Risk Of Acute Stent Thrombosis Research Articles

736 Hazy spots: through the eye of optical coherence tomography

Abstract Aims Acute stent thrombosis after coronary artery stent placement is a rare but serious complication in percutaneous coronary intervention (PCI). Stenting culprit lesions in acute coronary syndrome (ACS) has higher risk of acute stent thrombosis than stable coronary artery disease, and many local and systemic factors may contribute to increase this risk. Tissue protrusion (TP), and in particular, plaque prolapse after PCI can play a role in acute stent thrombosis, and intra-vessel imaging is the principal instrument to identify such underlying lumen alteration after stent implantation, and guide intervention. Methods and results We report the case of a 54-year-old man with a history of hypertension, dyslipidemia, type 2 diabetes mellitus, obesity and no other relevant comorbidities in remote history, who underwent a coronary angiography for an unstable angina. A long, calcific sub-occlusion of the left anterior descending artery (LAD), which involved LAD-first diagonal branch (D1) bifurcation (Medina 1.1.1) and LAD-D2 bifurcation (Medina 1.1.0) was found. After deployment of two overlapping drug-eluting stents (DES), (ULTIMASTER TANSEI 3.0 × 38 mm and 3.0 × 21 mm) and struts apposition optimization with sequence of proximal optimization technique (POT) on D1 and D2, and a kissing balloon technique (KS) on LAD-D2 bifurcation, a ‘hazy’ in-stent image was detected right after the LAD-D2 bifurcation, suggesting an acute in-stent thrombosis, in absence of flow alteration (TIMI 3), symptoms or ECG modifications. Multiple thrombus-aspiration were made and resulted in abundant thrombus removal and improvement in the angiographic image, with persistent valid flow on every three vessels (TIMI 3). After 5 days of triple anticoagulant therapy with ticagrelor, cardioaspirin and UFH infusion, he underwent a new coronary angiography control. A similar ‘hazy’ image was detected right after LAD-D2 bifurcation within the LAD. An optical coherence tomography (OCT) pullback was made to assess the nature of the angiographic finding. OCT showed good struts apposition in almost every cross-sectional images, but an evident TP was detected right on the angiographic hazy spot. OCT allowed to evaluate the lipid-richness of the stented plaque and the nature of the TP, which was mixed with evident both white and red thrombus apposition (minimum luminal area measured 4.5 mm2). OCT guided a new PCI, with a stent-in-stent implantation on LAD. TP was absent on the post-PCI OCT run. Conclusions In this report, we showed the usefulness of OCT in revealing a potential high risk thrombogenic source. OCT not only characterized something that angiography alone couldn’t, but suggested the etiology of the amount of thrombus removed by the vessel during the first PCI. Indeed, despite an optimized cycle of anticoagulant therapy, OCT still revealed several mixed thrombus apposition on the TP, and this suggested its role in the acute stent thrombosis. OCT guided the choice to appose a new stent-in-stent to solve a potential thrombogenic source.

Coronary artery bypass graft surgery in patients on ticagrelor therapy is not associated with adverse perioperative outcomes

BackgroundManagement of patients treated with Ticagrelor is challenging, as stopping Ticagrelor prior to coronary bypass graft surgery (CABG) may increase the risk of acute stent thrombosis. The aim of the study was to compare bleeding complications in patients treated with ticagrelor combined with acetylsalicylic acid (ASA) versus ASA alone until 1 day before surgery.MethodsBleeding complications, defined as the composite of red blood cell transfusion ≥1000 ml, chest drainage ≥2000 ml, and bleeding requiring surgical re-exploration, were compared in 161 patients, with 101 on preoperative acetylsalicylic acid (ASA) alone (group A) and 65 on ticagrelor + ASA (group B).ResultsThere were no differences in bleeding complications between the two groups (26% vs. 27% in group A and B, respectively), with similar chest drainage in the first 24 h (569 ± 393 ml and 649 ± 427 ml, respectively).ConclusionsContinuing ticagrelor until coronary artery bypass surgery was not associated with increased bleeding complications, suggesting that continued management with ticagrelor until surgery may be safe.

