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1.
Pharmacoepidemiol Drug Saf ; 33(6): e5816, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38773801

ABSTRACT

BACKGROUND: Antisecretory drugs are commonly prescribed with clopidogrel-based dual antiplatelet therapy (DAPT) to prevent gastrointestinal bleeding in high-risk patients after percutaneous coronary intervention (PCI). However, omeprazole and esomeprazole (inhibiting proton pump inhibitors [PPIs]) may increase cardiovascular event rates on co-administration with clopidogrel. This study aimed to examine trends in the use of antisecretory agents in patients administered clopidogrel-based DAPT and the concomitant use of clopidogrel and inhibiting PPIs. METHODS: We used National Inpatient Sample data compiled by the Health Insurance Review & Assessment Service from 2009 to 2020. Further, we identified patients who were prescribed clopidogrel-based DAPT after PCI and investigated the concomitant use of antisecretory agents with clopidogrel. To verify the annual trend of drug utilization, we used the Cochran-Armitage trend test. RESULTS: From 2009 to 2020, the percentage of H2 receptor antagonist users decreased steadily (from 82.5% in 2009 to 25.3% in 2020); instead, the percentage of PPI users increased (from 23.7% in 2009 to 82.0% in 2020). The use of inhibiting PPI also increased (from 4.2% in 2009 to 30.7% in 2020). Potassium competitive acid blockers (P-CABs) were rarely used before 2019; however, in 2020, it accounted for 7.8% of the antisecretory users. CONCLUSIONS: Our study demonstrates that the use of inhibiting PPIs increased steadily in patients administered clopidogrel-based DAPT therapy. This is a major concern since the concomitant use of inhibiting PPIs with clopidogrel could increase the risk of cardiovascular events.


Subject(s)
Clopidogrel , Gastrointestinal Hemorrhage , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Proton Pump Inhibitors , Humans , Clopidogrel/administration & dosage , Clopidogrel/therapeutic use , Clopidogrel/adverse effects , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Proton Pump Inhibitors/administration & dosage , Proton Pump Inhibitors/therapeutic use , Male , Female , Aged , Middle Aged , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/epidemiology , Gastrointestinal Hemorrhage/prevention & control , Dual Anti-Platelet Therapy/methods , Esomeprazole/administration & dosage , Esomeprazole/therapeutic use , Omeprazole/administration & dosage , Omeprazole/therapeutic use , Omeprazole/adverse effects , Drug Interactions , Drug Therapy, Combination , Histamine H2 Antagonists/administration & dosage , Histamine H2 Antagonists/therapeutic use
2.
EuroIntervention ; 20(10): e630-e642, 2024 May 20.
Article in English | MEDLINE | ID: mdl-38776146

ABSTRACT

BACKGROUND: A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. AIMS: We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. METHODS: This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. RESULTS: Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. CONCLUSIONS: Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.


Subject(s)
Acute Coronary Syndrome , Drug-Eluting Stents , Dual Anti-Platelet Therapy , Hemorrhage , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/instrumentation , Acute Coronary Syndrome/therapy , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Male , Middle Aged , Aged , Female , Hemorrhage/chemically induced , Treatment Outcome , Dual Anti-Platelet Therapy/methods , Prospective Studies , Time Factors , Risk Factors , Non-ST Elevated Myocardial Infarction/therapy , Non-ST Elevated Myocardial Infarction/mortality
3.
JACC Cardiovasc Interv ; 17(9): 1119-1130, 2024 May 13.
Article in English | MEDLINE | ID: mdl-38749592

ABSTRACT

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).


