October 31, 2017
The FDA is issuing this update to our March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent.
The FDA was made aware that the manufacturer has stopped global sales of the Absorb GT1 Bioresorbable Vascular Scaffold as of September 14, 2017. The FDA’s recommendations for health care providers outlined in our previous letter remain unchanged. Although health care providers with available inventory may continue to implant the BVS, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients.
While Abbott Vascular has discontinued sales of BVS, the manufacturer will continue to monitor patients currently enrolled in the ABSORB III and ABSORB IV US clinical studies through five years following BVS implantation. Patients enrolled in these studies will be followed through standard practice and care after five years.
The recently available three-year follow-up data from the ABSORB III study continue to show an increased rate of major adverse cardiac events in BVS patients, when compared to patients implanted with the XIENCE stent. Specifically, there was a 13.4 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 three years, compared with 10.4 percent in patients treated with Abbott Vascular's approved metallic drug-eluting stent, the XIENCE stent (p = 0.056).
The risk of BVS-treated patients developing scaffold thrombosis was higher than for patients treated with the XIENCE stent. The ABSORB III study showed a 2.3 percent rate of thrombosis within the BVS scaffold versus 0.7 percent within the XIENCE stent at 3 years (p = 0.01). Most cases of BVS scaffold thrombosis occurred within the first year after BVS implantation, but beyond 1 year, the rate of new thrombosis events remained higher in BVS patients versus XIENCE patients. Long-term follow-up clinical results, including higher rates of major adverse cardiac events and BVS scaffold thrombosis, from the non-US ABSORB II, ABSORB Japan, and ABSORB China studies were generally consistent with the US-based ABSORB III study.
The FDA recommends health care providers:
- Follow the instructions for target heart vessel selection (e.g., avoiding BVS use in small heart vessels) and optimal device implantation that are included in the BVS physician labeling.
- Advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care. For more information about risks associated with the BVS, refer to the BVS physician labeling.
- Advise BVS patients to follow the recommendations for dual antiplatelet therapy (DAPT) prescribed by their health care providers.
- Report any adverse events related to the BVS that come to your attention. If you suspect a problem with the BVS, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
The FDA will keep the public informed if significant new information becomes available.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
- March 18, 2017: FDA Investigating Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) - Letter to Health Care Providers