ABLAVAR™ Clinical Information
ABLAVAR™ Clinical Studies1
Safety and efficacy of ABLAVAR™ were assessed in 2 multicenter, open-label, phase 3 clinical trials. In both trials, patients with known or suspected peripheral vascular disease underwent MRA with and without ABLAVAR™ as well as catheter-based X-ray arteriography. Diagnostic efficacy was based upon comparisons of sensitivity and specificity between MRA with and without ABLAVAR™, with X-ray arteriography as the reference standard.
Out of 493 patients enrolled in these 2 trials, 424 were included in the comparison of the disgnositic efficacy of ABLAVAR™ MRA to that of noncontrast MRA in detection/exclusion of occlusive vascular disease (greater than or equal to 50% stenosis) in 7 vessel-segments in the aortoiliac region. The interpretation of MRA images from both trials was conducted by 3 independent radiologist readers who were blinded to clinical data, including the results of X-ray arteriography. In these 424 patients, the median age was 67 years with a range of 29 to 87 years; 58% of the patients were over 65 years of age; 83% were white and 68% were male.
The primary efficacy analyses were designed to demonstrate superiority in sensitivity and noninferiority in specificity of ABLAVAR™ MRA as compared to noncontrast MRA at the vessel-segment level. The uninterpretable images were assigned an outcome of “wrong diagnosis.” Additionally, success was also based upon acceptable performance characteristics for the uninterpretable noncontrast MRA vessel-segments that became interpretable following ABLAVAR™ administration. Specifically, the sensitivity and specificity for these ABLAVAR™ images were required to exceed 50%. These prespecified success criteria were to be achieved by at least the same 2 readers for all primary analyses.
Superiority in sensitivity and noninferiority in specificity was demonstrated for ABLAVAR™ MRA by all 3 blinded readers. On average, 316 vessel-segments were assessed for sensitivity and 2230 for specificity, by each reader. Table 1 summarizes the efficacy results, by reader.
| Reader | Sensitivity | Specificity | ||||
|---|---|---|---|---|---|---|
| ABLAVAR™ -MRA [A] |
Non-contrast MRA [B] |
[A]–[B] (95% CI)a |
ABLAVAR™ -MRA [A] |
Non-contrast MRA [B] |
[A]–[B] (95% CI)a |
|
| 1 | 89% | 69% | 20 % (15%, 25%) | 72% | 71% | 1% (-3%, 5%) |
| 2 | 82% | 70% | 12% (7%,17%) | 81% | 73% | 8% (4%, 12%) |
| 3 | 79% | 64% | 15% (9%, 21%) | 85% | 85% | 0% (-2%, 2%) |
| a Based on cluster-corrected McNemar Test. | ||||||
Among the 3 readers, 5% to 12% of the vessel segments were deemed uninterpretable by non-contrast MRA. For these vessel segments, sensitivity of ABLAVAR™ MRA ranged from 72% [95% CI (54%, 90%)] to 97% [95% CI (93%, 100%)], and specificity ranged from 72% [95% CI (67%, 76%)] to 84%
[95% CI (81%, 88%)].
Reference
1. ABLAVAR™ [package insert]. North Billerica, MA: Lantheus Medical Imaging, Inc.; 2009.
INDICATIONS:
ABLAVAR™ is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
CONTRAINDICATIONS:
History of a prior allergic reaction to a gadolinium-based contrast agent.
IMPORTANT SAFETY INFORMATION:
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.
ABLAVAR™ Injection: As with other contrast media: the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other paramagnetic contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.
In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.
Have emergency resuscitative equipment available prior to and during ABLAVAR™ administration.
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