scholarly journals Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial

Author(s):  
Ko Yamamoto ◽  
Hirotoshi Watanabe ◽  
Takeshi Morimoto ◽  
Takenori Domei ◽  
Masanobu Ohya ◽  
...  

Background: Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI). Methods: We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points. Results: Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10–0.92], P =0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47–1.20], P =0.23; P interaction =0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16–1.79], P =0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50–1.47], P =0.58; P interaction =0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P =0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P =0.02). Conclusions: The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02619760.

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e005781 ◽  
Author(s):  
Günter Christ ◽  
Jolanta M Siller-Matula ◽  
Marcel Francesconi ◽  
Cornelia Dechant ◽  
Katharina Grohs ◽  
...  

ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008 consecutive PCI patients with stent implantation, without exclusion criteria.InterventionPeri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).Outcome measuresThe primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).Results53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).ConclusionsIndividualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.Trial registration numberhttp://www.clinicaltrials.gov; NCT01515345.


Author(s):  
Matteo Bianco ◽  
Alessandro Careggio ◽  
Paola Destefanis ◽  
Alessia Luciano ◽  
Maria Giulia Perrelli ◽  
...  

Abstract Aims Dual antiplatelet therapy (DAPT) reduces the incidence of thrombotic complications at the cost of an increase in bleedings. New antiplatelet therapies focused on minimizing bleeding and maximizing antithrombotic effects are emerging. The aim of this study is to collect the current evidence coming from randomized controlled trials (RCTs) on early aspirin interruption after percutaneous coronary intervention (PCI) and current drug-eluting stent (DES) implantation and to perform a meta-analysis in order to evaluate the safety and efficacy of this strategy. Methods and results MEDLINE/PubMed was systematically screened for RCTs comparing P2Y12 inhibitors (P2Y12i) monotherapy after a maximum of 3 months of DAPT (S-DAPT) vs. DAPT for 12 months (DAPT) in patients undergoing PCI with DES. Baseline features were appraised. Major adverse cardiac and cerebrovascular events (MACCE: all causes of death, myocardial infarction, and stroke) and its single composites, stent thrombosis (ST) and Bleeding Academic Research Consortium (BARC) type 3 or 5 were considered and pooled with fixed and random-effects with inverse-variance weighting. A total of four RCTs including a total of 29 089 patients were identified. Overall, the majority of included patients suffered a stable coronary artery disease, while ST-elevation myocardial infarction was the least represented clinical presentation. Complex anatomical settings like left main intervention, bifurcations, and multi-lesions treatment were included although representing a minor part of the cases. At 1-year follow-up, MACCE rate was similar [odds ratio (OR) 0.90; 95% confidence intervals (CIs) 0.79–1.03] and any of its composites (all causes of death rate: OR 0.87; 95% CIs 0.71–1.06; myocardial infarction: OR 1.06; 95% CIs 0.90–1.26; stroke: OR 1.12; 95% CIs 0.82–1.53). Similarly, also ST rate was comparable in the two groups (OR 1.17; 95% CIs 0.83–1.64), while BARC 3 or 5 bleeding resulted significantly lower, adopting an S-DAPT strategy (OR 0.70; 95% CIs 0.58–0.86). Conclusion After a PCI with current DES, an S-DAPT strategy followed by a P2Y12i monotherapy was associated with a lower incidence of clinically relevant bleeding compared to 12 months DAPT, with no significant differences in terms of 1-year cardiovascular events.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C.-Y Hsu ◽  
J.-S Yeh ◽  
C.-Y Huang

Abstract Background Recently, both unguided (platelet function testing independent) and guided (platelet function testing dependent) DAPT de-escalation strategies have been investigated in different clinical studies but the data is still limited and conflicting. The aim of this study was to examine the effect of switching dual antiplatelet therapy (DAPT) on the major vascular risk after acute myocardial infarction (AMI) in patients undergoing percutaneous coronary intervention (PCI) by using Taiwan National Health Insurance Research Database. Methods In total, 1,903 and 4,059 patients defined as switched to aspirin and clopidogrel (switched DAPT) and continuation of aspirin and ticagrelor (unswitched DAPT) cohort, respectively who had received PCI during AMI hospitalization, on aspirin and ticagrelor initially and without occurring adverse events at 3 months were evaluated between 2013 and 2015. An inverse probability treatment of weighted approach was adopted to balance the baseline differences between two groups and Cox proportional hazard regression and competing risk regression were used to evaluated the effect of switching DAPT on death, AMI readmission, major bleeding and non-major clinically relevant bleeding. Results The incidence rates (per 100 person-year) of death and AMI readmission were 3.97 (95% confidence interval [CI] = 3.19–4.84) and 3.84 (95% CI = 3.09–4.73) in switched cohort and 1.83 (95% CI = 1.47–2.24) and 2.23 (95% CI = 1.82–2.68) in unswitched cohort, respectively. After adjustment for patients' clinical variables, switched cohort had higher risk of death (adjusted hazard ratio = 2.18, 95% CI = 1.62–2.93, P<0.001), and AMI readmission (adjusted sub-distribution ratio = 1.72, 95% CI = 1.27–2.34, P<0.001) compared to these in unswitched cohort; however, there was no difference in the risk of bleeding. Subgroup analysis showed a similar findings in many specific groups, except the patients who were younger age and had lower comorbidity score. Conclusion Switching DAPT might increase the risk of death and AMI readmission among patients with AMI undergoing PCI.


2019 ◽  
Vol 96 (1131) ◽  
pp. 9-13
Author(s):  
Chor Cheung Tam ◽  
Jeffrey Lee ◽  
Ki Wan Chan ◽  
Cheung Chi Lam ◽  
Yiu Tung Wong ◽  
...  

BackgroundAfter primary percutaneous coronary intervention (PPCI) in patients with acute ST elevation myocardial infarction (STEMI), dual antiplatelet therapy (DAPT) is recommended to continue for 1 year. Occasionally, DAPT interruption may be required due to bleeding issues or unplanned surgical procedures.ObjectiveTo systematically evaluate the incidence of DAPT interruption within 1 year after PPCI.Methods and resultsThis was a single-centre, retrospective registry study. Consecutive patients with STEMI who underwent PPCI from 2013 to 2017 (N=538) were recruited into the analysis. The primary outcome was the incidence of interruption of DAPT within 1 year from the index PPCI. Secondary outcomes included incidence of bleeding in 1 year and prevalence of high bleeding risk (HBR) criteria at index presentation. Within 1 year, 17.1% (84/490) of post-PPCI survivors needed DAPT interruption and 7.1% (35/490) had major bleeding (Bleeding Academic Research Consortium type 3 or 5). At index presentation, HBR criteria were present in 36.1% (194/538) of patients. On univariate analysis, age, female gender, anaemia, anticoagulation, diabetes, hypertension and being a non-smoker were associated with DAPT interruption. On multivariate analysis, age was the only independent factor to predict DAPT interruption.ConclusionDAPT interruption was not uncommon after PPCI in patients with STEMI particularly in the elderly. This has implication on stent selection during PPCI, and further studies are required to investigate which type of stent may best suit our real-life patients with STEMI.


2019 ◽  
Vol 40 (31) ◽  
pp. 2595-2604 ◽  
Author(s):  
Patrick W Serruys ◽  
Kuniaki Takahashi ◽  
Ply Chichareon ◽  
Norihiro Kogame ◽  
Mariusz Tomaniak ◽  
...  

Abstract Aims  To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). Methods and results In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48–0.85] and POCE (HR: 0.80, 95% CI: 0.69–0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67–1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69–0.92; Pinteraction = 0.011). Conclusion  Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.


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