Dataset Information

Real-world performance of indobufen versus aspirin after percutaneous coronary intervention: insights from the ASPIRATION registry.

ABSTRACT:

Background

Indobufen is widely used in patients with aspirin intolerance in East Asia. The OPTION trial launched by our cardiac center examined the performance of indobufen based dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, the vast majority of patients with acute coronary syndrome (ACS) and aspirin intolerance were excluded. We aimed to explore this question in a real-world population.

Methods

Patients enrolled in the ASPIRATION registry were grouped according to the DAPT strategy that they received after PCI. The primary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE) and Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Propensity score matching (PSM) was adopted for confounder adjustment.

Results

A total of 7135 patients were reviewed. After one-year follow-up, the indobufen group was associated with the same risk of MACCE versus the aspirin group after PSM (6.5% vs. 6.5%, hazard ratio [HR] = 0.99, 95% confidence interval [CI] = 0.65 to 1.52, P = 0.978). However, BARC type 2, 3, or 5 bleeding was significantly reduced (3.0% vs. 11.9%, HR = 0.24, 95% CI = 0.15 to 0.40, P < 0.001). These results were generally consistent across different subgroups including aspirin intolerance, except that indobufen appeared to increase the risk of MACCE in patients with ACS.

Conclusions

Indobufen shared the same risk of MACCE but a lower risk of bleeding after PCI versus aspirin from a real-world perspective. Due to the observational nature of the current analysis, future studies are still warranted to further evaluate the efficacy of indobufen based DAPT, especially in patients with ACS.

Trial registration

Chinese Clinical Trial Register ( https://www.chictr.org.cn ); Number: ChiCTR2300067274.

SUBMITTER: Dai C

PROVIDER: S-EPMC10986102 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Real-world performance of indobufen versus aspirin after percutaneous coronary intervention: insights from the ASPIRATION registry.

Dai Chunfeng C Liu Muyin M Yang Zheng Z Li Youran Y Zhou You Y Lu Danbo D Xia Yan Y Chen Ao A Li Chenguang C Lu Hao H Dai Yuxiang Y Ma Jianying J Chen Zhangwei Z Qian Juying J Ge Junbo J

BMC medicine 20240402 1

<h4>Background</h4>Indobufen is widely used in patients with aspirin intolerance in East Asia. The OPTION trial launched by our cardiac center examined the performance of indobufen based dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, the vast majority of patients with acute coronary syndrome (ACS) and aspirin intolerance were excluded. We aimed to explore this question in a real-world population.<h4>Methods</h4>Patients enrolled in the ASPIRATION regist ...[more]

PMID: 38561738

Similar Datasets

Project description:ObjectivesThe primary aim was to investigate the efficacy and safety of dual antiplatelet therapy (DAPT) using ticagrelor (T-DAPT) versus clopidogrel (C-DAPT) in a real-world ST-elevation myocardial infarction (STEMI) population.MethodsWe retrospectively analyzed 655 consecutive patients having primary percutaneous coronary intervention (PCI) for STEMI at Liverpool Hospital, Sydney, Australia (from January 2013 to April 2016). Medical and procedural therapies were at clinician discretion. Patient data were retrieved from hospital records and primary clinicians.ResultsT-DAPT (65%) was used more frequently, and in patients with lower mean CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines) score, than C-DAPT (24.6 vs. 32.2; p < 0.0001, respectively). All-cause mortality was 9.0% at 2.7 years follow-up, with fewer deaths for T-DAPT (4.5% vs. 17.2%; p < 0.0001). T-DAPT incurred less BARC (Bleeding Academic Research Consortium) 3-5 major bleeding (5.0% vs. 12.4%; p < 0.0001). Multivariate regression showed that C-DAPT, GRACE (Global Registry of Acute Cardiac Events) score, and renal insufficiency were independently associated with mortality. Intra-aortic balloon pump (IABP) and GRACE score independently predicted BARC 3-5 bleeding. Early DAPT discontinuation (1.7%) and ticagrelor intolerance (7.6%) was rare. Switching DAPT regimen was infrequent (21.7%) and mostly attributed to clinician preference (73.2%). Independent determinants of C-DAPT selection were older age, diabetes, prior PCI, IABP, and higher CRUSADE score.ConclusionTicagrelor was preferred in low bleeding risk patients, which may have contributed to less BARC 3-5 bleeding and lower mortality for T-DAPT. Thus, bleeding mitigation is a clinical priority when selecting DAPT for PCI-treated STEMI patients. Continuation of initial DAPT regimen was typical, but early switching from clopidogrel to ticagrelor shows willingness to optimize DAPT. Patients with very low CRUSADE scores (<21.5) may be appropriate for switching to a potent P2Y12 inhibitor.

