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AbstractObjectiveTo show that limiting dual antiplatelet therapy (DAPT) to six months in patients with event-free ST-elevation myocardial infarction (STEMI) results in a non-inferior clinical outcome versus DAPT for 12 months.DesignProspective, randomised, multicentre, non-inferiority trial.SettingPatients with STEMI treated with primary percutaneous coronary intervention (PCI) and second generation zotarolimus-eluting stent.ParticipantsPatients with STEMI aged 18 to 85 that underwent a primary PCI with the implantation of second generation drug-eluting stents were enrolled in the trial. Patients that were event-free at six months after primary PCI were randomised at this time point.InterventionsPatients that were taking DAPT and were event-free at six months were randomised 1:1 to single antiplatelet therapy (SAPT) (ie, aspirin only) or to DAPT for an additional six months. All patients that were randomised were then followed for another 18 months (ie, 24 months after the primary PCI).Main outcome measuresThe primary endpoint was a composite of all cause mortality, any myocardial infarction, any revascularisation, stroke, and thrombolysis in myocardial infarction major bleeding at 18 months after randomisation.ResultsA total of 1100 patients were enrolled in the trial between 19 December 2011 and 30 June 2015. 870 were randomised: 432 to SAPT versus 438 to DAPT. The primary endpoint occurred in 4.8% of patients receiving SAPT versus 6.6% of patients receiving DAPT (hazard ratio 0.73, 95% confidence interval 0.41 to 1.27, P=0.26). Non-inferiority was met (P=0.004 for non-inferiority), as the upper 95% confidence interval of 1.27 was smaller than the prespecified non-inferiority margin of 1.66.ConclusionsDAPT to six months was non-inferior to DAPT for 12 months in patients with event-free STEMI at six months after primary PCI with second generation drug-eluting stents.Trial registrationClinicaltrials.gov NCT01459627.

Despite improvements in the secondary prevention of atherothrombosis in patients with coronary artery disease during the past decade, it is estimated that approximately 19 million people annually die from cardiovascular diseases worldwide. Atherothrombosis remains the core pathobiology of acute complications including myocardial infarction (MI), and therefore, antithrombotic therapy plays a pivotal role in the strategies for major adverse cardiovascular event (MACE) prevention. Unlike early antithrombotic management after acute coronary syndrome, less evidence is available on long-term antithrombotic therapy in patients with chronic coronary syndrome (CCS). In addition, greater recognition of the impact of bleeding complications of such therapies has led to a more complex and personalized approach to their application. The purpose of this article is to review the available evidence on long-term antithrombotic therapy in patients with CCS including those with high-risk characteristics such as prior MI or polyvascular disease. A comprehensive literature review was performed in major databases including PubMed, Embase, and the Cochrane Library. The main focus of this narrative review was on available data from guidelines, meta-analysis, randomized controlled trials, and observational studies that assessed the efficacy and safety profile of long-term antithrombotic therapy in patients with CCS. Several studies suggest that long-term antithrombotic therapy is effective in reducing the risk of recurrent MACEs in patients with CCS. Current clinical guidelines recommend single antiplatelet therapy with aspirin as a first-line long-term strategy for patients without indication for oral anticoagulation. However, novel approaches focused on P2Y12 inhibitor monotherapy are emerging. More intensive antithrombotic strategies including long-term dual antiplatelet therapy and dual pathway inhibition further reduce ischemic risk but at the cost of increased bleeding. This review highlights the importance of close monitoring and regular reassessment of the risk-benefit balance of antithrombotic therapy in patients with CCS. Overall, long-term antithrombotic therapy with either single antiplatelet therapy or dual antiplatelet therapy/dual pathway inhibition is effective in reducing the risk of MACEs in patients with CCS. The choice of antithrombotic therapy should be individualized based on the patient's clinical profile, particularly for thrombohemorrhagic risk. Future research should focus on identifying the optimal antithrombotic regimen for specific subgroups of patients with prior MI particularly for those with high bleeding risk.

