Improving Adherence to Ticagrelor in Patients After Acute Coronary Syndrome: Results from the PROGRESS Trial

2020 ◽  
Vol 18 (3) ◽  
pp. 294-301 ◽  
Author(s):  
Mario Crisci ◽  
Felice Gragnano ◽  
Marco Di Maio ◽  
Vincenzo Diana ◽  
Elisabetta Moscarella ◽  
...  

Background: Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor is recommended for at least 12 months in patients after an acute coronary syndrome (ACS). However, its underuse and premature discontinuation are common in clinical practice. We aimed to investigate the impact of a dedicated follow-up strategy with clinical visits and counselling on adherence levels to ticagrelor in patients after ACS. Methods: PROGRESS (PROmotinG dual antiplatelet therapy adheREnce in the setting of acute coronary Syndromes) is a prospective, randomized trial enrolling 400 ACS patients treated with ticagrelor. Patients were randomized to be followed-up in a dedicated outpatient clinic (In-person follow-up group, [IN-FU], n=200), or with scheduled for phone interviews only (Telephone follow-up group [TEL-FU], n=200), to assess ticagrelor adherence and related complications. DAPT disruption was defined as an interruption of the administration of the drug due to complications or other reasons of non-adherence, and divided according to the duration into short (1-5 days), temporary (6-30 days) and permanent (≥30 days) disruption. The primary endpoint was the rate of DAPT disruption at 1-year follow-up. Results: The rate of ticagrelor disruption at 1 year follow-up was higher in the TEL-FU group than in the IN-FU group (19.6 vs 5.5%; p<0.0001). The IN-FU group reported a significantly lower rate of short (3.0 vs 8.5%; p=0.012) and permanent (2.0 vs 9.6%; p=0.012) disruption than TEL-FU group. The rate of major bleeding did not differ significantly between the 2 groups (p=0.450). Conclusion: The PROGRESS trial showed a net reduction in DAPT disruption in patients followed-up with clinical (in-person) follow-up visits in a dedicated outpatient clinic compared with those scheduled for phone interviews only.

2021 ◽  
Vol 10 (8) ◽  
pp. 1572
Author(s):  
Victoria A. Brazhnik ◽  
Larisa O. Minushkina ◽  
Olga I. Boeva ◽  
Niyaz R. Khasanov ◽  
Elena D. Kosmacheva ◽  
...  

The impact of the de-escalation strategy of antiplatelet therapy (APT) on the life expectancy after acute coronary syndromes (ACS) and percutaneous coronary intervention (PCI) requires an assessment in real clinical practice. Into the Russian multicentral observational trial (ORACLE II ClinicalTrials.gov number, NCT04068909), 1803 patients with ACS and PCI indications were enrolled. During 12 months of follow-up, 228 all-cause deaths have occurred. The analysis of death predictors was carried out by the classification tree method. Age, an option of antithrombotic therapy, a history of chronic heart failure, and uric acid level had the greatest prognostic value. The death prediction model’s sensitivity was 82.1% in the training cohort and 79.2% in the test cohort. During the observation period, ticagrelor was replaced with clopidogrel (APT de-escalation) in 357 patients. The groups of patients with different antiplatelet therapy options were adjusted for clinical parameters by the pseudorandomization method. The de-escalation group had the lowerest all-cause death rate. The incidence of bleeding and recurrent nonfatal coronary events in the study groups did not differ significantly. Thus, the APT regimen’s advantage of changing from the maximum in the first weeks after ACS to moderate at follow-up has been confirmed. There is an obvious need to study the possibilities of individualizing antiplatelet therapy in patients after acute coronary syndromes.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Verdoia ◽  
H Suryapranata ◽  
S Damen ◽  
C Camaro ◽  
E Benit ◽  
...  