Subject(s)
Aspirin , Coronary Artery Disease , Drug Administration Schedule , Drug-Eluting Stents , Dual Anti-Platelet Therapy , Everolimus , Hemorrhage , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Prasugrel Hydrochloride , Prosthesis Design , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Male , Time Factors , Female , Aspirin/administration & dosage , Aspirin/adverse effects , Aspirin/therapeutic use , Aged , Middle Aged , Treatment Outcome , Hemorrhage/chemically induced , Hemorrhage/prevention & control , Risk Factors , Prasugrel Hydrochloride/administration & dosage , Prasugrel Hydrochloride/adverse effects , Prasugrel Hydrochloride/therapeutic use , Everolimus/administration & dosage , Everolimus/adverse effects , Coronary Artery Disease/therapy , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Thrombosis/etiology , Coronary Thrombosis/prevention & control , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/diagnostic imaging , Chromium Alloys , Risk Assessment , Drug Therapy, Combination
4.
N Z Med J ; 137(1595): 64-72, 2024 May 17.
Article in English | MEDLINE | ID: mdl-38754114

ABSTRACT

AIM: The recommended duration of dual anti-platelet therapy (DAPT) following acute coronary syndrome (ACS) for patients without atrial fibrillation varies from 1 month to 1 year depending on the balance of risks of ischaemia and major bleeding. Patients on DAPT with a high risk of gastrointestinal bleeding are also recommended to receive a proton pump inhibitor (PPI). Our aim was to audit current practice against the 2020 European Society of Cardiology (ESC) guideline recommendations. METHODS: One hundred consecutive ACS patients treated with percutaneous coronary intervention discharged from Middlemore Hospital and without atrial fibrillation in the first quarter of 2023 were studied. ANZACS-QI ischaemic (I) and bleeding (B) risk scores were calculated, with patients categorised in four groups based on ESC recommendations-low I/low B risk, low I/high B, high I/low B and high I/high B. Guideline and clinician recommended duration of DAPT and prescription of PPI were compared. RESULTS: All patients were planned for DAPT at discharge and 91% a PPI. Up to four out of five ACS patients could have been planned for shorter DAPT durations based on the ESC guideline recommendations. Over half of included patients (53%) had a high bleeding risk, yet 85% of these patients received 12 months of DAPT despite ESC recommendations of 1-3 months. CONCLUSIONS: There was a divergence between clinical practice and the recommendations of the 2020 ESC guidelines. We discuss these results in relation to the updated August 2023 ESC guidelines, which have reaffirmed a 12-month duration of DAPT as the default position.


Subject(s)
Acute Coronary Syndrome , Dual Anti-Platelet Therapy , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Practice Guidelines as Topic , Proton Pump Inhibitors , Humans , Acute Coronary Syndrome/drug therapy , Male , Female , Aged , Middle Aged , Proton Pump Inhibitors/administration & dosage , Proton Pump Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Guideline Adherence , New Zealand , Gastrointestinal Hemorrhage/chemically induced
5.
JAMA Netw Open ; 7(5): e2411735, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38753327

ABSTRACT

Importance: Dual antiplatelet therapy (DAPT) appears to be an effective treatment option for minor (nondisabling) acute ischemic stroke. This conclusion is based on trials that include both transient ischemic attack (TIA) and minor stroke; however, these 2 conditions may differ. Objective: To compare DAPT regimens specifically for minor stroke. Data Sources: PubMed was searched for randomized clinical trials published up to November 4, 2023. Search terms strategy included TIA, transient ischemic attack, minor stroke, or moderate stroke, with the filter randomized controlled trial. Unpublished data on minor stroke were sourced from authors and/or institutions. Study Selection: Trials testing DAPT within the first 24 hours of a minor stroke (defined as a National Institutes of Health Stroke Scale score ≤5) were included by consensus. Of 1508 studies screened, 6 (0.3%) initially met inclusion criteria and were reviewed. Data Extraction and Synthesis: The study was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines by multiple observers. Bayesian fixed-effect network meta-analysis was conducted. Secondary analysis performed for high-risk TIA alone. Main Outcomes and Measures: Treatments were ranked using a probability measure called surface under the cumulative rank curve (SUCRA). The primary outcome was subsequent ischemic stroke at 90 days. Secondary outcomes included major hemorrhage, mortality, and hemorrhagic stroke. The number needed to treat (NNT) and number needed to harm (NNH) were obtained. Results: Five trials were included that described 28 148 patients, of whom 22 203 (78.9%) had a minor stroke. Of these, 13 995 (63.0%) were in DAPT groups and 8208 (37.0%) in aspirin (acetylsalicylic acid) groups. Aspirin and ticagrelor had a 94% probability of being the superior treatment for minor stroke (SUCRA, 0.94) for the primary outcome. Both aspirin and ticagrelor (NNT, 40; 95% CI, 31-64) and aspirin and clopidogrel (NNT, 58; 95% CI, 39-136) were superior to aspirin alone in the prevention of recurrent ischemic stroke at 90 days. Both treatments had higher rates of major hemorrhage than aspirin alone (NNH for aspirin and ticagrelor, 284; 95% CI, 108-1715 vs NNH for aspirin and clopidogrel, 330; 95% CI, 118-3430), but neither had increased risk of hemorrhagic stroke or death. For high-risk TIA, ticagrelor and aspirin had a 60% probability (SUCRA, 0.60) and clopidogrel and aspirin had a 40% probability (SUCRA 0.40) of being a superior treatment; neither was optimum, but both were superior to aspirin alone for the primary outcome. Conclusions and Relevance: These findings suggest that DAPT with aspirin and ticagrelor has higher probability of being the superior treatment among patients with minor stroke when presence of CYP2C19 loss-of-function alleles has not been excluded. For patients with TIA, the superiority of aspirin and ticagrelor vs aspirin and clopidogrel was not demonstrated.


