Intracoronary Bivalirudin Bolus in ST-Elevation Myocardial Infarction Patients Treated with Primary Angioplasty: Theoretical Bases, Clinical Experience, and Future Applications

Intracoronary thrombus is a common finding in acute coronary syndromes and often correlates with adverse prognosis and complications during percutaneous coronary interventions (PCIs). Bivalirudin, a direct thrombin inhibitor, is one of the recommended antithrombotic treatments for PCI in ST-elevation myocardial infarction (STEMI). The intracoronary administration of a bivalirudin loading dose, even if off-label, offers theoretical advantages over the standard intravenous route, providing a very high drug concentration in the infarct-related artery without increasing the total dose of the drug administered. After the description in case reports of such an approach, a larger scale experience was recently reported in a large cohort of patients with STEMI treated during primary PCI with a bivalirudin intracoronary loading dose followed by the standard intravenous maintenance infusion. As a control group, a propensity score-matched cohort of patients undergoing primary PCI treated with intravenous bivalirudin in the same institution was selected. Compared with the intravenous bolus, the intracoronary administration of bivalirudin was associated with improved ST-segment resolution, lower post-procedural peak CK-MB levels, and better Thrombolysis in Myocardial Infarction (TIMI) frame count values, without difference in bleeding rates. Thus, this new promising antithrombotic strategy, based on the intracoronary administration of a bivalirudin loading dose during primary PCI, appeared safe, improved myocardial reperfusion, and mitigated enzymatic myocardial infarct size compared with the standard intravenous protocol. Randomized trials are warranted to confirm these results and evaluate the possible long-term clinical benefits

Intracoronary bivalirudin: a new way to appease the hostile thrombus?

Intracoronary thrombi are a common finding in the setting of acute coronary syndromes and correlate with intraprocedural complications, adverse prognosis and unpredictable response to standard pharmacological and interventional treatment. Interventional cardiologists have learned to fear the so-called hostile thrombus, with its aggressive and unstable behavior often leading to abrupt and refractory vessel closure. Here we report a case series of intracoronary bivalirudin administration to treat massive intracoronary thrombi, leading to rapid clot disappearance and coronary blood flow restoration. Interventional cardiologists might consider intracoronary bivalirudin administration as a bailout strategy during unusual critical situations. (C) 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins

Pre-hospital ticagrelor in patients with ST-segment elevationmyocardial infarction with long transport time to primary PCI facility

Background: Pre-hospital ticagrelor, given less than 1 h before coronary intervention (PCI), failed to improve coronary reperfusion in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. It is unknownwhether a longer interval fromticagrelor administration to primary PCImight reveal any improvement of coronary reperfusion. Methods: Weretrospectively compared 143 patients, pre-treated in spoke centers or ambulancewith ticagrelor at least 1.5 h before PCI (Pre-treatment Group), with 143 propensity score-matched controls treated with ticagrelor in the hub before primary PCI (Control Group) extracted fromRENOVAMI, a large observational Italian registry of more than 1400 STEMI patients enrolled from Jan. 2012 to Oct. 2015 (ClinicalTrials. gov id: NCT01347580). The median time from ticagrelor administration and PCI was 2.08 h (95% CI 1.66-2.84) in the Pre-treatment Group and 0.56 h (95% CI 0.33-0.76) in the Control Group. TIMI flow grade before primary PCI in the infarct related artery was the primary endpoint. Results: The primary endpoint, baseline TIMI flowgrade, was significantly higher in Pre-treatment Group (0.88 +/- 1.14 vs 0.53 +/- 0.86, P = 0.02). However in-hospital mortality, in-hospital stent thrombosis, bleeding rates and other clinical and angiographic outcomes were similar in the two groups. Conclusions: In a real world STEMI network, pre-treatment with ticagrelor in spoke hospitals or in ambulance loading at least 1.5 h before primary PCI is safe and might improve pre-PCI coronary reperfusion, in comparison with ticagrelor administration immediately before PCI. (C) 2016 Elsevier Inc. All rights reserved

Intracoronary vs intravenous bivalirudin bolus in ST-elevation myocardial infarction patients treated with primary angioplasty

Background: Intracoronary bolus administration may provide high local bivalirudin concentration without changing the global dose, potentially offering a more favorable antithrombotic effect in the infarct related artery (IRA). Objectives: The purpose of this study was to investigate the feasibility and safety of intracoronary bolus administration of bivalirudin followed by the standard intravenous infusion in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). Methods: In 245 consecutive patients treated with primary PCI, bivalirudin bolus was given directly in the IRA, followed by a standard intravenous infusion. Clinical reperfusion markers, postprocedural coronary flow indexes, and bleeding events of the intracoronary group were compared with a propensity score-matched cohort of primary PCI patients (n=245) treated with the standard bivalirudin protocol of intravenous bolus and infusion. Results: Higher rates of 70% ST-segment resolution (72.7% vs 60.0%, p=0.004), lower postprocedural peak CK-MB levels (188.3148.7 vs 242.1 +/- 208.1 IU/dl, p=0.025) and better Thrombolysis in Myocardial Infarction (TIMI) frame count values (14.7 vs 17.9, p=0.001) were observed in the IC bolus group compared with the standard intravenous bolus group. Rates of bleeding were similar between groups. Only three cases of acute stent thrombosis were observed, all in the intravenous bolus group (p=0.25). Conclusions: Intracoronary bivalirudin bolus administration during primary PCI is safe and improves ST-segment resolution, postprocedural coronary flow and enzymatic infarct size compared with the standard intravenous route

Drug therapy during percutaneous coronary interventions in stable and unstable coronary artery disease: the Italian Drug Evaluation in Angioplasty (IDEA) study

BACKGROUND: Although periprocedural drug therapy has been shown to improve the outcome of percutaneous coronary intervention (PCI), information regarding its use in daily clinical practice is limited. METHODS: We conducted a national survey on periprocedural drug therapy across the spectrum of PCI practice in Italy. Seventy-nine centers (41% of the Italian interventional cath labs) with a fair distribution across the country volunteered to enroll consecutive patients undergoing PCI for any indication from September 15 to 29, 2003. RESULTS: Of the 1517 patients enrolled, 745 (49 %) had stable coronary disease and 772 (51%) acute coronary syndromes (ACS): 457 without and 315 with ST-segment elevation. Stenting was used in 89% of cases. N-acetylcysteine was used in 23% of the patients with preexisting renal dysfunction. Thienopyridine (63% clopidogrel) pretreatment was given in 49 % of the cases and, at logistic regression analysis, was independently associated with prior myocardial infarction (p 90% of cases, 50% of the patients were discharged on symptomatic anti-ischemic therapy. CONCLUSIONS: A wide gap exists between guideline recommendations and periprocedural drug therapy in PCI, the only exception being full prescription of aspirin and a thienopyridine at discharge after stenting. In patients with ACS, thienopyridine pretreatment is often used as a surrogate for GP IIb/IIIa blockade, whose use rather is associated with emergency procedures. Off-label use of drugs is not uncommon