Abstract P232: Influence of Individualized Risk Prediction and Patient Preferences on Selection of Prasugrel Versus Clopidogrel at the Time of Percutaneous Coronary Intervention for an Acute Coronary Syndrome

Author(s):  
Adam C Salisbury ◽  
Kaijun Wang ◽  
David J Cohen ◽  
Yan Li ◽  
John A Spertus

Introduction: Given the need to weigh prevention of ischemia against bleeding risk with prasugrel vs. clopidogrel at the time of PCI for an acute coronary syndrome (ACS), we developed risk models for both outcomes from TRITON-TIMI 38. We then applied these models to each TRITON patient and examined how preferences for outcomes could influence thienopyridine selection. Methods: We built separate multivariable regression models for ischemia (cardiac death, MI, stroke) and bleeding (TIMI major/minor) from 12,579 patients in TRITON-TIMI 38 with no history of stroke or TIA. For each patient, we calculated the probability of ischemic and bleeding events with prasugrel vs. clopidogrel and the associated benefit:risk ratio (predicted difference in ischemic events/predicted difference in bleeding). We then examined the impact of alternative outcome weights - benefit:risk preference thresholds - on individualized decision making. Results: Based on individualized risk predictions, the majority of ACS patients treated with PCI (66%) may choose prasugrel when preventing ischemia is considered equally important as avoiding bleeding (Figure), but this proportion varied from 32% to 80% when the benefit:risk preference threshold was varied from 3 (reflecting a 3-times greater preference for avoiding bleeding) to 0.25 (reflecting a 4-times greater preference for avoiding ischemia). Conclusions: Based on empirical analyses, the expected absolute benefits and risks of prasugrel vs. clopidogrel depend highly on patient characteristics and preferences. Presenting individualized predictions of benefits and risks with competing treatments may improve shared decision making.

Author(s):  
Guy Fradet ◽  
Carol Laberge ◽  
Andrew Kmetic ◽  
Ronnalea Hamman

Background: Regional variation in the utilization of health services is a well-documented phenomenon in health care with numerous studies reporting substantial and unexplained variations in coronary revascularization. In the Canadian province of British Columbia (BC), five cardiac centers provide coronary revascularization services. In 2011 Cardiac Services BC (CSBC) undertook a study that identified substantial regional variation in coronary revascularization that could not be explained by patient characteristics or risk factors. Following this initial project, CSBC launched an initiative to help better understand the regional variations and possibly devise and implement strategies to reduce them. To get a better understanding of the different processes of care/utilization, one of the approaches used is the application of Lean methodology to the care of acute coronary syndrome (ACS) patients. Methods: Lean methodology is being applied to the patient journey of ACS patients. At each revascularization center Value Steam Maps process maps (VSM) are being prepared through a series of meetings with support, frontline, administrative and clinical staff (see attached example). For each VSM the goal is to identify key decision points in the process of care for ACS patients and to drill down on (Root Cause Analysis) on the decision making environment and criteria used to determine the utilization of coronary revascularization services. Once VSM have been completed they will be compared across sites for similarities and differences. The differences in decision making will then be assessed to determine their effect on variation in utilization across the centers. Discussion: BC is attempting to reduce unexplained variation in coronary revascularization using the Lean methodology to take a systematic approach to the analysis of the process of ACS care across the province. The next step will be to determine to what extent it is possible to standardize decision making at the key decision points across the HAs. Standardization will be achieved through a mix of best practices, evidence and application of guidelines. While the undertaking is still in the early stages it is expected that it will lead to, at the very least, ACS patients receiving the same care regardless of where they receive their care in BC.


2021 ◽  
Vol 8 ◽  
Author(s):  
Xiujin Shi ◽  
Yunnan Zhang ◽  
Yi Zhang ◽  
Ru Zhang ◽  
Baidi Lin ◽  
...  

