hirudin and ST-Elevation-Myocardial-Infarction

The use of bivalirudin-based anticoagulation over heparin-based anticoagulation for coronary percutaneous intervention has been debated for a long time. Multiple trials have shown promising benefits of bivalirudin over heparin therapy with the most recent addition being the BRIGHT-4 trial. We performed a meta-analysis to assess evidence from these trials, focusing on the coronary intervention of the STEMI population.. This meta-analysis was performed based on PRISMA guidelines after registering in PROSPERO (CRD42023394701). Databases were searched for relevant articles published before January 2023. Pertinent data from the included studies were extracted and analyzed using RevMan v5.4.. Out of 2375 studies evaluated, 13 randomized control trials with 24 360 acute ST-elevation myocardial infarction patients were included for analysis. The bivalirudin-based anticoagulation reduced the net clinical events (OR 0.75, CI 0.61-0.92), major adverse cardiac or cerebral events (OR 0.85, CI 0.74-0.98), any bleeding (OR 0.61, CI 0.45-0.83), major bleeding (OR 0.54, CI 0.39-0.75), all-cause mortality (OR 0.79, CI 0.67-0.92) and cardiac mortality (OR 0.78, CI 0.65-0.93) significantly without increasing the risk of any stent thrombosis (OR 0.92, 95% CI 0.52-1.61), definite stent thrombosis (OR 1.17, 95% CI 0.62-2.22) and acute stent thrombosis (OR 2.06, 95% CI 0.69-6.09) significantly at 30 days.. Based on this meta-analysis, bivalirudin plus a post-PCI high-dose infusion-based anticoagulation during STEMI PCI has significant benefits over heparin therapy for cardiovascular outcomes without a significant increase in the risk of thrombotic outcomes.

Topics: Anticoagulants; Antithrombins; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Recombinant Proteins; ST Elevation Myocardial Infarction; Thrombosis

Bivalirudin and heparin are the principal anticoagulants used during primary percutaneous coronary intervention (PCI) for patients experiencing ST-elevation myocardial infarctions. Based on previous meta-analyses, bivalirudin improves 30-day mortality rates compared with heparin, especially when vascular access is predominantly femoral. However, no meta-analysis has yet reported whether this mortality benefit with bivalirudin persists beyond 30 days. Scientific databases and websites were searched to find randomized controlled trials, and risk ratios (RRs) were calculated using random effect models. Data from 4 trials were analyzed. Compared with heparin ± glycoprotein IIb/IIIa inhibitors, bivalirudin decreased all-cause mortality [RR, 0.81; 95% confidence interval (CI), 0.69-0.94; P = 0.008], cardiac mortality (RR, 0.72; 95% CI, 0.60-0.88; P = 0.001), and net adverse clinical events (RR, 0.83; 95% CI, 0.72-0.97; P = 0.016) at 1 year. In conclusion, a bivalirudin-based anticoagulation strategy during primary percutaneous coronary intervention significantly decreases the 1-year risks for all-cause mortality, cardiac mortality, and net adverse clinical events compared with heparin ± glycoprotein IIb/IIIa inhibitor.

Topics: Antithrombins; Evidence-Based Medicine; Female; Hemorrhage; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Recombinant Proteins; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Electrocardiogram sub-studies from the Hirulog Early Reperfusion/Occlusion 1 and 2 trials, which tested bivalirudin as an adjunctive anticoagulant to fibrinolysis in ST-elevation myocardial infarction, have contributed to the literature. The concept of using the presence of infarct lead Q waves to determine reperfusion benefit has subsequently been explored in multiple primary percutaneous coronary intervention studies. The angiographic findings before percutaneous coronary intervention combine with the baseline electrocardiogram to accurately diagnose ST-elevation myocardial infarction and evaluate its potential territory. This review discusses the relative merits of the presence of infarct lead Q waves versus time duration from symptom onset using observational data from cohorts of patients from multiple clinical trials. The presence of infarct lead Q waves at presentation has been repeatedly shown to be superior to time duration from symptom onset in determining prognosis, despite that continuous variable (time duration) statistically should be more powerful than dichotomous variable (Q wave). If quantitative or semi-quantitative measurement of Q waves correlates well with irreversible myocardial injury in vivo (a research goal of many cardiac magnetic resonance imaging studies), Q waves measurements by mirroring ST-elevation myocardial infarction evolution better than the current metric of time duration of symptoms will impact future ST-elevation myocardial infarction reperfusion management. Newer methodology will more quickly capture and transmit electrocardiogram information including infarct lead Q waves potentially before first medical contact, and help differentiate new evolving Q waves of the ongoing ST-elevation myocardial infarction from old changes. Q waves as the new metric in ST-elevation myocardial infarction reperfusion should be tested in upcoming trials.

Topics: Antithrombins; Electrocardiography; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Prognosis; Recombinant Proteins; Salvage Therapy; ST Elevation Myocardial Infarction; Thrombolytic Therapy; Time Factors; Treatment Outcome

In the review, we briefly describe antithrombotic drugs and the use evidence from evidence-based medicine to elucidate the optimal antithrombotic management for patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary stenting (PCI) at high risk of bleeding.. Mandatory use of intravenous anticoagulants and dual antiplatelet agents is the cornerstone strategy in acute and long-term antithrombotic management to optimize the clinical benefit of patients with STEMI undergoing PCI. Nevertheless, with the increasing occurrence of STEMI in old population with high risk of bleeding and renal insufficiency, as well as the specificity of high bleeding risk groups, the optimization of antithrombotic therapy still remains uncertain. Bivalirudin is the optimized intravenous anticoagulant agent for these patients based on the guideline recommendations and clinic data. Timely and potent ticagrelor and prasugrel with aspirin usage can increase the clinical benefit for the patients without increasing the clinical bleeding risk. At present, the multi-center, prospective clinical studies of EVOLVE short DAPT, MASTER DAPT, and POEM trials, targeting patients with high risk of bleeding, are in experimental stage. These clinical trials will provide more objective and optimal antithrombotic management strategy for the patients.

Topics: Anticoagulants; Fibrinolytic Agents; Hemorrhage; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Recombinant Proteins; ST Elevation Myocardial Infarction; Stents; Ticagrelor

This paper mainly focuses on the evidence above and gives brief discussion to the recent literature on anticoagulation in fibrinolytic therapy and advances in antiplatelet therapy.. To date, no robust evidence is available challenging unfractionated heparin as the primary choice for anticoagulation in patients presenting with ST-segment elevation myocardial infarction. Further research should include efforts to refine anticoagulation strategies on an individual patient level. For patients undergoing primary percutaneous coronary intervention, bivalirudin could be used as an alternative to unfractionated heparin, while enoxaparin or fondaparinux is an alternative agent for patients treated with fibrinolytic therapy.

Topics: Anticoagulants; Hemorrhage; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Thrombolytic Therapy; Thrombosis; Treatment Outcome

The first three hours after symptom onset hold the maximum potential for myocardial reperfusion and salvage in ST-elevation myocardial infarction (STEMI) patients. During this period timely primary percutaneous coronary intervention (PPCI) or, when PPCI is not promptly feasible, pre-hospital administration of fibrinolyis or a glycoprotein IIb/IIIa-inhibitor (GPI) have been shown to restore coronary patency and reperfusion and even result in myocardial infarction (MI) abortion. On the other hand, oral antiplatelet therapy may not yet guarantee sufficient platelet inhibition. Patients presenting after this golden time have less, if any, benefit from an aggressive antithrombotic treatment prior to PPCI. Antithrombotic treatment during primary angioplasty should be tailored on the basis of the coronary thrombotic burden, vascular approach and the patient's risk of bleeding complications. A GPI-based approach may be favourable in patients presenting early with large MI and high thrombus burden, whereas a bivalirudin-based approach without GPI may be preferred in patients with higher bleeding risk. There are no data to support the use of GPI in bailout conditions. The powerful oral P2Y

Topics: Angioplasty; Antithrombins; Emergency Medical Services; Hemorrhage; Hirudins; Humans; Meta-Analysis as Topic; Peptide Fragments; Recombinant Proteins; ST Elevation Myocardial Infarction

To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality.. In primary PCI, lower risk of bleeding with bivalirudin (vs. unfractionated heparin [UFH]) is counterbalanced by an increased risk of acute stent thrombosis (ST). Several randomized clinical trials (RCTs) and a recent meta-analysis suggest that acute ST risk may be eliminated without compromising the bleeding benefit, but only if the full dose, not a low dose, of bivalirudin is continued post-PCI. However, it is not known whether this improved risk leads to lower rates of NACEs and mortality.. Scientific databases and Web sites were searched for RCTs. Trials were included if study patients were undergoing primary PCI for acute ST-segment elevation myocardial infarction and were randomly assigned to bivalirudin or UFH treatment. The bivalirudin arm was divided based on post-PCI bivalirudin dosage: The Biv-Full group received 1.75 mg/kg/h, the Biv-Low group, 0.25 mg/kg/h, and the Biv-No group, none.. Six RCTs involving 16,842 patients were found. In pairwise meta-analysis, bivalirudin improved 30-day all-cause mortality by 35% and cardiac mortality by 32%, but did not yield a NACE rate better than that achieved with UFH. Subgroup analysis showed the Biv-Full group had a 46% lower NACE rate and 47% lower all-cause mortality than UFH. These effects were not seen in the other two groups. Network meta-analysis yielded similar results. At treatment ranking, the Biv-Full group yielded the best treatment efficacy.. In primary PCI, full-dose bivalirudin infusion for 3-4 hr after PCI appeared to improve NACE rates compared to UFH. It also seemed to be the most effective strategy for improving cardiac mortality and all-cause mortality. © 2016 Wiley Periodicals, Inc.

