Dual Antiplatelet Therapy In Patients Research Articles

Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk

Purinergic receptor P2Y12 (P2Y12) inhibitor monotherapy after a certain period of dual antiplatelet therapy (DAPT) may be an attractive option of maintenance antiplatelet treatment for patients undergoing percutaneous coronary intervention (PCI) who are at both high bleeding and ischemic risk (birisk). To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing DAPT with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in birisk patients with acute coronary syndromes (ACS). This was a multicenter, double-blind, placebo-controlled, randomized clinical trial including birisk patients with ACS who had completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months at 101 China centers between February 2018 and December 2020. Study data were analyzed from April 2023 to May 2023. Patients were randomized either to clopidogrel plus placebo or clopidogrel plus aspirin for an additional 9 months. The primary end point was Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding 9 months after randomization. The key secondary end point was major adverse cardiac and cerebral events (MACCE; the composite of all-cause death, myocardial infarction, stroke or clinically driven revascularization). The primary end point was tested for superiority, and the MACCE end point was tested for sequential noninferiority and superiority. A total of 7758 patients (mean [SD] age, 64.8 [9.0] years; 4575 male [59.0%]) were included in this study. The primary end point of BARC types 2, 3, or 5 bleeding occurred in 95 of 3873 patients (2.5%) assigned to clopidogrel plus placebo and 127 of 3885 patients (3.3%) assigned to clopidogrel plus aspirin (hazard ratio [HR], 0.75; 95% CI, 0.57-0.97; difference, -0.8%; 95% CI, -1.6% to -0.1%; P = .03). The incidence of MACCE was 2.6% (101 of 3873 patients) in the clopidogrel plus placebo group and 3.5% (136 of 3885 patients) in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96; difference, -0.9%; 95% CI, -1.7% to -0.1%; P < .001 for noninferiority; P = .02 for superiority). Among birisk patients with ACS who completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months before randomization, an extended 9-month clopidogrel monotherapy regimen was superior to continuing DAPT with clopidogrel in reducing clinically relevant bleeding without increasing ischemic events. ClinicalTrials.gov Identifier: NCT03431142.

Efficacy and safety of 3-month dual antiplatelet therapy in patients after mechanical thrombectomy for acute ischemic stroke: a retrospective study.

Mechanical thrombectomy (MT) is one of the effective treatment methods for acute ischemic stroke (AIS), which requires a period of dual antiplatelet therapy (DAPT) after endovascular treatment. This study aimed to compare the efficacy and safety of 3-month DAPT and 1-month DAPT in AIS patients receiving MT through a retrospective study. AIS patients who received MT from May 2018 to March 2023 were grouped into a 1-month group (1-M group) and a 3-month group (3-M group) according to the duration of DAPT after MT. The primary outcome was the mRS score at 90 days. Secondary outcomes included a good prognosis (mRS score of 0-2) at 90 days post-surgery, 6-month mortality, recurrence of cerebral infarction, Barthel's index, Montreal Cognitive Assessment (MoCA) score, and incidence of symptomatic intracranial hemorrhage (sICH) during hospitalization. A total of 147 patients with AIS were included in the final analysis, with 78 patients in the 1-M group and 69 patients in the 3-M group. The baseline and neurological characteristics were comparable between both groups. At 3-month follow-up, a total of 61 patients had an mRS of 0-2 at 90 days, with an average mRS of 3.3 ± 0.9 for all patients. There was no statistically significant difference in the mRS between the two groups of patients at 90 days (P > 0.05). There was no statistically significant difference in the mortality rate and incidence of sICH between the two groups of patients during the 6-month follow-up period (P > 0.05), but the recurrence rate of AIS in the 3-M group was lower than that in the 1-M group (P < 0.05). The improvement of Barthel index and MoCA in patients in the 3-M group was higher than those in the 1-M group at 6 months but not statistically different (P > 0.05). For AIS patients undergoing mechanical thrombectomy, compared to 1-month DAPT, 3-month DAPT can reduce the recurrence rate of IS during a 6-month follow-up period, without increasing the mortality and risk of cerebral hemorrhage.

