Heparin-Induced thrombocytopenia (HIT) & Percutaneous coronary intervention (PCI)

Percutaneous coronary interventions (PCIs) are an important group of technologies for the diagnosis and treatment of patients with cardiovascular disease. In addition to balloon angioplasty, PCI now includes other new techniques capable of relieving coronary narrowing, including[37]:

•	Intracoronary stents are placed in the majority of PCI patients
•	Various forms of atherectomy are occasionally performed (eg, rotational, directional, extraction, laser)

More than 500,000 interventional procedures are performed annually in the United States, and it has been estimated that more than 1 million procedures are performed worldwide.[37]

Intensive anticoagulation is a critical requirement during PCI to reduce the risk of thrombosis. Heparin is used in virtually all interventional coronary procedures as it has been shown to prevent clot formation at the site of arterial injury and on the hardware used in PCI. [37]

Unfortunately, the use of heparin has the potential to increase the occurrence of HIT. The hypercoagulable state characterizing HIT plus the endovascular disruption resulting from PCI may place patients with HIT at particular risk of thrombosis during PCI.[4] Heparin is contraindicated in HIT patients and the use of LMWH and danaparoid are also contraindicated because both cross-react with HIT antibodies.

Indications
Argatroban is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.

Argatroban is indicated as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI).

Important Safety Information

As with all anticoagulants, bleeding is a serious concern. Argatroban is contraindicated in patients with overt major bleeding or those with hypersensitivity to the product or any of its components. Argatroban should be used with extreme caution in disease states or other circumstances in which there is an increased risk of hemorrhage. Overall major bleeding was reported in 5.3% of patients with HIT treated with Argatroban versus 6.7% of the historical controls. Overall major bleeding was reported in 1.8% of patients undergoing PCI treated with Argatroban versus 3.1% of the historical controls. Intracranial bleeding was not observed in the 568 patients treated with Argatroban for HIT (with or without thrombosis) or in the 91 patients who underwent PCI. The most common nonhemorrhagic side effects in HIT patients, regardless of the relationship to treatment, were dyspnea, hypotension, and fever. In patients undergoing PCI, the nonhemorrhagic side effects, regardless of the relationship to treatment, included chest pain, hypotension, and back pain. Please see full Prescribing Information for additional safety information on Argatroban.