Topics: Anticoagulants; Antithrombins; Coronary Thrombosis; Hemorrhage; Heparin; Hirudins; Humans; Infusions, Intravenous; Odds Ratio; Peptide Fragments; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Recombinant Proteins; Risk Factors; ST Elevation Myocardial Infarction; Stents; Time Factors; Treatment Outcome

To evaluate the impact of bivalirudin versus heparin on efficacy and safety outcomes of ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) and to explore the impact of differential use (bailout vs. routine) of glycoprotein IIb/IIIa inhibitors (GPI).. Five randomized controlled trials encompassing 10,350 patients were included. Primary efficacy and safety endpoints were all-cause death and major bleeding, respectively. All-cause death at 30 days did not significantly differ with bivalirudin compared to heparin (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.74-1.28; P=0.84). Major bleeding was significantly reduced by bivalirudin compared to heparin (OR 0.58, 95% CI 0.40-0.85; P=0.005). Bivalirudin use was associated with non-significantly different rates of 30-day definite stent thrombosis (ST) (OR 1.71, 95% CI 0.84-3.49; P=0.14), albeit with higher rates of acute ST (OR 3.55, 95% CI 1.67-7.56; P=0.001) and non-significantly different rates of subacute ST (OR 0.86, 95% CI 0.46-1.61; P=0.64). There were non-significant differences in the 30-day rates of reinfarction (OR 1.47, 95% CI 0.94-2.30; P=0.10) and cardiovascular death (OR 0.76, 95% CI 0.56-1.02; P=0.07). There were no significant interactions between bailout versus routine GPI use in the heparin arm for any of the safety or efficacy outcomes (all Pinteraction>0.10).. Bivalirudin compared with heparin was associated with comparable 30-day rates of mortality with reduced major bleeding, at the price of an increased risk of acute ST, with non-significant differences in the overall 30-day rates of ST and reinfarction. Intended use of GPI in the heparin arm did not significantly modify the treatment effects of bivalirudin. Given the important differences between trials, as well as evolution in technique and adjunct pharmacotherapy, further randomized trials are warranted to discriminate whether there are substantial safety and efficacy differences between these agents during primary PCI in STEMI.

Topics: Aged; Female; Hemorrhage; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Recombinant Proteins; ST Elevation Myocardial Infarction

The study sought to compare the clinical efficacy and safety of P2Y12 inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention (PPCI).. Limited data exist regarding the comparative efficacy and safety of P2Y12 inhibitors in STEMI patients undergoing PPCI.. Clinical trials enrolling STEMI patients were identified and relevant data was extracted. Major adverse cardiovascular events (MACE) were defined as the composite of all cause mortality, MI, and target vessel revascularization. Network meta-analysis was performed using Bayesian methods.. A total of 37 studies with 88,402 STEMI patients and 5,077 MACE were analyzed. Outcomes at 1 month (22 studies and 60,783 patients) suggest that prasugrel was associated with: lower MACE than clopidogrel (standard dose odds ratio [OR]: 0.59, 95% confidence interval [CI]: 0.50 to 0.69; high-dose OR: 0.60, 95% CI: 0.51 to 0.71; upstream OR: 0.79, 95% CI: 0.66 to 0.94), and ticagrelor (standard dose OR: 0.69, 95% CI: 0.56 to 0.84; upstream OR: 0.72, 95% CI: 0.50 to 1.05); lower mortality and MI than clopidogrel and standard ticagrelor; lower stroke risk than standard clopidogrel and standard or upstream ticagrelor; and lower stent thrombosis than standard or upstream clopidogrel. At 1-year (10 studies, n = 40,333) prasugrel was associated with lower mortality and MACE than other P2Y12 inhibitors. MACE was particularly lower with prasugrel in studies where patients received bivalirudin, drug-eluting stents, and but not glycoprotein IIb/IIIa inhibitor.. In STEMI patients undergoing PPCI, prasugrel and ticagrelor are more efficacious than clopidogrel; in addition, prasugrel was superior to ticagrelor particularly in conjunction with bivalirudin and drug-eluting stents.

Topics: Adenosine; Antithrombins; Bayes Theorem; Blood Platelets; Clinical Trials as Topic; Clopidogrel; Coronary Thrombosis; Drug-Eluting Stents; Evidence-Based Medicine; Hirudins; Humans; Markov Chains; Monte Carlo Method; Network Meta-Analysis; Odds Ratio; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Receptors, Purinergic P2Y12; Recombinant Proteins; Risk Factors; ST Elevation Myocardial Infarction; Ticagrelor; Ticlopidine; Treatment Outcome

The aim of this study was to evaluate the efficacy of various doses of post-primary percutaneous coronary intervention (PCI) bivalirudin infusion to prevent acute stent thrombosis (AST).. In several recent randomized controlled trials, bivalirudin infusion was continued post-PCI as either a full PCI dose (Biv-Full) or a reduced dose (Biv-Low) to reduce the risk for AST. The results of these trials varied, so the authors performed a meta-analysis of RCTs to determine whether the risk for AST is dose dependent.. Scientific databases and Web sites were searched for RCTs. A traditional meta-analysis was performed using moderator analyses and network meta-analysis using mixed-treatment comparison models to compare the efficacy of various bivalirudin doses in reducing AST.. Data from 5 trials including 16,294 patients were analyzed. Compared with heparin, bivalirudin increased AST risk 2-fold, but this was ameliorated by continuing Biv-Full (risk ratio: 0.90, 95% confidence interval: 0.32 to 2.54; p = 0.852). This effect was not seen with Biv-Low. Similarly, in mixed-treatment models, no difference in AST rate was found between heparin and Biv-Full (odds ratio: 0.97; 95% confidence interval: 0.36 to 2.21). After 30 days, bivalirudin decreased the risk for major bleeding by 47% compared with heparin; this benefit persisted even with continued Biv-Full post-PCI (risk ratio: 0.29; 95% confidence interval: 0.16 to 0.53; p < 0.001).. Although bivalirudin is associated with a greater risk for AST than heparin post-primary PCI, this limitation may be mitigated by continuing Biv-Full (not Biv-Low) 3 to 4 h post-operatively. The decrease in bleeding risk with bivalirudin compared with heparin is not compromised by this strategy.

Topics: Acute Disease; Anticoagulants; Antithrombins; Coronary Thrombosis; Dose-Response Relationship, Drug; Evidence-Based Medicine; Hemorrhage; Heparin; Hirudins; Humans; Odds Ratio; Peptide Fragments; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Recombinant Proteins; Risk Factors; ST Elevation Myocardial Infarction; Stents; Time Factors; Treatment Outcome

The optimal antithrombotic therapy in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) remains a matter of debate. This updated meta-analysis investigated the impact of (1) bivalirudin (with and without prolonged infusion) and (2) prolonged PCI-dose (1.75 mg/hg per hour) bivalirudin infusion compared with conventional antithrombotic therapy on clinical outcomes in patients undergoing primary PCI.. Eligible randomized trials were searched through MEDLINE, EMBASE, Cochrane database, and proceedings of major congresses. Prespecified outcomes were major bleeding (thrombolysis in myocardial infarction major and Bleeding Academic Research Consortium 3-5), acute stent thrombosis, as well as all-cause and cardiac mortality at 30 days. Six randomized trials (n=17 294) were included. Bivalirudin compared with heparin (+/- glycoprotein-IIb/IIIa inhibitor) was associated with reduction in major bleeding (odds ratio [OR]: 0.65, 95% CI: 0.48-0.88, P=0.006, derived from all 6 trials), increase in acute stent thrombosis (OR: 2.75, 95% CI: 1.46-5.18, P=0.002, 5 trials), and lower rate of all-cause mortality (OR: 0.81, 95% CI: 0.67-0.98, P=0.03, 6 trials) as well as cardiac mortality (OR: 0.69, 95% CI: 0.55-0.87, P=0.001, 5 trials). The incidence of acute stent thrombosis did not differ between the prolonged PCI-dose bivalirudin and comparator group (OR: 0.81, 95% CI: 0.27-2.46, P=0.71, 3 trials), whereas the risk of bleeding was reduced despite treatment with high-dose bivalirudin infusion (OR: 0.28, 95% CI: 0.13-0.60, P=0.001, 3 trials).. Bivalirudin (with and without prolonged infusion) compared with conventional antithrombotic therapy in ST-segment-elevation myocardial infarction patients undergoing primary PCI reduces major bleeding and death, but increases the rate of acute stent thrombosis. However, prolonging the bivalirudin infusion at PCI-dose (1.75 mg/kg per hour) for 3 hours eliminates the excess risk of acute stent thrombosis, while maintaining the bleeding benefits.

Topics: Antithrombins; Hemorrhage; Hirudins; Humans; Infusions, Intravenous; Odds Ratio; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Stents; Thrombosis

Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y. In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days.

Topics: Aged; Anticoagulants; Antithrombins; Heparin; Hirudins; Humans; Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up.. To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI).. Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI.. 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm. The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.

Topics: Aged; Anticoagulants; Antithrombins; Coronary Thrombosis; Female; Hemorrhage; Heparin; Hirudins; Humans; Infusions, Parenteral; Italy; Male; Middle Aged; Neointima; Peptide Fragments; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Recombinant Proteins; ST Elevation Myocardial Infarction; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

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.. 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.. 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.. 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.

Topics: Age Factors; Aged; Aged, 80 and over; Anticoagulants; Antithrombins; Coronary Thrombosis; Female; Hemorrhage; Heparin; Hirudins; Humans; Male; Non-ST Elevated Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Recombinant Proteins; Recurrence; Registries; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Stroke; Sweden; Time Factors; Treatment Outcome

Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated.. The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%).. The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.

Topics: Anticoagulants; Double-Blind Method; Enoxaparin; Heparin; Hirudins; Humans; Multicenter Studies as Topic; Peptide Fragments; Percutaneous Coronary Intervention; Postoperative Period; Prospective Studies; Randomized Controlled Trials as Topic; Recombinant Proteins; ST Elevation Myocardial Infarction; Time Factors

Our aim was to study the impact of sex on anticoagulant treatment outcomes during percutaneous coronary intervention in acute myocardial infarction patients.. This study was a prespecified analysis of the 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 (VALIDATE-SWEDEHEART) trial, in which patients with myocardial infarction were randomised to bivalirudin or unfractionated heparin during percutaneous coronary intervention. The primary outcome was the composite of death, myocardial infarction or major bleeding at 180 days.. There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26),. In women, bivalirudin was associated with a lower risk of adverse outcomes, compared to unfractionated heparin, primarily due to a significant reduction in Bleeding Academic Research Consortium 2 bleeds.

