Abstract P163: Disparities By Patient Sex? Treatment Duration and Outcomes Of P2Y 12 Inhibitor Therapy in Women Compared to Men After an Acute Myocardial Infarction Among Medicare Beneficiaries

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Ryan P Hickson ◽  
Anna M Kucharska-Newton ◽  
Jo Ellen Rodgers ◽  
Allison E Aiello ◽  
Betsy Sleath ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Disease Risk ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Response To Therapy ◽  
Inhibitor Therapy ◽  
Risk Scores ◽  
Administrative Claims ◽  
Ischemic Event ◽  
Ischemic Events

Introduction: P2Y 12 inhibitors prevent ischemic events while increasing bleeding risk. It is unclear if clinical differences by sex justify different therapy durations after myocardial infarction (MI). Hypothesis: Women will discontinue P2Y 12 inhibitor therapy earlier than men after MI. Methods: MI hospitalizations in 2008-2013 were identified in a 20% Medicare administrative claims sample. Patients were ≥66 years old; had no recent P2Y 12 inhibitor indication; and had a P2Y 12 inhibitor prescription fill within 30 days post-MI. Therapy duration was measured using days supply and 30-day drug-free interval; duration was modeled as risk of discontinuation over time. Patients were followed up to 24 months. Adjusting for sociodemographics, clinical risks, prescriber characteristics, and contextual factors, disease risk scores (DRSs) were estimated from 4 hazard models predicting P2Y 12 inhibitor discontinuation and 3 competing risks: 1) death or hospice admission, 2) ischemic event (MI, ischemic stroke, revascularization), and 3) bleeding event. Male and female patients were matched 1:1 on the 4 DRSs using Mahalanobis distance. Cause-specific risk differences (RDs) were estimated with the Aalen-Johansen estimator and bootstrapped confidence intervals (CIs). Results: Median time on P2Y 12 inhibitor was 388 days (interquartile range 133-720). Of 30,613 patients (51.2% female), 20,002 were matched. At 24 months, women compared to men had a similar risk of treatment discontinuation (RD 0.84%; 95% CI -0.52, 2.19). While still on a P2Y 12 inhibitor, women were less likely to experience death/hospice admission (RD -0.82%; 95% CI -1.39, -0.24) or ischemic event (RD -0.92%; 95% CI -1.81, 0.06) at 24 months but had a similar bleeding risk (RD -0.07%; 95% CI -0.52, 0.39). Conclusions: Duration of P2Y 12 inhibitor use was similar in men and women. Risks for death/hospice admission and ischemic events while taking a P2Y 12 inhibitor were lower in women, suggesting a differential response to therapy that should be investigated further.

P2539Impact of sex (female vs male) in the ischemic-bleeding profile after hospital discharge for acute coronary syndrome during treatment with dual antiplatelet therapy

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Lopez Rodriguez ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
F D'Ascenso ◽  
S Manzano Fernandez ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Ischemic Event ◽  
Coronary Syndrome ◽  
Baseline Characteristics ◽  
Event Rates ◽  
Ischemic Events

Abstract Introduction Sex-specific differences exist in the presentation, pathophysiological mechanisms, and outcomes in patients with acute myocardial infarction. These differences could condition the treatment and prognosis of women compared to men with Acute Coronary Syndrome (ACS). The aim of our study was to determine, after matching the baseline characteristics of patients according to gender, the prognosis of women versus men during treatment with Dual Antiplatelet Therapy (DAPT), after an ACS undergoing Percutaneous Coronary Intervention (PCI). 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 according to gender (female vs male). The impact of gender 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, whereas for bleeding risk we have considered major bleeding defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 6,091 were women PAD (23.4%). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), 640 had myocardial infarction (2.5%) and 685 had major bleeding (2.6%). After propensity-score matching, we obtained two matched groups (according gender) of 5,341 patients. In comparison with male, female had similar risk of myocardial infarction (sHR 1.14, 95% CI 0.91–1.44, p=0.001) with lower risk of major bleeding (sHR 0.75, 95% CI 0.61–0.92, p=0.006). The cumulative incidence of myocardial infarction was 26 and 30 per 1,000 patients/year in men and women, respectively, during DAPT. And the cumulative incidence of major bleeding was 43 and 32 per 1,000 patients/year in men and women, respectively. The difference between myocardial infarction rate and major bleeding rate was −17 in male (more bleeding than ischemic event rates; p<0.05) and +3 in women (similar bleeding and ischemic event rates; p>0.05), per 1,000 patient-years (Figure). Figure 1 Conclusions After an ACS underwent PCI, during DAPT, the ischemic-bleeding balance is different between women and men. In women, the annual incidence of ischemic events was similar to the incidence of bleeding events. However, in men, the incidence of bleeding events is higher than the incidence of ischemic events,

