scholarly journals Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry

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.

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.


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.


Author(s):  
Vibhu Parcha ◽  
Brittain F. Heindl ◽  
Peng Li ◽  
Rajat Kalra ◽  
Nita A. Limdi ◽  
...  

Background: Among patients receiving percutaneous coronary intervention (PCI), the role of a genotype-guided approach for antiplatelet therapy compared with usual care is unclear. We conducted a Bayesian analysis of the entire TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention) randomized clinical trial population to evaluate the effect of the genotype-guided antiplatelet therapy post-PCI compared with the usual care on the risk of major adverse cardiovascular events (MACE). Methods: The primary outcome for our study was the composite of MACE (myocardial infarction, stroke, and cardiovascular death). Secondary outcomes included cardiovascular death, stroke, myocardial infarction, stent thrombosis, and major/minor bleeding. Bayesian modeling was used to estimate the probability of clinical benefit of genotype-guided therapy using (1) noninformative priors (ie, analyzing the TAILOR-PCI trial) and (2) informative priors derived from the ADAPT, POPular Genetics, IAC-PCI, and PHARMCLO trials (ie, analyzing TAILOR-PCI trial in the context of prior evidence). Risk ratio (RR: ratio of cumulative outcome incidence between genotype-guided and conventional therapy group) and 95% credible interval (CrI) were estimated for the study outcomes, and probability estimates for RR <1 were computed. Results: Using noninformative priors, in TAILOR-PCI the RR for MACE was 0.78 (95% CrI, 0.55–1.07) in genotype-guided therapy after PCI, and the probability of RR <1 was 94%. Using noninformative priors, the probability of RR <1 for cardiovascular death (RR, 0.95 [95% CrI, 0.52–1.74]), stroke (RR, 0.68 [95% CrI, 0.44–1.06]), myocardial infarction (RR, 0.84 [95% CrI, 0.37–1.89]), stent thrombosis (RR, 0.75 [95% CrI, 0.37–1.45]), and major or minor bleeding (RR, 1.22 [95% CrI, 0.84–1.77]) were 57%, 96%, 67%, 94%, and 15%, respectively. Using informative priors, the posterior probability of RR <1 for MACE, from genotype-guided therapy, was 99% (RR, 0.69 [95% CrI, 0.57–0.84]). Using informative priors, the posterior probability of RR <1 for cardiovascular death (RR, 0.86 [95% CrI, 0.61–1.19]), stroke (RR, 0.69 [95% CrI, 0.48–0.99]), myocardial infarction (RR:0.56 [95% CrI, 0.40–0.78]), stent thrombosis (RR, 0.59 [95% CrI, 0.38–0.94]), and major or minor bleeding (RR, 0.84 [95% CrI, 0.70–0.99]) were 81%, 99%, 99%, 99%, and 99%, respectively. Conclusions: Bayesian analysis of the TAILOR-PCI trial provides clinically meaningful data on the posterior probability of reducing MACE using genotype-guided P2Y 12 inhibitor therapy after PCI.


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.


Angiology ◽  
2016 ◽  
Vol 68 (1) ◽  
pp. 29-39 ◽  
Author(s):  
Zhenyu Liu ◽  
Johanne Silvain ◽  
Mathieu Kerneis ◽  
Olivier Barthélémy ◽  
Laurent Payot ◽  
...  

Elderly (≥75 years old) patients with ST-segment elevation myocardial infarction (STEMI) have higher ischemic and bleeding risk compared with those <75 years old. We investigated the efficacy and safety of intravenous (IV) enoxaparin versus IV unfractionated heparin (UFH) in elderly patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. A prespecified analysis of the Acute Myocardial Infarction Treated with Primary Angioplasty and Intravenous Enoxaparin or Unfractionated Heparin to Lower Ischemic and Bleeding Events at Short- and Long-term Follow-up (ATOLL) study was performed examining the 30-day outcomes in the elderly patients. Of the 165 elderly patients in the ATOLL study, 85 patients received IV enoxaparin 0.5 mg/kg and 80 patients received IV UFH. Intravenous enoxaparin did not reduce the primary end point, the main secondary efficacy end point, major bleeding, major or minor bleeding, and all-cause mortality compared with IV UFH. The rate of minor bleeding (5.9% vs 22.8%, Padjusted = .01) was significantly lower with IV enoxaparin compared with IV UFH. Intravenous enoxaparin appears to be a safe alternative to IV UFH in primary PCI of the elderly patients with STEMI.


2019 ◽  
Vol 27 (7) ◽  
pp. 696-705 ◽  
Author(s):  
Fabrizio D'Ascenzo ◽  
Maurizio Bertaina ◽  
Francesco Fioravanti ◽  
Federica Bongiovanni ◽  
Sergio Raposeiras-Roubin ◽  
...  

Introduction The benefits of short versus long-term dual antiplatelet therapy (DAPT) based on the third generation P2Y12 antagonists prasugrel or ticagrelor, in patients with acute coronary syndromes treated with percutaneous coronary intervention remain to be clearly defined due to current evidences limited to patients treated with clopidogrel. Methods All acute coronary syndrome patients from the REgistry of New Antiplatelets in patients with Myocardial Infarction (RENAMI) undergoing percutaneous coronary intervention and treated with aspirin, prasugrel or ticagrelor were stratified according to DAPT duration, that is, shorter than 12 months (D1 group), 12 months (D2 group) and longer than 12 months (D3 group). The three groups were compared before and after propensity score matching. Net adverse clinical events (NACEs), defined as a combination of major adverse cardiac events (MACEs) and major bleedings (including therefore all cause death, myocardial infarction and Bleeding Academic Research Consortium (BARC) 3–5 bleeding), were the primary end points, MACEs (a composite of all cause death and myocardial infarction) the secondary one. Single components of NACEs were co-secondary end points, along with BARC 2–5 bleeding, cardiovascular death and stent thrombosis. Results A total of 4424 patients from the RENAMI registry with available data on DAPT duration were included in the model. After propensity score matching, 628 patients from each group were selected. After 20 months of follow up, DAPT for 12 months and DAPT for longer than 12 months significantly reduced the risk of NACE (D1 11.6% vs. D2 6.7% vs. D3 7.2%, p = 0.003) and MACE (10% vs. 6.2% vs. 2.4%, p < 0.001) compared with DAPT for less than 12 months. These differences were driven by a reduced risk of all cause death (7.8% vs. 1.3% vs. 1.6%, p < 0.001), cardiovascular death (5.1% vs. 1.0% vs. 1.2%, p < 0.0001) and recurrent myocardial infarction (8.3% vs. 5.2% vs. 3.5%, p = 0.002). NACEs were lower with longer DAPT despite a higher risk of BARC 2–5 bleedings (4.6% vs. 5.7% vs. 6.2%, p = 0.04) and a trend towards a higher risk of BARC 3–5 bleedings (2.4% vs. 3.3% vs. 3.9%, p = 0.06). These results were not consistent for female patients and those older than 75 years old, due to an increased risk of bleedings which exceeded the reduction in myocardial infarction. Conclusion In unselected real world acute coronary syndrome patients treated with percutaneous coronary intervention, DAPT with prasugrel or ticagrelor prolonged beyond 12 months markedly reduces fatal and non-fatal ischaemic events, offsetting the increased risk deriving from the higher bleeding risk. On the contrary, patients >75 years old and female ones showed a less favourable risk–benefit ratio for longer DAPT due to excess of bleedings.


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.


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