Immobilisation of an anti-platelet adhesion and anti-thrombotic drug (EP224283) on polydopamine coated vascular stent promoting anti-thrombogenic properties.

Current vascular drug-eluting stents based on immuno-proliferative drugs would reduce the rate of in-stent restenosis (ISR) but may be associated with a higher risk of acute stent thrombosis due to non-selective activity. In this paper, we aimed to develop a polydopamine (PDA) coated chromium‑cobalt (CoCr) stent functionalised with EP224283 (Endotis Pharma SA), which combines both a GPIIbIIIa antagonist (tirofiban moiety) and a factor Xa inhibitor (idraparinux moiety) to reduce acute stent thrombosis. PDA-coated chromium‑cobalt (CoCr) samples were first immersed in a polyethylenimine (PEI, pH8.5) solution to increase amine function density (36.0±0.1nmol/cm2) on the CoCr surface. In a second step, avidin was grafted onto CoCr-PDA-PEI through the biotin linkage (strategy 1) or directly by coupling reactions (strategy 2). The HABA titration proved the fixation of biotin onto CoCr-PDA-PEI surface with a density of 0.74nmol/cm2. The fixation of avidin was demonstrated by water contact angle (WCA) and surface plasmon resonance (SPR). SEM micrograph shows the flexibility of the thin layer coated onto the stent after balloon inflation. Independently of the strategy, a qualitative SEM analysis showed a reduction in platelet activation when the molecule EP224283 was immobilised on avidin. In parallel, the measurement of anticoagulant activity (anti-Xa) revealed a higher anti-factor Xa activity (2.24IU/mL vs. 0.09IU/mL in control) when EP224283 was immobilised on avidin. Interestingly, after seven days of degradation, the anticoagulant activity was persistent in both strategies and looked more important with the strategy 2 than in strategy 1. Throughout this work, we developed an innovative vascular stent through the immobilisation of EP224283 onto CoCr-PDA-PEI-(avidin) system, which provides a promising solution to reduce ISR and thrombosis after stent implantation.

Bivalirudin Versus Heparin During Intervention in Acute Coronary Syndrome: A Systematic Review of Randomized Trials.

Introduction: Bivalirudin and heparin are the two most commonly used anticoagulants used during Percutaneous Coronary Intervention (PCI). The results of Randomized Controlled Trials (RCTs) comparing bivalirudin versus heparin monotherapy in the era of radial access are controversial, questioning the positive impact of bivalirudin on bleeding. The purpose of this systematic review is to summarize the results of RCTs comparing the efficacy and safety of bivalirudin versus heparin with or without Glycoprotein IIb/IIIa Inhibitors (GPI).Methods:This systematic review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA statements for reporting systematic reviews. We searched the National Library of Medicine PubMed, Clinicaltrial.gov and the Cochrane Central Register of Controlled Trials to include clinical studies comparing bivalirudin with heparin in patients undergoing PCI. Sixteen studies met inclusion criteria and were reviewed for the summary.Findings: Several RCTs and meta-analyses have demonstrated the superiority of bivalirudin over heparin plus routine GPI use in terms of preventing bleeding complications but at the expense of increased risk of ischemic complications such as stent thrombosis. The hypothesis of post- PCI bivalirudin infusion to mitigate the risk of acute stent thrombosis has been tested in various RCTs with conflicting results. In comparison, heparin offers the advantage of having a reversible agent, of lower cost and reduced incidence of ischemic complications.Conclusion:Bivalirudin demonstrates its superiority over heparin plus GPI with better clinical outcomes in terms of less bleeding complications, thus making it as anticoagulation of choice particularly in patients at high risk of bleeding. Further studies are warranted for head to head comparison of bivalirudin to heparin monotherapy to establish an optimal heparin dosing regimen and post-PCI bivalirudin infusion to affirm its beneficial effect in reducing acute stent thrombosis.

