Duration Of Dual Antiplatelet Therapy Research Articles

Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention

BackgroundIt remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). ObjectivesThis study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years. MethodsSTOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 2) is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding). ResultsAmong 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31). ConclusionsClopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.

Duration of dual-antiplatelet therapy after stent-assisted coil for unruptured intracranial aneurysm: A nationwide cohort study.

Stent-assisted coil (SAC) is increasingly used to treat unruptured intracranial aneurysm (UIA). However, the optimal duration of dual-antiplatelet therapy (DAPT) after SAC insertion remains unknown. To assess the time-dependent effect of DAPT on the risk of ischemic and hemorrhagic complications after SAC. This is a retrospective cohort study among patients with UIA treated with SAC using the nationwide health claims database in South Korea between 2009 and 2020. Multivariate Cox regression analysis was used, which included the use of DAPT as a time-dependent variable. The effect of DAPT was investigated for each period of "within 90 days," "91 to 180 days," "181 to 365 days," and "366 to 730 days" after SAC. The primary outcome was a composite of ischemic stroke and major bleeding in each period within two years after SAC. Of the 15,918 patients, mean age at SAC was 57.6 ± 10.8 years, and 3815 (24.0%) were men. The proportion of patients on DAPT was 79.4% at 90 days, 58.3% at 180 days, and 28.9% at 1 year after SAC. During the 2 years after SAC, the primary composite outcome occurred in 356 patients (2.2%). DAPT significantly reduced the primary composite outcome within 90 days after SAC (adjusted hazard ratio (aHR), 0.44; 95% confidence interval (CI), 0.28-0.69; p < 0.001); however, this was not the case after 90 days (all p > 0.05). DAPT reduced ischemic stroke risk within 90 days (aHR, 0.31; 95% CI 0.18-0.54; p < 0.001), and 91 to 180 days after SAC (aHR 0.40; 95% CI 0.18-0.88; p = 0.022); however, after 180 days, DAPT was no longer beneficial. In patients with UIA treated with SAC, 3 months of DAPT was associated with a decreased risk of the composite of ischemic and hemorrhagic complications.

1- or 3-Month DAPT in Patients With HBR With or Without Oral Anticoagulant Therapy After PCI

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain. ObjectivesThe aim of this analysis was to assess the effects of 1- vs 3-month DAPT in patients with and those without concomitant OAC included in the XIENCE Short DAPT program. MethodsThe XIENCE Short DAPT program enrolled patients with high bleeding risk who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. DAPT was discontinued at 1 or 3 months in patients free from ischemic events and adherent to treatment. The effect of 1- vs 3-month DAPT was compared in patients with and those without OAC using propensity score stratification. The primary endpoint was all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI. ResultsAmong 3,364 event-free patients, 1,462 (43%) were on OAC. Among OAC patients, the risk for death or MI was similar between 1- and 3-month DAPT (7.4% vs 8.8%; adjusted HR: 0.74; 95% CI: 0.49-1.11; P = 0.139), whereas BARC types 2 to 5 bleeding was lower with 1-month DAPT (adjusted HR: 0.71; 95% CI: 0.51-0.99; P = 0.046). These effects were consistent in patients with and those without OAC (P for interaction = NS). ConclusionsBetween 1 and 12 months after PCI, 1-month compared with 3-month DAPT was associated with similar rates of all-cause death or MI and a reduced rate of BARC types 2 to 5 bleeding, irrespective of OAC treatment.

TCT-30 Predicting Individual Treatment Effects to Determine Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation

TCT-30 Predicting Individual Treatment Effects to Determine Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation

TCT-638 New Insights Into Long- Versus Short-Term Dual Antiplatelet Therapy Duration in Patients After Stenting for Left Main Coronary Artery Disease: Findings From a Prospective Observational Study

TCT-638 New Insights Into Long- Versus Short-Term Dual Antiplatelet Therapy Duration in Patients After Stenting for Left Main Coronary Artery Disease: Findings From a Prospective Observational Study

Nonadherence to ticagrelor versus clopidogrel and clinical outcomes in patients with ACS. Results from the CREA-ARIAM registry