Japan is one of the world's most aging societies and the number of elderly patients taking antithrombotic drugs is increasing. In recent years, dual antiplatelet therapy (DAPT), in which two antiplatelet drugs are administered, has become common in anticipation of its high therapeutic efficacy. However, there are concerns about increased bleeding complications in use of DAPT. Therefore, the goal of this study was to investigate the effects of DAPT in patients with traumatic brain injury (TBI). A prospective, multicenter, observational study was conducted from December 2019 to May 2021 to examine the effects of antithrombotic drugs and reversal drugs in 721 elderly patients with TBI. In the current study, the effect of DAPT on TBI was examined in a secondary analysis. Among the registered patients, 132 patients taking antiplatelet drugs only were divided into those treated with single antiplatelet therapy (SAPT) (n=106) and those treated with DAPT (n=26) prior to TBI. Glasgow Coma Scale (GCS) on admission, pupillary findings, course during hospitalization, and outcome were compared in the two groups. A similar analysis was performed in patients with a mild GCS of 13–15 (n=95) and a moderate to severe GCS of 3–12 (n=37) on admission. The DAPT group had significantly more males (67.0 % vs. 96.2 %), a higher severity of illness on admission, and a higher frequency of brain herniation findings on head CT (21.7 % vs. 46.2 %), resulting in significantly higher mortality (12.3 % vs. 30.8 %). The only significant factor for mortality was severity on admission. The rate of DAPT was significantly higher in patients with a moderate to severe GCS on admission, and DAPT was the only significant factor related to severity on admission. These findings suggest that the severity of injury on admission influences the outcome six months after injury, and that patients with more severe TBI on admission are more likely to have been treated with DAPT compared to SAPT. •Elderly TBI patients taking DAPT have worse severity on admission.•DAPT was the only factor that had a significant effect on severity on admission.•The severity of the injury on admission influences the outcome.

Sex-specific evidence on de-escalation strategies of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention in patients with acute coronary syndromes (ACS) remains limited. Females are often under-represented in randomized controlled trials (RCTs) and sex-based subgroup analysis in RCTs yield conflicting results. We searched PubMed and EMBASE in September 2024 for RCTs that investigated DAPT strategies for patients with ACS. We examined whether there are differences in the efficacy and safety of de-escalation strategies (i.e., short-term DAPT (≤6 months), unguided de-escalation, and guided de-escalation with genotype or platelet function tests) compared to standard DAPT (12 months) between sexes. A systematic review and meta-analysis were performed to compare the efficacy and safety between sexes with p-value for test of moderators. The primary efficacy outcome was major adverse cardiovascular events (MACEs), defined as a composite of cardiovascular death, myocardial infarction, and stroke. The primary safety outcome was major or minor bleeding. Fourteen RCTs involving 35,901 patients with ACS (7,652 female patients, 28,249 male patients) were included. The effect of de-escalation strategies on the primary efficacy outcome was significantly different between female (HR, 0.74; 95% CI, 0.57-0.95; I2 = 0%) and male patients (HR, 1.04; 95% CI, 0.90-1.19; I2 = 15%), with p-value for test of moderators 0.019. The primary safety outcome showed no significant sex differences (p-value for test of moderators = 0.67). In conclusions, in patients with ACS, compared to standard DAPT, de-escalation strategies were more effective in reducing MACE in female than in their male counterparts. Meanwhile, de-escalation strategies were similarly safer for both sexes.

BackgroundFlow diversion (FD) remains a potential treatment option following aneurysmal subarachnoid hemorrhage (aSAH) when standard options may not be feasible. However, it should not be considered a first-line treatment due to the need for dual antiplatelet therapy (DAPT). The hydrophilic polymer coating on the p48MW flow diverter (HPC, phenox) is a surface modification that inhibits platelet adhesion. This study aims to report on our early single-center experience using the p48MW HPC (phenox) flow diverter with single antiplatelet therapy (SAPT) following an aSAH.Materials and MethodsWe retrospectively identified all patients who had been treated with the p48MW HPC for aSAH under SAPT. All patients treated within 30 days following an aSAH were included. Any occurrence of thromboembolic and hemorrhagic complications was recorded alongside angiographic and clinical follow-up details.ResultsEight patients were identified. The mean interval between aSAH and FD was 6 days. Of the eight ruptured aneurysms, one was blister-like, one saccular, one mycotic, and the remaining five were dissecting aneurysms. Intraprocedural transient thrombus formation was observed in four patients (50%). Stent thrombosis was observed in one patient (12.5%) on day 3 with spontaneous recanalization after being switched onto DAPT. None of the aneurysms rebled after treatment. Two patients died due to cerebral vasospasm. Complete aneurysm occlusion had been achieved in all but one patient at angiographic follow-up (average 6 months).ConclusionsThis small series highlights the possibility and limitations of using the p48MW HPC with SAPT in ruptured aneurysms. Randomized trials with longer follow-up in larger cohorts are underway.

