prasugrel-hydrochloride and Non-ST-Elevated-Myocardial-Infarction

Elderly patients are at increased risk of hemorrhagic and thrombotic complications after an acute coronary syndrome (ACS). Frailty, comorbidities and low body weight have emerged as conditioning the prognostic impact of dual antiplatelet therapy (DAPT). The aim of the present study was to investigate the prognostic impact of body mass index (BMI) on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study comparing low-dose (5 mg) prasugrel vs clopidogrel among elderly patients with ACS.. Our population is represented by 1408 patients enrolled in the Elderly-ACS 2 trial. BMI was calculated at admission. The primary endpoint of this analysis was cardiovascular (CV) mortality. Secondary endpoints were all-cause death, recurrent MI, Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding, and re-hospitalization for cardiovascular reasons or stent thrombosis within 12 months after index admission. Patients were grouped according to median values of BMI (

Topics: Acute Coronary Syndrome; Age Factors; Aged; Aged, 80 and over; Body Mass Index; Cause of Death; Clopidogrel; Comorbidity; Female; Frail Elderly; Geriatric Assessment; Hemorrhage; Humans; Italy; Male; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Recurrence; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Although oral P2Y. The purpose of this study was to compare downstream and upstream oral P2Y. We performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit).. We randomized 1,449 patients to downstream or upstream oral P2Y. Downstream and upstream oral P2Y

Topics: Acute Coronary Syndrome; Aged; Coronary Angiography; Female; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Ticagrelor

Current guidelines recommend intensified platelet inhibition by prasugrel or ticagrelor in patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI).. This study sought to investigate the benefits and risks of ticagrelor as compared with prasugrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management.. This post hoc analysis combines the pre-specified subgroups of UA and NSTEMI of the randomized ISAR-REACT 5 trial. It included 1,179 patients assigned to ticagrelor and 1,186 assigned to prasugrel. Ticagrelor was started immediately after randomization and prasugrel after coronary angiography. The primary endpoint was a composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3-5.. The primary endpoint was reached in 101 (8.7%) patients in the ticagrelor and in 73 (6.3%) patients in the prasugrel group (hazard ratio [HR]: 1.41; 95% confidence interval [CI]: 1.04 to 1.90). The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19). The safety endpoint occurred in 49 (5.2%) patients in the ticagrelor and in 41 (4.7%) patients in the prasugrel group (HR: 1.09; 95% CI: 0.72 to 1.65). Landmark analysis revealed persistence of the efficacy advantage with prasugrel after the first month.. In patients with NSTE-ACS, we found that prasugrel was superior to ticagrelor in reducing the combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding. Due to the post hoc nature of the analysis, these findings need confirmation by further studies. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome; NCT01944800).

Topics: Acute Coronary Syndrome; Aged; Coronary Angiography; Female; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Ticagrelor

The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.. In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.. Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.

Topics: Aged; Anticoagulants; Antithrombins; Female; Hemorrhage; Heparin; Hirudins; Humans; Male; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Recombinant Proteins; Stents; Sweden; Thrombosis; Ticagrelor

In the ACCOAST (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction) trial, the prasugrel pre-treatment strategy versus placebo was associated with excess bleeding complications and no improved ischemic outcome in non-ST-segment elevation myocardial infarction (MI). Whether patients with the longest pre-treatment duration had an ischemic benefit is unknown.. This pre-specified analysis of the ACCOAST trial aimed to assess the effect of pre-treatment duration with prasugrel (time from randomization to angiography) on outcomes.. Within the 4,033 patients randomized in the ACCOAST trial, pre-treatment duration was available in 4,001 patients (99.2%). The population of the trial was divided into quartiles of pre-treatment duration (0.1 to 2.5 h, 2.5 to 3.9 h, 3.9 to 13.6 h, and >13.6 h) with an evaluation of the primary efficacy endpoint of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use. Secondary efficacy outcomes including cardiovascular death, MI, or stroke; all-cause death; stent thrombosis and safety outcomes (all coronary artery bypass graft [CABG] or non-CABG TIMI [Thrombolysis In Myocardial Infarction] major bleeding) were also evaluated at 7 days.. The primary efficacy outcome of cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa inhibitor bailout use did not differ between the quartiles of pre-treatment duration in the trial population (p = 0.17 for interaction). None of the secondary efficacy outcomes were found to be dependent on pre-treatment duration. The safety outcome of all CABG or non-CABG TIMI major bleeding did not differ between the quartiles of pre-treatment duration (p = 0.37 for interaction).. In non-ST-segment elevation MI patients, the excess risk of bleeding and the absence of ischemic benefit were consistent across the quartiles of increasing duration of prasugrel pre-treatment. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287).