Introduction and objectivesPrior studies have not determined whether the effect of dual antiplatelet therapy (DAPT) cessation on the subsequent risk of major adverse cardiac events (MACE) varies by the choice of P2Y12-inhibitor after acute coronary syndrome (ACS). MethodsWe performed a prespecified subanalysis of a multicenter, prospective registry of ACS patients discharged on ticagrelor or clopidogrel between 2015 and2019. Nonadherence to DAPT was categorized as physician-guided discontinuation and disruption due to adverse effects, nonadherence, or bleeding. The association between DAPT cessation and 1-year MACE was analyzed using multivariate time-updated Cox models with inverse probability of censoring weighted estimators. ResultsOut of 2180 patients, 174 (8.3%) prematurely discontinued DAPT (physician-guided, n=126; disruption, n=48). Nonadherent patients were older and had more comorbidities than those on DAPT. Compared with physician-guided discontinuation, disruption occurred earlier after discharge and was more frequent with ticagrelor than with clopidogrel. In time-varying analysis, DAPT cessation was associated with an increased risk of MACE (adjusted HR, 1.32, 95%CI, 1.10-1.76), largely driven by disruption (adjusted HR, 1.47, 95%CI, 1.22-1.73). There was an exponential increase in MACE risk after DAPT cessation within 90 days after ACS, especially after disruption of ticagrelor compared with clopidogrel (Pinteraction<.001). After adjustment for DAPT duration, this interaction was not statistically significant on the additive scale (relative excess risk due to interaction 0.12, 95%CI,−0.99-1.24). ConclusionsIn this all-comers registry, 1 in 12 patients prematurely discontinued DAPT within 1 year after ACS. Compared with physician-recommended discontinuation, disruption resulted in a significantly higher risk of MACE. After adjustment for DAPT duration, this association was not moderated by the choice of P2Y12-inhibitor.Clinical trial registered at ClinicalTrials.gov (Identifier: NCT02500290)

Antiplatelet therapy around CABG: the latest evidence.

The optimal antiplatelet strategy in patients after coronary artery bypass graft (CABG) surgery is unclear. We review the evidence on the efficacy and safety of DAPT after CABG and discuss potential novel antiplatelet strategies that reduce the risk of bleeding without loss of efficacy. Adding the potent P2Y12 inhibitor ticagrelor to aspirin for 1 year after CABG is associated with a reduction in the risk of vein graft failure, at the expense of an increased risk of clinically important bleeding. Ticagrelor monotherapy is not associated with better efficacy than aspirin alone, but is not associated with increased bleeding risk. Dual antiplatelet therapy (DAPT) is recommended after acute coronary syndrome events, but aspirin as single antiplatelet therapy remains the cornerstone of antithrombotic therapy in stable ischemic heart disease because of a lack of solid evidence on the benefit of DAPT on clinical outcomes. Shorter duration DAPT, based on the pathophysiology of vein graft failure, may be a promising strategy that requires testing in adequately powered randomized trials.

Optimising antithrombotic therapy after acute coronary syndromes and percutaneous coronary interventions

Dual antiplatelet therapy, combining aspirin with a platelet P2Y12 receptor inhibitor, is the standard treatment for acute coronary syndrome patients undergoing percutaneous coronary intervention. The optimal type and duration of dual antiplatelet therapy depend on the patient's risk for ischemic and hemorrhagic complications. De-escalation strategies, such as switching to a less potent P2Y12 inhibitor, reducing the dose, or discontinuing one of the antiplatelet agents, may be suitable for high-risk bleeding patients with low risk of recurrent ischemic events, and platelet function testing and genetic testing can guide de-escalation. For patients at high ischemic risk, strategies include drug switching, dose escalation, or adding a new drug. Patients at high ischemic and hemorrhagic risk require individualized treatment decisions and trade-off considerations.