Background: The clinical benefits of cytochrome P450 (CYP) 2C19 genotype-guided antiplatelet therapy in Asians remain unclear. In this study, we aimed to investigate the clinical outcomes of pharmacogenomic antiplatelet therapy in Chinese patients.Methods: Patients with acute coronary syndrome planning to undergo percutaneous coronary intervention were eligible for this study and were randomly divided into a genotype-guided treatment (GT) group and routine treatment (RT) group, with a ratio of 2:1. Patients in the GT group underwent CYP2C19 genotyping (*2 and *3 alleles), and the results were considered in selecting P2Y12 receptor inhibitors. Patients in the RT group were treated with P2Y12 receptor inhibitors according to their clinical characteristics. The primary endpoint was a composite of major adverse cardiovascular or cerebrovascular events (MACCE). The secondary endpoint was significant bleeding events.Results: Finally, 301 patients were enrolled; 75.1% were men and the mean age was 59.7 ± 9.8 years. In total, 281 patients completed the follow-up procedure. The primary endpoint occurred in 16 patients, 6 patients in the GT group and 10 in the RT group. The GT group showed lower MACCE rates than the RT group (6/189 vs. 10/92, 3.2 vs. 10.9%, hazard ratio: 0.281, 95% confidence interval: 0.102–0.773, P = 0.009). There was no statistically difference in significant bleeding events between the GT and RT groups (4.2 vs. 3.3%, hazard ratio: 1.315, 95% confidence interval: 0.349–4.956, P = 0.685).Conclusion: Personalized antiplatelet therapy that is based on CYP2C19 genotypes could decrease MACCE within a 12-month period in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.Clinical Trial Registration:http://www.chictr.org.cn, identifier: ChiCTR2000034352.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Cespon Fernandez ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
S Manzano-Fernandez ◽  
F Dascenzo ◽  
...  

Abstract Introduction Peripheral artery disease (PAD) is associated with heightened ischemic and bleeding risk in patients with acute coronary syndrome (ACS). With this study from real-life patients, we try to analyze the balance between ischemic and bleeding risk during treatment with dual antiplatelet therapy (DAPT) after an ACS according to the presence or not of PAD. Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients with and without PAD. The impact of prior PAD in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction (AMI), whereas for bleeding risk we have considered major bleeding (MB) defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 1,600 have PAD (6.1%). Patients with PAD were older, and with more cardiovascular risk factors. DAPT with prasugrel/ticagrelor was less frequently prescribed in patients with PAD in comparison with the rest of the population (8.2% vs 22.8%, p<0.001). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), and 640 AMI (2.5%) and 685 MB (2.6%) were reported. After propensity-score matching, we obtained two matched groups of 1,591 patients. Patients with PAD showed a significant higher risk of both AMI (sHR 2.17, 95% CI 1.51–3.10, p<0.001) and MB (sHR 1.51, 95% CI 1.07–2.12, p=0.018), in comparison with those without PAD. The cumulative incidence of AMI was 63.9 and 29.8 per 1,000 patients/year in patients with and without PAD, respectively. The cumulative incidence of MB was 55.9 and 37.6 per 1,000 patients/year in patients with and without PAD, respectively. The rate difference per 1,000 patient-years for AMI between patients with and without PAD was +34.1 (95% CI 30.1–38.1), and for MB +18.3 (16.1–20.4). The net balance between ischemic and bleeding events comparing patients with and without PAD was positive (+15.8 per 1,000 patients/year, 95% CI 9.7–22.0). Conclusions PAD was associated with higher ischemic and bleeding risk after hospital discharge for ACS treated with DAPT. However, the balance between ischemic and bleeding risk was positive for patients with PAD in comparison with patients without PAD. As summary, ACS patients with PAD had an ischemic risk greater than the bleeding risk.


2018 ◽  
Vol 118 (09) ◽  
pp. 1656-1667 ◽  
Author(s):  
Lisa Gross ◽  
Dietmar Trenk ◽  
Claudius Jacobshagen ◽  
Anne Krieg ◽  
Meinrad Gawaz ◽  
...  

