Journal of Invasive Cardiology

ABSTRACT: Subacute thrombosis is an infrequent but potentially life-threatening complication of percutaneous coronary intervention (PCI) that has received much attention in association with drug-eluting stent (DES) deployment. We performed a retrospective case record review of 186 patients receiving PCI with DES placement at our facility. Patients received either bivalirudin (n = 115) or heparin (n = 71) as the foundation anticoagulant, with additional antiplatelet therapy as warranted. Two subacute thrombosis complications occurred and are described in detail. There were no deaths, major bleeding episodes or other significant complications. We report our findings and conclude that the addition of a glycoprotein IIb/IIIa inhibitor does not eliminate the risk of subacute thrombosis and that bivalirudin appears to provide effective anticoagulation for patients undergoing PCI with placement of a DES. J INVAS CARDIOL 2004;16:236–239

Key words: antithrombotic treatment, percutaneous coronary intervention

Subacute thrombosis is an infrequent but serious complication of intracoronary stent deployment during percutaneous coronary intervention (PCI).^1,2 The impact of subacute stent thrombosis can be dramatic, frequently leading to the total occlusion of the treated vessel and an acute myocardial infarction (MI) or sudden death. Bivalirudin (Angiomax®, The Medicines Company, Parsippany, New Jersey), a direct thrombin inhibitor, has demonstrated reductions in both ischemic and bleeding complications compared to anticoagulation with heparin in PCI. In a recent contemporary, double-blind, randomized PCI trial, bivalirudin plus provisional glycoprotein (GP) IIb/IIIa inhibition was shown to be as effective as heparin plus GP IIb/IIIa inhibition, with a lower incidence of major bleeding.3 However, there are no data on the use of bivalirudin with drug-eluting stents (DES).

DESs have been recently approved in the United States for the treatment of de novo coronary stenosis, as they have been found to decrease in-stent restenosis by inhibiting the development of intimal hyperplasia.⁴ The effect of DESs on the incidence of subacute thrombosis is unknown. Though a significant increase in subacute thrombosis has not been reported in clinical trials, there have been isolated reports of its occurrence. The manufacturer of the Cypher™ DES (Cordis Corp., Miami Lakes, Florida) recently issued a letter strongly advising against the use of stents smaller than the vessel diameter and against poor or inadequate stent apposition to vessel walls, and recommending antiplatelet therapy before and for 3 months after stenting.

Our laboratory has had extensive experience with the use of bivalirudin both as monotherapy and in combination with GP IIb/IIIa inhibitors prior to the approval of the Cypher DES, and we have maintained our interest in bivalirudin as the foundation anticoagulant during PCI procedures with DES deployment. This retrospective study reviews our experience with bivalirudin as antithrombotic therapy during DES implantation since the approval of the Cypher DES earlier this year.