Association of the CHA2DS2VASc Score with Acute Stent Thrombosis in Patients with an ST Elevation Myocardial Infarction Who Underwent a Primary Percutaneous Coronary Intervention

Objective: In this study, we aimed to determine the predictive value of the CHA₂DS₂VASc score for acute stent thrombosis in patients with an ST elevation myocardial infarction treated with a primary percutaneous coronary intervention (pPCI). Methods: This was a retrospective study conducted among 3,460 consecutive patients with STEMI who underwent a pPCI. The stent thrombosis was considered a definite or confirmed event in the presence of symptoms suggestive of acute coronary syndrome and angiographic confirmation of stent thrombosis based on the diagnostic guidelines of the Academic Research Consortium. The stent thrombosis was classified as acute if it developed within 24 h. Results: The mean CHA₂DS₂VASc score was 3.29 ± 1.73 in the stent thrombosis group, whereas it was 2.06 ± 1.14 in the control group (p < 0.001). In multivariable logistic regression analysis, CHA₂DS₂VASc scores ≥ 4 were independently associat ed with acute stent thrombosis (OR = 1.64; 95% CI 1.54–1.71, p < 0.001). In a receiver operating characteristic curve ana­lysis, the best cut-off value for the CHA₂DS₂VASc score was ≥4, with 60% sensitivity and 73% specificity. Of note, pa tients with a CHA₂DS₂VASc score of 4 had a 4.3 times higher risk of acute stent thrombosis compared to those with a CHA₂DS₂VASc score of 1. Conclusions: The CHA₂DS₂VASc score may be a significant independent predictor of acute stent thrombosis in patients with STEMI treated with a pPCI. Therefore, the CHA₂DS₂VASc score may be used to assess the risk of acute stent thrombosis in patients with STEMI following a pPCI.

Risks of Opioids in ST-Elevation Myocardial Infarction: A Review.

Although opioids are recommended and frequently used in the acute phase of ST-elevation myocardial infarction (STEMI), their use is accompanied by serious side effects. In particular, gastrointestinal adverse effects may disturb absorption of essential oral medication like platelet inhibitors. This may cause suboptimal platelet inhibition and increased risk of acute stent thrombosis. Some clinical studies have already demonstrated these negative results. Alternative strategies to optimize platelet inhibition and pain relief in STEMI are being investigated. Clinicians should become more aware of the potential side effects of opioids in STEMI.

Use of Bivalirudin for Anticoagulation in Interventional Cardiovascular Procedures

Anticoagulation is imperative to reduce the incidence of thrombotic complications in patients undergoing percutaneous interventional cardiovascular procedures; however, this is at the expense of increased risk of bleeding. The optimal anticoagulation strategy for these procedures remains unclear. Unfractionated heparin is the most commonly used anticoagulant during interventional procedures, but has several limitations, such as relatively high incidence of bleeding events, occurrence of heparin-induced thrombocytopenia, and a paradoxical thrombotic effect. Contemporary studies have demonstrated that bivalirudin decreases the occurrence of bleeding complications, but potentially increases the risk of acute stent thrombosis. This review discusses the pharmacology of bivalirudin and its current clinical application in patients undergoing percutaneous coronary intervention and transcatheter aortic valve replacement procedures.

Antithrombotic efficacy of bivalirudin compared to unfractionated heparin during percutaneous coronary intervention for acute coronary syndrome