462Impact of severe anemia (hemoglobin <10 g/dl) in the ischemic-bleeding profile during treatment with dual antiplatelet therapy after hospital discharge for acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Castineira Busto ◽  
S Raposeiras Roubin ◽  
E Abu Assi ◽  
F D'Ascenzo ◽  
S Manzano Fernandez ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Propensity Score ◽  
Major Bleeding ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Severe Anemia ◽  
Ischemic Event ◽  
Baseline Characteristics ◽  
Event Rates

Abstract Introduction Anemia is strongly associated with increased risk of morbidity and mortality in patients after acute coronary syndromes (ACS). The aim of our study was to determine, after matching the baseline characteristics, the bleeding-ischemic risk profile during treatment with Dual Antiplatelet Therapy (DAPT) of patients with severe anemia (hemoglobin <10 g/dL) after an ACS undergoing Percutaneous Coronary Intervention (PCI). 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 according to presence or not of severe anemia (hemoglobin <10 g/dL). The impact of severe anemia 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, whereas for bleeding risk we have considered major bleeding defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 630 had severe anemia (2.4%). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), 640 had myocardial infarction (2.5%) and 685 had major bleeding (2.6%). After propensity-score matching, we obtained two matched groups (with hemoglobin < and ≥10 g/dL) of 621 patients. In comparison with patients without severe anemia, patients with hemoglobin <10 g/dL had similar risk of myocardial infarction (sHR 1.37, 95% CI 0.82–2.31, p=0.231) with higher risk of major bleeding (sHR 1.89, 95% CI 1.18–2.72, p=0.006). After propensity score matching, the cumulative incidence of myocardial infarction was 6 and 5 per 100 patients/year in patients with and without severe anemia, respectively, during DAPT. And the cumulative incidence of major bleeding was 12 and 6 per 100 patients/year in patients with and without severe anemia, respectively. The difference between myocardial infarction rate and major bleeding rate was −6 in patients with severe anemia (more bleeding than ischemic event rates; p<0.05) and −1 in patients with hemoglobin ≥10 g/dL (similar bleeding and ischemic event rates; p>0.05), per 100 patient-years (Figure). Conclusions After an ACS underwent PCI, during DAPT, the ischemic-bleeding balance of patients with severe anemia (hemoglobin <10 g/dL) is not favorable. In those patients, a short-term DAPT (<6 months) should be recommended.

scholarly journals Prevalence and impact of ischemic risk on long-term bleeding and ischemic event for high bleeding risk patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Shima ◽  
K Miura ◽  
T Tada ◽  
H Tanaka ◽  
Y Fuku ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Academic Research ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Diabetic Patients ◽  
Kaplan Meier ◽  
Research Consortium ◽  
High Bleeding Risk ◽  
Ischemic Events