Background Phenotype-guided de-escalation (PGDE) of P2Y12-inhibitor treatment with an early switch from prasugrel to clopidogrel was identified as an effective alternative treatment strategy in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). The Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Genotyping Substudy aimed to investigate whether CYP2C19 genotypes correlate with on-treatment platelet reactivity (PR) in ACS patients treated with clopidogrel or prasugrel and thus might be useful for guidance of early de-escalation of anti-platelet treatment. Methods and Results A total of 603 ACS consecutive patients were enrolled in four centres (23.1% of the overall TROPICAL-ACS population). Rapid genotyping (Spartan RX) for CYP2C19*2, *3 and *17 alleles was performed. Associations between PR and the primary and secondary endpoints of the TROPICAL-ACS trial and CYP2C19*2 and CYP2C19*17 carrier status were evaluated.For the PGDE group, the on-clopidogrel PR significantly differed across CYP2C19*2 (p < 0.001) and CYP2C19*17 genotypes (p = 0.05). Control group patients were not related (p = 0.90, p = 0.74) to on-prasugrel PR. For high PR versus non-high PR patients within the PGDE group, significant differences were observed for the rate of CYP2C19*2 allele carriers (43% vs. 28%, p = 0.007). Conclusion CYP2C19*2 and CYP2C19*17 carrier status correlates with PR in ACS patients treated with clopidogrel and thus might be useful for pre-selecting patients who will and who may not be suitable for PGDE of anti-platelet treatment. Regarding phenotype-guided treatment, we did not observe added benefit of genotyping to predict ischaemic and bleeding risk in patients who underwent a PGDE approach. Clinical Trial Registration URL: https//www.clinicaltrials.gov. Unique Identifier: NCT: 01959451.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Alak ◽  
E Ozpelit ◽  
D Cirgamis ◽  
M Abusharekh ◽  
N Baris

Abstract Introduction International guidelines recommend using risk score tools that allow us to assess the risk of bleeding and ischemia when deciding on DAPT. In our research, we aimed to examine the mortality relationship of new risk scores, DAPT and PRECISE-DAPT scores. Method Between 2013–2014, 948 patients admitted to our clinic with ACS were included in our study. We excluded 688 patient (no contact number,CABG, medical treatment, use of oral anticoagulation, active malignant cancer). 260 patients admitted with acute coronary syndrome (58%, 8 STEMI, 35%, 4 non-STEMI, 5%, 4 Unstable angina pectoris) who undergo coronary stent implantation were included in the study. We aimed to focus on the patients who undergo percutaneous coronary intervention and their risk of mortality. The patients' records were retrospectively analyzed through the hospital information system and archive records. Laboratory results, echocardiography and CAG reports of the patients, disease histories were obtained from the information recorded through the system. With these data, PRECISE-DAPT and DAPT scores of patients were calculated. Results The number of patients with a PRECISE-DAPT Score ≥25 was 62 (23.8%). The number of patients with DAPT Score ≥2 was 193 (74.2%). Mortality occurred in 49 (18.8%) patients. Patients with PRECISE-DAPT ≥25 and those with PRECISE-DAPT &lt;25 were compared in terms of mortality and mortality was significantly higher in the high-scoring group [P &lt;0.001 OR 6.94 C (3.53–13.62)]. The patients were divided into 4 groups (PRECISE-DAPT 25 and DAPT ≥2, PRECISE-DAPT ≥25 and DAPT ≥2, PRECISE-DAPT 25 and DAPT 2, PRECISE-DAPT ≥25 and DAPT 2) according to PRECISE-DAPT and DAPT score. Mortality was significantly higher regardless of DAPT score in patients with high PRECISE-DAPT scores (p&lt;0.001). We evaluated the relationship between PRECISE-DAPT score and major bleeding and all bleeding. Compared to the group there was no significant difference in all bleeding events (P=0.56) and major bleeding events (P=0.23). The relationship between bleeding events and mortality was evaluated. There was no significant difference in mortality (p=0.689) with all bleeding events; but mortality was significantly increased in patients with major bleeding [P=0.025 OR 6.16 (1,33–28,49)]. Conclusion In our study, we observed that the patient group with a high PRECISE-DAPT score had a high mortality rate regardless of the DAPT score. The PRECISE-DAPT score is a useful tool in determining the group with high long-term mortality in patients who present with acute coronary syndrome and undergo percutaneous coronary intervention. The clinician should use the PRECISE-DAPT score when deciding on the duration of dual antiplatelet therapy in this patient group and these patients with high scores need to be monitored more closely. The data we have obtained from our study is retrospective and these results need to be supported by prospective and large studies. FUNDunding Acknowledgement Type of funding sources: None.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
Y Minematsu ◽  
M Natsuaki ◽  
G Yoshioka ◽  
K Shinzato ◽  
Y Nishimura ◽  
...  