Bivalirudin is associated with an increased risk of acute stent thrombosis (AST) compared to unfractionated heparin (UFH) in acute coronary syndrome patients (ACS) during short-duration percutaneous coronary intervention (PCI). The mechanisms involved are unknown. We aimed to investigate the antithrombotic efficacy of bivalirudin compared to UFH during PCI. In a monocenter study, we prospectively enrolled 30 patients undergoing PCI for a non–ST elevation ACS. They were randomly assigned to a single intravenous (IV) bolus of UFH (70 IU/kg) or an IV bolus of bivalirudin 0.75 mg/kg followed by a 1.75 mg/kg/h infusion during PCI. All patients received a loading dose (LD) of 180 mg of ticagrelor at the time of PCI. The VASP index and activated partial thromboplastin time (aPTT) were used to assess the course of platelet reactivity (PR) and antithrombotic activity. The two groups were similar regarding baseline, angiographic, and interventional characteristics. There was no difference between the two groups in the course of PR following ticagrelor LD. An optimal PR inhibition was obtained 4 h after the LD of ticagrelor. The level of antithrombotic activity was significantly lower in the bivalirudin group compared to the UFH group (p < 0.001) during PCI but similar at 2 and 4 h post-PCI. We observed that, in ACS undergoing PCI, the antithrombotic efficacy of an IV bolus of bivalirudin is significantly lower than that of a 70-IU/kg UFH bolus. This could contribute to the excess in thrombotic acute events observed during short-duration PCI.

SAFETY OF HEPARIN COMPARED WITH BIVALIRUDIN IN PATIENTS UNDERGOING TRANSRADIAL PERCUTANEOUS CORONARY INTERVENTION

Background: Randomized clinical trials (RCTs) comparing heparin with bivalirudin during percutaneous coronary intervention (PCI) for myocardial infarction (MI) have produced mixed results: heparin may be associated with a lower risk of acute stent thrombosis (ST) but more bleeding. We tested the

Effect of post-primary percutaneous coronary intervention bivalirudin infusion on net adverse clinical events and mortality: A comprehensive pairwise and network meta-analysis of randomized controlled trials.

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.

Prolonged High-Dose Bivalirudin Infusion Reduces Major Bleeding Without Increasing Stent Thrombosis in Patients Undergoing Primary Percutaneous Coronary Intervention: Novel Insights From an Updated Meta-Analysis.

BackgroundThe 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.Methods and ResultsEligible 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).ConclusionsBivalirudin (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.

Antithrombotic Selection in ST-Segment Elevation Myocardial Infarction: a Year in Review.

In ST-segment elevation myocardial infarction (STEMI), interventional cardiologists must move quickly to safely re-establish blood flow while choosing an antithrombotic to preclude wire thrombosis, aid in the restoration of flow, minimize thrombus propagation, and reduce the risk of stent thrombosis. Currently, operators have a choice between heparin and bivalirudin with the possible addition of glycoprotein IIb/IIIa inhibitors (GPIs). Prior studies have shown that bivalirudin use lowers rates of bleeding, but with a clear risk of acute stent thrombosis. Recent studies have examined this question in the modern era of radial access and newer antiplatelet agents. Despite these studies, there remains a question regarding which antithrombotic agent is to be selected in STEMI.

BIVALIRUDIN FOR PERCUTANEOUS CORONARY INTERVENTIONS: REVIEW OF CURRENT GUIDELINES

Purpose. The purpose of this article was a review of contemporary international guidelines for the analysis of the evidence base for bivalirudin use as a medical support of percutaneous coronary intervention (PCI) in patients with different forms of coronary artery disease. Materials and methods. Based on a review of European and American guidelines for management and revascularization in patients with different forms of coronary artery disease of 2013, 2014 and 2015, the evidence base of bivalirudin use as a medical support for PCI in patients with different forms of coronary artery disease was analyzed. Results. The current evidence base for anticoagulant PCI support in patients with different forms of coronary artery disease means choosing safe and effective anticoagulant accordance to the profiles of ischemic and hemorrhagic risk. The direct thrombin inhibitor bivalirudin has a short half-life, predictable anticoagulant profile and has indications for use it in any form of coronary artery disease (Stable coronary artery disease, Non-STEMI and STEMI), based on a large number of randomized clinical trials. Conclusions . There is no doubt that bivalirudin for patients with stable coronary artery disease and heparin-induced thrombocytopenia and for a cohort of patients with a high risk of bleeding complications has benefits and efficacy. Bivalirudin as the anticoagulant support for PCI in non-STEMI patients has the highest class and level of evidence. Class and level of evidence for the use of bivalirudin as PCI support in STEMI patients in 2014 decreased to class IIa, level A however increased risk of acute stent thrombosis associated with the bivalirudin using in this group of patients does not lead to an increased risk of death compared with unfractionated heparin.