Topics: Acute Disease; Administration, Intravenous; Aged; Anticoagulants; Antithrombins; Female; Hemorrhage; Heparin; Hirudins; Humans; Male; Middle Aged; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Registries; Risk Assessment; Sex Factors; ST Elevation Myocardial Infarction; Sweden

Topics: Antithrombins; Coronary Thrombosis; Drug Administration Schedule; Hirudins; Humans; Infusions, Parenteral; Peptide Fragments; Percutaneous Coronary Intervention; Predictive Value of Tests; Recombinant Proteins; ST Elevation Myocardial Infarction; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Recent randomized controlled trials comparing femoral and radial access in primary percutaneous coronary intervention (PPCI) have shown conflicting results regarding the incidence of major adverse cardiovascular events (MACE) and major bleeding.. Using data from the HEAT-PPCI trial, we compared the primary efficacy (all-cause mortality, stroke, new myocardial infarction or unplanned repeat revascularization) and safety (major bleeding BARC 3-5) outcomes at 28 days, by final access site used (radial or femoral) and by default operator type. We then assessed outcomes in femoral cases performed by both operator types.. Radial access (RA) was associated with fewer MACE (91/1472 = 6.2% vs. 36/332 = 10.8% P = .003) and major bleeding events (38/1472 = 2.6% vs 22/332 = 6.6% P = .001) when compared to femoral access (FA). When analyzing outcomes by default operator type, there was a similar incidence of MACE (111/1575 = 7% vs 16/229 = 7% P = .97) and major bleeding events (49/1575 = 3.1% vs 11/229 = 4.8% P = .18). In cases where FA was performed by default radial operators, there was a higher rate of MACE (22/122 = 18% vs 14/210 = 6.7% P = .003) and major bleeding events (11/122 = 9% vs 11/210 = 5.2% P < .001), potentially explained by a higher risk profile in these cases.. Default femoral operators achieved comparable outcomes when compared to default radial operators. The less favorable outcomes observed in FA cases may result from its selective use by radial operators in high risk cases.

Topics: Aged; Anticoagulants; Antithrombins; Cause of Death; Femoral Artery; Heparin; Hirudins; Humans; Incidence; Middle Aged; Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Postoperative Complications; Postoperative Hemorrhage; Pressure; Radial Artery; Recombinant Proteins; Recurrence; Reoperation; ST Elevation Myocardial Infarction; Stroke; Surgeons; Treatment Outcome; Vascular Closure Devices

The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear.. The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation.. The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding).. Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups.. In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).

Topics: Acute Coronary Syndrome; Aged; Antithrombins; Dose-Response Relationship, Drug; Female; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Postoperative Care; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

In the 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 (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin.. Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.

Topics: Acute Coronary Syndrome; Aged; Anticoagulants; Antithrombins; Female; Femoral Artery; Hemorrhage; Heparin; Hirudins; Humans; Male; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Prospective Studies; Radial Artery; Recombinant Proteins; Registries; ST Elevation Myocardial Infarction; Treatment Outcome

The predictors of improvement in left ventricular ejection fraction (LVEF) after primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) are poorly understood. We sought to determine the prevalence and clinical and angiographic predictors of LVEF improvement after primary PCI in STEMI. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction trial, 3,602 patients presenting with STEMI were randomized to heparin + a glycoprotein IIb/IIIa inhibitor versus bivalirudin. Routine 13-month angiographic follow-up was performed in a prespecified substudy of 656 stented patients. The median [25%, 75%] change in LVEF from baseline to 13 months was +2.4% [-5.9%, 11.8%]; LVEF increased or remained unchanged in 379 patients (57.8%; median Δ +9.8% [4.3%, 16.4%]) and fell in 277 patients (42.2%; median Δ -7.0% [-11.8%, -3.6%]). Independent predictors of LVEF improvement were female gender (p = 0.002), lower baseline LVEF (p <0.0001), Thrombolysis in Myocardial Infarction 3 flow after PCI (p = 0.03), shorter lesion length (p = 0.04), and lower post-PCI peak MB isoenzyme of creatine kinase (p <0.0001). In conclusion, in the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction trial, although LVEF improved during follow-up after primary PCI in more than half of patients, left ventricular function worsened over time in a substantial proportion, the occurrence of which may be predicted by clinical, angiographic, and laboratory variables.

Topics: Aged; Antithrombins; Biomarkers; Coronary Angiography; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Platelet Glycoprotein GPIIb-IIIa Complex; Predictive Value of Tests; Recombinant Proteins; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Stents; Stroke Volume; Treatment Outcome; Ventricular Dysfunction, Left

A history of diabetes mellitus (DM) is an independent predictor for adverse events in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Outcomes of patients with STEMI and newly diagnosed DM (NDM) are less well described. We used the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial database to identify the outcomes at 30 days and 3 years according to no, known, and NDM in patients with STEMI. In HORIZONS-AMI, 3,602 patients with STEMI were randomized to bivalirudin versus heparin and a glycoprotein IIb/IIIa inhibitor, and eligible patients were randomized again to a paclitaxel-eluting stent or a bare-metal stent. DM was defined as a history of hyperglycemia managed by insulin, oral hypoglycemic agents, or diet. NDM was defined as the absence of previous diagnosis or treatment for DM at baseline and its addition at discharge. DM was present in 593/3,599 patients (16.5%), and NDM was diagnosed in 130 cases (3.6%). Compared with nondiabetics, those with DM and NDM had higher 3-year rates of death (11.4% and 12.0% vs 5.6%, respectively, p <0.0001) and major adverse cardiac events (29.6% and 30.2% vs 19.9%, respectively, p <0.0001). There were no significant differences in adverse events between new and known diabetic patients. DM and NDM were independent predictors of 3-year mortality and 3-year major adverse cardiac events. In conclusion, patients with NDM have a similarly poor prognosis after primary percutaneous coronary intervention in STEMI as those with previously established DM.

Topics: Aged; Cause of Death; Diabetes Mellitus; Drug-Eluting Stents; Electrocardiography; Female; Follow-Up Studies; Heparin; Hirudins; Humans; Hypoglycemic Agents; Incidence; Male; Middle Aged; Paclitaxel; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Period; Prognosis; Recombinant Proteins; ST Elevation Myocardial Infarction; Survival Rate; Time Factors; Treatment Outcome; United States

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors.. Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes.. The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required.. The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.

Topics: Adenosine; Antithrombins; Cause of Death; Disease-Free Survival; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Follow-Up Studies; Hirudins; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Period; Prasugrel Hydrochloride; Prospective Studies; Purinergic P2Y Receptor Antagonists; Recombinant Proteins; ST Elevation Myocardial Infarction; Survival Rate; Ticagrelor; Time Factors; Treatment Outcome

Since older age is a strong predictor of not only bleeding but also of ischemic events, understanding the risk:benefit profile of bivalirudin in the elderly undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation (STEMI) is important. For this, we aim to compare elderly with young patients, who all underwent pPCI for STEMI and randomly received either bivalirudin or heparin.. We performed a patient-level pooled analysis (n=5800) of two large randomized trials. A total of 2149 (37.1%) elderly patients (>65 years of age) with STEMI were enrolled and randomly assigned to either bivalirudin or heparin with or without a GPI (control group) before pPCI. Clinical outcomes at 30 days were analyzed.. In elderly patients, bivalirudin significantly reduced non-CABG major bleeding (7.1% vs 10.4%; P<.01), subacute ST (0.4% vs 1.5%; P<.01), and net adverse clinical events (NACE; composite of all-cause mortality, reinfarction, IDR, stroke or protocol-defined non-CABG major bleeding [13.7% vs 17.2%; P=.03]) with comparable rates of stroke, MI, acute ST, or all-cause death, when compared with heparin with or without GPI.. In a large group of elderly patients enrolled in the EUROMAX and HORIZONS-AMI trials, bivalirudin was associated with lower 30-day rates of non-CABG major bleeding, subacute ST and NACE, with similar 30-day rates of acute ST and mortality.

Topics: Age Distribution; Age Factors; Aged; Antithrombins; Cause of Death; Dose-Response Relationship, Drug; Europe; Female; Fibrinolytic Agents; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Risk Factors; ST Elevation Myocardial Infarction; Survival Rate; Treatment Outcome; United States

Post-procedural anticoagulation (AC) for routine prophylaxis may be administered after primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI), but the risks and benefits of this practice are uncertain. We therefore sought to assess the utility of routine post-procedural AC after primary PCI.. Patients undergoing primary PCI in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial were grouped according to whether they received post-PCI AC for routine prophylaxis. Outcomes were assessed using propensity-adjusted multivariable analysis. Among 2932 patients in whom primary PCI for STEMI was performed, 869 (29.6%) received post-PCI AC for routine prophylaxis (median duration four days) and 2063 (70.4%) received no post-PCI AC. Time from PCI to ambulation was similar in both groups (median 0.9 vs 1.0 days, p=0.40), although hospitalization was prolonged in patients receiving AC for routine prophylaxis (median 6.0 vs 4.0 days, p<0.0001). After propensity-adjustment, patients who received and did not receive AC for routine prophylaxis after PCI experienced similar rates of 30-day adverse ischemic and major bleeding events. Deep venous thrombosis or pulmonary emboli developed rarely (0.3%) within 30 days, and were not significantly reduced by use of post-PCI AC for routine prophylaxis.. In this large-scale prospective study, use of post-procedural AC for routine prophylaxis was relatively common, and was not associated with improved clinical outcomes, although the duration of hospitalization was prolonged. These data suggest that post-PCI AC for routine prophylaxis may not provide benefit after successful primary PCI in patients in whom early ambulation is likely.

Topics: Aged; Antithrombins; Aspirin; Clopidogrel; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Electrocardiography; Female; Fibrinolytic Agents; Follow-Up Studies; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Care; Postoperative Complications; Prospective Studies; Recombinant Proteins; Secondary Prevention; ST Elevation Myocardial Infarction; Survival Rate; Thrombolytic Therapy; Ticlopidine; Treatment Outcome

Myocardial reperfusion after primary percutaneous coronary intervention (PCI) can be assessed by the extent of post-procedural ST-segment resolution. The European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trial compared pre-hospital bivalirudin and pre-hospital heparin or enoxaparin with or without GPIIb/IIIa inhibitors (GPIs) in primary PCI. This nested substudy was performed in centres routinely using pre-hospital GPI in order to compare the impact of randomized treatments on ST-resolution after primary PCI.. Residual cumulative ST-segment deviation on the single one hour post-procedure electrocardiogram (ECG) was assessed by an independent core laboratory and was the primary endpoint. It was calculated that 762 evaluable patients were needed to show non-inferiority (85% power, alpha 2.5%) between randomized treatments.. A total of 871 participated with electrocardiographic data available in 824 patients (95%). Residual ST-segment deviation one hour after PCI was 3.8±4.9 mm versus 3.9±5.2 mm for bivalirudin and heparin+GPI, respectively ( p=0.0019 for non-inferiority). Overall, there were no differences between randomized treatments in any measures of ST-segment resolution either before or after the index procedure.. Pre-hospital treatment with bivalirudin is non-inferior to pre-hospital heparin + GPI with regard to residual ST-segment deviation or ST-segment resolution, reflecting comparable myocardial reperfusion with the two strategies.