Subject(s)
Bayes Theorem , Dual Anti-Platelet Therapy , Ischemic Stroke , Network Meta-Analysis , Platelet Aggregation Inhibitors , Humans , Aspirin/therapeutic use , Dual Anti-Platelet Therapy/methods , Ischemic Attack, Transient/drug therapy , Ischemic Stroke/drug therapy , Platelet Aggregation Inhibitors/therapeutic use , Randomized Controlled Trials as Topic
6.
J Am Heart Assoc ; 13(10): e032248, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38761068

ABSTRACT

BACKGROUND: Carriers of CYP2C19 loss-of-function alleles have increased adverse events after percutaneous coronary intervention, but limited data are available for older patients. We aimed to evaluate the prognostic impact of CYP2C19 genotypes on clinical outcomes in older patients after percutaneous coronary intervention. METHODS AND RESULTS: The study included 1201 older patients (aged ≥75 years) who underwent percutaneous coronary intervention and received clopidogrel-based dual antiplatelet therapy in South Korea. Patients were grouped on the basis of CYP2C19 genotypes. The primary outcome was 3-year major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and stent thrombosis. Older patients were grouped into 3 groups: normal metabolizer (36.6%), intermediate metabolizer (48.1%), and poor metabolizer (15.2%). The occurrence of the primary outcome was significantly different among the groups (3.1, 7.0, and 6.2% in the normal metabolizer, intermediate metabolizer, and poor metabolizer groups, respectively; P=0.02). The incidence rate of all-cause death at 3 years was greater in the intermediate metabolizer and poor metabolizer groups (8.1% and 9.2%, respectively) compared with that in the normal metabolizer group (3.5%, P=0.03) without significant differences in major bleeding. In the multivariable analysis, the intermediate metabolizer and poor metabolizer groups were independent predictors of 3-year clinical outcomes. CONCLUSIONS: In older patients, the presence of any CYP2C19 loss-of-function allele was found to be predictive of a higher incidence of major adverse cardiac events within 3 years following percutaneous coronary intervention. This finding suggests a need for further investigation into an optimal antiplatelet strategy for older patients. REGISTRATION: URL: https://clinicaltrials.gov. Identifier: NCT04734028.


Subject(s)
Clopidogrel , Cytochrome P-450 CYP2C19 , Genotype , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Humans , Cytochrome P-450 CYP2C19/genetics , Cytochrome P-450 CYP2C19/metabolism , Percutaneous Coronary Intervention/adverse effects , Male , Female , Aged , Platelet Aggregation Inhibitors/pharmacokinetics , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Republic of Korea/epidemiology , Clopidogrel/pharmacokinetics , Clopidogrel/therapeutic use , Clopidogrel/adverse effects , Aged, 80 and over , Prognosis , Treatment Outcome , Time Factors , Coronary Artery Disease/genetics , Coronary Artery Disease/surgery , Coronary Artery Disease/mortality , Coronary Artery Disease/therapy , Risk Factors , Dual Anti-Platelet Therapy/adverse effects , Risk Assessment , Age Factors , Myocardial Infarction/genetics , Myocardial Infarction/epidemiology , Pharmacogenomic Variants
8.
J Am Heart Assoc ; 13(10): e033611, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38761083