Abstract Background Impact of ischemic risk (IR) on long term outcomes in patients at high bleeding risk (HBR) after everolimus-eluting stent (EES) implantation remains unclear. Purpose We aimed to evaluate long term bleeding and ischemic events in patient with HBR or IR after EES implantation. Methods The study population comprised 1219 patients treated with EES without in-hospital events between 2010 and 2011. The follow-up period was 2996±433 days. HBR was defined as Academic research consortium. IR defined as high-risk features of stent-driven recurrent ischemic events in Europe society of cardiology guidelines in 2019: prior stent thrombosis on adequate antiplatelet therapy, diffuse multivessel disease especially in diabetic patients, creatinine clearance &lt;60 ml/min, at least three stents implanted, bifurcation two stents implanted, total stent length &gt;60 mm, and treatment of a chronic total occlusion. Major bleeding (MB) was defined as defined as the occurrence of a Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding event. Primary ischemic events included myocardial infarction, definite stent thrombosis, and cardiac death. The Kaplan-Meier method was used for time-to-event analyses. Results Of the 1219 patients, 317 (26.0%) patients had no risk, 114 (9.4%) patients had only HBR, 288 (23.6%) patients had only IR, and 500 (41.0%) patients had both risks. The 81.4% of HBR patients had IR. The figure of Kaplan-Meier showed MB and CE for 7–8 years. Both risk groups had higher bleeding risk and Ischemic events (log rank p=0.0039, 0.0001). Conclusion HBR patients with EES had a high incidence of IR. Patients who had both HBR and IR are especially at risk for both ischemic events and bleeding compared to those who had no or only one risk. Funding Acknowledgement Type of funding source: None

scholarly journals Disparities by sex in P2Y12 inhibitor therapy duration, or differences in the balance of ischaemic-benefit and bleeding-risk clinical outcomes in older women versus comparable men following acute myocardial infarction? A P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050236
Author(s):  
Ryan P Hickson ◽  
Anna M Kucharska-Newton ◽  
Jo E Rodgers ◽  
Betsy L Sleath ◽  
Gang Fang
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Older Women ◽  
Retrospective Cohort ◽  
Claims Data ◽  
Cohort Analysis ◽  
Inhibitor Therapy ◽  
Secondary Outcome ◽  
Administrative Claims ◽  
P2y12 Inhibitor

ObjectivesTo determine if comparable older women and men received different durations of P2Y12 inhibitor therapy following acute myocardial infarction (AMI) and if therapy duration differences were justified by differences in ischaemic benefits and/or bleeding risks.DesignRetrospective cohort.Setting20% sample of 2007–2015 US Medicare fee-for-service administrative claims data.Participants≥66-year-old P2Y12 inhibitor new users following 2008–2013 AMI hospitalisation (N=30 613). Older women compared to older men with similar predicted risks of study outcomes.Primary and secondary outcome measuresPrimary outcome: P2Y12 inhibitor duration (modelled as risk of therapy discontinuation). Secondary outcomes: clinical events while on P2Y12 inhibitor therapy, including (1) death/hospice admission, (2) composite of ischaemic events (AMI/stroke/revascularisation) and (3) hospitalised bleeds. Cause-specific risks and relative risks (RRs) estimated using Aalen-Johansen cumulative incidence curves and bootstrapped 95% CIs.Results10 486 women matched to 10 486 men with comparable predicted risks of all 4 study outcomes. No difference in treatment discontinuation was observed at 12 months (women 31.2% risk; men 30.9% risk; RR 1.01; 95% CI 0.97 to 1.05), but women were more likely than men to discontinue therapy at 24 months (54.4% and 52.9% risk, respectively; RR 1.03; 95% CI 1.00 to 1.05). Among patients who did not discontinue P2Y12 inhibitor therapy, women had lower 24-month risks of ischaemic outcomes than men (13.1% and 14.7%, respectively; RR 0.90; 95% CI 0.84 to 0.96), potentially lower 24-month risks of death/hospice admission (5.0% and 5.5%, respectively; RR 0.91; 95% CI 0.82 to 1.02), but women and men both had 2.5% 24-month bleeding risks (RR 0.98; 95% CI 0.82 to 1.14).ConclusionsRisks for death/hospice and ischaemic events were lower among women still taking a P2Y12 inhibitor than comparable men, with no difference in bleeding risks. Shorter P2Y12 inhibitor durations in older women than comparable men observed between 12 and 24 months post-AMI may reflect a disparity that is not justified by differences in clinical need.