Topics: Abciximab; Aged; Ambulances; Antibodies, Monoclonal; Anticoagulants; Antithrombins; Coronary Angiography; Dose-Response Relationship, Drug; Electrocardiography; Emergency Medical Services; Female; Follow-Up Studies; Heparin; Hirudins; Humans; Immunoglobulin Fab Fragments; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Recombinant Proteins; Retrospective Studies; ST Elevation Myocardial Infarction; Time Factors; Transportation of Patients; Treatment Outcome

Many sites routinely continue anticoagulation after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI), despite an unclear benefit-risk ratio. We evaluated the impact of this strategy on 30-day outcomes from a pooled patient-level database of two large primary percutaneous coronary intervention trials.. EUROMAX and HORIZONS-AMI were both multicentre, international randomised trials comparing bivalirudin to heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention. Outcomes at 30 days were analysed according to the use of post-procedural anticoagulation (unfractionated or low-molecular-weight heparins or fondaparinux) outside of the catheterisation laboratory.. Among 5239 patients undergoing primary percutaneous coronary intervention, 2153 (41.1%) received post-procedural anticoagulation. After adjusting for differences in baseline variables, there were no differences in the 30-day rates of adverse ischaemic events between patients without versus with post-procedural anticoagulation: adjusted odds ratio for major adverse cardiac events 0.80; 95% confidence interval 0.60-1.07; P=0.14; adjusted odds ratio for stent thrombosis 0.82; 95% confidence interval 0.55-1.24; P=0.35; adjusted odds ratio for death 1.07; 95% confidence interval 0.69-1.66; P=0.77. Conversely, protocol-defined major bleeding was decreased without post-procedural anticoagulation: adjusted odds ratio 0.74; 95% confidence interval 0.58-0.94; P=0.01. Similar results were observed for Thrombolysis In Myocardial Infarction major and minor bleeding.. In this large STEMI database, a substantial proportion of primary percutaneous coronary intervention patients received post-procedural anticoagulation, which in turn was associated with higher bleeding rates without any reduction in ischaemic events. Therefore, routine post-procedural anticoagulation after primary percutaneous coronary intervention seems to have an unfavourable benefit-risk profile and should be avoided unless a well-established indication is present.. ClinicalTrials.gov , EUROMAX Identifier NCT01087723; HORIZONS Identifier NCT00433966.

Topics: Aged; Antithrombins; Coronary Angiography; Coronary Thrombosis; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Fibrinolytic Agents; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Care; Recombinant Proteins; ST Elevation Myocardial Infarction; Thrombolytic Therapy; Treatment Outcome

To explore the efficiency and safety of bivalirudin in patients undergoing emergency percutaneous coronary intervention via radial access.. Bivalirudin reduces bleeding risks over heparin in patients undergoing PCI. However, bleeding advantages of bivalirudin in patients undergoing transradial intervention is uncertain.. In the BRIGHT trial, 1,723 patients underwent emergency PCI via radial access, with 576 patients in the bivalirudin arm, 576 in the heparin arm and 571 in the heparin plus tirofiban arm. The primary outcome was 30-day net adverse clinical event (NACE), defined as a composite of major cardiac and cerebral events or any bleeding.. 30-day NACE occurred in 5.7% with bivalirudin, 7.8% with heparin alone (vs. bivalirudin, P = 0.159), and 10.3% with heparin plus tifofiban (vs. bivalirudin, P = 0.004). The 30-day bleeding rate was 0.9% for bivalirudin, 2.3% for heparin (vs. bivalirudin, P = 0.057), and 5.8% for heparin plus tirofiban (vs. bivalirudin, P < 0.001). Major cardiac and cerebral events (4.9 vs. 5.7 vs. 4.6%, P = 0.899), stent thrombosis (0.5 vs. 0.5 vs. 0.7%, P = 0.899) and acquired thrombocytopenia (0.2 vs. 0.5 vs. 0.9%, P = 0.257) at 30 days were similar among three arms. The interaction test for PCI access and randomized treatment showed no significance on all bleeding (P > 0.05).. The bleeding benefit of bivalirudin was independent of artery access. Bivalirudin lead to statistical reduction on bleeding risks in comparison to heparin plus tirofiban, and only small numerical difference in comparison to heparin, with comparable risks of ischemic events and stent thrombosis in patients with acute myocardial infarction (AMI) undergoing emergency transradial PCI. © 2016 Wiley Periodicals, Inc.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anticoagulants; Antithrombins; Cardiac Catheterization; China; Emergencies; Female; Hemorrhage; Hirudins; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Radial Artery; Recombinant Proteins; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Time Factors; Tirofiban; Treatment Outcome; Tyrosine; Warfarin; Young Adult

Bivalirudin has been associated with reduced bleeding and mortality during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). However, increased rates of acute stent thrombosis (AST) have been noted when bivalirudin is discontinued at the end of the procedure, which is perhaps related to this medication's short half-life.. To evaluate the clinical effect of procedure duration on AST when either bivalirudin or heparin plus glycoprotein IIb/IIIa receptor inhibitor (GPI) is used.. An ad hoc analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) clinical trial was performed between March 1, 2015, and April 30, 2016, on patients who underwent primary percutaneous coronary intervention with stents and were randomized 1:1 to bivalirudin or heparin plus GPI. Defined as the difference between the patient's arrival at the catheterization laboratory and the patient's final angiogram. Participants included 3602 patients with STEMI, aged 18 years or older, who were undergoing primary percutaneous coronary intervention and presenting less than 12 hours from symptom onset.. Clinical events committee-adjudicated definite AST (occurring ≤24 hours after percutaneous coronary intervention).. Among patients included in this analysis, procedure time was identified in 1286 receiving bivalirudin and 1412 receiving heparin plus GPI. Shorter procedures were defined as the lowest quartile of duration (<45 minutes). Patients undergoing shorter procedures were younger and less likely to be hypertensive and smokers. Shorter procedures were less complicated with fewer stents implanted, less multivessel stenting, less thrombus, and less no-reflow. An increased risk of definite AST was associated with shorter than with longer procedures with bivalirudin (7 [2.1%] vs 7 [0.7%]; relative risk, 2.87; 95% CI, 1.01-8.17; P = .04) but not with heparin plus GPI (0 vs 3 [0.3%]; P = .30).. Despite less procedural complexity, shorter primary percutaneous coronary intervention time was associated with an increased risk of AST in patients treated with bivalirudin but not patients treated with heparin plus GPI, possibly because of the rapid offset of bivalirudin's antithrombotic effect during a window of limited oral antiplatelet action.. clinicaltrials.gov Identifier: NCT00433966.

Topics: Acute Disease; Aged; Anticoagulants; Antithrombins; Drug Therapy, Combination; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Operative Time; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Complications; Recombinant Proteins; Risk Factors; ST Elevation Myocardial Infarction; Stents; Thrombosis

Uncertainty exists regarding potential survival benefits of bivalirudin compared with heparin with routine or optional use of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with ST-segment elevation myocardial infarction (STEMI). Few data are available regarding long-term mortality in the context of contemporary practice with frequent use of radial access and novel platelet adenosine diphosphate P2Y12 receptor inhibitors.. To assess the effect of bivalirudin monotherapy compared with unfractionated or low-molecular-weight heparin plus optional GPIs on 1-year mortality.. This international, randomized, open-label clinical trial (EUROMAX [European Ambulance Acute Coronary Syndrome Angiography]) included 2198 patients with STEMI undergoing transport for primary percutaneous coronary intervention from March 10, 2010, through June 20, 2013, and followed up for 1 year. Patients were randomized (1:1) in ambulance to bivalirudin monotherapy vs unfractionated or low-molecular-weight heparin plus optional GPIs (control group). Analysis was based on intention to treat.. The primary outcome of this prespecified analysis was 1-year mortality. All deaths were adjudicated as cardiac or noncardiac by an independent, blinded clinical events committee. One-year mortality was assessed and examined across multiple prespecified subgroups.. Of the 2198 patients enrolled (1675 men [76.2%] and 523 women [23.8%]; median [interquartile range] age, 62 [52-72] years), complete 1-year follow-up data were available for 2164 (98.5%). All-cause 1-year mortality occurred in 118 patients (5.4%). The number of all-cause deaths was the same for both treatment groups (59 deaths; relative risk [RR], 1.02; 95% CI, 0.72-1.45; P = .92). No differences were noted in the rates of 1-year cardiac death (44 [4.0%] for the bivalirudin group vs 48 [4.3%] for the control group; RR, 0.93; 95% CI, 0.63-1.39; P = .74) or noncardiac death (15 [1.4%] for the bivalirudin group vs 11 [1.0%] for the control group; RR, 1.39; 95% CI, 0.64-3.01; P = .40). Results were consistent across the prespecified patient subgroups. The rate of deaths occurring from 30 days to 1 year was also similar (27 [2.5%] in the bivalirudin group vs 25 [2.3%] in the control group; RR, 1.10; 95% CI, 0.64-1.88; P = .73).. In patients with STEMI who were being transported for primary percutaneous coronary intervention, treatment with bivalirudin or with heparin with optional use of GPI resulted in similar 1-year mortality. The reduced composite end point of death and/or major bleeding at 30 days in the bivalirudin arm of the EUROMAX trial did not translate into reduced cardiovascular or all-cause death at 1 year.. clinicaltrials.gov Identifier: NCT01087723.

