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Observational design, selection bias of study cohort.
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Thienopyridines are metabolized to active metabolites that irreversibly inhibit the platelet P2Y(12) adenosine diphosphate receptor. The pharmacodynamic response to clopidogrel is more variable than the response to prasugrel, but the reasons for variation in response to clopidogrel are not well characterized.
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Clopidogrel is a prodrug that has to be converted in vivo to its active metabolite by cytochrome (CYP)P450 iso-enzymes. As calcium channel blockers (CCBs) are inhibitors of CYP3A4, concomitant use of these drugs might play a role in the wide inter-individual variability in the response to clopidogrel. However, some CCBs also have strong inhibitory effects on the drug transporter P-glycoprotein (Pgp), which mediates clopidogrel's intestinal absorption. It was the aim of this study to evaluate the effect of co-administration of Pgp-inhibiting and non-Pgp-inhibiting CCBs on on-clopidogrel platelet reactivity in patients on dual antiplatelet therapy undergoing elective percutaneous coronary intervention (PCI). In a total of 623 consecutive patients undergoing elective PCI treated with clopidogrel and aspirin, platelet reactivity to 5 and 20 muM adenosine diphospate (ADP) and clopidogrel poor-response (defined as > 70% platelet aggregation to 20 muM ADP) were evaluated by light transmittance aggregometry. A total of 222 patients (35.6%) were on CCB treatment, of which 98 used Pgp-inhibiting CCBs (verapamil, nifedipine, diltiazem, barnidipine) and 124 patients used the non-Pgp-inhibiting CCB amlodipine. Adjusted mean ADP-induced on-clopidogrel platelet reactivity was significantly higher in both users of Pgp-inhibiting CCBs and amlodipine as compared to CCB non-users (all p<0.05). However, only the use of amlodipine was significantly associated with a 2.3-fold increased risk of clopidogrel poor-response. This study demonstrates that concomitant use of Pgp-inhibiting CCBs and amlodipine increases on-clopidogrel platelet reactivity. Only amlodipine was associated with clopidogrel poor-response. The drug-drug interaction between clopidogrel and amlodipine might be more clinically relevant as compared to P-glycoprotein-inhibiting CCBs.
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The present work identifies decreased platelet miR-223 expression as a novel mechanism involved in blunted platelet response to clopidogrel in a Chinese population.
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Vorapaxar, a novel antiplatelet thrombin protease-activated receptor 1 (PAR-1) inhibitor, has been evaluated in the successful TRA2P trial and failed TRACER trial. The drug is currently approved for post myocardial infarction and peripheral artery disease indications on top of clopidogrel and/or aspirin. The stroke data after vorapaxar are mixed, dominated with heavy excess of intracranial bleeding risks and slightly worsened second stroke rates, but show less primary ischemic strokes. Fortunately, these conflicting data do not belong purely to vorapaxar per se but rather, reflect unreasonably aggressive strategies, including predominantly triple antiplatelet therapy, utilized in both Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients with Arteriosclerosis (TRA2P) and especially in Thrombin-Receptor Antagonist Vorapaxar in Acute Coronary Syndromes (TRACER). The FDA-confirmed evidence strongly suggests that unique pharmacokinetics and a very mild "comfort zone" antiplatelet profile makes vorapaxar a good candidate for improved secondary stroke prevention. The outcome-driven, randomized trial should test head-to-head monotherapy with vorapaxar (Zontivity®) versus clopidogrel (Plavix®) and versus dipyridamole with very low dose aspirin (Aggrenox®). The advantages and potential pitfalls of such a trial are discussed in this article.
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Transcatheter aortic valve implantation (TAVI) has been adopted worldwide as the standard treatment for severe aortic stenosis in symptomatic patients at prohibitive or high surgical risk, but there are still several areas where consensus and evidence are lacking. The purpose was to obtain a global view of current practice related to TAVI with the potential to identify the main areas of consensus and divergence between centers.
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A 35-year-old man with primary antiphospholipid syndrome and no risk factors for atherosclerosis presented with postinfarction angina.
