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FDA approves cangrelor for reduction of thrombotic events in patients with CAD needing PCI
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The FDA announced that it has approved cangrelor, an intravenous P2Y12 receptor antagonist, for the reduction of thrombotic events in adult patients with CAD undergoing PCI.
According to a release from the agency, cangrelor (Kengreal, The Medicines Company) reduces the risk for serious complications related to PCI such as MI and stent thrombosis.
“For patients undergoing [PCI], blood clotting can cause serious problems,” Norman Stockbridge, MD, PhD, director of the FDA’s division of cardiovascular and renal drugs, said in the release. “The approval of Kengreal provides another treatment option for patients.”
In April, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2 with one abstention that cangrelor should be approved. It based its decision on a new analysis of the CHAMPION PHOENIX trial, which indicated that cangrelor was associated with beneficial outcomes, including reduced risk for MI, repeat revascularization and stent thrombosis, compared with clopidogrel even when components from the primary endpoint deemed not clinically meaningful were removed (OR = 0.69; 95% CI, 0.51-0.92).
In February 2014, the committee voted against approval for cangrelor, partly due to concern about the meaningfulness of the primary endpoint in CHAMPION PHOENIX, but also because of insufficient data for another proposed indication: maintenance of P2Y12 inhibition in patients with ACS or stents who are at increased risk for thrombotic events when oral P2Y12 inhibition is interrupted due to surgery. The Medicines Company did not seek approval for the surgery indication at the April 2015 advisory committee meeting.
Perspective
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Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
The approval of cangrelor is a significant step and adds to the armamentarium of antiplatelet agents available for patients undergoing stenting. Given that it is an IV agent, the advantage is that the antiplatelet activity is very predictable and the clinical trials data support benefit in reducing the risk for clot-related complications. It therefore would be a valuable addition when patients are undergoing stenting but haven’t been ‘loaded’ with an oral antiplatelet agent for any reason. The benefits of the drug should be weighed against a small increase in the risk for bleeding, suggesting that a one-size-fits-all approach is not true for this drug.
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