236 Assessing communication of duration of Dual Antiplatelet Therapy on discharge letters: an acute stroke unit audit

Abstract Background Short term Dual Anti-Platelet Therapy (DAPT) is commonly used for secondary prevention of major acute ischemic stroke events. However, long-term DAPT is associated with increased risk of bleeding without reduction in cardiovascular events. Proton pump inhibitors (PPI) are often co-prescribed for prevention of gastroduodenal toxicity of DAPT, but long-term use has potential side effects. This audit aims to assess if clear instructions are provided regarding to duration of DAPT prescription in stroke medicine unit in tertiary referral hospital. Methods Retrospective analysis Electronic Medical Records (EMRs; discharge and clinical letters) who were admitted with TIA or AIS in 3-month period, excluding those who were transferred back to their referring hospital. Results 100 patients’ EMRs were reviewed. 34 were discharged on DAPT. 21 patients were reviewed in stroke OPD while 6 were readmitted to hospital. DAPT duration was documented in Discharge Letters (DL) of 28 patients (82%). In 28 (82%) patients, recommended durations of DAPT were documented in DL, 5(18%) of those were still inappropriately on DAPT on returning to OPD/readmission. 1 out of the 6 patients with no clear documentation of DAPT duration on DL were still inappropriately on DAPT. 22 patients were co-prescribed PPI, 19 of those had no documented recommended plan for PPI post completion of DAPT, and 12 of those were still on PPI on returning to OPD/readmission. 3 patients had a documented plan for PPI post completion of DAPT, 2 were still on PPI on returning to OPD/readmission. Conclusion Results were presented in stroke unit teaching. Key recommendations included education of NCHDs regarding clear documentation and communication with patients, pharmacists and GPs. Improvement in EMRs to highlight DAPT plan. Regular audits in this area.

Identifying the Incidence, Predictors, Outcomes, and Prevention of Stent Thrombosis (ST) in Post-percutaneous Coronary Revascularization Patients With Drug-Eluting Stents (DES): A Systematic Review.

Stent thrombosis (ST) is a rare but catastrophic event to happen to a stented coronary artery. The incidence of ST has greatly been reduced after the advent of modern drug-eluting stent (DES) implants, which have become the most preferred treatment option in the stenting category for coronary artery disease (CAD). Although the risk reduction by newer category implant provides substantial benefits, the possibility of thrombosis still exists mostly during the early stage of DES implantation. The development of ST after percutaneous coronary intervention (PCI) can be predicted by multiple factors, but advancements in early diagnostic techniques and modified stent types have greatly reduced the occurrence of this complication. Mortality, which is one of the complications of ST, is primarily influenced by patient-related factors such as incomplete treatment duration of dual antiplatelet therapy (DAPT). The duration of DAPT after DES implantation in patients with acute coronary syndrome (ACS) is determined based on individual characteristics, mainly considered in view of bleeding or ischemia risk. Risk evaluation systems like DAPT/precise-DAPT scores help tailor and personalize the duration of DAPT for each individual patient. This systematic review contains pertinent articles extracted from the PubMed database. We retrieved articles from various study categories, encompassing publications from the period spanning 2014 to 2022. Our analysis highlighted results from studies investigating different aspects contributing to ST development. The most favorable prevention option was the use of customized DAPT intervention based on patient-specific predictable factors. Several complications associated with ST were identified, including recurrent ST, major adverse cardiovascular events (MACE) encompassing all-cause mortality (including cardiac and non-cardiac mortality), cerebrovascular accidents (CVA) or transient ischemic attacks (TIA), hospitalization due to heart failure, and myocardial infarction requiring revascularization. Mortality was also observed as a significant outcome. The umbrella term of ST includes multiple causative factors. Although DES has improved patient survival rates vastly with its usage, careful risk factor assessment and required follow-up, in each individual being stented, further guarantee a more promising reduction in late adverse outcomes.

Comparison of Supraflex Cruz 60 μm Versus Ultimaster Tansei 80 μm Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial

Up to 45% of patients who underwent percutaneous coronary intervention (PCI) may have a high bleeding risk (HBR), depending on the bleeding risk definition.1 This condition is often associated with an enhanced risk of thrombotic events with a negative impact on short- and long-term outcomes,2-8 making the choice of an appropriate antithrombotic regimen after PCI particularly challenging. Advances in stent technologies, in which the introduction of newer generations of thinner strut drug-eluting stents (DES), have significantly reduced the rate of thrombotic complications and may justify a shorter dual antiplatelet therapy (DAPT) duration. Both in vitro and in vivo studies have shown that local hemodynamic factors may critically affect the natural history of atherosclerosis. Strut thickness correlates with flow disturbances and endothelial shear stress. Flow separation within struts determines areas of recirculation with low endothelial shear stress which promotes local concentration of activated platelets.9 By mitigating inflammation, vessel injury, and neointimal proliferation, thin and streamlined struts have been associated with faster vascular healing and re-endothelization and have resulted in lower rates of thrombotic events after PCI.10,11 The use of thin strut and ultra-thin strut stents may lead to a favorable trade-off in bleeding and ischemic events in patients with HBR. However, dedicated studies evaluating the performance of thin strut versus ultrathin strut stents in patients with HBR are lacking.