Performance of bleeding risk scores in dialysis patients

2019 ◽  
Vol 34 (7) ◽  
pp. 1223-1231 ◽  
Author(s):  
Gurbey Ocak ◽  
Chava Ramspek ◽  
Maarten B Rookmaaker ◽  
Peter J Blankestijn ◽  
Marianne C Verhaar ◽  
...  
Keyword(s):  
Bleeding Event ◽  
Bleeding Risk ◽  
Incidence Rates ◽  
Risk Scores ◽  
Dialysis Patients ◽  
Bleeding Events ◽  
Discriminative Performance ◽  
C Statistic ◽  
Ethanol Abuse ◽  
Informed Treatment

Abstract Background Bleeding risk scores have been created to identify patients with an increased bleeding risk, which could also be useful in dialysis patients. However, the predictive performances of these bleeding risk scores in dialysis patients are unknown. Therefore, the aim of this study was to validate existing bleeding risk scores in dialysis patients. Methods A cohort of 1745 incident dialysis patients was prospectively followed for 3 years during which bleeding events were registered. We evaluated the discriminative performance of the Hypertension, Abnormal kidney and liver function, Stroke, Bleeding, Labile INR, Elderly and Drugs or alcohol (HASBLED), the AnTicoagulation and Risk factors In Atrial fibrillation (ATRIA), the Hepatic or kidney disease, Ethanol abuse, Malignancy, Older age, Reduced platelet count or Reduced platelet function, Hypertension, Anaemia, Genetic factors, Excessive fall risk and Stroke (HEMORR2HAGES) and the Outcomes Registry for Better Informed Treatment (ORBIT) bleeding risk scores by calculating C-statistics with 95% confidence intervals (CI). In addition, calibration was evaluated by comparing predicted and observed risks. Results Of the 1745 dialysis patients, 183 patients had a bleeding event, corresponding to an incidence rate of 5.23/100 person-years. The HASBLED [C-statistic of 0.58 (95% CI 0.54–0.62)], ATRIA [C-statistic of 0.55 (95% CI 0.51–0.60)], HEMORR2HAGES [C-statistic of 0.56 (95% CI 0.52–0.61)] and ORBIT [C-statistic of 0.56 (95% CI 0.52–0.61)] risk scores had poor discriminative performances in dialysis patients. Furthermore, the calibration analyses showed that patients with a low risk of bleeding according to the HASBLED, ATRIA, HEMORR2HAGES and ORBIT bleeding risk scores had higher incidence rates for bleeding in our cohort than predicted. Conclusions The HASBLED, ATRIA, HEMORR2HAGES and ORBIT bleeding risk scores had poor predictive abilities in dialysis patients. Therefore, these bleeding risk scores may not be useful in this population.

P2551A randomized, pharmacodynamic comparison of low dose ticagrelor (60mg bid) to low dose prasugrel (5mg od) in patients with prior myocardial infarction: the ALTIC-2 study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I Lianos ◽  
D Sfantou ◽  
C Pappas ◽  
I Revela ◽  
H Triantafyllidi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Low Dose ◽  
Platelet Reactivity ◽  
Bleeding Event ◽  
Chronic Phase ◽  
Bleeding Risk ◽  
Multivessel Disease ◽  
Period Effect ◽  
Prior Myocardial Infarction