The present guidelines recommend dual antiplatelet therapy (DAPT) for 6 to 12 months after percutaneous coronary intervention (PCI), with recent trials assessing the safety and efficacy of shortening DAPT duration to ≤3 months. A systematic search of PubMed, Scopus, and Cochrane Central databases identified studies comparing short DAPT, followed by P2Y12i monotherapy (78% ticagrelor) versus standard 12-month DAPT in patients who underwent PCI with a drug-eluting stent. A total of 9 randomized controlled trials, including 42,770 patients (short DAPT n = 21,370, 49.96%), of whom 28,307 (66.18%) presented with acute coronary syndrome (ACS). Short DAPT significantly reduced net adverse clinical events (NACEs) (risk ratio [RR] 0.78, 95% confidence interval [CI] 0.67 to 0.91, p = 0.001, I2 = 62%), major bleeding (RR 0.54, 95% CI 0.39 to 0.73, p <0.001, I2 = 63%), and any bleeding (RR 0.55, 95% CI 0.43 to 0.72, p <0.001, I2 = 77%) at 12 months compared with 1-year DAPT. No significant differences were observed in major adverse cardiovascular/cerebrovascular events, myocardial infarction, stroke, stent thrombosis, mortality, or revascularization. Ticagrelor monotherapy after short DAPT further reduced major adverse cardiovascular/cerebrovascular events (RR 0.85, 95% CI 0.73 to 0.99, p = 0.040, I² = 22%), NACE (RR 0.74, 95% CI 0.61 to 0.89, p = 0.001, I² = 68%), and major bleeding (RR 0.56, 95% CI 0.40 to 0.78, p <0.001, I² = 71%) compared with 1-year DAPT; however, the test for subgroup interaction (Pinteraction >0.05) for clopidogrel subgroup was not significant. P2Y12i monotherapy reduced the risk of NACEs (RR 0.77, 95%CI 0.66 to 0.90, p = 0.001, I2 = 52%, Pinteraction = 0.58) and major bleeding (RR 0.44, 95%CI 0.35 to 0.55, p <0.001, I2 = 0%, Pinteraction <0.01) in the ACS cohort but not in the chronic coronary syndrome cohort. In conclusion, short DAPT for ≤3 months followed by P2Y12i monotherapy (particularly, ticagrelor) was associated with decreased NACEs and bleeding without differences in other outcomes and should be considered a favorable option in patients with either ACS or chronic coronary syndrome after PCI with a drug-eluting stent.

At least 12 months of dual antiplatelet therapy (DAPT) is 1 of the standards of care following percutaneous coronary intervention in patients with acute coronary syndrome. However, study on prolonged DAPT for patients with acute myocardial infarction (AMI) without revascularization is limited. We studied 1,744 patients with AMI without revascularization from the China Acute Myocardial Infarction registry between January 2013 and September 2014. These patients were on DAPT and did not experience AMI, stroke, or bleeding events at the 12-month follow-up. We divided them into 2 groups: 12-month DAPT group (DAPT for at least 12 months but <18 months) and 18-month DAPT group (DAPT for at least 18 months). The primary outcome was 24-month all-cause death. Overall, 1,221 patients (70.0%) took DAPT for ≥12 months but <18 months, whereas 523 patients (30.0%) took DAPT for ≥18 months. The proportion of patients at high ischemic risk and the proportion of patients at high bleeding risk were similar in the 2 groups. At 24 months, the all-cause mortality rate of the 18-month DAPT group was significantly lower than that for the 12-month DAPT group (3.7% vs 5.9%, p = 0.0471). The adjusted hazard ratio for all-cause death also showed statistical significance (0.59, 95% confidence interval 0.35 to 0.99, p = 0.0444). In conclusion, DAPT for at least 18 months appears to be associated with lower 24-month mortality for non-revascularization AMI patients without events within 12 months after onset.