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TAVR is a new technology that compresses a tissue valve onto an expandable stent. Technical and procedural issues have been solved, but strokes and major bleeding still affect patients' life despite double antiplatelet therapy given to reduce MACCE. To balance pros and cons, antithrombotic therapy with Warfarin or new anticoagulants can be used in patients with previous AF or NOAF to prevent stroke; while single antiplatelet with PPI is a better alternative in patients with liver disease, gastric ulcer or drug abuse to avoid bleeding events. While waiting for randomized trials, a tailored therapy based upon physician's experience and close patient follow-up is the safest, most effective treatment.
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Direct caroticocavernous fistula (CCF) has traditionally been treated by detachable balloon placement within the affected cavernous sinus. We describe a case of a direct CCF treated solely with flow-diverting stents. These novel devices may offer a simpler and potentially safer vessel-sparing option in this rare condition.
There is some controversy as to whether tirofiban or eptifibatide, two small anti-aggregating drugs (AAD), may reduce the incidence of composite ischemic events within one year in patients undergoing percutaneous coronary intervention (PCI) in the real clinical world.
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One hundred fifty-three elective percutaneous coronary intervention patients were randomized to clopidogrel 150 mg/day (n = 58) or 75 mg/day (n = 95) for 4 weeks, with vasodilator-stimulated phosphoprotein assay-guided switching to clopidogrel 150 mg/day after 2 weeks in low responders (platelet reactivity index >or=69%). All patients received aspirin 75 mg/day.
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Discussion of a patient with non-ST elevation ACS illustrates some of the clinical issues surrounding PCI and stent implantation, including selection and use of antiplatelet therapy.
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CYP2C19*2 genotype was associated with diminished platelet response to clopidogrel treatment and poorer cardiovascular outcomes.
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We included eight RCTs involving 625 participants. Only one study was judged as 'low risk' of bias. There were insufficient published data from the eight studies for all planned primary and secondary outcomes. No patients died from ischemic stroke or from adverse drug effects, bleeding or infections among the 444 participants in the six studies where these outcomes were reported. Statin treatment did not reduce all-cause mortality compared with placebo or no treatment (OR 1.51, 95% CI 0.60 to 3.81) in the 431 patients enrolled in seven studies. No cases of rhabdomyolysis (the breakdown of muscle fibres resulting in the release of muscle fibre contents (myoglobin) into the bloodstream) occurred in 274 patients enrolled in three studies.
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The above in vivo data suggest that the inactive metabolite displaces the active metabolite from binding sites. Thus, the inactive metabolite might increase the free concentration of the active metabolite leading to enhanced inhibition of platelet aggregation. The plasma protein binding mechanism would offer an additional therapeutic strategy to optimize clopidogrel pharmacotherapy.
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The incidence of MACE in patients undergoing NCS after previous PCI is high in spite of adequate perioperative antiplatelet therapy.
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Three thousand and eighty confirmed ACS patients enrolled in this registry were followed up for 1 year at 3-month intervals. Patient data on medical interventions as well as clinical events were recorded and analyzed by descriptive statistics.
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We found no association between discharge clopidogrel use and long-term risk of major adverse cardiac events among older, unrevascularized non-ST-segment elevation myocardial infarction patients. Clopidogrel use in this population requires further prospective evaluation.
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Dual antiplatelet therapy is associated with increased rates of intracerebral hemorrhage, especially in the context of subarachnoid hemorrhage. We present a case of a spontaneous hemorrhage in a patient treated with a Pipeline stent for a ruptured dissecting vertebrobasilar aneurysm and the novel use of direct application of platelets during surgery to control bleeding.
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This article provides an overview of the available antiplatelet pharmacogenetics literature. Evidence supporting the significance of candidate genes and their potential influence on antiplatelet response and clinical outcomes are summarized and evaluated. Additional focus is directed at CYP2C19 and clopidogrel response, including the availability of clinical testing and genotype-directed antiplatelet therapy.