Abstract Background In patients with prior myocardial infarction (MI) and features of high ischemic and low bleeding risk, extending dual antiplatelet therapy beyond 1 year or reinitiating treatment is reasonable. A lower than the standard dose, namely ticagrelor 60mg bid instead of 90mg bid and prasugrel 5mg od instead of 10mg od, may be associated with reduced bleeding risk. In the Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial, ticagrelor 60mg bid reduced the ischemic events, at the cost of increased bleeding events. There is no data on the pharmacodynamic efficacy of ticagrelor 60mg bid over low dose prasugrel (5mg od). Purpose To compare platelet reactivity (PR) between prasugrel 5mg od and ticagrelor 60 mg bid in the chronic phase of stable post-MI patients. Methods The ALTIC-2 was a prospective, single-center, randomized, crossover study involving patients on aspirin 100mg od and PEGASUS-TIMI 54 characteristics: >50 years old with MI 1–3 years earlier and at least one high risk feature (age >65 years, diabetes mellitus, a second MI, multivessel disease, or renal dysfunction). After a 14-day washout period–if on P2Y12 receptor antagonist therapy-, patients were randomized to either ticagrelor 60mg bid or prasugrel 5mg od for 14 days, with a crossover directly to the alternate treatment for another 14 days. PR was assessed by the VerifyNow P2Y12 reaction assay in PRU at baseline, pre and post-crossover, 2 hours post last study-drug dose. Statistical analysis was performed with STATA13.0. Results We recruited 20 eligible patients (80% men, 40% diabetics, 65% smokers, 70% multivessel disease, with a mean age of 64.8±6.3 years) for participation in the study (10 in each treatment sequence). During pre-crossover period, in the group allocated first in prasugrel PR levels (mean ± standard deviation) decreased from 238.4±50 to 128±47 (p<0.0001), while in the group allocated first in ticagrelor levels of PR decreased from 259.6±36 to 30.8±29 (p<0.0001). At the end of the 2 treatments, PR levels decreased to 33±26 in the group allocated first in prasugrel (p=0.0001), while in the group allocated first in ticagrelor levels of PR increased to 136±61 (p=0.0001). Analysis of combined data of PR levels (pre- and post-crossover, primary endpoint) adjusted for baseline values and age showed a difference of PR levels (β: −103, 95% CI: −120 to −85) in favor of ticagrelor. A non-significant period effect was observed and no carry effect was found. The secondary endpoint of high PR (>208 PRU) rate was 0% for ticagrelor and 5.0% for prasugrel. No patient exhibited a major bleeding event at either treatment group. Conclusions In patients with previous MI and at least one other high-risk feature, low dose of ticagrelor results in a significantly lower PR compared to prasugrel 5mg od. Acknowledgement/Funding National and Kapodistrian University of Athens

Sex differences in door-to-balloon time and long-term adverse events after percutaneous coronary intervention for acute coronary syndrome: a sub-study from the Prospective JAMIR study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Kimura ◽  
T.I Ito ◽  
S Honda ◽  
K Nishihira ◽  
S Kojima ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Sex Differences ◽  
Bleeding Event ◽  
Coronary Intervention ◽  
Interquartile Range ◽  
Ischemic Event ◽  
Percutaneous Coronary ◽  
Door To Balloon ◽  
Type 3

Abstract Background Shortening of onset to admission time (OAT) and door-to-balloon time (DBT) is associated with lower adverse cardiac event after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). Bleeding event also results in poor outcome in patients with AMI after primary PCI. Little is known about sex differences in DBT and ischemic, bleeding events after AMI. Purpose This study aimed to assess the sex differences of OAT, DTB and adverse cardiac event, incident of bleeding event after primary PCI in patients with AMI. Methods The Japan AMI Registry (JAMIR) is a multicenter, nationwide, prospective registry enrolling patients with AMI from 50 institutes between December 2015 and May 2017. Primary endpoints of this study were ischemic event (composite of cardiovascular death, myocardial infarction and ischemic stroke) and bleeding event (BARC type 3 or 5,).Median follow-up period was 12 months. Results A total of 3,411 patients were enrolled at first. Among them, 329 patients without treated with PCI and 199 patients missing OAT time were excluded from this study. A total 2883 patients of men (n=2240, 77.7%) and women (n=643, 22.3%) were enrolled. OAT and DBT of women were significantly longer than that of men (OAT: 130min, interquartile range 62–300 min vs. 155 min, interquartile range 69–350 min, p=0.040, DBT: 67 min, interquartile range 50–95 min vs. 75 min, interquartile range 53–120 min, p&lt;0.001). There was no significant difference in ischemic events between men and women (7.1% vs. 7.5%, log-rank p=0.741, Figure 1). Multivariate Cox regression analysis showed female sex was significantly associated with lower ischemic event (hazard ratio 0.57; 95% confidence interval 0.38–0.85; p=0.007). Bleeding event of women was significantly higher than that of men (BARC type 3 or 5: 3.8% vs. 7.8%, p&lt;0.001, Figure 2). Conclusion The real-world database of the JAMIR showed that the female sex was significant factor for the delay in primary percutaneous coronary intervention and high incident of bleeding, however, ischemic event was lower than that of male sex. Sex difference appears to be associated with ischemic and bleeding event after acute myocardial infarction. Funding Acknowledgement Type of funding source: None

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