Background and Aim According to randomized controlled trials (RCTs), dual antiplatelet therapy (DAPT) is more effective for secondary prevention of ischemic events attributable to large artery atherosclerosis (LAA) than other mechanisms. We investigated whether real‐world application may impact DAPT effectiveness and safety in the REAl‐life study on short‐term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack (READAPT, NCT05476081). Methods READAPT was an observational multicenter study including patients with minor ischemic stroke or TIA treated with short‐term DAPT. At 90 days, we assessed primary effectiveness (ischemic recurrence, severe bleeding, or vascular death) and safety (severe to moderate bleeding) outcomes. We explored associations between LAA and outcomes using Cox regression. Within patients with and without LAA, outcomes were compared between subgroups based on age, NIHSS score (for ischemic stroke patients), ABCD2 score (for TIA patients), presence and number of MRI acute lesions, and DAPT regimen characteristics. Results Among 1920 analyzed patients (of 2278 enrolled), 452 had LAA. Unlike RCTs, 21.2% of patients with LAA had NIHSS > 5, and 48.2% received DAPT > 30 days. Patients with LAA had higher bleeding rates (3.5% vs. 2.1%, p = 0.004), primarily hemorrhagic infarctions and moderate bleeding, than those without LAA. However, primary effectiveness outcomes were similar (4.9% vs. 3.5%, p = 0.201) between the groups. In patients with LAA, prolonged DAPT (> 21 days), multiple MRI lesions, age ≥ 65, and loading doses increased bleeding risk. Conclusions The real‐world DAPT use in patients with LAA exceeds RCTs boundaries with possible drawbacks on treatment safety.

Clinical practice guidelines from the American Heart Association recommend consideration of prophylactic anticoagulation to prevent left ventricular thrombus (LVT) formation in patients with anterior ST-elevation myocardial infarction. These guidelines were given a low certainty of evidence (class IIb, level C), relying primarily on case studies and expert consensus to inform practice. Our objective was to compare the safety and efficacy of prophylactic anticoagulation, in addition to dual antiplatelet therapy, in the current era of timely primary percutaneous coronary intervention. Electronic databases, including EMBASE, MEDLINE, and Cochrane Library, were systematically searched from January 2012 through June 2022. A total of 7,378 publications were screened, and 5 publications were eventually included in this review: 1 randomized control trial and 4 retrospective studies involving 1,461 patients. Data were pooled using a fixed-effects model and reported as odds ratios (ORs) with 95% confidence intervals (CIs). The primary outcome of interest was the rate of LVT formation, and the secondary outcomes were the rate of major bleeding and systemic embolism. Pooled analysis showed a significantly lower rate of LVT formation (OR 0.28, 95% CI 0.11 to 0.73, p <0.01) and significantly higher rates of bleeding (OR 2.85, 95% CI 1.13 to 7.24, p = 0.03) in the triple therapy group compared with dual antiplatelet therapy. No significant difference was observed in the rate of systemic embolism between the groups (OR 0.37, 95% CI 0.12 to 1.13, p = 0.08). In this meta-analysis, there is no conclusive evidence to either support or oppose the use of triple therapy for LVT prevention in patients with anterior ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. Appropriately powered randomized controlled trials are warranted to further evaluate the benefits of LVT prevention against the risks of major bleeding in this population.

This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from 3 prospective, single-arm studies (XIENCE Short DAPT Program), including patients with high bleeding risk successfully treated with an everolimus-eluting stent (XIENCE, Abbott) were analyzed. DAPT was discontinued at 1 or at 3 months in patients free from ischemic events and adherent to DAPT. Patients were stratified according to age (≥75 and <75 years). The primary end point was all-cause death or myocardial infarction (MI). The key secondary end point was Bleeding Academic Research Consortium type 2 to 5 bleeding. The outcomes were assessed from 1 to 12 months after index PCI. Of 3,364 patients, 2,241 (66.6%) were aged ≥75 years. The risk of death or MI was similar with 1- versus 3-month DAPT in patients aged ≥75 (8.5% vs 8.0%, adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.69 to 1.30) and <75 years (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60 to 1.57, interaction p = 0.478). Bleeding Academic Research Consortium type 2 to 5 bleeding was consistently lower with 1- than with 3-month DAPT in patients aged ≥75 years (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48 to 0.91) and <75 years (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57 to 1.29, interaction p = 0.737). In conclusion, in patients at high bleeding risk who underwent PCI, patients older and younger than 75 years derived a consistent benefit from 1- compared with 3-month DAPT in terms of bleeding reduction, with no increase in all-cause death or MI at 1 year.