hirudin and Coronary-Occlusion

Recent randomized control trials (RCTs) showed conflicting efficacy and safety between bivalirudin and heparin during percutaneous coronary intervention (PCI). We aimed to perform an updated meta-analysis, including real-world and trial data to examine the factors affecting their risk-benefit ratio.. We searched Medline, the Cochrane library, and meeting abstracts for studies comparing bivalirudin versus heparin during PCI. Random-effect meta-analyses for MACE (major adverse cardiovascular events), stent thrombosis (ST) and major bleeding were performed. p-Value <0.05 was considered statistically significant.. Meta-analysis of 20 RCTs and 31 observation studies (n=165,835) showed that bivalirudin and heparin were similar in the risk of MACE in RCTs (OR 1.05, 95% CI 0.97-1.13) and observational studies (OR 0.94, 95% 0.81-1.10). Major bleeding was lower with bivalirudin in both RCTs (OR 0.60, 95% CI 0.51-0.70) and observational studies (OR 0.56, 95% CI 0.47-0.68). However, in the metaregression analysis, every 10% increase of transradial access decreased the bleeding benefit of bivalirudin by 4.9% (p=0.046, adjusted for GPI and heparin loading dose). ST with bivalirudin was higher with ST-segment elevation myocardial infarction (STEMI) in RCTs (OR 1.51, 95% CI 1.15-1.99) but not in observational studies (p=0.65).. In this large meta-analysis, bivalirudin is associated with a lower risk of bleeding compared to heparin in both RCTs and observational studies, however, transradial PCI mitigated most of this bleeding benefit. Heparin should be the preferred agent in transradial PCI given its lower cost and comparable outcomes.

Topics: Anticoagulants; Comparative Effectiveness Research; Coronary Occlusion; Hemorrhage; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Risk Assessment

To assess the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in high-bleeding-risk elderly patients.. Bivalirudin reduces PCI-related bleeding; however, its efficacy and safety in patients with CTO, especially elderly patients with a high bleeding risk, remain unclear.. This single-center prospective randomized controlled trial assigned 123 high-bleeding-risk elderly patients with CTO to either the unfractionated heparin (UFH) group (n = 55) or the bivalirudin group (n = 68). The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up. The safety endpoint was bleeding or procedure (access)-related complications after PCI.. MACE incidence was 17.6% and 20.0% in the bivalirudin and UFH groups, respectively (P = 0.82). Bleeding Academic Research Consortium (BARC) type 1-2 bleeding events during hospitalization were comparable between the groups (UFH: 10.9% vs. bivalirudin: 8.8%, P = 0.77). No BARC type 3-5 bleeding events or severe procedure (access)-related complications (subcutaneous hematoma >5 cm) occurred in either group. At the 6-month follow-up, MACE incidence was comparable between the groups (UFH: 3.6% vs. bivalirudin: 1.5%, P = 0.59). The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43). One case of BARC type 3-5 bleeding (fatal intracranial hemorrhage) was observed in the UFH group at the 6-month follow-up.. Bivalirudin and UFH showed comparable efficacy and safety in elderly patients with a high bleeding risk, undergoing PCI for CTO lesions.

Topics: Age Factors; Aged; Anticoagulants; Antithrombins; China; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Female; Hemorrhage; Heparin; Hirudins; Humans; Male; Middle Aged; Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Progression-Free Survival; Prospective Studies; Recombinant Proteins; Risk Assessment; Risk Factors; Time Factors

Bivalirudin has been reported to be an alternative to unfractionated heparin (UFH) for anticoagulation during percutaneous coronary intervention (PCI) and associated with less bleeding risk. However, the feasibility of bivalirudin during PCI of chronic total occlusion lesions (CTO) remains unknown.. To evaluate the efficacy and safety of bivalirudin versus UFH in CTO PCI.. In this prospective and randomized controlled trial in single center, CTO patients with high bleeding risk were randomized to treatment with bivalirudin (bolus 0.75 mg/kg followed by infusion of 1.75, extra bolus 0.3 mg/kg before stenting) or UFH (100 IU/kg). The primary efficacy end point was the incidence of major adverse cardiac events (MACEs, composite of all-cause mortality, cardiac death, stent thrombosis, periprocedural myocardial infarction, or additional unplanned target lesion revascularization, or any other post-PCI ischemic event) in-hospital, and at 1-year follow-up. The primary safety end point was the occurrence of any bleeding or entry-site complications after PCI.. A total of 84 high bleeding risk patients undergoing PCI for CTO lesions were enrolled. The baseline characteristics were similar in both treatment arms. In hospital MACEs rates were 21.4% in the bivalirudin group and 14.3% in the UFH group (P = 0.393). During 1-year's follow-up, end points did not significantly differ between the groups either. Occurrence of the major bleeding events were 4.8% in the bivalirudin group and 9.5% in the UFH group (P = 0.676). No entry-site complication was observed.. In CTO patients at high risk for bleeding undergoing PCI, our data indicates that bivalirudin appears to be at least comparable in efficacy and safety to UFH. A larger clinical trial should be designed to further elucidate its efficacy and safety.

Topics: Aged; Anticoagulants; Antithrombins; China; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Feasibility Studies; Female; Hemorrhage; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Pilot Projects; Prospective Studies; Recombinant Proteins; Risk Factors; Time Factors; Treatment Outcome

The safety and efficacy of bivalirudin during percutaneous coronary intervention (PCI) in high bleeding risk patients with chronic total occlusion lesions (CTO) has not been studied till date. The use of bivalirudin may increase the thrombotic events during CTO-PCI.Between May 2013 and April 2014, a total of 117 high bleeding risk patients with CTOs underwent PCI. Bivalirudin was used in 89 cases with different strategies, including standard usage, combination of heparin, and additional bolus of bivalirudin on the basis of standard usage. The clinical characteristics, procedural details and antithrombotic strategies were assessed, and the bleeding and ischemic events were evaluated. The first 7 of 9 patients with standard application of bivalirudin exhibited acute thrombogenesis in the procedure. Heparin was then added in decreasing amounts in the next 8 patients wherein no thrombosis occurred; however, 2 patients had bleeding complications. The subsequent 72 patients were randomly assigned to the heparin bolus or additional bivalirudin bolus groups before the percutaneous transluminal coronary angioplasty (PTCA) was performed. The baseline clinical characteristics and procedure information were identical in both the groups. There were no ischemic and bleeding events in both the groups during the 6-month follow-up.Monotherapy with bivalirudin in CTO-PCI should be treated with caution, as the potential risk of thrombogenesis may be due to the long procedure time, the frequent change of equipment and temporary blood flow convection. Combination of heparin or an additional bolus of bivalirudin before PTCA was observed to be likely to decrease the incidence of thrombogenesis.

Topics: Aged; Antithrombins; Blood Loss, Surgical; Coronary Occlusion; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Postoperative Hemorrhage; Recombinant Proteins

Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies.. INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding.. INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.

Topics: Abciximab; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal; Antithrombins; Coronary Occlusion; Coronary Thrombosis; Endpoint Determination; Hirudins; Humans; Immunoglobulin Fab Fragments; Infusions, Intra-Arterial; Magnetic Resonance Imaging, Cine; Myocardial Infarction; Patient Selection; Peptide Fragments; Platelet Aggregation Inhibitors; Recombinant Proteins; Research Design; Thrombectomy

Topics: Coronary Occlusion; Hirudins; Humans; Recombinant Proteins; Stents; Treatment Outcome; Ventricular Function, Left