Patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) are at greater risk of having a major cardiac event compared to patients treated with the metallic XIENCE drug-eluting stent, according to a Food and Drug Administration (FDA) Safety Communication. 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 and gradually dissolves and is fully absorbed by the body over time.
The FDA’s initial review of data from a pivitol clinical trial involving the BVS showed an 11 percent rate of major adverse cardiac events including cardiac death, heart attack, or the need for additional procedures to re-open the treated heart vessel, in patients treated with the BVS within two years. This was compared with a 7.9 percent risk in patients treated with the already FDA approved Abbott Vascular’s metallic XIENCE drug-eluting stent.
The study also showed a 1.9 percent rate of developing blood clots with BVS versus a 0.8 percent with the XIENCE stent at two years. The higher adverse cardiac event rates in BVS patients was more likely when the device was placed in small heart vessels.
Patients with BVS devices who are experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath should seek medical attention. Any adverse events related to this Safety Communication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Alerts