Guideline Adherence for Dual Antiplatelet Therapy in Patients with Acute Ischemic Stroke/Transient Ischemic Attack in Community Hospital: A Prospective Observational Study (P7-5.005)

Guideline Adherence for Dual Antiplatelet Therapy in Patients with Acute Ischemic Stroke/Transient Ischemic Attack in Community Hospital: A Prospective Observational Study (P7-5.005)

Safety and Efficacy of Dual Antiplatelet Therapy in Patients with Minor Ischemic Stroke or High-risk Transient Ischemic Attack After Intravenous Thrombolysis (P8-5.029)

Safety and Efficacy of Dual Antiplatelet Therapy in Patients with Minor Ischemic Stroke or High-risk Transient Ischemic Attack After Intravenous Thrombolysis (P8-5.029)

Stroke and high-risk TIA outcomes with reduction of treatment duration when treatment initiated in emergency rooms (SHORTER-study).

Following transient ischemic attack (TIA) and minor stroke, the risk of recurrent stroke can be significantly reduced with short-duration dual antiplatelet therapy (DAPT). We wish to investigate whether 10 days of DAPT is as effective as 21 days' treatment. This is an open-label, randomized, parallel-group study comparing whether 10 days of DAPT treatment (ASA + clopidogrel) is non-inferior to 21 days of DAPT in patients with acute ischemic stroke (AIS) or high-risk TIA. In both groups, DAPT is started within 24 hours of symptom onset. This study is being conducted in approximately 15 study sites in the Kingdom of Saudi Arabia. The planned sample size is 1932. Non-inferiority of 10 days compared to 21 days of DAPT in the prevention of the composite endpoint of stroke and death at 90 days in AIS/TIA patients. The primary safety outcome is major intra-cranial and systemic hemorrhage. Enrolment started in the second quarter of 2023, and the completion of the study is expected in the fourth quarter of 2025. The trial is expected to show that 10 days of DAPT is non-inferior for the prevention of early recurrence of vascular events in patients with high-risk TIAs and minor strokes.

Author Response: IV Thrombolysis vs Early Dual Antiplatelet Therapy in Patients With Mild Noncardioembolic Ischemic Stroke.

Author Response: IV Thrombolysis vs Early Dual Antiplatelet Therapy in Patients With Mild Noncardioembolic Ischemic Stroke.

STENOSIS: Long-term single versus dual antiplatelet therapy in patients with ischaemic stroke due to intracranial atherosclerotic disease – a randomised trial

RationaleIntracranial atherosclerotic disease (ICAD) is a pathological process that causes progressive stenosis and cerebral hypoperfusion, leading to stroke occurrence and recurrence around the world. The exact duration of dual antiplatelet...

Cilostazol-based dual antiplatelet treatment in ischemic stroke or transient ischemic attack patients with asymptomatic carotid artery disease: a propensity score matching analysis.

The optimal treatment for asymptomatic atherosclerotic carotid artery disease remains controversial. Data on the efficacy of antiplatelet agents and stroke outcomes are limited. This study aimed to examine the efficacy and safety of cilostazol-based dual antiplatelet therapy in patients with ischemic stroke or transient ischemic attack and asymptomatic carotid artery disease. This retrospective cohort study was conducted in a tertiary-care setting and included baseline characteristics and clinical outcomes of participants. The study included patients who had experienced first-ever ischemic stroke or transient ischemic attack and asymptomatic atherosclerotic carotid artery stenosis, with a minimum follow-up period of 1 year. Asymptomatic carotid artery stenosis refers to stenosis in patients without neurological symptoms referable to the carotid arteries. Propensity scores were estimated using a logistic regression model based on participants' baseline characteristics. The efficacy outcome was the composite outcome of recurrent ischemic events and vascular-related death in patients with ischemic stroke or transient ischemic attack and asymptomatic carotid artery stenosis. The safety outcome was the occurrence of hemorrhagic complications such as intracranial hemorrhages or extracranial hemorrhages. The effectiveness of dual therapy compared to monotherapy was evaluated at various time points following the initiation of antiplatelet treatment. This study included 516 patients with a 1-year follow-up period. At 1 year, composite events occurred in 10 (6.3%) patients in the dual antiplatelet group compared with 12 (7.6%) in the single antiplatelet group (HR, 0.74; 95% CI, 0.61-0.90; p = 0.024). Extracranial hemorrhage occurred in 12 (7.6%) patients in the dual antiplatelet group compared with nine (5.7%) in the single antiplatelet group (HR, 1.35; 95% CI, 1.13-1.48; p = 0.017). No intracranial hemorrhages were observed in this cohort. Patients with asymptomatic carotid artery stenosis who received cilostazol-based dual antiplatelet therapy had a lower risk of composite events but a higher risk of minor extracranial hemorrhage than those who received a single antiplatelet agent.