Topics: Cause of Death; Coronary Angiography; Dose-Response Relationship, Drug; Electrocardiography; Female; Follow-Up Studies; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Survival Rate; Time Factors; Treatment Outcome

Patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) are sometimes treated with medical management alone rather than an invasive strategy. Among those medically managed without revascularization and discharged, a proportion will require revascularization later on, but little is known about this population. In TRILOGY ACS, 9,326 patients with NSTE ACS who were selected for medical management alone were randomized to treatment with prasugrel or clopidogrel and discharged without revascularization. Patient characteristics and ischemic and bleeding outcomes through 30 months were compared between patients who underwent downstream revascularization after the index hospitalization and those who did not. A total of 662 patients (7.1%) underwent later revascularization by percutaneous coronary intervention (73.1%), coronary artery bypass graft surgery (26.4%), or the two (0.5%). Median time to revascularization was 121 days (twenty-fifth, seventy-fifth percentiles: 41, 326). Revascularized patients were younger, more likely to be male, and had higher rates of hyperlipidemia, diabetes mellitus, prior myocardial infarction, and prior revascularization compared with those not revascularized. Europe and North America had the highest rates of revascularization. During the follow-up period, those who underwent revascularization had a higher rate of the composite outcome of cardiovascular death, myocardial infarction, or stroke occurring after revascularization compared with those not revascularized (hazard ratio [HR] 2.73 [95% confidence interval {CI} 2.21 to 3.38], p < 0.001) as well as a higher rate of each of the individual outcomes. Major bleeding was also higher in those who underwent revascularization (GUSTO severe or life-threatening: HR 2.61 [95% CI 1.02 to 6.67], p = 0.045; TIMI major: HR 2.24 [95% CI 1.12 to 4.48], p = 0.022). There was no evidence that bleeding and ischemic outcomes varied by treatment with clopidogrel versus prasugrel. In conclusion, among patients initially medically managed after NSTE ACS, a small proportion later require revascularization and have a high rate of ischemic and major bleeding outcomes compared with those not requiring downstream revascularization.

Topics: Acute Coronary Syndrome; Aged; Clopidogrel; Coronary Artery Bypass; Double-Blind Method; Female; Humans; Male; Middle Aged; Myocardial Revascularization; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Complications; Prasugrel Hydrochloride; Treatment Outcome

Background Cardiovascular clinical trials have traditionally incorporated separate time-to-first-event analyses for their primary efficacy and safety comparisons, but this framework has a number of limitations, including limited patient-centeredness and a traditional requirement for central adjudication. Days alive and out of the hospital (DAOH) has the potential to provide additional insight. Methods and Results TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a randomized, multinational clinical trial that compared the effect of prasugrel versus clopidogrel in patients stabilized after non-ST segment elevation acute coronary syndrome treated without revascularization; the trial had a neutral result. DAOH was calculated for each patient using site-submitted adverse event reporting data. We described patterns of DAOH overall, and among younger adults (<75 years old), older adults (≥75 years old), and frail/prefrail patients over 12 months follow-up and used Poisson regression to compare DAOH for patients randomized to prasugrel versus clopidogrel. Of 9249 patients in the overall trial population, 500 (5.4%) died, and 2504 (27.1%) were hospitalized 4150 times over 12 months' follow-up; the mean±SD DAOH was 317±86. The distribution of DAOH over 12 months was left-skewed, with median DAOH 363 days. Among younger adults, older adults, and frail/prefrail patients, mean DAOH were 323, 293, and 304 days, respectively. There were no differences in DAOH by treatment arm in the overall population (rate ratio, 1.00; 95% CI, 0.99-1.01) or any subgroup. Conclusions These results support the feasibility of determining DAOH, a patient-centered outcome that can potentially overcome many of the disadvantages of the traditional time-to-composite-event framework in the clinical trial setting. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00699998.