Project description:Purpose: This study compared the effect of indobufen with that of aspirin on platelet function in patients with stable coronary heart disease after percutaneous coronary intervention (PCI). Methods: Patients with stable coronary heart disease who had undergone PCI and received dual antiplatelet therapy (aspirin 100 mg + clopidogrel 75 mg once daily) for at least 12 months were allocated to receive indobufen 100 mg twice daily + clopidogrel 75 mg once daily, clopidogrel 75 mg once daily alone, indobufen 100 mg twice daily alone, and aspirin 100 mg once daily alone for 1 month each in an open-label crossover manner. Platelet function was assessed by using the rates of arachidonic acid (AA)-induced platelet aggregation (AA-PAR) and adenosine diphosphate (ADP)-induced platelet aggregation (ADP-PAR) measured by light transmission aggregometry, the platelet reactivity index measured by vasodilator-stimulated phosphoprotein (PRI-VASP), and the plasma and urinary thromboxane B2 (TXB2) concentrations recorded at baseline and during each treatment phase. Results: Of 56 patients enrolled, 52 completed the study. The AA-PAR was lower in the indobufen alone group than in the aspirin alone group [5.21% (3.39, 7.98) vs. 5.27% (4.06, 6.60), p = 0.038], while biologically, a difference of 0.06% may represent no significant difference; there was no significant between-group difference in the plasma [531.16 pg/ml (203.89, 1035.06) vs. 373.93 pg/ml (194.04, 681.71), p = 0.251] or urinary [3951.97 pg/ml (2006.95, 6077.01) vs. 3610.48 pg/ml (1664.60, 6247.61), p = 0.717] TXB2 concentration. When the aspirin + clopidogrel group and indobufen + clopidogrel group were compared, similar results were found for AA-PAR [3.97% (3.05, 5.12) vs. 3.83% (3.10, 5.59), p = 0.947] and both plasma [849.47 pg/ml (335.96, 1634.54) vs. 455.41 pg/ml (212.47, 1489.60), p = 0.629], and urinary [4122.97 pg/ml (2044.96, 7459.86) vs. 3812.81 pg/ml (1358.95, 6021.07), p = 0.165] TXB2 concentrations. ADP-PAR was lower in the clopidogrel alone group than in the indobufen alone group (47.04% ± 16.89 vs. 61.7% ± 10.50, p < 0.001), as was PRI-VASP (66.53% ± 18.06 vs. 77.72% ± 19.87, p = 0.002). Conclusion: These findings suggest that indobufen has antiplatelet effects similar to those of aspirin in patients with stable coronary heart disease after PCI, and may be an alternative for patients with aspirin intolerance after coronary stenting.

Project description:Background and objectivesIt is unclear whether more potent P2Y12 inhibitors are of benefit to older patients who are at high risk for both ischemia and bleeding. We conducted an observational study to compare the clinical outcomes of clopidogrel and ticagrelor uses in older patients with an acute coronary syndrome (ACS).MethodsOlder patients (aged ≥65 years) with ACS who underwent percutaneous coronary intervention (PCI) were divided into clopidogrel-treated and ticagrelor-treated groups. The primary observational endpoint was the occurrence of net adverse clinical and cerebral events (NACCEs) during a 12-month period, which is defined as the composite endpoint of all-cause death, myocardial infarction (MI), stroke, stent thrombosis, urgent coronary revascularization, and clinically significant bleeding. The secondary endpoints were clinically significant bleeding and major adverse clinical and cerebral events (MACCEs).ResultsThis study included a total of 2,611 patients. Of them, 1,636 received clopidogrel and 975 received ticagrelor. Between patients receiving clopidogrel and those receiving ticagrelor, no significant differences were noted in NACCE (8.4 vs. 9.7%, respectively; adjusted hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.66-1.12) or MACCE (7.1 vs. 7.0%, respectively; adjusted HR, 1.13; 95% CI, 0.83-1.55) during the 12-month follow-up period. In contrast, the occurrence of clinically significant bleeding was significantly less in clopidogrel-treated patients compared with that in ticagrelor-treated patients (27, 1.7%, vs. 31, 3.2%, respectively; adjusted HR, 0.42; 95% CI, 0.25-0.69). Stratified analyses revealed no significant association between age (≥75 years vs. <75 years) and treatment condition in terms of primary or secondary endpoints.ConclusionThis study showed that clopidogrel and ticagrelor had comparable net clinical benefits in patients with ACS aged ≥65 years. Additionally, clopidogrel was associated with a significantly lower risk of major bleeding than ticagrelor without an increase in ischemic risk. These findings suggest that clopidogrel is an effective alternative to the more potent P2Y12 inhibitor ticagrelor in older patients.

Dataset Information

Real-world performance of indobufen versus aspirin after percutaneous coronary intervention: insights from the ASPIRATION registry.

Background

Methods

Results

Conclusions

Trial registration

Publications

Real-world performance of indobufen versus aspirin after percutaneous coronary intervention: insights from the ASPIRATION registry.

Similar Datasets

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