Bivalirudin Versus Heparin Monotherapy in Elderly Patients With Myocardial Infarction

Abstract

Background: Elderly patients with acute myocardial infarction undergoing percutaneous coronary intervention are at increased risk of both ischemic and bleeding complications. The optimal anticoagulation strategy in these patients is uncertain. Therefore, we compared bivalirudin to heparin monotherapy in a contemporary cohort of such patients. Methods: A prespecified subgroup analysis of elderly patients with myocardial infarction (≥75 years) from the VALIDATE-SWEDEHEART trial (Bivalirudin Versus Heparin in ST-Segment and Non–ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial) was performed. In the trial, patients were randomized to either bivalirudin or heparin monotherapy during percutaneous coronary intervention, with mandatory potent P2Y12 inhibition, routine radial artery access, and only bail-out glycoprotein IIb/IIIa inhibition. Kaplan-Meier event rates were assessed for the primary end point, consisting of a composite of all-cause death, myocardial reinfarction, or major bleeding, within 180 days. Results: The elderly (n=1592) had more than twice the risk of all events compared with younger patients (n=4406). Baseline and periprocedural characteristics were equal between bivalirudin (n=799) and heparin (n=793) treated patients ≥75 years. No differences were found in the elderly between bivalirudin and heparin monotherapy regarding the primary end point (180-day all-cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke. Conclusions: In this prespecified subgroup analysis of the VALIDATE-SWEDEHEART trial, elderly patients with myocardial infarction had a highly increased risk of all events. However, no difference in outcomes could be observed with an anticoagulation strategy with either bivalirudin or heparin as monotherapy in this patient group.

Epidemiology, Pathophysiology, and Management of Coronary Artery Disease in the Elderly

“…There was also no substantial benefit from enoxaparin over fondaparinux in decreasing ischemic events. 68 69 However, as with many other trials, no specific outcome in patients ≥ 80 years of age were reported. Moreover, fondaparinux increases catheter thrombosis, primarily excreted by the renal system and contraindicated in advanced renal disease or those undergoing primary percutaneous coronary intervention (PCI).…”

“…There was also no substantial benefit from enoxaparin over fondaparinux in decreasing ischemic events. 68,69 However, as with many other trials, no specific outcome in patients ! 80 years of age were reported.…”

“…75 years with either heparin or bivalirudin monotherapy. 68 The reduced risk of bleeding from factor Xa inhibitors, fondaparinux, made it an attractive selection following the OASIS-5 (Fifth Organization to Assess Strategies in Acute Ischemic Syndromes) trial. There was also no substantial benefit from enoxaparin over fondaparinux in decreasing ischemic events.…”

“…Direct thrombin inhibitors such as bivalirudin were thought to have a safer bleeding profile, but subgroup analysis of the VALIDATE-SWEDEHEART (Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy) trial showed no difference in outcomes for patients ≥ 75 years with either heparin or bivalirudin monotherapy. 68…”

Safety of Bivalirudin Combined with Ticagrelor in the Emergency PCI in Patients with Acute ST-Segment Elevation Myocardial Infarction

“…12 As an indirect inhibitor of thrombin, unfractionated heparin is first synthesized into glycoprotein through the metabolism in the liver, 13 and further combines with antithrombin to form a heparin-antithrombin complex, and then combines with the thrombin catalytic site to exert an action. [14][15][16] During the medication of heparin, if thrombocytopenia occurs in the patient, it will greatly increase the risk of hemorrhage and death. 17 As a synthetic thrombin direct inhibitor, bivalirudin does not require the metabolism in the liver, and can directly bind with thrombin to exert an action.…”