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Major Cardiac Events Reported with Absorb GT1 Bioresorbable Vascular Scaffold

Washington, DC: The US Food and Drug Administration (FDA) has issued information regarding the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) made by Abbott Vascular stating that that there is an increased rate of major adverse cardiac events seen in patients receiving the BVS, compared to patients treated with the approved metallic XIENCE drug-eluting stent.

The BVS is used to open heart blood vessels (coronary arteries) blocked by scar tissue (plaque) in order to increase blood flow to the heart muscle. The BVS is implanted during an angioplasty procedure, gradually dissolving until it is fully absorbed by the body over time.

The FDA’s initial review of two-year data from the BVS pivotal clinical study (the ABSORB III trial) shows an 11 percent rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the BVS at two years. This compares with a 7.9 percent incident rate in patients treated with the already-approved Abbott Vascular’s metallic XIENCE drug-eluting stent (p = 0.03).

The ABSORB III trial also shows a 1.9 percent rate of developing blood clots (thrombosis) within the BVS versus 0.8 percent within the XIENCE stent at two years. These observed higher adverse cardiac event rates seen in BVS patients were more likely when the device was placed in small heart vessels.

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Published on Mar-22-17


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