Abstract WP238: Efficacy of Dual Antiplatelet Therapy After Lacunar versus Non-Lacunar Syndromes in the POINT Trial

Introduction: About 20% of ischemic strokes are lacunar infarcts, the pathophysiology of which differs from that of other stroke etiological subtypes. The POINT trial demonstrated the efficacy of dual antiplatelet therapy (DAPT) for secondary stroke prevention in patients with minor ischemic stroke and high-risk TIA, but it remains unknown whether this benefit differed in lacunar versus non-lacunar strokes. Method: In a secondary analysis of POINT trial data, we compared the efficacy of DAPT in patients with an index lacunar syndrome versus not. A lacunar syndrome was defined based on common classic lacunar syndromes (e.g., pure motor hemiparesis, clumsy-hand dysarthria) and ascertained using subcomponents of the National Institutes of Health Stroke Scale documented at baseline. Our primary efficacy outcome was ischemic stroke and the safety outcome was intracranial hemorrhage. We used survival analysis and tests of interaction to compare the effect of DAPT between the lacunar and non-lacunar subgroups. Result: Among 4,881 patients enrolled in the study, 1,083 (22.1%) were classified as having an index lacunar syndrome. The effect of DAPT on the risk of ischemic stroke did not vary significantly after a lacunar syndrome (HR, 0.76; 95% CI, 0.52-1.09) versus after a non-lacunar syndrome (HR, 0.69; 95% CI, 0.50-0.95) (P value for interaction, 0.70). Similarly, the effect of DAPT on the risk of intracranial hemorrhage did not vary significantly after a lacunar syndrome (HR, 2.82; 95% CI, 0.29-27.1) versus after a non-lacunar syndrome (HR, 2.10; 95% CI, 0.63-6.99) (P for interaction, 0.82). Conclusion: In a post hoc secondary analysis of the POINT trial, we found no evidence of a lesser benefit of DAPT after a minor ischemic stroke or TIA in patients presenting with a lacunar syndrome compared to other stroke subtypes.

Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design

BackgroundPatients treated with drug-coated balloons (DCB) have the theoretical advantage of adopting a low-intensity antiplatelet regimen due to the absence of struts and polymers. Nevertheless, the optimal antiplatelet strategy for patients undergoing DCB-only treatment remains a topic of debate and has not been investigated in randomized trials.MethodsThe REC-CAGEFREE II is an investigator-initiated, prospective, open-label, multi-center, randomized, non-inferiority trial aimed to enroll 1908 patients from ≥ 40 interventional cardiology centers in China to evaluate the non-inferiority of an antiplatelet regimen consisting of Aspirin plus Ticagrelor for one month, followed by five months Ticagrelor monotherapy, and then Aspirin monotherapy for six months (Experimental group) compared to the conventional treatment of Aspirin plus Ticagrelor for 12 months (Reference group) in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) using paclitaxel-coated balloons (DCB) exclusively. Participants will be randomly assigned to the Experimental or Reference group in a 1:1 ratio. The randomization will be stratified based on the center and the type of lesion being treated (De novo or in-stent restenosis). The primary endpoint is net adverse clinical events (NACE) within 12 months of PCI, which includes the composite of all-cause death, any stroke, any myocardial infarction, any revascularization and Bleeding Academic Research Consortium (BARC) defined type 3 or 5 bleeding. The secondary endpoint, any ischemic and bleeding event, which includes all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization, and BARC-defined type 2 bleeding events, will be treated as having hierarchical clinical importance in the above order and analyzed using the win ratio method.DiscussionThe ongoing REC-CAGEFREE II trial aims to assess the efficacy and safety of a low-intensity antiplatelet approach among ACS patients with DCB. If non-inferiority is shown, the novel antiplatelet approach could provide an alternative treatment for ACS patients with DCB.Trial registrationClinicalTrials.gov identifier: NCT04971356.

De-escalation of dual antiplatelet therapy for patients with acute coronary syndrome after percutaneous coronary intervention: a systematic review and network meta-analysis.