Chronic total occlusions of the right coronary and left anterior descending coronary arteries in a young adult patient with antiphospholipid syndrome

A 36-year-old male appeared to have an old myocardial infarction on electrocardiogram, and coronary angiography (CAG) was performed. The CAG showed total occlusions of the right coronary artery and left anterior descending artery. He was successfully treated with drug-eluting stent implantation for both occluded coronary arteries. Such serious coronary lesions are uncommon for his young age. The patient was diagnosed as having antiphospholipid syndrome (APS) based on elevation of anticardiolipin antibody and anti-β2 glycoprotein I antibody. Two years after stent implantation, the patient was well without ischemia or thrombosis. APS should be considered a potential cause of serious coronary disease in young adults.<Learning objective: Antiphospholipid syndrome (APS) should be considered a potential cause of serious coronary disease in young adults. Although there is a high risk of acute stent thrombosis and restenosis after multiple stents implantation, percutaneous coronary intervention with drug-eluting stent implantation could be an appropriate therapy for chronic total occlusion in APS patients.>

Morphine delays the onset of action of prasugrel in patients with prior history of ST-elevation myocardial infarction.

Delays in the onset of action of prasugrel during primary percutaneous coronary intervention (PPCI) have been reported and could be related to the effects of morphine on gastric emptying and subsequent intestinal absorption. The study objective was to determine whether morphine delays the onset of action of prasugrel in patients with a prior history of ST-elevation myocardial infarction (STEMI) treated with PPCI. This was a crossover study of 11 aspirin-treated patients with prior history of STEMI treated with PPCI, for which prasugrel and morphine had been previously administered. Patients were randomised to receive either morphine (5 mg) or saline intravenously followed by 60 mg prasugrel. Blood samples were collected before randomised treatment and over 24 hours after prasugrel administration. The inhibitory effects of prasugrel on platelets were determined using the VerifyNow P2Y12 assay and light transmission aggregometry. Plasma levels of prasugrel and prasugrel active metabolite were measured. Platelet reactivity determined by VerifyNow PRU, VerifyNow % Inhibition and LTA was significantly higher at 30-120 minutes (min) when morphine had been co-administered compared to when saline had been co-administered. Morphine, compared to saline, significantly delayed adequate platelet inhibition after prasugrel administration (158 vs 68 min; p = 0.006). Patients with delayed onset of platelet inhibition also had evidence of delayed absorption of prasugrel. In conclusion, prior administration of intravenous morphine significantly delays the onset of action of prasugrel. Intravenous drugs may be necessary to reduce the risk of acute stent thrombosis in morphine-treated STEMI patients undergoing PPCI.

Bivalirudin versus unfractionated heparin: a meta-analysis of patients receiving percutaneous coronary intervention for acute coronary syndromes

ObjectiveAcute coronary syndrome (ACS) encompasses ST segment elevation myocardial infarction (STEMI), with generally high thrombus burden and non-ST segment elevation ACS (NSTE-ACS), with lower thrombus burden. In the setting of...

One Shot, Staged Procedures or Immediate Full Revascularization Strategy for Patients with Multivessel Disease Admitted for STEMI: Still a Bone of Contention

In patients admitted for ST-segment sus-elevation myocardial infarction (STEMI), revascularization is the corner stone of the management, completing the medical treatments [1,2]. Although it is widely accepted and strongly recommended that the culprit lesion has to be treated during the Primary Percutaneous Coronary Intervention (PPCI), the better option regarding the other lesions in case of multivessel disease remains controversial. On the one hand, treating only the culprit lesion allows a shorter procedure with less renal impairment and lower risk of acute stent thrombosis. On the other hand, treating all the stenoses allow to shorten the hospitalization, stabilize the unstable plaques (See Table 1 for a detailed description of the advantages/disadvantages imbalance of the two sides of the medal). Importantly, this dilemma is not at all rare but should represent 30% to half of the patients admitted for STEMI [1,2].

