A Randomized Trial to Evaluate the Relative Protection Against Post-Percutaneous Coronary Intervention Microvascular Dysfunction, Ischemia, and Inflammation Among Antiplatelet and Antithrombotic Agents

• Published in: Journal of the American College of Cardiology 2006-06, Vol.47 (12), p.2364-2373
• Main Authors: Gibson, C. Michael, Morrow, David A., Murphy, Sabina A., Palabrica, Theresa M., Jennings, Lisa K., Stone, Peter H., Lui, Henry H., Bulle, Thomas, Lakkis, Nasser, Kovach, Richard, Cohen, David J., Fish, Polly, McCabe, Carolyn H., Braunwald, Eugene
• Format: Article
• Language: English
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2005.12.077

A Randomized Trial to Evaluate the Relative Protection Against Post-Percutaneous Coronary Intervention Microvascular Dysfunction, Ischemia, and Inflammation Among Antiplatelet and Antithrombotic Agents: The PROTECT–TIMI-30 Trial C. Michael Gibson, David A. Morrow, Sabina A. Murphy, Theresa M. Palabrica, Lisa K. Jennings, Peter H. Stone, Henry H. Lui, Thomas Bulle, Nasser Lakkis, Richard Kovach, David J. Cohen, Polly Fish, Carolyn H. McCabe, Eugene Braunwald, for the TIMI Study Group The Randomized Trial to Evaluate the Relative Protection Against Post-Percutaneous Coronary Intervention Microvascular Dysfunction and Post-Percutaneous Coronary Intervention Ischemia Among Anti-Platelet and Anti-Thrombotic Agents (PROTECT–TIMI-30) was a randomized trial of eptifibatide in addition to an antithrombin compared with bivalirudin monotherapy among 857 patients with non–ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention (PCI). The results of the trial showed that among moderate- to high-risk patients with acute coronary syndrome undergoing PCI, coronary flow reserve was greater with bivalirudin than eptifibatide. Eptifibatide improved myocardial perfusion and reduced the duration of post-PCI ischemia but was associated with greater rates of minor bleeding and transfusion rates. The goal of this study was to evaluate glycoprotein IIb/IIIa inhibition with eptifibatide when administered with indirect thrombin inhibition as compared with monotherapy with direct thrombin inhibition with bivalirudin among patients with non–ST-segment elevation acute coronary syndromes (ACS). The optimal combination of antiplatelet and antithrombin regimens that maximizes efficacy and minimizes bleeding among patients with non–ST-segment elevation ACS undergoing percutaneous coronary intervention (PCI) is unclear. A total of 857 patients with non–ST-segment elevation ACS were assigned randomly to eptifibatide + reduced dose unfractionated heparin (n = 298), eptifibatide + reduced-dose enoxaparin (n = 275), or bivalirudin monotherapy (n = 284). Among angiographically evaluable patients (n = 754), the primary end point of post-PCI coronary flow reserve was significantly greater with bivalirudin (1.43 vs. 1.33 for pooled eptifibatide arms, p = 0.036). Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade more often was normal with eptifibatide treatment compared with bivalirudin (57.9% vs. 50.9%, p = 0.048). The duration of ischemia o