ABSTRACT

BACKGROUND: Recent clinical trials established the benefit of dual antiplatelet therapy with aspirin and clopidogrel (DAPT-AC) in early-presenting patients with minor ischemic stroke. However, the impact of these trials over time on the use and outcomes of DAPT-AC among the patients with nonminor or late-presenting stroke who do not meet the eligibility criteria of these trials has not been delineated. METHODS AND RESULTS: In a multicenter stroke registry, this study examined yearly changes from April 2008 to August 2022 in DAPT-AC use for stroke patients ineligible for CHANCE/POINT (Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events/Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) clinical trials due to National Institutes of Health Stroke Scale >4 or late arrival beyond 24 hours of onset. A total of 32 118 patients (age, 68.1±13.1 years; male, 58.5%) with National Institutes of Health Stroke Scale of 4 (interquartile range, 1-7) were analyzed. In 2008, DAPT-AC was used in 33.0%, other antiplatelets in 62.7%, and no antiplatelet in 4.3%. The frequency of DAPT-AC was relatively unchanged through 2013, when the CHANCE trial was published, and then increased steadily, reaching 78% in 2022, while other antiplatelets decreased to 17.8% in 2022 (Ptrend<0.001). From 2011 to 2022, clinical outcomes nonsignificantly improved, with an average relative risk reduction of 2%/y for the composite of stroke, myocardial infarction, and all-cause mortality, both among patients treated with DAPT-AC and patients treated with other antiplatelets. CONCLUSIONS: Use of DAPT-AC in stroke patients with stroke ineligible for recent DAPT clinical trials increased markedly and steadily after CHANCE publication in 2013, reaching deployment in nearly 4 of every 5 patients by 2022. The secondary prevention in patients with ischemic stroke seems to be gradually improving, possibly due to the enhancement of risk factor control.


Subject(s)
Aspirin , Clopidogrel , Dual Anti-Platelet Therapy , Ischemic Stroke , Platelet Aggregation Inhibitors , Registries , Humans , Clopidogrel/therapeutic use , Aspirin/therapeutic use , Male , Aged , Female , Ischemic Stroke/drug therapy , Ischemic Stroke/mortality , Ischemic Stroke/diagnosis , Ischemic Stroke/prevention & control , Dual Anti-Platelet Therapy/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Middle Aged , Treatment Outcome , Aged, 80 and over , Time Factors , Japan/epidemiology , Secondary Prevention/methods , Secondary Prevention/trends , Drug Therapy, Combination , Risk Factors
9.
Acta Neurochir (Wien) ; 166(1): 216, 2024 May 15.
Article in English | MEDLINE | ID: mdl-38744753

ABSTRACT

PURPOSE: Despite growing evidence for the effectiveness of stent-assisted coil embolization (SAC) in treating acutely ruptured aneurysms, the safety of stent placement in acute phase remains controversial because of concerns for stent-induced thromboembolism and hemorrhagic events attributable to the necessity of antiplatelet therapy. Therefore, we investigated the safety and efficacy of SAC with periprocedural dual antiplatelet therapy (DAPT) compared with the coiling-only technique to determine whether it is a promising treatment strategy for ruptured aneurysms. METHODS: We retrospectively evaluated 203 enrolled patients with acutely ruptured aneurysms, categorizing them into two groups: SAC and coiling-only groups. Comparative analyses between the two groups regarding angiographic results, clinical outcomes, and procedure-related complications were performed. A subgroup analysis of procedural complications was conducted on patients who did not receive chronic antithrombotic medications to alleviate their influence before hospitalization. RESULTS: 130 (64.0%) patients were treated using the coiling-only technique, whereas 73 (36.0%) underwent SAC. There was a trend to a higher complete obliteration rate (p = 0.061) and significantly lower recanalization rate (p = 0.030) at angiographic follow-up in the SAC group compared to the coiling-only group. Postprocedural cerebral infarction occurred less frequently in the SAC group (8.2%) than in the coiling-only group (17.7%), showing a significant difference (p = 0.044). Although the ventriculostomy-related hemorrhage rate was significantly higher in the SAC group than in the coiling-only group (26.2% vs. 9.3%, p = 0.031), the incidence of symptomatic ventriculostomy-related hemorrhage was comparable. Subgroup analysis excluding patients receiving chronic antithrombotic medications showed similar results. CONCLUSION: SAC with periprocedural DAPT could be a safe and effective treatment strategy for acutely ruptured aneurysms. Moreover, it might have a protective effect on postprocedural cerebral infarction without increasing the risk of symptomatic hemorrhagic complications.


