7) as compared to groups 2 (n=21) and 1 (n=26). Additionally:

    While heart rates immediately before imaging were similar in the three groups, the HR at the end of imaging was significantly lower in patients receiving Visipaque 320 5.0 ml/s than those who received either Visipaque 320 6.2 ml/s (53.7 vs. 56.7 bpm, p=0.001) or Iomeron 400 5.0ml/s (53.7 vs. 56.2 bpm, p=0.008).
    During the scan, heart rate decreased in all groups while patients held their breath. However, the heart rate decrease was significantly higher in Visipaque 320 5.0 ml/s than those who received Visipaque 320 6.2ml/s (-6.6 vs. -4.8 bpm, p=0.001) or Iomeron 400 5.0ml/s (-6.6 vs. -3.8 bpm, p=0.0001).
    The number of patients with at least one premature heart beat during the scan was significantly lower in Visipaque 320 5.0 ml/sec than in those receiving Visipaque 320 6.2 ml/s (0 vs. 7, p=0.008) or Iomeron 400 5.0ml/s (0 vs. 8, p=0.003).

Finally patients receiving Visipaque 320 at 5.0 ml/s or 6.2 ml/s experienced less heat sensation compared to those receiving Iomeron 400 at 5.0ml/s (4.3 vs. 5.3 mm, p=0.0001 ; 5.3 vs. 8 mm, p=0.001) respectively.

"This independent study, using Visipaque, is significant and adds to the growing body of evidence that supports continued research in contrast media to improve patient care," said Jan Makela, General Manager, Core Imaging, GE Healthcare Life Sciences. "It provides relevant information to both referring physicians and imaging specialists, which may help them choose appropriate contrast media. And, most importantly, Visipaque provided more comfort for the patient during scanning."

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

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VISIPAQUE

Int'l English prescribing information

PRESCRIBING INFORMATION VISIPAQUE™ iodixanol

Indications and approvals may vary in different countries. Please refer to the local Summary of Product Characteristics [SPC] before prescribing. Further information available on request.

PRESENTATION

An isotonic, aqueous solution containing iodixanol, a non-ionic, dimeric contrast medium, available in two strengths containing either 270 mg or 320 mg iodine per ml.

INDICATIONS

This medicinal product is for diagnostic use only. X-ray contrast medium for cardioangiography, cerebral angiography, peripheral arteriography, abdominal angiography, urography, venography, CT enhancement. Lumbar, thoracic and cervical myelography. Arthrography, hysterosalpingography (HSG) and studies of the gastrointestinal tract.

DOSAGE AND ADMINISTRATION

Adults and children: Dosage varies depending on the type of examination, age, weight, cardiac output, general condition of patient and the technique used (see SPC and package leaflet).

CONTRA-INDICATIONS

Hypersensitivity to the active substance or to any of the excipients. Manifest thyrotoxicosis. History of serious hypersensitivity reaction to Visipaque.