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We included 2099 patients, with a mean age of 64 (SD=13) years, 69% males. In our sample, 55.1% presented with ST-segment elevation ACS and 13.1% in Killip class ≥ 2. Only 25% were known diabetic at admission. In-hospital mortality was 5.8% and 9.7% at one-year follow-up. The best cut-point for blood glucose was 160 mg/dl (sensitivity 62% and specificity 68%), and 35.2% of the patients had increased levels. This group was elderly, had more prevalence of cardiovascular risk factors, worse renal function and GRACE score as well as more frequently Killip class ≥2. Treatment was similar in both groups besides less frequent use of clopidogrel in high glycaemic patients. The hyperglycaemia group had higher one-year mortality (17.2% vs. 5.6%, p<0.001). Moreover, binary blood glucose remained a predictor of death independently of the GRACE risk score and the presence of diabetes (odds ratio (OR) 1.99, 95% CI 1.40-2.84, p<0.001). The inclusion of blood glucose, as a continuous variable, in a logistic regression model with GRACE score, increased the area under the ROC curve from 0.80 to 0.82 (p=0.018) as well as the goodness-of-fit and was associated with an improvement in both the NRI (37%) and the IDI (0.021), suggesting effective reclassification.
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Data were collected from 100 dentists. Of these, 17 had no knowledge of coronary stents, but only one did not interrupt dual therapy: 12 consulted a cardiologist and the remaining four discontinued therapy themselves. Of the 83 who knew about stents, only 28 (34%) understood the difference between bare metal and drug-eluting stents. The drug clopidogrel's name was known by 21%, while 60% recognized one of the drug's commercial names and 45% recognized the other. Of the 83 aware of stents, 48 (58%) knew of the possibility of stent thrombosis, but only three knew about possible mortality. Cardiologists were consulted before dental procedures in 83% of cases. Only 36% knew about the existence of the guidelines.
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Surgery increased TG in vascular-patients despite intra-operative unfractioned heparin administration when compared to orthopedic patients (MRI:P=0.039, ETP:P=0.001, PGT:P=0.003), but this perioperative prothrombotic status was reversed by postoperative thromboprophylaxis. No thromboembolic events were observed. Similar TG parameter values between the 8th and 32nd postoperative day indicate that vascular patients were adequately protected after prophylaxis withdrawal, probably due to the synergic action of clopidogrel, while orthopedic patients increased TG on day-32 compared to the 8th postoperative day (P=0.03, for both lag-time and ttPeak). Furthermore, on day-32, a prothrombotic status (increased TG) was observed in the orthopedic patients (P=0.034, and 0.004 for ttPeak and lag-time, respectively). Inter-individual variability to enoxaparin response was observed in both groups:7/15 vascular and 10/15 orthopedic patients increased TG despite anticoagulant administration, which reveals heparin-resistance. Among the heparin-resistant patients, 4 vascular and 6 orthopedic increased TG after anticoagulant withdrawal, depicting a rebound effect to activation of coagulation.
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After undergoing routine EMG, if any of seven predetermined high-risk muscles were tested, study subjects then underwent ultrasound to evaluate for hematoma formation.
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A 48-year-old man was admitted to our cardiac catheterization unit with severe chest pain 75 minutes after onset of symptoms. Two years before he had undergone percutaneous coronary intervention (PCI) for stable angina pectoris with implantation of a drug-eluting stent (TAXUS) into the proximal left anterior descending artery. Antiplatelet therapy with 75 mg clopidogrel was given for one year, together with 100 mg aspirin. Subsequently he was put on low-dose aspirin monotherapy. Eight days before admission aspirin was discontinued because a tooth extraction was planned.
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This survey was performed in 102 level 2 hospitals from 15 provinces or autonomous region in China. Patients admitted to these hospitals with acute coronary syndrome during September 2011 to May 2012 were eligible for this study. Information on TCM use was obtained from their medical records. Chi-square test and logistic regression analysis were used to explore the related factors of TCM use in these patients.
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A total of 68 (65%) of the 104 enrolled patients were carriers of the CYP2C19 reducedfunction allele. On-clopidogrel platelet aggregation (PA), measured using light transmittance aggregometry and the VerifyNow(®) P2Y12 system, and the platelet reactivity index (PRI) were significantly higher at all time points in the carriers than in the noncarriers (p＜0.05), whereas there were no differences in the levels of the coagulation and inflammatory biomarkers or serum hs-TnT. Simple and multiple logistic regression analyses identified on-clopidogrel PA and PRI as being significant predictors of carriers of the CYP2C19 reduced-function allele.