Subject(s)
Aneurysm, Ruptured , Embolization, Therapeutic , Intracranial Aneurysm , Platelet Aggregation Inhibitors , Stents , Humans , Female , Male , Intracranial Aneurysm/therapy , Intracranial Aneurysm/surgery , Middle Aged , Embolization, Therapeutic/methods , Embolization, Therapeutic/adverse effects , Aneurysm, Ruptured/surgery , Aneurysm, Ruptured/therapy , Retrospective Studies , Aged , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Treatment Outcome , Adult , Dual Anti-Platelet Therapy/methods
13.
Catheter Cardiovasc Interv ; 103(6): 843-855, 2024 May.
Article in English | MEDLINE | ID: mdl-38639169

ABSTRACT

INTRODUCTION: Among different coronary stents implanted in High Bleeding Risk (HBR) patients with an indication for short antiplatelet therapy, no comparisons in terms of efficacy have been provided. METHODS: A Network Meta Analysis was performed including all randomized controlled trials comparing different coronary stents evaluated in HBR patients. Major Adverse Cardiovascular Events (MACEs) as defined by each included trial were the primary end point, whereas TLR (target lesion revascularization), TVR (target vessel revascularization), stent thrombosis and total and major (BARC3-5) bleedings were the secondary ones. RESULTS: A total of four studies (ONYX ONE, LEADERS FREE, SENIOR and HBR in BIO-RESORT) including 6637 patients were analyzed with different kind of stents and dual antiplatelet therapy (DAPT) length (1 or 6 months) on 12 months follow-up. About one-third of these patients were defined HBR due to indication for oral anticoagulation. All drug eluting stents (DESs) reduced risk of MACE compared to Bare Metal Stents (BMSs) when followed by a 1-month DAPT. At SUCRA analysis, Orsiro was the device with the highest probability of performing best. Rates of TLR and TVR were significantly lower when using Resolute Onyx, Synergy and BioFreedom stents in comparison to BMS when followed by 1-month DAPT, with Synergy ranking best. Synergy also showed a significantly lower number of stent thrombosis compared to BMS (RR 0.28, 95% CI 0.06-0.93), while Orsiro and Resolute Integrity showed the highest probability of performing best. CONCLUSION: In HBRs patients, all DESs were superior to BMSs in terms of efficacy and safety. Among DESs, Orsiro was the one with the highest ranking in terms of MACE, mainly driven by a reduced incidence of repeated revascularization and stent thrombosis.


Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Hemorrhage , Network Meta-Analysis , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Humans , Coronary Artery Disease/therapy , Coronary Thrombosis/etiology , Coronary Thrombosis/prevention & control , Dual Anti-Platelet Therapy , Hemorrhage/prevention & control , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Prosthesis Design , Randomized Controlled Trials as Topic , Risk Factors , Time Factors , Treatment Outcome
14.
High Blood Press Cardiovasc Prev ; 31(2): 141-155, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38557855