To compare dual antiplatelet therapy (DAPT) de-escalation with five alternative DAPT strategies in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We conducted a systematic review and network meta-analysis (NMA). Parallel-arm randomised controlled trials (RCTs) comparing DAPT strategies were included and arms of interest were compared via NMA. Partial ranking of each identified arm and for each investigated endpoint was also performed. Adult patients with ACS (≥18 years) undergoing PCI with indications for DAPT. A comprehensive search covered several databases (PubMed, Embase, Cochrane Central, MEDLINE, Conference Proceeding Citation Index-Science) from inception to 15 October 2023. Medical subject headings and keywords related to ACS, PCI and DAPT interventions were used. Reference lists of included studies were screened. Clinical trials registers were searched for ongoing or unpublished trials. Six strategies were assessed: T1 arm: acetylsalicylic acid (ASA) and prasugrel for 12 months; T2 arm: ASA and low-dose prasugrel for 12 months; T3 arm: ASA and ticagrelor for 12 months; T4 arm: DAPT de-escalation (ASA+P2Y12 inhibitor for 1-3 months, then single antiplatelet therapy with potent P2Y12 inhibitor or DAPT with clopidogrel); T5 arm: ASA and clopidogrel for 12 months; T6 arm: ASA and clopidogrel for 3-6 months. Primary outcome: Cardiovascular mortality. bleeding events (all, major, minor), stent thrombosis (ST), stroke, myocardial infarction (MI), all-cause mortality, major adverse cardiovascular events (MACE). 23 RCTs (75 064 patients with ACS) were included. No differences in cardiovascular mortality, all-cause death, recurrent MI or MACE were found when the six strategies were compared, although with different levels of certainty of evidence. ASA and clopidogrel for 12 or 3-6 months may result in a large increase of ST risk versus ASA plus full-dose prasugrel (OR 2.00, 95% CI 1.14 to 3.12, and OR 3.42, 95% CI 1.33 to 7.26, respectively; low certainty evidence for both comparisons). DAPT de-escalation probably results in a reduced risk of all bleedings compared with ASA plus full-dose 12-month prasugrel (OR 0.49, 95% CI 0.26 to 0.81, moderate-certainty evidence) and ASA plus 12-month ticagrelor (OR 0.52, 95% CI 0.33 to 0.75), while it may not increase the risk of ST. ASA plus 12-month clopidogrel may reduce all bleedings versus ASA plus full-dose 12-month prasugrel (OR 0.66, 95% CI 0.42 to 0.94, low certainty) and ASA plus 12-month ticagrelor (OR 0.70, 95% CI 0.52 to 0.89). DAPT de-escalation and ASA-clopidogrel regimens may reduce bleeding events compared with 12 months ASA and potent P2Y12 inhibitors. 3-6 months or 12-month aspirin-clopidogrel may increase ST risk compared with 12-month aspirin plus potent P2Y12 inhibitors, while DAPT de-escalation probably does not.

Early tirofiban versus heparin for bridging dual antiplatelet therapy in patients undergoing coronary endarterectomy combined with coronary artery bypass grafting: a multicenter randomized controlled trial protocol (the THACE-CABG trial)

BackgroundFor complete revascularization, patients with diffuse coronary artery disease should have a coronary endarterectomy and a coronary artery bypass graft (CE-CABG). Sadly, CE can lead to a lack of endothelium, which raises the risk of thrombotic events. Even though daily dual antiplatelet therapies (DAPT) have been shown to reduce thrombotic events, the risk of perioperative thrombotic events is high during the high-risk period after CE-CABG, and there is no consistent protocol to bridge DAPT. This trial aims to compare safety and efficacy between tirofiban and heparin as DAPT bridging strategies after CE-CABG.MethodsIn phase I, 266 patients undergoing CE-CABG will be randomly assigned to tirofiban and heparin treatment groups to compare the two treatments in terms of the primary safety endpoint, chest tube drainage in the first 24 h. If the phase I trial shows tirofiban non-inferiority, phase II will commence, in which an additional 464 patients will be randomly assigned. All 730 patients will be studied to compare major cardiovascular and cerebrovascular events (MACCEs) between the groups in the first 30 days after surgery.DiscussionGiven the possible benefits of tirofiban administration after CE-CABG, this trial has the potential to advance the field of adult coronary heart surgery.Trial registrationchictr.org.cn, ChiCTR2200055697. Registered 6 January 2022. https://www.chictr.org.cn/com/25/showproj.aspx?proj=149451. Current version: 20,220,620.