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Several methods provide new insights into understanding clinical trial composite endpoints, using both conventional and novel methods. The TRILOGY ACS trial is used as a contemporary example to prospectively compare these methods side by side.
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Patients with atrial fibrillation usually are elderly and may have cognitive dysfunction. These patients may receive less effective oral anticoagulation, resulting in more vascular events and bleeding.
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Combined antiplatelet agents (cAPA), aspirin plus clopidogrel, increase the risk of bleeding. We hypothesised that recombinant activated FVIIa (rFVIIa), which normalises thrombin generation in platelet-rich plasma from patients treated with cAPA, could limit this bleeding risk. It was the objective of this study to investigate the efficacy and safety of rFVIIa compared to placebo, in a bleeding and thrombosis model in rabbits treated with aspirin and clopidogrel. New-Zealand rabbits, randomised into two groups (Placebo1, n=36 ; cAPA, n=34), were anaesthetised, ventilated and monitored for blood pressure, temperature and carotid blood flow. The Folts model was applied to a carotid artery. Cyclic flow reductions (CFR) were recorded over a first 20-min period (Obs1). Each rabbit was then randomly assigned into one of three subgroups (Placebo2, 40μg/kg rFVIIa, 160 μg/kg rFVIIa) and CFR were monitored for a second 20-min period (Obs2). Ear bleeding time (BT) was measured at the end of each period. Hepatosplenic (HS) section was performed at the end of the experiment and HS blood loss defines the primary endpoint. Secondary endpoints were thrombosis (CFR), prothrombin time, platelet aggregation, and thrombin generation. Non- parametric statistical tests were used (p<0.05). cAPA significantly increased HS blood loss, BT and suppressed CFR compared to Placebo1 (p<0.05). rFVIIa injection did not modify HS blood loss, BT or CFR rate in Placebo1 rabbits nor in cAPA animals. These effects were unaffected by either rFVIIa dose. rFVIIa accelerated thrombin generation but had no effect on platelet aggregation in citrated platelet-rich plasma. rFVIIa did not modify HS blood loss associated with cAPA in rabbits.
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Therapy with clopidogrel and aspirin after ACS does not seem to increase the risk of real-life bleeding following OS, regardless of the platelet activity response to DAPT. © 2015 S. Karger AG, Basel.
The anticoagulants and antiplatelet agents that patients are receiving preoperatively apart from unfractionated heparin include low-molecular-weight heparins (LMWHs); a pentasaccharide (fondaparinux); oral anticoagulants: vitamin K antagonists (warfarin), new oral Xa inhibitors (rivaroxaban, apixiban), or the oral direct thrombin inhibitor (DTI) dabigatran; platelet inhibitors: thienopyridines (clopidogrel, ticlopidine, prasugrel) or IIb/IIIa receptor antagonists (tirofiban, abciximab, eptifibatide); or DTIs (r-hirudin, bivalirudin, argatroban).
Controlled localised bipolar conjunctival cautery before STA injection may significantly reduce the frequency of SCH, especially in patients on warfarin or aspirin.
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Our registry showed that underlying medical conditions may affect antiplatelet prescriptions at discharge. During the first year following an ACS episode, the prescription rate of dual antiplatelet therapy declined over time, mainly due to physician's judgment leading to the discontinuation of clopidogrel. Adherence to dual antiplatelet treatment was associated with lower total mortality at 1 year.
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Out of 535 IS patients, 208 (38.88%) were CR and 327 (61.12%) were clopidogrel sensitive (CS). Diabetes was independently associated with risk of CR (odds ratio: 2.42, 95% confidence interval [CI], 1.22-4.97, P <.01). During the follow-up period, the incidence of ischemic vascular events was higher in the CR group than in the CS group; the proportion of patients with mRS score of 0-2 points at 6 months was significantly lower in CR group than in CS group. CR (hazard ratio [HR]: 2.82, 95% CI, 1.23-6.94, P <.01), diabetes (HR: 1.61, 95% CI, 1.01-3.49, P = .02), and hypertension (HR: 1.84, 95% CI, 1.12-4.72, P = .03) were independent risk factors for ischemic vascular events.