ABSTRACT

INTRODUCTION: Patients of acute coronary syndrome (ACS) at a high-bleeding risk (HBR) often require dual antiplatelet therapy (DAPT) to reduce the risk of recurrent cardiovascular events. Clopidogrel and ticagrelor are the most commonly used antiplatelet agents in DAPT regimens. However, the safety profiles of these drugs in ACS patients at HBR remain a subject of ongoing debate. AIM: To investigate any difference between the safety of clopidogrel and ticagrelor used as a part of DAPT regimen in ACS patients at HBR. METHODS: A systematic search on PubMed, Cochrane Library, and Google Scholar was conducted to identify experimental and observational studies published up to the knowledge cutoff date in September 2023. Studies comparing the safety of clopidogrel and ticagrelor in ACS patients at HBR were included for analysis. The primary outcomes assessed were major bleeding events, stroke, and myocardial infarction (MI), while secondary outcomes included all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and net adverse clinical and cerebral events (NACCE). RESULTS: We included a total of 8 observational studies in our meta-analysis. The pooled analysis revealed a statistically significant increase in the risk of MI (pooled RR = 1.43; 95% CI 1.12-1.83; P = 0.005) in the patients using clopidogrel. There were no statistically significant differences in major bleeding events (pooled RR = 0.94; 95% CI 0.82-1.09; P = 0.44), stroke (pooled RR = 1.36; 95% CI 0.86-2.14; P = 0.18), all-cause mortality (pooled RR = 1.17; 95% CI 0.97-1.41; P = 0.10), MACCE (pooled RR = 1.07; 95% CI 0.76-1.50; P = 0.69) and NACCE (pooled RR = 0.95; 95% CI 0.66-1.37; P = 0.78) between the two groups. Subgroup analyses based on region were performed. CONCLUSION: Both drugs are generally safe for treating ACS patients with HBR at baseline, although a higher risk of MI was observed with the use of clopidogrel. Nevertheless, drug choice should factor in regional variations, patient-specific characteristics, cost, accessibility, and potential drug interactions.


Subject(s)
Acute Coronary Syndrome , Clopidogrel , Dual Anti-Platelet Therapy , Hemorrhage , Platelet Aggregation Inhibitors , Ticagrelor , Aged , Female , Humans , Male , Middle Aged , Acute Coronary Syndrome/mortality , Clopidogrel/adverse effects , Clopidogrel/therapeutic use , Clopidogrel/administration & dosage , Dual Anti-Platelet Therapy/adverse effects , Hemorrhage/chemically induced , Observational Studies as Topic , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/therapeutic use , Risk Assessment , Risk Factors , Ticagrelor/adverse effects , Ticagrelor/therapeutic use , Ticagrelor/administration & dosage , Treatment Outcome
17.
Lancet ; 403(10439): 1866-1878, 2024 May 11.
Article in English | MEDLINE | ID: mdl-38599220

ABSTRACT

BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). METHODS: In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). INTERPRETATION: In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section.


Subject(s)
Acute Coronary Syndrome , Aspirin , Drug Therapy, Combination , Hemorrhage , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Ticagrelor , Humans , Ticagrelor/therapeutic use , Aspirin/therapeutic use , Aspirin/administration & dosage , Percutaneous Coronary Intervention/methods , Acute Coronary Syndrome/therapy , Double-Blind Method , Male , Female , Middle Aged , Platelet Aggregation Inhibitors/therapeutic use , Aged , Hemorrhage/chemically induced , Purinergic P2Y Receptor Antagonists/therapeutic use , Purinergic P2Y Receptor Antagonists/administration & dosage , Dual Anti-Platelet Therapy/methods , Treatment Outcome
18.
Circ J ; 88(6): 876-884, 2024 May 24.
Article in English | MEDLINE | ID: mdl-38569870

ABSTRACT

BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain.Methods and Results: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.


Subject(s)
Absorbable Implants , Clopidogrel , Drug-Eluting Stents , Dual Anti-Platelet Therapy , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Purinergic P2Y Receptor Antagonists , Registries , Humans , Male , Aged , Female , Percutaneous Coronary Intervention/adverse effects , Middle Aged , Purinergic P2Y Receptor Antagonists/administration & dosage , Purinergic P2Y Receptor Antagonists/adverse effects , Purinergic P2Y Receptor Antagonists/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Clopidogrel/therapeutic use , Clopidogrel/adverse effects , Clopidogrel/administration & dosage , Prospective Studies , Japan , Dual Anti-Platelet Therapy/methods , Hemorrhage/chemically induced , Prasugrel Hydrochloride/administration & dosage , Prasugrel Hydrochloride/therapeutic use , Prasugrel Hydrochloride/adverse effects , Polymers , Treatment Outcome
19.
J Neurol ; 271(6): 3030-3038, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38580815