Topics: Aged; Ambulances; Anticoagulants; Antithrombins; Drug Therapy, Combination; Emergency Medical Services; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Mortality; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Recombinant Proteins; ST Elevation Myocardial Infarction

The optimal anticoagulant for patients with acute coronary syndrome treated with percutaneous coronary intervention (PCI) has not been validated in current practice of radial approach and pretreatment with potent P2Y12 inhibitors. Several studies have indicated increased bleeding rate and, in some instances, even increased mortality by the routine use of heparin and glycoprotein IIb/IIIa inhibitors compared to bivalirudin. Direct comparison of bivalirudin versus heparin alone has yielded contradictory results depending on study designs.. The VALIDATE-SWEDEHEART trial is a multicenter, prospective, randomized, registry-based, controlled, and open-label clinical trial in patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing PCI pretreated with ticagrelor, prasugrel, or cangrelor. We hypothesize that bivalirudin is superior to heparin alone in reducing death, myocardial infarction, and major bleeding events at 180 days (primary end point). The trial will enroll 3,000 patients with STEMI and 3,000 patients with non-STEMI undergoing PCI. The trial will use a hybrid registry-based randomized clinical trial design where inclusion, randomization, and baseline data collection are performed using The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry. The primary composite end point (death, myocardial infarction, or major bleeding events at 180 days) will be identified through active screening after 7 and 180 days and adjudicated by a blinded central end point committee. Secondary end points and long-term outcomes will be recorded from national registries.. The VALIDATE-SWEDEHEART trial is founded on a nationwide clinical registry and uses a hybrid registry-based randomized clinical trial (RRCT) design methodology to evaluate efficacy and safety of bivalirudin as compared to heparin alone for acute coronary syndrome, in a large population receiving contemporary recommended therapies including predominantly radial invasive approach and pretreatment with potent P2Y12 inhibitors.

Topics: Administration, Intravenous; Aged; Anticoagulants; Combined Modality Therapy; Dose-Response Relationship, Drug; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Outcome and Process Assessment, Health Care; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Recombinant Proteins; Registries; ST Elevation Myocardial Infarction; Treatment Outcome

In the HORIZONS-AMI trial, bivalirudin compared to unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) improved net clinical outcomes in patients undergoing primary percutaneous coronary intervention (PCI) at the cost of an increased rate of acute stent thrombosis. We sought to examine whether these effects are dependent on time to treatment.. The interaction between anticoagulation regimen and symptom onset to first balloon inflation time (SBT) on the 30-day and three-year rates of major adverse cardiac events (MACE) was examined in 3,199 randomised patients according to SBT ≤3 hours versus >3 hours. Among patients with an SBT ≤3 hours, bivalirudin resulted in higher 30-day rates of MACE compared to UFH plus a GPI. Non-significant differences were observed in patients with an SBT >3 hours. Similar results were found for MACE at three years and stent thrombosis and reinfarction at 30 days and three years. By multivariable analysis, bivalirudin was an independent predictor of MACE at 30 days and three years in patients with an SBT ≤3 hours, but not in patients with SBT >3 hours.. Bivalirudin compared to UFH plus a GPI is associated with an increased rate of stent thrombosis and MACE in patients with short SBTs, but not in those with longer SBTs.

Topics: Aged; Anticoagulants; Antithrombins; Cause of Death; Drug Therapy, Combination; Female; Graft Occlusion, Vascular; Heparin; Hirudins; Humans; Male; Middle Aged; Mortality; Myocardial Infarction; Myocardial Revascularization; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Complications; Recombinant Proteins; Recurrence; ST Elevation Myocardial Infarction; Stroke; Thrombosis; Time-to-Treatment; Treatment Outcome

Topics: Antithrombins; Heparin; Hirudins; Humans; Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

Although bivalirudin has been recently made available for purchase in China, large-scale analyses on the safety profile of bivalirudin among Chinese patients is lacking. Thus, this study aimed to compare the safety profile of bivalirudin and heparin as anticoagulants in Chinese ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). A total of 1063 STEMI patients undergoing PCI and receiving bivalirudin (n=424, bivalirudin group) or heparin (n=639, heparin group) as anticoagulants were retrospectively enrolled. The net adverse clinical events (NACEs) within 30 days after PCI were recorded, including major adverse cardiac and cerebral events (MACCEs) and bleeding events (bleeding academic research consortium (BARC) grades 2-5 (BARC 2-5)). The incidences of NACEs (10.1 vs 15.6%) (P=0.010), BARC 2-5 bleeding events (5.2 vs 10.3%) (P=0.003), and BARC grades 3-5 (BARC 3-5) bleeding events (2.1 vs 5.5%) (P=0.007) were lower in the bivalirudin group compared to the heparin group, whereas general MACCEs incidence (8.9 vs 6.4%) (P=0.131) and each category of MACCEs (all P>0.05) did not differ between two groups. Furthermore, the multivariate logistic analyses showed that bivalirudin (vs heparin) was independently correlated with lower risk of NACEs (OR=0.508, P=0.002), BARC 2-5 bleeding events (OR=0.403, P=0.001), and BARC 3-5 bleeding events (OR=0.452, P=0.042); other independent risk factors for NACEs, MACCEs, or BARC bleeding events included history of diabetes mellitus, emergency operation, multiple lesional vessels, stent length >33.0 mm, and higher CRUSADE score (all P<0.05). Thus, bivalirudin presented a better safety profile than heparin among Chinese STEMI patients undergoing PCI.

Topics: Anticoagulants; Antithrombins; East Asian People; Fibrinolytic Agents; Hemorrhage; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Retrospective Studies; ST Elevation Myocardial Infarction; Treatment Outcome

This prospective, multi-center, intensive monitoring study aimed to systematically assess the occurrence of adverse events (AEs) and adverse drug reactions (ADRs), especially thrombocytopenia and bleeding, as well as their risk factors in Chinese ST-segment elevation myocardial infraction (STEMI) patients receiving bivalirudin as anticoagulant for percutaneous coronary intervention (PCI).. In total, 1244 STEMI patients undergoing PCI and receiving bivalirudin as anticoagulant were enrolled in the present study. Safety data were collected from hospital admission to 72 h after bivalirudin administration; in addition, patients were further followed up at the 30th day with safety data collected at that time.. AEs, severe AEs, ADRs and severe ADRs were reported in 224 (18.0%), 15 (1.2%), 49 (3.9%) and 5 (0.4%) patients, respectively. Importantly, 4 (0.3%) patients were submitted to hospitalization and 6 (0.5%) patients died due to AEs, while 1 (0.1%) patient was submitted to hospitalization but no (0.0%) patient died due to ADRs. Meanwhile, thrombocytopenia and bleeding occurred in 24 (1.9%) and 21 (1.7%) patients, respectively. Further multivariate logistic analysis identified several important independent factors related to AEs, ADRs, thrombocytopenia or bleeding, which included history of cardiac surgery and renal function impairment, high CRUSADE risk stratification, elective operation and combination with glycoprotein IIb/IIIa inhibitors. Moreover, 4 multivariate models were constructed based on the above-mentioned factors, which all showed acceptable predictive value for AEs, ADRs, thrombocytopenia and bleeding, respectively.. Bivalirudin is a well-tolerant anticoagulant in Chinese STEMI patients undergoing PCI procedure.

Topics: Anticoagulants; Antithrombins; China; Hemorrhage; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Prospective Studies; Recombinant Proteins; ST Elevation Myocardial Infarction; Thrombocytopenia; Treatment Outcome

Topics: Anticoagulants; Heparin; Hirudins; Humans; Percutaneous Coronary Intervention; ST Elevation Myocardial Infarction; Treatment Outcome

Topics: Hirudins; Humans; Peptide Fragments; ST Elevation Myocardial Infarction

Topics: COVID-19; Heparin; Hirudins; Humans; SARS-CoV-2; ST Elevation Myocardial Infarction

The efficacy and safety of continued bivalirudin infusion after percutaneous coronary intervention (PCI) remains uncertain. We sought to investigate the association between post-PCI bivalirudin infusion and the risk of net adverse clinical events (NACE) at 30 days.. In the GLOBAL LEADERS study, all patients who received bivalirudin during PCI were categorized according to the use of bivalirudin infusion after the procedure. The primary endpoint of the present analysis was NACE [a composite of all-cause death, any stroke, any myocardial infarction, all revascularization, and bleeding assessed according to the Bleeding Academic Research Consortium (BARC) criteria Type 3 or 5] at 30 days. The key safety endpoint was BARC Type 3 or 5 bleeding and definite stent thrombosis. Of 15 968 patients, 13 870 underwent PCI with the use of bivalirudin. In total, 7148 patients received continued bivalirudin infusion after procedure, while 6722 patients received standard care. After propensity score covariate adjustment, the risk of NACE did not significantly differ between two treatments after PCI [continued bivalirudin infusion vs. no bivalirudin infusion: 3.2% vs. 3.1%, adjusted hazard ratio (aHR) 1.35, 95% confidence interval (CI) 0.99-1.84, P = 0.06] nor the BARC Type 3 or 5 bleeding (0.7% vs. 0.7%, aHR 0.89, 95% CI 0.44-1.79; P = 0.743) and definite stent thrombosis (0.5% vs. 0.3%, aHR 1.71, 95% CI 0.77-3.81, P = 0.189). However, continued bivalirudin infusion was associated with an increased risk of NACE and definite stent thrombosis in ST-elevation myocardial infarction (STEMI) patients.. In an all-comers population undergoing PCI, there was no significant difference in the risk of NACE at 30 days between continued bivalirudin infusion vs. no bivalirudin infusion after procedure but continued bivalirudin infusion was associated with a higher risk of NACE in STEMI patients when compared with no infusion.

Topics: Aged; Antithrombins; Coronary Artery Disease; Coronary Thrombosis; Female; Hemorrhage; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Recombinant Proteins; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Stents; Time Factors; Treatment Outcome

Topics: Antithrombins; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction

ST-segment elevation myocardial infarction (STEMI) is the most serious type of acute coronary syndrome. This study aimed to investigate the efficacy and safety of bivalirudin application during primary percutaneous coronary intervention (PPCI) in older patients with acute STEMI.. A total of 672 older patients with STEMI (>75 years) who underwent PPCI were studied. The primary endpoints were 30-day net adverse clinical events (NACEs) post-emergency percutaneous coronary intervention, including major adverse cardiac and cerebrovascular events (MACCEs) and Bleeding Academic Research Consortium grades 2 to 5 (BARC 2-5) bleeding events.. The incidence of NACEs and BARC 2-5 bleeding events in the bivalirudin group was significantly lower than that in the unfractionated heparin group. Multivariate Cox regression analysis showed that bivalirudin significantly reduced 30-day NACEs (odds ratio: 0.700, 95% confidence interval: 0.492-0.995) and BARC 2-5 bleeding events (odds ratio: 0.561, 95% confidence interval: 0.343-0.918). At 1-year follow-up, these results were similar.. Bivalirudin can be safely and effectively used during PPCI in older patients with STEMI. Bivalirudin reduces the risks of NACEs and bleeding within 30 days after PPCI, without increasing the risks of MACCEs and stent thrombosis compared with heparin.