Abstract Background Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). Therefore, the impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) treated is still unclear and was therefore the aim of the present sub-study. Methods REDUCE is a prospective, multicenter, randomized, investigator-initiated study, designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a non-inferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleeding (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint. Results From June 2014 to May 2016 300 women and 1196 men were randomized in the trial. Among them 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, but of a lower rate of TIMI flow <3 (p<0.001) and lower systolic blood pressure (p<0.05) among women and a more advanced age (p=0.05) among men receiving a shorted DAPT. At 1 year follow-up, no difference in the primary endpoint was observed according to DAPT duration (females: 6.9% vs 5.9%, HR [95% CI]=1.19 [0.48–2.9], p=0.71; males: 8.2% vs 9%, HR [95% CI]=0.92 [0.63–1.35], p=0.67). Results were confirmed after correction for baseline differences (females: adjusted HR [95% CI]=1.12 [0.45–2.78], p=0.81; males: adjusted HR [95% CI]=0.90 [0.61–1.32], p=0.60). Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. Conclusions The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 1-year follow-up in both male and female gender. Acknowledgement/Funding None


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Michael W Weber ◽  
Eva Keil ◽  
Michael Stanisch ◽  
Holger Nef ◽  
Helge Moellmann ◽  
...  

Background BNP und NT-proBNP provide prognostic information in patients with acute coronary syndromes (ACS). Even though it is generally accepted, that gender, age and atrial fibrillation are important determinants for BNP respectively NT-proBNP values, there is no data available evaluating the impact of those factors on the predictive value of those biomarkers. Therefore it was our aim to evaluate the predictive value of NT-proBNP for mortality after an ACS in association to gender, age and rhythm Methods and results We included 1123 consecutive patients (age 64±12 years; 342 females) with an ACS within the last 48 hours. Follow up data after median of 204 days were available for 1115 (99%) patients. During the follow up 77 (6.8%) patients died. NT-proBNP values on admission were higher in patients who deceased compared to those who survived (2047 (576 –5624) pg/ml vs. 465 (127–1519) pg/ml; p<0,001). The AUC of the ROC curve for NT-proBNP as a predictor for mortality was 0.714 (p<0.001) and an optimised cut-off value of 1815 pg/ml could be calculated. Patients with NT-proBNP above this cut-off had a significantly higher mortality rate (16% vs. 4%; p<0,001; Log Rank 48; p<0,001)). Even though patients with AF had higher NT-proBNP values as those patients with SR (1952 (770 – 4070) pg/ml vs. 452 (121–1492) pg/ml) NT-proBNP at the same cut-off value of 1815 pg/ml was highly discriminative for mortality (27.9% vs. 7.5%; p<0.022; Log Rank 5.7; p=0,017). Patients with an age above 65 years had higher NT-proBNP values as compared to patients younger than 65 years (894 (255–2642) pg/ml vs. 279 (75–945) pg/ml; p<0,001). However the predictive value of NT-proBNP in both age groups was comparable. Women had higher NT-proBNP values as compared to men (966 (237–2549) pg/ml vs. 407 (102–1273) pg/ml; p<0,001). But in dissimilarity, in women NT-proBNP values above 1815 pg/ml were not associated with a higher mortality and thus were without predictive value (10,6% vs. 6,8%; p<0,304; Log Rank 1,556; p<0,212). Conclusion Gender, age and rhythm are important determinants for NT-proBNP values of patients presenting with an ACS. However, only gender had impact on the predictive value of NT-proBNP for mortality. In women cut-off values need to be adopted.


2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.


Author(s):  
Shaoyi Guan ◽  
Xiaoming Xu ◽  
Yi Li ◽  
Jing Li ◽  
Mingzi Guan ◽  
...  

Background Long‐term use of antiplatelet agents after acute coronary syndrome in diabetic patients is not well known. Here, we describe antiplatelet use and outcomes in such patients enrolled in the EPICOR Asia (Long‐Term Follow‐up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia) registry. Methods and Results EPICOR Asia is a prospective, observational study of 12 922 patients with acute coronary syndrome surviving to discharge, from 8 countries/regions in Asia. The present analysis included 3162 patients with diabetes mellitus (DM) and 9602 patients without DM. The impact of DM on use of antiplatelet agents and events (composite of death, myocardial infarction, and stroke, with or without any revascularization; individual components, and bleeding) was evaluated. Significant baseline differences were seen between patients with DM and patients without DM for age, sex, body mass index, cardiovascular history, angiographic findings, and use of percutaneous coronary intervention. At discharge, ≈90% of patients in each group received dual antiplatelet therapy. At 2‐year follow‐up, more patients with DM tended to still receive dual antiplatelet therapy (60% versus 56%). DM was associated with increased risk from ischemic but not major bleeding events. Independent predictors of the composite end point of death, myocardial infarction, and stroke in patients with DM were age ≥65 years and use of diuretics at discharge. Conclusions Antiplatelet agent use is broadly comparable in patients with DM and patients without DM, although patients with DM are more likely to be on dual antiplatelet therapy at 2 years. Patients with DM are at increased risk of ischemic events, suggesting an unmet need for improved antithrombotic treatment. Registration URL: https://www.clini​caltr​ials.gov ; Unique identifier: NCT01361386.