Temporal variations in ischemic and bleeding event risks after acute coronary syndrome during dual antiplatelet therapy

BackgroundThis study estimates the temporal risk variations of ischemic and bleeding events during dual antiplatelet therapy (DAPT) among patients stratified according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria, suggesting the optimal period for DAPT after acute coronary syndrome (ACS). MethodsA total of 1264 ACS patients receiving either clopidogrel or prasugrel with aspirin were classified by ARC-HBR; HBR (n = 574) and non-HBR groups (n = 690). This study was designed as a multicenter observation to evaluate the primary endpoints of ischemic, including cardiovascular death, myocardial infarction, or ischemic stroke, and bleeding events, defined as Bleeding Academic Research Consortium type 3/5. The temporal risk variations were estimated using the Cox hazard and Royston-Parmar models. ResultsIschemic and bleeding events were observed in 9.4% and 7.4%, respectively, during an average observation period of 313 days. The HBR group had a higher incidence of both events than the non-HBR group (15.3% vs. 4.5%, P < 0.01 for ischemic; 11.9% vs. 3.8%, P < 0.01 for bleeding). The estimated risk curves for both events revealed peaks and steep declines in the first few days, followed by constant declines. The peak of risk was higher for bleeding than for ischemic events, but this relationship reversed early, with ischemic events displaying a higher risk in both the HBR and non-HBR groups until at least 60 days. ConclusionsA 60-day period of DAPT is appropriate to balance the risks of adverse events after ACS, regardless of ARC-HBR criteria.

Short Versus Long Duration of Dual Antiplatelet Therapy After Second-Generation Drug-Eluting Stents Implantation in Patients with Diabetes.

Duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) remains uncertain, with increasing data suggestive of acceptable short-term duration. Metabolically accelerated atherosclerosis associated with diabetes makes it essential to study short-term DAPT in this subgroup. With limited studies determining optimal DAPT strategies after second-generation stents in this subset, we aimed to establish the optimal duration of DAPT in the diabetic population using second-generation stents. To determine optimal DAPT duration in diabetic population undergoing PCI in 2nd generation stents. We conducted an electronic database search of randomized controlled trials from PubMed/Medline, Embase, Cochrane, and Web of Science databases. A meta-analysis was conducted comparing outcomes of short-term (3-6 months) DAPT therapy versus long-term (12 months) DAPT therapy in the diabetic population undergoing PCI with second-generation stents. A total of 5 randomized controlled trials were included with a total of 3117 diabetic patients. Short-term DAPT did not show any statistical difference from long-term DAPT in achieving primary outcomes (relative ratio: 0.96, 95% confidence interval (CI) 0.68-1.35, P = 0.84). Overall mortality (OR 0.92; 95% CI, 0.52-1.63, P = 0.98), myocardial infarction [odds ratio (OR)OR 1.02; 95% CI, 0.53-1.94, P = 0.85], stent thrombosis (OR 1.20; 95% CI, 0.55-2.60, P = 0.55), target vessel revascularization (OR 1.10; 95% CI, 0.45-2.73, P = 0.74), and stroke (OR 0.50; 95% CI, 0.082-2.43, P = 0.81) did not show any statistical difference between the 2 groups. Similarly, a subgroup analysis of study population comparing 6 versus 12 months of DAPT in diabetic population did not show any difference in net primary outcomes (relative ratio: 0.86, 95% CI 0.45-1.45, P = 0.60). There was no significant heterogeneity noted between the 2 groups. This meta-analysis showed no statistically significant benefit of longer DAPT over shorter DAPT therapy in patients undergoing PCI with drug-eluting stent in patients with diabetes.