Topics: Aged; Anticoagulants; Antithrombins; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

A pharmacoinvasive strategy for ST-segment elevation myocardial infarction (STEMI) management combines the use of fibrinolysis with the routine transfer to coronary angiography, with percutaneous coronary intervention (PCI) if needed. This method reduces the risk of major adverse cardiovascular event (MACE) compared with fibrinolysis alone; however, it is associated with higher bleeding risk. We sought to assess the bivalirudin compared with unfractionated heparin (UFH) used during PCI as part of a pharmacoinvasive strategy.. We identified consecutive patients referred to the University of Ottawa Heart Institute between April 2009 and May 2011 as part of a pharmacoinvasive strategy for STEMI. The primary efficacy outcome was MACE, defined as a composite of death, reinfarction, or stroke during index hospitalization. The primary safety outcome was TIMI bleeding.. We identified 200 patients meeting inclusion criteria: 123 patients (61.5%) in the bivalirudin group and 77 patients (37.5%) in the UFH group. Median fibrinolysis to balloon time was 324 minutes in the bivalirudin group and 226 minutes in the UFH group (P<.001). Initial TIMI grade 3 flow was higher in the bivalirudin group vs the UFH group, but there was no difference in the rates post PCI. MACE rates were 4.9% vs 7.8% (P=.40) and TIMI bleeding rates were 7.3% vs 11.7% (P=.29) in patients treated with bivalirudin vs UFH, respectively.. The periprocedural use of bivalirudin vs UFH was associated with similar rates of MACE and bleeding. Given the expense of bivalirudin and lack of demonstrable clinical superiority, UFH remains the first-line periprocedural anticoagulant in a pharmacoinvasive strategy.

Topics: Coronary Angiography; Female; Fibrinolytic Agents; Hemorrhage; Heparin; Hirudins; Humans; Male; Middle Aged; Outcome and Process Assessment, Health Care; Peptide Fragments; Percutaneous Coronary Intervention; Perioperative Care; Postoperative Complications; Recombinant Proteins; Risk Adjustment; ST Elevation Myocardial Infarction

Whether heparin, bivalirudin, or bivalirudin delivered on the background of prior heparin therapy, during primary PCI therapy is associated with a better outcome is difficult to ascertain from any one study. Meta-analysis of available trials suggests that the use of bivalirudin on top of prior heparin therapy may be associated with the lowest all-cause mortality and major adverse cardiovascular events while preserving much of the access site bleeding reduction of bivalirudin alone. There may be a role for initial therapy of STEMI with a broad-spectrum anticoagulant such as heparin that is then focused to a more specific direct-thrombin inhibitor (bivalirudin) in primary PCI.

Topics: Anticoagulants; Antithrombins; Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

To compare prolonged bivalirudin infusion vs. an intra-procedural only bivalirudin infusion administration in subjects with ST-segment elevation myocardial infarction (STEMI) regarding residual stent strut thrombosis.. Multivessel STEMI patients undergoing primary percutaneous coronary intervention (PPCI) and scheduled for a staged percutaneous coronary intervention (PCI) before hospital discharge were selected among those allocated to either prolonged bivalirudin or intra-procedural only bivalirudin infusion in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of PPCI and 4-5 days thereafter during staged intervention. The predefined endpoint was the percentage difference in the number of stent cross-sections with a thrombotic area >5% at the end of PPCI and at the time of staged PCI (ΔThCS). Between September 2013 and November 2015, 137 were randomized to either intra-procedural only bivalirudin infusion (N = 64) or prolonged bivalirudin (N = 73) at 16 European sites. Mean stent area, minimum lumen area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The difference in the proportion of frames with percent thrombotic area >5% (ΔTh > 5%) were -7.7 (-22.1 to 5.1) in the intra-procedural bivalirudin infusion group and -8.8 (-23.1 to 2.6) in the prolonged infusion group (P = 0.994). Time from index to follow-up OCT imaging and the infarct vessel artery did not affect this OCT-based endpoint.. A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).

Topics: Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Stents; Thrombosis; Tomography, Optical Coherence; Treatment Outcome

Topics: Heparin; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Stents; Thrombosis; Treatment Outcome

Topics: Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

The best combination of access site and anticoagulant used during primary percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction is not known.. We conducted a retrospective cohort study of all patients >18 years of age who underwent primary PCI in 2 large regional ST segment elevation myocardial infarction centers in Massachusetts between 2012 and 2014. The cohort was divided into 3 groups: bival/fem, hep/rad, or off-protocol, based on anticoagulation and access used. We used multiple logistic regression model to compare major cardiovascular events-major adverse cardiovascular events (MACE) and bleeding complications between the 2 on-protocol groups (bival/fem and hep/rad).. Of the 1074 patients in this study, there were 443 (41%), 501 (47%), and 130 (12%) patients in bival/fem, hep/rad, and off-protocol groups, respectively. There were significantly higher number of cardiogenic shock patients in the bival/fem compared to the hep/rad group (6.5% vs. 3.0%, P < 0.001). There was a trend toward reduced MACE in the hep/rad group compared to bival/fem (2.8 % vs. 5.1%, P = 0.068). When cardiogenic shock patients are excluded, there is no significant difference in mortality rates (bival/fem: 2.7% vs. hep/rad: 1.0%, P = 0.07) or bleeding complications between the groups (hep/rad: 4.5% vs. bival/fem: 2.1%, P = 0.06).. In patients undergoing primary PCI, there was a trend toward reduced inpatient MACE with the use of heparin and radial access compared with bivalirudin with femoral access. In patients without cardiogenic shock, there is no significant difference in mortality or bleeding rates between the 2 groups.

Topics: Antithrombins; Catheterization, Peripheral; Female; Femoral Artery; Fibrinolytic Agents; Hemorrhage; Heparin; Hirudins; Humans; Male; Massachusetts; Middle Aged; Outcome and Process Assessment, Health Care; Peptide Fragments; Percutaneous Coronary Intervention; Radial Artery; Recombinant Proteins; Retrospective Studies; Shock, Cardiogenic; ST Elevation Myocardial Infarction

Bleeding events in relation to treatment of ST-segment elevation myocardial infarction (STEMI) have previously been associated with mortality. In this study, we investigated the incidence and prognosis of, and variables associated with serious bleedings within 30 days after primary percutaneous coronary intervention in patients from The Third Danish Study of Optimal Acute Treatment of Patients with ST-Segment Elevation Myocardial Infarction (DANAMI-3) (n = 2,217). Hospital charts were read within 30 days postadmission to assess bleeding events using thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium criteria. TIMI minor/major bleeding (TMMB) occurred in 59 patients (2.7%). Variables associated with TMMB were female gender (hazard ratio [HR] 3.9, 95% confidence interval [CI] 2.2 to 6.7, p <0.0001), symptom-to-catheterization time >3 hours (HR 1.9, 95% CI 1.1 to 3.3, p = 0.02), use of glycoprotein IIb/IIIa inhibitor (HR 2.1, 95% CI 1.2 to 3.7, p = 0.01), and increasing S-creatinine (HR 1.1, 95% CI 1.0 to 1.2, p = 0.001). Undergoing 2 in-hospital procedures were not associated with increased risk of TMMB. TMMB was strongly associated with 30-day mortality in multivariable analysis (HR 4.8, 95% CI 2.2 to 10.4, p <0.0001) but not with mortality days 31 to 365. When excluding fatal bleedings from the analysis, a TMMB was no longer associated with 30-day mortality. In conclusion, we found that in a contemporary STEMI-population, the incidence of 30-day TMMB was low. A TMMB was strongly associated with 30-day mortality but not with mortality days 31 to 365. If patients survived a serious bleeding, their short- and long-term prognoses were not affected.

Topics: Aged; Aged, 80 and over; Anticoagulants; Antithrombins; Aspirin; Creatinine; Female; Heparin; Hirudins; Humans; Incidence; Male; Middle Aged; Mortality; Multivariate Analysis; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Hemorrhage; Prognosis; Proportional Hazards Models; Purinergic P2Y Receptor Antagonists; Recombinant Proteins; Sex Factors; ST Elevation Myocardial Infarction; Time-to-Treatment

Early stent thrombosis occurs in ∼1% of patients treated with primary PCI and increases shock, stroke, and mortality. Early stent thrombosis was associated with small stent diameter, failure to use glycoprotein inhibitors, and bivalirudin use. Minimizing stent thrombosis may require the use of imaging and aggressive antithrombotic therapy.

Topics: Antithrombins; Hirudins; Humans; Incidence; Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Registries; ST Elevation Myocardial Infarction; Stents; Thrombosis; Treatment Outcome

 Cardiac-enriched micro ribonucleic acids (miRNAs) are released into the circulation following ST-elevation myocardial infarction (STEMI). Lack of standardized approaches for reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR) data normalization and presence of RT-qPCR inhibitors (e.g. heparin) in patient blood samples have prevented reproducible miRNA quantification in this cohort and subsequent translation of these biomarkers to clinical practice..  Using a RT-qPCR miRNA screening platform, we identified and validated an endogenous circulating miRNA as a normalization control. In addition, we assessed the effects of in vivo and in vitro anticoagulant drugs administration (heparin and bivalirudin) on three RT-qPCR normalization strategies (global miRNA mean, exogenous spike-in control [cel-miR-39] and endogenous miRNA control). Finally, we evaluated the effect of heparin and its in vitro inhibition with heparinase on the quantification of cardiac-enriched miRNAs in STEMI patients..  miR-425-5p was validated as an endogenous miRNA control. Heparin administration in vitro and in vivo inhibited all RT-qPCR normalization strategies. In contrast, bivalirudin had no effects on cel-miR-39 or miR-425-5p quantification. In vitro RNA sample treatment with 0.3 U of heparinase overcame heparin-induced over-estimation of cardiac-enriched miRNA levels and improved their correlation with high-sensitivity troponin T..  miRNA quantification in STEMI patients receiving heparin is jeopardized by its effect on all RT-qPCR normalization approaches. Use of samples from bivalirudin-treated patients or in vitro treatment of heparin-contaminated samples with heparinase are suitable alternatives for miRNA quantification in this cohort. Finally, we reinforce the evidence that cardiac-enriched miRNAs early after myocardial reperfusion reflect the severity of cardiac injury.