Optimal time of dual antiplatelet therapy in patients with coronary heart disease (literature review)

However, the choice of optimal time of DAPT after PCI is still a difficult and urgent problem for the attending physician. An increase in DAPT duration after PCI correlates with a lower frequency of ischemic events. At the same time, with a longer DAPT regime, there is a more significant increase in the risks of postoperative bleeding. Hence, it is important to find a balance between the potential risks of bleeding and the expected benefits in reducing ischemic events, while taking into account the individual clinical characteristics of each patient. Intravascular imaging methods, such as intravascular coherence tomography, allow obtaining a highly informative lifetime morphological assessment of the coronary arteries, the formation of the neointima and the malposition of the implanted stent, which, in turn, can help in choosing the optimal timing of the DAPT and prevention of undesirable side events.

1- Versus 3-Month DAPT in Older Patients at a High Bleeding Risk Undergoing PCI: Insights from the XIENCE Short DAPT Global Program

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 three prospective, single-arm studies (XIENCE Short DAPT Program), including high bleeding risk (HBR) patients 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 endpoint was all-cause death or myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2-5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI. Out of 3,364 patients, 2,241 (66.6%) were ≥75 years old. The risk of death or MI was similar with 1- vs 3-month DAPT in patients ≥75 (8.5% vs 8.0%, adjusted HR 0.95, 95% CI 0.69-1.30) and <75 years old (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60-1.57; interaction p-value 0.478). BARC type 2-5 bleeding was consistently lower with 1- than with 3-month DAPT in patients ≥75 years old (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48-0.91) and <75 years old (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57-1.29; interaction p-value 0.737). In conclusion, among HBR patients undergoing PCI, patients older and younger than 75 years of age derived a consistent benefit from 1- as compared with 3-month DAPT in terms of bleeding reduction with no increase in all-cause death or MI at 1 year.

Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk

Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. ClinicalTrials.gov Identifier: NCT03023020.

Vascular healing of Combo plus stents in patients with acute coronary syndrome

Abstract Background The Combo stent has an abluminal sirolimus-eluting coating composed of a biodegradable polymer to form a drug-eluting stent platform. Sirolimus release is completed in 30 days, and the biodegradable polymer disappears within 90 days. This dual therapy approach aims for neointimal suppression while retaining the endothelial progenitor cell–capturing prohealing benefits enabling rapid endothelialization. However, in patients with acute coronary syndrome (ACS), early vascular healing after COMBO stent implantation remains unknown. Purpose The aim of this study is to elucidate the early phase vascular responses in patients with ACS after COMBO stent implantation at 1 month and 6 months follow-up by using optical coherence tomography (OCT). Methods Twenty-eight patients who underwent primary percutaneous coronary intervention (PCI) for AMI with COMBO stent between March 2020 and July 2020 were examined. All patients received follow-up OCT at 1 and 6 months after primary PCI. For assessment of each strut, OCT images were analyzed at 1.0-mm intervals throughout the stented segment. The degree of strut coverage by OCT were measured both 1 month and 6 months. Results The neointimal thickness were 0.110 ± 0.036 mm at 1 months and 0.217 ±0.083 mm at 6 months (P&amp;lt; 0.001). The median rate of any covered struts was 40.2% at 1 month and 89.5% at 6 months (P&amp;lt; 0.001). The median rate of definite uncovered struts was 14.4% at 1 month and 0.7% at 6 months (P&amp;lt; 0.001). Major adverse cardiac events (MACE) were limited to two target vessel failure without target lesion revascularization. No definite or probable stent thrombosis was noted. Conclusions In patients with MI, the COMBO stent is associated with a high degree of neointimal strut coverage at 1 monthfs. Furthermore, almost complete vascular healing at 6 months is observed. These findings may have impact on the duration of dual anti-platelet therapy in patients with MI who underwent PCI using COMBO stent.

Rivaroxaban plus aspirin vs. dual antiplatelet therapy in endovascular treatment in peripheral artery disease and analysis of medication utilization of different lesioned vascular regions.