Bivalirudin Started during Emergency Transport for Primary PCI

BackgroundBivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown.MethodsWe randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding.ResultsBivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients.ConclusionsBivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis. (Funded by the Medicines Company; EUROMAX ClinicalTrials.gov number, NCT01087723.)

Endothelialisation of 3rd generation orsiro hybrid drug eluting stents at 6 months follow-up: analysis by optical coherence tomography

Background: Since the introduction of 2rd generation DES and dual antiplateled therapy (DAPT) stent thrombosis is a rare complication of PCI. DAPT is recommended for 6-12 months after DES implantation. Long term DAPT involves the risk of bleeding events, shorter DAPT duration would be beneficial. The Hybrid Orsiro DES presenting a new concept by combination of passive and active components. The passive coating seals the stent and minimizes tissue interaction. The active component is a bioresorbable polymer matrix combined with sirolimus. Stent thrombosis correlates to mal-apposition and incomplete stent coverage. IVUS is not able to monitor strut coverage due to lack of resolution. Intracoronary optical coherence tomography (OCT) is able to solve this shortcoming. Stent endothelialisation is associated to OCT strut coverage although not fully identical. We tested, whether the Orsiro Hybrid DES has no strut malapposition related to the polymer/drug combination as measured by OCT after 6 months. Methods: Patients (n=13, with n =21 Orsiro Hybrid-DES) were readmitted for routine coronary angiography and OCT 6 months after PCI. (Figure 1) Stent struts (n= 702) were classified according to previously described criteria (mean ± SEM): type I (embedded struts with>0.15 mm neointima): 25.5±11.2%; type II (embedded struts with< 0.15mm neointima): 49.9±21.5%; type IIIa (protruding/covered struts): 19.6±9.7%; type IIIb (protruding/ uncovered): 3.3±3.1%; type IV (malapossed/uncovered struts): 1.7±3.1%. ![Figure][1] Figure 1 Conclusion: The data support the hypothesis that Orsiro Hybrid DES achieved nearly complete strut coverage as measured by OCT at 6 months. Therefore an early termination of DAPT could be an option to prevent major bleeding events without increasing the risk of acute stent-thrombosis. [1]: pending:yes

Bleeding Complications With Regional Adaptation of a Prolonged Bivalirudin Regimen for ST-Elevation Acute Myocardial Infarction

Bivalirudin (BIV) is superior to a heparin/glycoprotein IIb/IIIa receptor inhibitor (GPI) strategy with respect to net adverse cardiovascular events for ST-segment elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI), albeit with an increased risk of acute stent thrombosis. We hypothesized that a 2-hour BIV infusion after PCI (BIV + 2) could be used without increased bleeding risk as a potential method of mitigating early thrombotic risk. We analyzed a 6-center regional protocol involving routine therapy with aspirin, clopidogrel, and bolus heparin followed by primary PCI for STEMI using BIV. All consecutive patients presenting with STEMI requiring primary PCI were included (2009 to 2011). We compared baseline characteristics and clinical outcomes of the University of Vermont Regional Registry to the historical groups of BIV (BIV terminated at end of PCI) or unfractionated heparin/GPI from the HORIZONS trial and determined independent predictors of bleeding. Of 346 patients undergoing PCI for STEMI, 98% received BIV; 82% of patients received BIV + 2, and 13.3% of all patients receiving BIV received GPI bailout. All-cause mortality was 3.1%. Overall bleeding rates were 50% less than in the HORIZONS GPI arm and similar to the HORIZONS BIV arm. Acute stent thrombosis occurred in <1.0% of patients. Bailout GPI was a potent independent predictor of bleeding complications. In conclusion, BIV + 2 is a feasible regional pharmacologic algorithm for STEMI PCI; BIV + 2 for STEMI PCI is not associated with increased bleeding risk and warrants further study as a mechanism of mitigating very early thrombosis risk.