Topics: Aged; Anticoagulants; Circulating MicroRNA; Female; Genetic Markers; Heparin; Heparin Lyase; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Real-Time Polymerase Chain Reaction; Recombinant Proteins; Reproducibility of Results; Reverse Transcriptase Polymerase Chain Reaction; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Optimal adjunctive therapy in ST-segment elevation myocardial infarction (STEMI) patients treated with primary PCI (PPCI) remains a matter of debate. Our aim was to compare the efficacy and safety of bivalirudin to unfractionated heparin (UFH), with or without glycoprotein IIb/IIIa inhibitors (GPI) in a large real-world population, using data from the Swedish national registry, SWEDEHEART.. From 2008 to 2014 we identified 23,800 STEMI patients presenting within 12 hours from symptom onset treated with PPCI and UFH ± GPI or bivalirudin±GPI. Primary outcomes included 30-day all-cause mortality and major in-hospital bleeding. Multivariable regression models and propensity score modelling were utilized to study adjusted association between treatment and outcome.. Treatment with UFH ± GPI was associated with similar risk of 30-day mortality compared to bivalirudin±GPI (5.3% vs 5.5%, adjusted HR 0.94; 95% CI 0.82-1.07). The adjusted risk for 1-year mortality, 30-day and 1-year stent thrombosis and re-infarction did not differ significantly between UFH ± GPI and bivalirudin±GPI. In contrast, treatment with UFH ± GPI was associated with a significant higher risk of major in-hospital bleeding (adjusted OR 1.62; 95% CI 1.30-2.03). When including GPI use in the multivariable analysis, the difference was attenuated and no longer significant (adjusted OR 1.25; 95% CI 0.92-1.70).. Bivalirudin±GPI was associated with significantly lower risk for major inhospital bleeding but no significant difference in 30-day or one year mortality, stent thrombosis or re-infarction compared with UFH ± GPI. The bleeding reduction associated with bivalirudin could be explained by the greater GPI use with UFH.

Topics: Aged; Antithrombins; Cause of Death; Coronary Angiography; Coronary Restenosis; Female; Fibrinolytic Agents; Follow-Up Studies; Heparin; Hirudins; Humans; Incidence; Male; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Registries; Retrospective Studies; ST Elevation Myocardial Infarction; Stents; Sweden; Treatment Outcome

Topics: Anticoagulants; Heparin; Hirudins; Humans; Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

The optimal antithrombotic regimen for urgent percutaneous coronary interventions (PCI) following thrombolytic therapy for ST segment myocardial infarction (STEMI) is currently unknown.. We performed a retrospective analysis of all patients referred to our institution from January 2005 to July 2014 who underwent urgent PCI within 24 hr after receiving thrombolytic therapy. The patients were divided into three cohorts based on the anticoagulation strategy during PCI-bivalirudin, heparin alone or heparin plus Glycoprotein IIb/IIIa inhibitor (GPI). The primary end point of major adverse cardiovascular events (MACE) was defined as a composite of inpatient death, myocardial infarction (MI) and stroke. Net adverse clinical events (NACE) were defined as a combination of MACE plus major bleeding complications. Univariable, multivariable and propensity-weighted modeling were used to compare MACE and NACE between the three treatment groups.. A total of 695 patients met the inclusion criteria during the study period. In the univariable analysis, there was no significant difference treatment in MACE between the three groups (Bivalirudin: 1.2% vs. Heparin + GPI: 4.4%; Heparin alone: 2.7%, P = 0.11). In the reduced logistic regression model, compared to bivalirudin, the odds of NACE was significantly higher with heparin alone (OR: 3.58, 95% CI: 1.21, 10.54, P = 0.02) or with heparin plus GPI (OR: 9.0, 95% CI: 2.83, 28.64, P <0.001).. In STEMI patients undergoing PCI within 24 hr after thrombolytic therapy, bivalirudin was associated with a strong trend toward reduced bleeding complications as compared to heparin alone or heparin plus GPI. The optimal antithrombotic regiment for urgent PCI following thrombolytic therapy is currently unknown. Our study demonstrated that use of bivalirudin during PCI following thrombolytic therapy is associated with a trend toward reduced bleeding complications compared to heparin alone or heparin plus GPI. Large randomized trials of adjunctive anticoagulation during PCI in this complex post-thrombolytic population are warranted. © 2017 Wiley Periodicals, Inc.

Topics: Anticoagulants; Drug Therapy, Combination; Female; Follow-Up Studies; Heparin; Hirudins; Humans; Incidence; Male; Massachusetts; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Complications; Recombinant Proteins; Retrospective Studies; ST Elevation Myocardial Infarction; Survival Rate; Thrombolytic Therapy; Treatment Outcome

The aim of this study was to compare bivalirudin with heparin as anticoagulant agents in patients with ST-segment elevation myocardial infarction treated with radial primary percutaneous coronary intervention (PCI).. Recent studies in which PCI was performed predominantly via radial access did not show bivalirudin to be superior to heparin.. Outcomes were compared in patients with STEMI included in the National Cardiovascular Data Registry CathPCI database from 2009 to 2015 who underwent primary PCI via radial access and who were anticoagulated with bivalirudin or heparin.. The sample included 67,368 patients, of whom 29,660 received bivalirudin and 37,708 received heparin. The 2 groups of patients did not differ significantly in their mean age or percentage of men. The unadjusted comparison showed no significant difference in the rate of the composite endpoint of death, myocardial infarction, or stroke (4.6% vs. 4.7%; p = 0.47) and a significantly higher rate of acute stent thrombosis (1.00% vs. 0.60%; p < 0.001) with bivalirudin compared with heparin. After adjusting for multiple variables, including a propensity score reflecting the probability of receiving bivalirudin, the odds ratio of the composite endpoint of death, myocardial infarction, or stroke for bivalirudin versus heparin was 0.95 (95% confidence interval: 0.87 to 1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95% confidence interval: 1.73 to 2.57) for bivalirudin versus heparin. Major bleeding rates were not significantly different.. In patients undergoing primary PCI via transradial access anticoagulated with bivalirudin or heparin, there was no difference in the composite endpoint of death, myocardial infarction, or stroke.

Topics: Aged; Anticoagulants; Chi-Square Distribution; Coronary Thrombosis; Female; Hemorrhage; Heparin; Hirudins; Hospital Mortality; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Peptide Fragments; Percutaneous Coronary Intervention; Propensity Score; Radial Artery; Recombinant Proteins; Registries; Retrospective Studies; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Stroke; Time Factors; Treatment Outcome; United States

The beneficial effects of bivalirudin during primary PCIs are controversially discussed, data on unselected patients are rare. It was the aim of the study to compare bivalirudin versus heparin and provisional glycoprotein IIb/IIIa inhibitors (GPIs) in a "real-world" study.. From 05/2013 until 11/2014, the STEMI-patients in the Bremen STEMI registry were treated with periinterventional bivalirudin; before and after this period the standard anticoagulative treatment was heparin and provisional GPIs.. In 714 patients bivalirudin was used for PCI, this cohort was compared to 683 patients with heparin and provisional GPIs. In patients with bivalirudin a significantly lower rate of hospital bleedings was observed compared to patients with heparin (4.6% vs 8.1%, P < 0.01, multivariate HR 0.57, 95%CI 0.35-0.93), in an exclusive analysis of severe bleedings a trend toward less bleedings was found in patients with bivalirudin (2.0% vs 3.5%, P = 0.07, multivariate HR 0.66, 95%CI 0.30-1.42). The rate of stent thromboses reinfarctions and mortality was not different between the bivalirudin and the heparin group. During 1-year follow-up bivalirudin was associated with a lower rate of bleedings and no significant differences in stent thromboses, reinfarctions, and mortality. Bivalirudin was not associated with an excess of bleedings or stent thromboses in subgroups that are regularly underrepresented in randomized trials (older patients, women, cardiogenic shock).. In this "real-world" cohort of patients with STEMI bivalirudin compared to heparin and GPIs was associated with less bleedings and no significant differences in stent thromboses, reinfarctions, and mortality during hospital and long-term course.

Topics: Aged; Antithrombins; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Complications; Recombinant Proteins; Registries; Retrospective Studies; ST Elevation Myocardial Infarction; Treatment Outcome

Topics: Fibrinolytic Agents; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction

Aspiration thrombectomy was performed to retrieve intact thrombus in a 69-year-old woman. Bradycardia and hypotension rapidly resolved. Balloon angioplasty was performed at the site of proximal RCA in-stent restenosis with improved angiographic appearance and TIMI 3 flow in the major branches.

Topics: Aged; Angioplasty, Balloon, Coronary; Antithrombins; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Electrocardiography; Female; Hirudins; Humans; Peptide Fragments; Recombinant Proteins; ST Elevation Myocardial Infarction; Syncope; Treatment Outcome

BACKGROUND Diffuse alveolar hemorrhage (DAH) is a rare but potentially fatal complication of anticoagulant or antiplatelet therapy. Bivalirudin is a specific and reversible direct thrombin inhibitor (DTI). CASE REPORT We report a case of severe DAH, possibly related to bivalirudin use, in a 61-year-old patient undergoing coronary intervention. The patient had presented with an out-of-hospital cardiac arrest due to acute ST elevation myocardial infarction (STEMI). During the coronary intervention, shortly after receiving bivalirudin, the patient started having frank bleeding from the endotracheal tube and developed hemodynamic compromise. Despite aggressive intervention and intensive care, the patient died. CONCLUSIONS At this time, to our knowledge, there have been no reports of DAH associated with the use of bivalirudin.

Topics: Antithrombins; Fatal Outcome; Hemorrhage; Hirudins; Humans; Lung Diseases; Male; Middle Aged; Out-of-Hospital Cardiac Arrest; Peptide Fragments; Percutaneous Coronary Intervention; Pulmonary Alveoli; Recombinant Proteins; ST Elevation Myocardial Infarction

This study aimed to evaluate the effect of prolonged full-dose bivalirudin infusion in real-world population with ST-elevation myocardial infarction (STEMI).. Subgroup data as well as meta-analysis from randomized clinical trials have shown the potency of postprocedural full-dose infusion (1.75 mg/kg/h) of bivalirudin on attenuating acute stent thrombosis (ST) after primary percutaneous coronary intervention (PCI).. In this multicenter retrospective observational study, 2047 consecutive STEMI patients treated with bivalirudin during primary PCI were enrolled in 65 Chinese centers between July 2013 and May 2016. The primary outcome was acute ST defined as ARC definite/probable within 24 hours after the index procedure, and the secondary endpoints included total ST, major adverse cardiac or cerebral events (MACCE, defined as death, reinfarction, stroke, and target vessel revascularization), and any bleeding at 30 days.. Among 2047 STEMI patients, 1123 (54.9%) were treated with postprocedural bivalirudin full-dose infusion (median 120 minutes) while the other 924 (45.1%) received low-dose (0.25 mg/kg/h) or null postprocedural infusion. A total of three acute ST (0.3%) occurred in STEMI patients with none or low-dose prolonged infusion of bivalirudin, but none was observed in those treated with post-PCI full-dose infusion (0.3% vs 0.0%, P=.092). Outcomes on MACCE (2.1% vs 2.7%, P=.402) and total bleeding (2.1% vs 1.4%, P=.217) at 30 days showed no significant difference between the two groups, and no subacute ST was observed.. Post-PCI full-dose bivalirudin infusion is safe and has a trend to protect against acute ST in STEMI patients undergoing primary PCI in real-world settings.