In the management of Peripheral Arterial Disease (PAD), the administration of anticoagulant or antiplatelet agents is imperative. The use of Dual Antiplatelet Therapy (DAPT) in conjunction with rivaroxaban has shown potential in mitigating adverse outcomes. Given the heterogeneity in the pathology of lower limb arteries, there is a compelling case for individualized treatment strategies. In a single-center retrospective study on pharmacotherapy for peripheral artery disease, patients were treated with either aspirin combined with rivaroxaban or aspirin coupled with clopidogrel. The primary efficacy outcome encompassed a composite of increases in the Rutherford classification, acute limb ischemia, amputations due to vascular causes, target lesion revascularization, myocardial infarction, ischemic stroke, and cardiovascular death. The primary safety outcome was major bleeding, as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria; meanwhile, major bleeding as categorized by the International Society on Thrombosis and Haemostasis (ISTH) served as a secondary safety outcome. The study differentiated between two subgroups: patients with only above-the-knee and below-the-knee arterial lesions. From January 2016 to December 2021, 455 patients received either clopidogrel plus aspirin or rivaroxaban plus aspirin following endovascular treatment (EVT). The rivaroxaban group (n = 220) exhibited a lower incidence of primary efficacy outcomes [49.1% vs. 60.4%, hazard ratio (HR) 0.77, P = 0.006] but had more TIMI major bleeding events (5.9% vs. 2.1%, HR 2.6, P = 0.04). ISTH major bleeding events did not show a significant difference, though a higher percentage of rivaroxaban patients discontinued medication due to bleeding (10% vs. 4.7%, HR 2.2, P = 0.03). In the above-the-knee arterial disease subgroup, the rivaroxaban group demonstrated a lower incidence of primary efficacy outcomes (28.2% vs. 45.2%, HR 0.55, P = 0.02). In the below-the-knee arterial disease subgroup, no significant difference was observed in the occurrence of primary efficacy events between the two groups (58.7% vs. 64.8%, HR 0.76, P = 0.14). Rivaroxaban plus aspirin improved outcomes compared to DAPT in patients with lower extremity artery disease. Similar findings were observed in the above-the-knee artery lesion-only group. However, in the below-the-knee artery lesion-only group, rivaroxaban plus aspirin did not surpass DAPT in efficacy. Regarding safety, rivaroxaban plus aspirin exhibited higher bleeding risks and more frequent treatment discontinuation than aspirin combined with clopidogrel.

One-month dual antiplatelet therapy following stent implantation in patients with acute coronary syndromes and high bleeding risk

Abstract Background/introduction There is a paucity of data regarding the safety of a one-month dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). Purpose We aimed to compare the clinical outcomes of patients at HBR with ACS or chronic coronary syndromes (CCS) treated with PCI using bioresorbable-polymer everolimus-eluting stent followed by one-month DAPT. Methods This is a pre-specified sub-analysis of the POEM trial, an interventional, prospective, multicenter, single-arm trial, that evaluated the safety of PCI with bioresorbable-polymer everolimus-eluting stent followed by one-month DAPT in patients with HBR against an objective performance criterion (OPC). The OPC was derived from the reported 1-year primary endpoint rate of 9.4% observed in the LEADERS FREE trial. According to the POEM protocol, patients were treated with one-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for one month, followed by oral anticoagulation only after that. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. Results 263 (59.4%) patients with CCS and 180 (40.6%) patients with ACS were included. Most of the HBR inclusion criteria were comparable between the two groups, Figure 1. At one year, the rates of the primary outcome were 4.3% (95% CI, 2.4-7.6%) and 5.7% (95% CI, 3.1-10.3%) among patients with CCS and ACS, respectively. Both 1-sided 97.5% upper confidence limits of the risk difference between the primary outcome and the prespecified OPC of 9.4% were below the non-inferiority margin of 3.85 % (CCS: -1.8 %; ACS: 0.9 %), Figure 2. No significant difference was evident between CCS and ACS patients for each isolated component of the primary endpoint (cardiac death: 1.7% vs. 2.0%, p= 0.857; myocardial infarction: 3.9% vs. 3.1%, p= 0.934; definite/probable stent thrombosis: 1.2% vs. 0.8%, p= 0.689). The risk for Bleeding Academic Research Consortium (BARC) type 1-5 or type 3-5 bleedings was also similar between CCS and ACS patients (4.3% vs. 5.2%, p=0.677, and 1.6% vs. 2.9%, p=0.351, respectively). Conclusions Among HBR patients with ACS who underwent PCI with BP-EES, a one-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared to those with CCS. These findings support the hypothesis that DAPT should be tailored to patients’ bleeding risk profiles and that a one-month strategy might be safely applied also in a particular setting of ACS.Figure 1.HBR inclusion criteria.Figure 2.Primary endpoint analysis.