Abstract Background/Introduction CREDO-Kyoto bleeding risk score was developed to predict the post-discharge bleeding events in patients with percutaneous coronary intervention. However, there were limited reports of the effectiveness of this score to predict the in-hospital bleeding events in patients with acute coronary syndrome (ACS). Methods We evaluated 562 consecutive ACS patients in Saga university hospital between 2014 and 2019. Primary outcome was major bleeding during hospitalization. Major bleeding was defined as the GUSTO moderate/severe bleeding. Patients were classified into three groups according to the CREDO-Kyoto bleeding risk score (low, intermediate and high). Results Major bleeding events occurred in 12.1% of all patients during hospitalization. Patients in the high risk group (n=22) had significantly higher incidence of major bleeding than those in the intermediate (n=113) and the low risk groups (n=427) (22.7%, 18.6%, versus 9.8%, respectively, p=0.018, see figure). Multivariate analysis showed that intermediate and high risk groups were independent predictors for the in-hospital major bleeding. Conclusions CREDO-Kyoto risk score successfully identified high risk ACS patients for the major bleeding during hospitalization. FUNDunding Acknowledgement Type of funding sources: None. Results


Kardiologiia ◽  
2019 ◽  
Vol 59 (1) ◽  
pp. 36-38
Author(s):  
N. M. Kuzmina ◽  
N. I. Maximov

Purpose: to study adherence to therapy after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). We analyzed retrospectively 127 case histories of patients who underwent PCI for ACS in 2015 (in Udmurtia at that time PCIs were mostly carried out later than 6 hours after onset of symptoms). Inclusion criteria: age 25–75 years; confirmed ACS; stenting of coronary arteries for the first time. Exclusion criteria: pregnancy; prisoners; incompetent persons; history of PCI or coronary artery bypass grafting. In two years after the PCI 95 patients were questioned concerning use of statins (including their doses) and dual antiplatelet therapy (DAPT). Results. In 2 years after index PCI 83% of patients took statins regularly. DAPT for 1 year or more after PCI received 85% of patients. Conclusion. Adherence to therapy with statins and antiplatelet therapy was found to be high. PCI in patients with ACS was mainly delayed (more than 6 hours from the onset of symptoms). It is necessary to further improve the routing of patients to PCI performing centers from Udmurtia regions for the timely myocardial revascularization.


2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Mauro Chiarito ◽  
Davide Cao ◽  
Usman Baber ◽  
Carlo Pivato ◽  
Carlo Briguori ◽  
...  

Abstract Aims Patients with history of myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) remain at risk of recurrent ischaemic events. The optimal antithrombotic strategy for this cohort remains debated. Methods and results In this prespecified analysis of the TWILIGHT trial, we evaluated the impact of prior MI on treatment effect of ticagrelor monotherapy vs. ticagrelor plus aspirin in patients undergoing PCI with at least one clinical and one angiographic high-risk feature and free from adverse events at 3 months after the index PCI. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5, the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization. 1937 (29.7%) patients with and 4595 (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. Patients with prior MI had increased rates of death, MI or stroke (5.7 vs. 3.2%, P &lt; 0.001) but similar BARC 2–5 bleeding (5.0 vs. 5.5%, P = 0.677). Ticagrelor monotherapy reduced the risk of BARC 2–5 bleeding in patients with [3.4% vs. 6.7%; hazard ratio (HR): 0.50; 95% confidence interval (CI): 0.33–0.76] and without prior MI [4.2% vs. 7.0%; HR: 0.58; 95% CI: 0.45–0.76; pinteraction = 0.54). Rates of the key secondary ischaemic outcome were similar between treatment groups irrespective of history of MI (prior MI: 6.0% vs. 5.5%; HR: 1.09; 95% CI: 0.75–1.58; no prior MI: 3.1% vs. 3.3%; HR: 0.92; 95% CI: 0.67–1.28; pinteraction = 0.52). Conclusions Ticagrelor monotherapy is associated with significantly lower risk of bleeding events as compared to ticagrelor plus aspirin without any compromise in ischaemic prevention among high-risk patients with history of MI undergoing PCI.


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