Topics: Aged; Antithrombins; China; Coronary Angiography; Coronary Thrombosis; Female; Hemorrhage; Hirudins; Humans; Infusions, Parenteral; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Recurrence; Retrospective Studies; Risk Factors; ST Elevation Myocardial Infarction; Stents; Time Factors; Treatment Outcome

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).. 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).. 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.. Higher rates of ⩾70% ST-segment resolution (72.7% vs 60.0%, p=0.004), lower postprocedural peak CK-MB levels (188.3±148.7 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).. 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.

Topics: Administration, Intravenous; Aged; Coronary Angiography; Female; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; ST Elevation Myocardial Infarction; Treatment Outcome

In recent studies of primary percutaneous coronary intervention (PCI), bivalirudin compared with heparin has been associated with increased risk of stent thrombosis (ST). Our aim was to describe incidence and outcome of definite, early ST in a large contemporary primary PCI population divided in antithrombotic therapy subgroups.. A prospective, observational cohort study of all 31,258 ST-elevation myocardial infarction patients who received a stent in Sweden from January 2007 to July 2014 in the SWEDEHEART registry was conducted. Patients were divided into 3 groups: bivalirudin, heparin alone, or glycoprotein IIb/IIIa inhibitor treated. Primary outcome measure was incidence of definite early ST (within 30 days of PCI). Secondary outcomes included all-cause mortality. Incidence of early ST was low, regardless of bivalirudin, heparin alone, or glycoprotein IIb/IIIa inhibitor treatment (0.84%, 0.94%, and 0.83%, respectively). All-cause mortality at 1 year was 20.7% for all ST patients (n = 265), compared with 9.1% in those without ST (n = 31,286; P < .001). Patients with ST days 2-30 had numerically higher all-cause mortality at 1 year compared with patients with ST days 0-1 (23% vs 16%, P = .20).. In this real-world observational study of 31,258 ST-elevation myocardial infarction patients, the incidence of early ST was low, regardless of antithrombotic treatment strategy. Early ST was associated with increased mortality. Numerically higher all-cause mortality at 1 year was noted with ST days 2-30 compared with ST days 0-1 post-PCI.

Topics: Aged; Antithrombins; Coronary Restenosis; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Outcome and Process Assessment, Health Care; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Glycoprotein GPIIb-IIIa Complex; Prospective Studies; Recombinant Proteins; Registries; ST Elevation Myocardial Infarction; Stents; Sweden

The optimal antithrombotic treatment during a primary percutaneous coronary intervention (pPCI) is not known. This single center registry study aims to assess the safety of a novel antithrombotic regimen combining enoxaparine and prasugrel at presentation, followed by bivalirudin at the catheterisation laboratory.. All consecutive patients who underwent a pPCI were collected prospectively. The primary endpoint was major bleeding within 30 days. The secondary endpoints were a composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, a new target vessel revascularisation and all-cause mortality at 30 days.. Ninety-nine out of the total of 390 patients were treated according to the new regimen (protocol-treated group). The rest received other antithrombotic treatment (non-protocol-treated group). The protocol-treated group had a lower risk than the non-protocol-treated group according to the GRACE ischaemic (112 vs. 124, p = 0.002) and CRUSADE bleeding scores (21 vs. 28, p < 0.0001). The incidences of bleeding were similar: severe GUSTO or TIMI bleeding occurred in 0 % of the protocol-treated group and in 1.0 and 0.3 %, respectively, of the other group (p = 0.311 for GUSTO and p = 0.559 for TIMI). The incidence of MACE in the groups was 6.1 and 10.7 %, respectively (p = 0.178). The respective incidences of all-cause mortality were 5.1 and 9.6 % (p = 0.158).. Administration of the novel antithrombotic regimen seems to be safe.

Topics: Aged; Antithrombins; Cause of Death; Dose-Response Relationship, Drug; Drug Therapy, Combination; Electrocardiography; Enoxaparin; Female; Finland; Follow-Up Studies; Hirudins; Humans; Incidence; Infusions, Intravenous; Inpatients; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Hemorrhage; Prasugrel Hydrochloride; Recombinant Proteins; Retrospective Studies; ST Elevation Myocardial Infarction; Survival Rate; Treatment Outcome

The use of antithrombotic therapy (ATT) (bivalirudin or unfractionated heparin) is a class I recommendation for patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI). This survey was conducted to better understand current United States (US) practices in terms of preferences regarding the selection of ATT in STEMI-PPCI, particularly in light of recent clinical trials.. An electronic survey consisting of 9 focused questions was forwarded to 2676 US interventional cardiologists who were members of the Society for Cardiovascular Angiography and Interventions (SCAI).. Among 390 responders (14.5%), bivalirudin with bail-out glycoprotein IIb/IIIa inhibitor (GPI) was the predominant strategy for 53% of operators, whereas 32% preferred heparin with bail-out GPI and 15% preferred heparin with more routine GPI. The duration of bivalirudin infusion varied widely among operators, and significant variability existed in the bolus dose of heparin that was preferred by operators. About 49% of respondents stated that the choice of ATT was not affected by the bleeding risk of the patient, although access site did appear to affect the choice of ATT for some operators. Notably, 43% of operators reported to have changed their practice regarding ATT in light of recent trial results.. There is marked variability in self-reported ATT use in STEMI-PPCI among US interventional cardiologists. Given the patient-related variability in bleeding risk and mixed clinical trial results between the two predominant ATT agents, bivalirudin and unfractionated heparin, more data are needed in order to further inform and potentially unify clinical practice in STEMI-PPCI.

Topics: Adult; Anticoagulants; Attitude of Health Personnel; Cardiologists; Cross-Sectional Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Electrocardiography; Female; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Radiology, Interventional; Recombinant Proteins; Risk Factors; ST Elevation Myocardial Infarction; Surveys and Questionnaires; Treatment Outcome; United States

Despite numerous studies in recent years, the best anticoagulant option for primary percutaneous coronary intervention (PCI) remains a matter of debate.. To compare in-hospital outcomes after prehospital administration of low-dose unfractionated heparin (UFH)±glycoprotein IIb/IIIa inhibitors (GPIs), enoxaparin±GPIs, or bivalirudin in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI).. A total of 1720 patients (median age 62.0 years, 79.2% male) who had been enrolled in a prospective registry and received an injectable anticoagulant in physician-staffed mobile intensive care units before primary PCI were included in the study. The main outcomes were in-hospital major adverse cardiovascular events (MACE) (a composite of all-cause mortality, non-fatal myocardial infarction, stroke or definite stent thrombosis) and in-hospital major bleeding (Bleeding academic research consortium type 3 or 5).. UFH was administered in 420 (24.4%) patients, enoxaparin in 1163 (67.6%) patients and bivalirudin in 137 patients (8.0%). Rates of in-hospital MACE were 7.4% with UFH, 6.0% with enoxaparin and 6.6% with bivalirudin, with no significant differences between groups (P=0.628). In-hospital major bleeding occurred in 1.7% of patients on UFH, 1.4% on enoxaparin and 1.5% on bivalirudin (P=0.851). By multivariable analysis, the prehospital anticoagulant used was not an independent predictor of MACE or major bleeding.. In this prospective registry, there were no significant differences in the rates of in-hospital MACE or major bleeding after prehospital initiation of UFH, enoxaparin or bivalirudin in patients treated by primary PCI for STEMI.

Topics: Anticoagulants; Antithrombins; Electrocardiography; Enoxaparin; Female; Follow-Up Studies; Heparin; Hirudins; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Preoperative Care; Prospective Studies; Recombinant Proteins; Registries; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

The purpose of this study was to describe temporal trends and determine the comparative effectiveness of bivalirudin versus unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).. Several clinical trials have compared the safety and effectiveness of bivalirudin versus UFH during PCI for STEMI, but results have been conflicting.. Trends in anticoagulant use were examined among 513,775 PCIs for STEMI from July 2009 through December 2014 within the National Cardiovascular Data Registry CathPCI Registry. We conducted an instrumental variable analysis comparing bivalirudin with UFH, using operator preference for bivalirudin as the instrument. We used a test of mediation to determine the extent to which differences in outcomes between anticoagulants were due to differences in use of glycoprotein IIb/IIIa inhibitors (GPI). Primary outcomes were in-hospital bleeding and mortality.. Bivalirudin use increased from 2009 through 2013, followed by a new decline. GPIs were used in 74.7% of UFH PCIs versus 26.5% of bivalirudin PCIs. In unadjusted analyses, bivalirudin was associated with decreased bleeding (risk difference [RD]: -4.2%; p < 0.001) and mortality (RD: -0.84%; p < 0.001). After instrumental variable analyses, bivalirudin remained associated with less bleeding (RD: -3.75%; p < 0.001), but not mortality (RD: -0.10%; p = 0.280). The higher rate of GPI use with UFH was responsible for more than one-half of bivalrudin's bleeding reduction (GPI-adjusted RD: -1.57%; p < 0.001). Bleeding reductions were negligible for transradial PCI (RD: -0.11%; p = 0.842).. The use of bivalirudin during STEMI has decreased. Bivalirudin was associated with reduced bleeding and no mortality difference. The bleeding reduction with bivalirudin was largely explained by the greater use of GPIs with UFH.

Topics: Aged; Anticoagulants; Antithrombins; Comparative Effectiveness Research; Coronary Thrombosis; Drug Utilization Review; Female; Hemorrhage; Heparin; Hirudins; Hospital Mortality; Humans; Male; Middle Aged; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Recombinant Proteins; Registries; Risk Factors; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome; United States