Angiology ◽  
2019 ◽  
Vol 71 (3) ◽  
pp. 235-241 ◽  
Author(s):  
Plinio Cirillo ◽  
Luigi Di Serafino ◽  
Vittorio Taglialatela ◽  
Paolo Calabrò ◽  
Emilia Antonucci ◽  
...  

Optimal medical therapy (OMT) at discharge is recommended after acute coronary syndrome (ACS). Few studies report the impact of OMT on long-term clinical outcome in a real-world scenario. We evaluated the impact of discharge OMT on top of dual-antiplatelet therapy (DAPT) on clinical outcome in the real-world ACS population of the Survey on anTicoagulated pAtients RegisTer ANTIPLATELET registry. The primary end point was major adverse cardiac and cerebrovascular event (MACCE), a composite of death, myocardial infarction, stroke, or target vessel revascularization. The co-primary end point was net adverse cardiac and cerebrovascular event (NACE), based on MACCE plus major bleeding. Consecutive patients with ACS with 1-year follow-up were enrolled. They were evaluated at discharge for the use of a β-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers and statins. Optimal medical therapy was defined as the use of ≥2 of 3 medications. At multivariate analysis, both MACCE and NACE were significantly higher in non-OMT patients than in OMT patients (MACCE 18 [19] vs 59 [9], hazard ratio [HR] = 0.44 [0.26-0.75], P = .002, NACE 19 [20] vs 67 [10], HR = 0.47 [0.28-0.79], P = .004). In this real-world scenario, OMT at discharge on top of DAPT seems associated with a better clinical outcome compared with patients discharged on non-OMT.


2018 ◽  
Vol 8 (2) ◽  
pp. 121-129 ◽  
Author(s):  
Uwe Zeymer ◽  
Lieven Annemans ◽  
Nicolas Danchin ◽  
Stuart Pocock ◽  
Simon Newsome ◽  
...  

Background: Atrial fibrillation (AF) is associated with increased morbidity in acute coronary syndrome patients, but impact on outcomes beyond 1 year is unclear. Methods: This was a post-hoc analysis from the long-tErm follow-uP of antithrombotic management patterns In acute CORonary syndrome patients (EPICOR) registry (NCT01171404), a prospective, observational study conducted in Europe and Latin America, which enrolled acute coronary syndrome survivors at discharge. Antithrombotic management patterns, mortality, a composite endpoint of death/new non-fatal myocardial infarction/stroke and bleeding events were assessed after 2 years of follow-up in patients with or without AF. Results: Of 10,568 patients enrolled, 397 (4.7%) had prior AF and 382 (3.6%) new-onset AF during index hospitalisation. Fewer patients with AF underwent percutaneous coronary intervention (52.1% vs. 66.6%; P<0.0001). At discharge, fewer AF patients received dual antiplatelet therapy (71.6% vs. 89.5%; P<0.0001); oral anticoagulant use was higher in AF patients but was still infrequent (35.0% vs. 2.5%; P<0.0001). Use of dual antiplatelet therapy and oral anticoagulants declined over follow-up with over 50% of all AF/no AF patients remaining on dual antiplatelet therapy (55.6% vs. 60.6%), and 23.3% (new-onset AF) to 42.1% (prior AF) on oral anticoagulants at 2 years. At 2 years, mortality, composite endpoint and bleeding rates were higher in AF patients (all P<0.0001) compared to patients without AF. On multivariable analysis, the risk of mortality or the composite endpoint was significant for prior AF ( P=0.003, P=0.001) but not new-onset AF ( P=0.88, P=0.92). Conclusions: Acute coronary syndrome patients with AF represent a high-risk group with increased event rates during long-term follow-up. Prior AF is an independent predictor of mortality and/or ischaemic events at 2 years. Use of anticoagulants in AF after acute coronary syndrome is still suboptimal.


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