Short dual antiplatelet therapy duration after percutaneous coronary intervention in high bleeding risk patients: Systematic review and meta-analysis.

Dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) reduces major adverse cardiovascular events (MACE) and stent thrombosis. However, DAPT duration is a concern in high bleeding risk (HBR) patients. We evaluated the effect of short DAPT (1-3 months) compared to standard DAPT (6-12 months) on bleeding and ischemic events in HBR PCI. We searched MEDLINE, Embase and CENTRAL up to August 18, 2022. Randomized controlled trials (RCTs) comparing short DAPT (1-3 months) versus standard DAPT in HBR PCI were included. We assessed risk of bias (RoB) using the Cochrane RoB2 tool, and certainty of evidence using GRADE criteria. Outcomes included MACE, all-cause death, stent thrombosis, major bleeding, and the composite of major or clinically-relevant non-major bleeding. We estimated risk ratios (RR) and 95% confidence intervals (CI) using a random-effects model. From 503 articles, we included five RCTs (n = 7,242) at overall low risk of bias with median follow-up of 12-months. Compared to standard DAPT, short DAPT did not increase MACE (RR 1.02, 95% CI 0.84-1.23), all-cause death (RR 0.92, 95% CI 0.71-1.20) or stent thrombosis (RR 1.47, 95% CI 0.73-2.93). Short DAPT reduced major bleeding (RR 0.34, 95% CI 0.13-0.90) and the composite of major or clinically-relevant non-major bleeding (RR 0.60, 95% CI 0.44-0.81), translating to 21 and 34 fewer events, respectively, per 1000 patients. In HBR PCI, DAPT for 1-3 months compared to 6-12 months reduced clinically-relevant bleeding events without jeopardizing ischemic risk. Short DAPT should be considered in HBR patients receiving PCI.

Dual Antiplatelet Therapy Duration After Percutaneous Coronary Interventions of Left Main Coronary Artery Disease: A Meta-Analysis

Dual Antiplatelet Therapy Duration After Percutaneous Coronary Interventions of Left Main Coronary Artery Disease: A Meta-Analysis

Dual antiplatelet therapy after percutaneous coronary intervention in patients at high bleeding risk: A systematic review and meta-analysis.

To date, it has not been ascertained whether shortening the duration of dual antiplatelet therapy (DAPT) can benefit high bleeding risk (HBR) patients. This systematic review and meta-analysis was performed to investigate the safety and efficacy of short (≤ 3 months) DAPT in HBR patients after percutaneous coronary intervention (PCI). The PubMed, Embase, and Clinical Trials databases were searched from inception until November 2021 to identify studies that evaluated the safety and efficacy of short DAPT in HBR patients implanted with new-generation drug-eluting stents (DES). Primary endpoints included major bleeding, definite or probable stent thrombosis (ST), and myocardial infarction (MI), while secondary endpoints included all-cause death and ischemic stroke. Based on the fixed and random effect model, the risk ratio (RR) and 95% confidence interval of each endpoint were measured. Five observational studies and one randomized controlled trial were included, involving 15,432 HBR patients. Short DAPT for HBR patients undergoing PCI had a lower incidence of major bleeding in comparison with standard (> 3 months) DAPT (2.3% vs. 3.2%, RR 0.64 [0.44, 0.95], p = 0.03), while short DAPT was comparable to standard DAPT with regard to definite or probable ST (0.4% vs. 0.3%, RR 1.31 [0.77, 2.23], p = 0.32) and MI (2.4% vs. 2.0%, RR 1.17 [0.95, 1.45], p = 0.14). Among HBR patients implanted with new-generation DES, short DAPT was associated with reduced risk of major bleeding without significantly increasing the risk of definite or probable ST and MI in comparison with standard DAPT.

Comparison of Different Chronic Maintenance Antithrombotic Strategies in Patients with Coronary Artery Disease: A Systematic Review and Network Meta-Analysis.

