FDA Approval of Cangrelor Expands Antiplatelet Options for PCI


Giving interventional cardiologists more flexibility in the choice of antiplatelet therapy leading up to PCI, the FDA approved cangrelor on June 22, 2015.

Outlook: FDA Approval of Cangrelor Expands Antiplatelet Options for PCI

Cangrelor (Kengreal; The Medicines Company), an intravenous P2Y12 inhibitor, has rapid onset and offset of antiplatelet activity and is indicated for the reduction of periprocedural thrombotic events in patients who have not been preloaded with an oral P2Y12 inhibitor and will not receive a glycoprotein IIb/IIIa inhibitor.

“It’s a very welcome addition to the armamentarium,” Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview. “It is going to give us more options to be able to prevent periprocedural myocardial infarction and stent thrombosis without unnecessarily delaying patients who need bypass surgery.”

Cangrelor was initially rejected by the FDA after its Cardiovascular and Renal Drugs Advisory Committee voted against approval at a February 2014 meeting because of numerous concerns, including questions about the adequacy of antiplatelet therapy in the control arm of the CHAMPION PHOENIX trial, the clinical relevance of the events prevented by the drug, and the failure of prior trials.

At another advisory committee meeting earlier this year in April, The Medicines Company presented additional analyses that convinced committee members the benefits of cangrelor outweighed the risks. Though several panelists expressed concern over the narrow benefit-risk margin, the consensus was that cangrelor could fill a clinical need. 

Who Will Benefit?

“In my mind, the drug can definitely have a role in the ACS population, especially for hospitals that do not preload with oral P2Y12 agents,” Ajay J. Kirtane, MD, SM, also of Columbia University Medical Center, told TCTMD in an email. He added that “hospitals already preloading may in fact reassess their stance on preloading, though, now that this agent is available…, [and] this has substantial implications for the processes of care for patients with ACS.”

If the availability of cangrelor sways practice away from preloading, he elaborated, “it could either delay or prevent the use of oral agents, which could be problematic in patients who experience longer delays to cath and/or ultimately get treated with medical therapy only.”

Dr. Stone said that cangrelor might have a role both in stable CAD cases when preloading is not used and in ACS. Many patients with unstable angina and NSTEMI are not preloaded, he explained, because of a concern that angiography will show that a patient requires bypass surgery. In those cases, the patient would have to wait 5 to 7 days for the preloaded antiplatelets to wear off before undergoing the operation. And in the setting of STEMI, he said, oral agents “have delayed absorption and are not effective enough to work during the PCI procedure given the rapid door-to-balloon times.

“Intravenous cangrelor, which is essentially immediately acting and very potent,” Dr. Stone continued, “overcomes most of those limitations.”

He reported being unconcerned about the potential move away from preloading now that cangrelor is available. “There’s an appropriate expectation that it will delay oral antiplatelet therapy in appropriate situations,” he said, citing NSTE-ACS patients who have a high likelihood of needing surgery before going for angiography as an example. For STEMI, he said, “people will continue to oral preload because almost all of those patients undergo PCI, but in addition we’ll use intravenous cangrelor to ensure immediate potent P2Y12 inhibition during the procedure.”

Daniel I. Simon, MD, of University Hospitals Case Medical Center (Cleveland, OH), also pointed to STEMI as a setting in which cangrelor could be most beneficial, suggesting that cangrelor might be combined with bivalirudin (Angiomax; The Medicines Company) as a way to mitigate the early stent thrombosis risk seen with the latter drug.

He told TCTMD in a telephone interview that patients undergoing ad hoc PCI, in whom the need for surgery is unclear, represent another potential target for cangrelor. “It allows you to make clinical decisions that you won’t have to pull back from,” he said. “You have a reversible agent and it gives you flexibility, and whenever a doctor has flexibility for treating the patient in front of them, I think that’s a good thing.”

Dr. Simon added that every potential scenario for the use of cangrelor cannot be studied in a trial, saying that he will look to his colleagues and postapproval registries to work out where the drug will have the most impact.

Dr. Kirtane said: “I think that it is great to have a rapid onset/offset P2Y12 agent for use in the cath lab. In my mind though, uptake will largely depend upon the price of the agent, especially relative to the other alternatives that clinicians are currently familiar with (eg, preloading oral agents and bolus-only glycoprotein IIb/IIIa inhibitors).”


Source:

FDA approves new antiplatelet drug used during heart procedure [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452172.htm. Published June 22, 2015. Accessed June 25, 2015. 


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Disclosures
  • Dr. Kirtane reports receiving institutional research grants from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, Medtronic, St. Jude Medical, and Vascular Dynamics.
  • Dr. Simon reports serving on the advisory board for Medtronic Vascular.
  • Dr. Stone reports no relevant conflicts of interest.

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