ABSTRACT

BACKGROUND: Dual antiplatelet therapy (DAPT) with clopidogrel plus aspirin is a well-established practice after a minor stroke or transient ischemic attack (TIA). However, ticagrelor plus aspirin may be an alternative. AIMS: We systematically searched PubMed, Embase, and Cochrane Central from inception to January 2024. We included randomized controlled trials (RCTs) enrolling adults with acute minor stroke or TIA within 72 hours of the onset of the symptoms. RESULTS: A total of 8 RCTs were included in our meta-analysis. Ticagrelor plus aspirin (RR, 0.70; 95% CrI 0.52, 0.91) and clopidogrel plus aspirin (RR, 0.79; 95% CrI 0.64, 0.98) were superior to aspirin in preventing stroke recurrence in overall analysis. Excluding studies with dual antiplatelet up to 90 days, ticagrelor plus aspirin was the only strategy that maintained superiority compared with aspirin regarding stroke recurrence (RR, 0.70; 95% CrI 0.51, 0.95) and ischemic stroke (RR, 0.68; 95% CrI 0.47, 0.94). There was no significant difference between treatment groups regarding hemorrhagic stroke, functional disability, and mortality. CONCLUSIONS: DAPTs were superior to aspirin in preventing recurrence or ischemic stroke. Although no significant difference was observed between DAPTs, ticagrelor plus aspirin may be related to worse major bleeding results, including intracranial bleeding. Ticagrelor plus aspirin is a considerable option for patients after a minor stroke or TIA.


Subject(s)
Clopidogrel , Dual Anti-Platelet Therapy , Ischemic Attack, Transient , Network Meta-Analysis , Platelet Aggregation Inhibitors , Stroke , Ticagrelor , Humans , Ticagrelor/administration & dosage , Clopidogrel/administration & dosage , Ischemic Attack, Transient/drug therapy , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/therapeutic use , Stroke/drug therapy , Aspirin/administration & dosage , Aspirin/therapeutic use , Randomized Controlled Trials as Topic , Drug Therapy, Combination , Ischemic Stroke/drug therapy
20.
Inflammopharmacology ; 32(3): 1999-2006, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38642222

ABSTRACT

BACKGROUND: This work evaluated the effects of proton pump inhibitors (PPIs) on cardiovascular events (CVEs) and inflammatory factors in patients with upper gastrointestinal bleeding (UGIB) undergoing dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. Clinical data from these patients were analysis, intending to provide relevant theoretical evidence for clinical practice. MATERIALS AND METHODS: Data of 166 patients who underwent percutaneous coronary intervention and developed UGIB while on DAPT at The First People' Hospital of Linping District from April 2021 to April 2023 were retrospectively analyzed. The patients were rolled into two groups: those who received PPI treatment and those who did not, namely, PPI and non-PPI group, respectively. Furthermore, occurrence of CVEs and the levels of inflammatory factors of patients in all groups were statistically analyzed. RESULTS: In patients with UGIB, melena is a common presentation. The incidence of CVE in the PPI group showed no statistically significant difference compared to the control group, and there was no significant variance observed in the distribution of CVE incidence among different PPIs. However, levels of C-reactive protein (CRP) and tumor necrosis factor-alpha (TNF-α) were significantly lower in the PPI group compared to the non-PPI group (P < 0.05). CONCLUSION: Melena was the most frequent clinical manifestation in UGIB patients. The use of PPIs did not increase the risk of CVEs, and different PPI drugs did not affect the occurrence of CVEs. Furthermore, PPIs lowered CRP and TNF-α levels in serum of these patients.


Subject(s)
Cardiovascular Diseases , Gastrointestinal Hemorrhage , Platelet Aggregation Inhibitors , Proton Pump Inhibitors , Humans , Proton Pump Inhibitors/adverse effects , Proton Pump Inhibitors/administration & dosage , Male , Female , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Retrospective Studies , Gastrointestinal Hemorrhage/chemically induced , Aged , Middle Aged , Dual Anti-Platelet Therapy/methods , Dual Anti-Platelet Therapy/adverse effects , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , C-Reactive Protein/metabolism , Inflammation/drug therapy , Tumor Necrosis Factor-alpha/metabolism
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