Optimal antithrombotic therapy during the chronic maintenance period in patients with coronary artery disease (CAD) is unknown. We compared five kinds of mainstream chronic maintenance antithrombotic strategies at least one year after the acute phase: aspirin alone, clopidogrel alone, ticagrelor alone, continued dual antiplatelet therapy (DAPT) for a period of time, and maintenance with aspirin combined with a low-dose anticoagulant such as rivaroxaban. Ten randomized, controlled trials were selected using PubMed, Ovid MEDLINE, Embase, and Cochrane library through February 2023. The primary outcome was main adverse cardiac events (MACEs), and secondary outcomes include net adverse clinical events (NACEs), cardiac death, all-cause death, ischemic stroke, stent thrombosis, total bleeding, and major bleeding. A network meta-analysis was conducted with a random-effects model. Data extraction was performed by three independent reviewers. Our search identified ten eligible randomized controlled trials enrolling a total of 82,084 patients comparing different chronic maintenance antithrombotic strategies. As for the primary endpoint, there was no statistical difference in MACE outcomes between any two of the five methods. As for the secondary endpoint, there was no statistical difference in NACE, major bleeding, all-cause death, cardiac death, and stent thrombosis between any two methods. The aspirin plus low-dose rivaroxaban group had a lower incidence of ischemic stroke compared to the aspirin group (OR = 0.49, 95% CrI 0.26-0.91). And the prolonged DAPT group had a higher total bleeding rate compared to aspirin group (OR = 2.4, 95% CrI 1.1-5.9). In terms of MACE, NACE, all-cause death, cardiac death, stent thrombosis, and major bleeding, there were no significant differences between using aspirin alone, clopidogrel alone, and ticagrelor alone; extending DAPT duration; and using aspirin combined with low-dose rivaroxaban for chronic maintenance antithrombotic regimens. However, choosing aspirin combined with low-dose rivaroxaban can reduce the incidence of ischemic stroke, and prolonged DAPT may have a higher rate of total bleeding. However, it is important to note that this study is based on indirect comparisons, and there is currently a lack of direct evidence comparing various maintenance antiplatelet therapy regimens. Further high-quality studies are needed to address this gap and provide more conclusive evidence on the comparative effectiveness of different maintenance antiplatelet strategies.

Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing PCI

BackgroundOver the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DesignThe PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SummaryThe PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI.

Paired risk scores to predict ischaemic and bleeding risk twenty-eight days to one year after an acute coronary syndrome

ObjectiveThe recommended duration of dual anti-platelet therapy (DAPT) following acute coronary syndrome (ACS) varies from 1 month to 1 year depending on the balance of risks of ischaemia and major...

Preferred monotherapy after short-term dual antiplatelet therapy: Systematic review and network meta-analysis of randomized trials

BackgroundRandomized controlled trials (RCTs) have demonstrated the efficacy and safety of P2Y12 inhibitor monotherapy following short-term dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI). However, no studies have compared P2Y12 inhibitor and aspirin monotherapy following short-term DAPT. We aimed to compare available strategies for DAPT duration and post-DAPT antiplatelet monotherapy following PCI. MethodsSeven DAPT strategies [ticagrelor or clopidogrel following 1-month DAPT, ticagrelor following 3-month DAPT, aspirin following 3–6 months of DAPT (reference strategy), aspirin or P2Y12 inhibitor following 6–18-months of DAPT, and DAPT for ≥18 months] were compared using a network meta-analysis. The primary efficacy outcome was defined as a composite of all-cause death, myocardial infarction, and stroke. The primary bleeding outcome was trial-defined major or minor bleeding. ResultsOur analysis identified 25 eligible RCTs, including 89,371 patients who underwent PCI. Overall, none of the strategies negatively affected the primary efficacy outcomes. For primary bleeding outcomes, ticagrelor following 3-month DAPT was associated with a reduced risk of primary bleeding outcomes (HR 0.73; 95 % CI 0.57–0.95). Clopidogrel following 1-month DAPT was also associated with a reduced risk of primary bleeding outcomes (HR 0.54; 95 % CI 0.34–0.85), however, the strategy was associated with an increased risk of myocardial infarction or stent thrombosis. Similar trends were observed among patients with acute coronary syndrome and high bleeding risk. ConclusionsCompared with aspirin monotherapy following short-term DAPT, ticagrelor following 3-month DAPT was associated with a reduced risk of primary bleeding outcomes without increasing any ischemic outcomes.