Abstract 17654: Sarpogrelate versus Clopidogrel for Arterial Interventions Systematic Review and Meta Analysis

Background: Sarpogrelate has been used to alleviate ischemic changes by preventing thrombosis, vasoconstriction, and vascular smoothmuscle proliferation. The worldwide use of Sarpogrelate is arguable due to the lack of reliable data regarding its efficacy and safety.Accordingly, our meta-analysis aims to compare the complications after receiving Sarpogrelate with Aspirin (S&amp;A) vs. Clopidogrel withAspirin (C&amp;A) as part of dual anti-platelet therapy in patients with endovascular intervention. Methods: Multiple electronic databases weresearched to identify relevant articles, including MEDLINE, Cochrane CENTRAL, Scopus, Google Scholar, Web of Science, and EMBASE. Allclinical studies that investigated the complication after performing Sarpogrelate versus clopidogrel with Aspirin for arterial interventionswere included in the meta-analysis. Reviews, case reports, conference abstracts, editorials, and animal studies were all excluded. Data wereanalyzed by using comprehensive meta-analysis studies. A complete quality assessment was performed using the Cochrane Risk of Bias toolversion 2 for randomized clinical trials (RCTs). Results: A total of 2588 studies were screened, with three studies included. Two multicenterRCTs and one retrospective cohort study including 527 patients (251 S&amp;A and 276 C&amp;A) were included. The overall quality was high in 2studies and fair in one. No statistically significant difference in restenosis, mortality, and bleeding risk as follows, respectively: (RR:0.81, 95%CI:0.52-1.2, P-value:0.36), (RR:0.37, 95% CI:0.06-2, P-value:0.25) and (RR:0.4, 95% CI:0.13-1.19, P-value:0.1). Conclusion: The antithromboticeffects of Aspirin with Sarpogrelate after vascular intervention are comparable to those of Aspirin plus Clopidogrel. Further large clinicalstudies are required to identify the actual difference in early and late complications after using Sarpogrelate versus clopidogrel.

Abstract 14885: Updated Meta-Analysis of 1 Month versus Greater Than 1 Month of Dual Anti-Platelet Therapy (DAPT) After Percutaneous Coronary Intervention Supports Shorter DAPT Duration

Introduction: The ideal duration of dual anti-platelet therapy (DAPT) after percutaneous coronary intervention (PCI) remains elusive, a balancing act between bleeding and ischemic risks. Recent evidence suggests a shorter duration may be safe. This updated meta-analysis evaluates the safety and efficacy of 1 month of DAPT in patients after PCI with a drug eluting stent. Hypothesis: 1 month of DAPT will be more favorable than greater than 1 month of DAPT Methods: This meta-analysis reviewed literature obtained systematically. Inclusion criteria encompassed randomized study designs comparing the efficacy of 1-month DAPT versus greater than 1-month of DAPT treatment in patients with PCI for stable coronary artery disease (CAD) or acute coronary syndrome (ACS), minimum follow-up of 12 months, and full-text studies published in peer-reviewed journals. Exclusion criteria include studies that did not include DAPT longer than 1-month, non-randomized studies, unpublished studies, and ongoing trials. We reviewed 96 articles; 7 were included in our meta-analysis. We included 2 more studies compared to the most recent meta-analysis. Our statistical analysis calculated weighted pooled risk ratios, confidence intervals, and p-values using the Mantel-Haenszel method. Results: The sample size was 24,412. The primary outcome of overall mortality favored 1 month of DAPT compared to greater than one month DAPT [RR 0.57, (CI 0.48-0.66) P&lt;0.00001]. The secondary outcomes of cardiovascular death [RR 0.68, (CI 0.56-0.83) P=0.0001] and bleeding [RR 0.70, (CI 0.63-0.78) P&lt;0.00001) favored 1 month of DAPT compared to greater than 1 month of DAPT. The secondary outcome of myocardial infarction [RR 1.25, (CI 1.08-1.44) P=0.002] favored greater than 1 month of DAPT compared to 1 month of DAPT. Stent thrombosis [RR 1.21, (CI 0.84-1.74) P= 0.31] did not meet statistical significance. Conclusions: Our meta-analysis suggests that 1 month of DAPT was associated with improved overall mortality, cardiovascular death and bleeding, at the expense of increased myocardial infarction. One month of DAPT is a reasonable treatment option for high bleeding risk patients undergoing PCI.