Topics: Acute Coronary Syndrome; Aged; Clopidogrel; Double-Blind Method; Feasibility Studies; Female; Health Status; Hospitalization; Humans; Length of Stay; Male; Non-ST Elevated Myocardial Infarction; Patient-Centered Care; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The relationship between troponin level and outcomes among patients with non-ST-segment elevation ACS is established, but the relationship of troponin level with long-term outcomes among medically managed non-ST-segment elevation ACS patients receiving contemporary antiplatelet therapy is inadequately defined.. In 6763 medically managed non-ST-segment elevation ACS patients randomized in TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) (prasugrel versus clopidogrel), we examined relationships between categories of peak troponin/upper limit of normal (ULN) ratio within 48 hours of the index ACS event (≈4.5 days before randomization) and 30-month outcomes (cardiovascular death, myocardial infarction, or stroke; cardiovascular death or myocardial infarction; and all-cause death). Patients with peak troponin levels <1×ULN were younger, were more often women, and had lower GRACE risk scores than those in other troponin groups. Those with ratios ≥5×ULN were more frequently smokers but less often had prior myocardial infarction or percutaneous coronary intervention. Diabetes mellitus prevalence, body mass index, serum creatinine, and hemoglobin were similar across groups. For all end points, statistically significant differences in 30-month event rates were observed between peak troponin categories. The relationship was linear for 30-month mortality (<1×ULN, n=1849 [6.2%]; 1 to <3×ULN, n=1203 [9.6%]; 3 to <5×ULN, n=581 [10.8%]; and ≥5×ULN, n=3405 [12.8%]) but plateaued for composite end points beyond peak troponin values ≥3×ULN. There was no statistically significant heterogeneity in treatment effect by peak troponin ratio for any end point.. Among medically managed non-ST-segment elevation ACS patients selected for medical management, there was a graded relationship between increasing peak troponin and long-term ischemic events but no heterogeneity of treatment effect for prasugrel versus clopidogrel according to peak troponin.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00699998.

Topics: Acute Coronary Syndrome; Aged; Biomarkers; Chi-Square Distribution; Clopidogrel; Double-Blind Method; Female; Humans; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Multivariate Analysis; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Proportional Hazards Models; Risk Factors; Ticlopidine; Time Factors; Treatment Outcome; Troponin; Up-Regulation

This study compared adenosine-associated pleiotropic effects of the 2 P2Y. Both ticagrelor and prasugrel have potent antiplatelet effects. However, only ticagrelor inhibits cellular uptake of adenosine.. Using a randomized, crossover design with 10-week follow-up ticagrelor or prasugrel was administered to type 2 diabetic patients with non-ST-segment elevation acute coronary syndrome requiring stent implantation. A total of 62 patients underwent randomization in a 1:1 ratio to receive ticagrelor or prasugrel for 5 weeks followed by a direct cross over to the alternative treatment for 5 additional weeks. Brachial artery flow-mediated dilation, inflammatory markers, and number of circulating EPCs were compared.. Improvement in brachial artery flow-mediated dilation was greater in the ticagrelor group (0.15 ± 0.19 mm vs. -0.03 ± 0.18 mm; p < 0.001). Moreover, ticagrelor compared with prasugrel decreased interleukin 6 (-0.58 ± 0.43 pg/ml vs. -0.05 ± 0.24 pg/ml; p < 0.001), tumor necrosis factor alpha (-5.62 ± 4.40 pg/ml vs. -0.42 ± 2.64 pg/ml; p < 0.001), and increased adiponectin (2.31 ± 2.00 μg/ml vs. 0.08 ± 1.50 μg/ml; p < 0.001) during 10-week follow-up. Other inflammatory cytokines like high-sensitivity C-reactive protein and soluble vascular cell adhesion molecule-1 were decreased in both groups. Ticagrelor compared with prasugrel significantly increased absolute numbers of circulating EPCs CD34+/KDR+ (42.5 ± 37.8 per μl vs. -28.2 ± 23.7 per μl; p < 0.001), CD34+/CD117+ (51.9 ± 77.2 per μl vs. -66.3 ± 45.2 per μl; p < 0.001), and CD34+/CD133+ (55.2 ± 69.2 per μl vs. -28.0 ± 34.1 per μl; p < 0.001).. Compared with prasugrel, ticagrelor significantly decreased inflammatory cytokines such as interleukin 6 and tumor necrosis factor alpha and increased circulating EPCs, contributing to improved arterial endothelial function in diabetic non-ST-segment elevation acute coronary syndrome patients. Thus, data support that pleiotropic effects of ticagrelor beyond its potent antiplatelet effects could contribute to additional clinical benefits. (Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome [NSTE-ACS] Requiring Coronary Stenting; NCT02487732).

Topics: Acute Coronary Syndrome; Adenosine; Adult; Aged; Anti-Inflammatory Agents; Biomarkers; Brachial Artery; Cross-Over Studies; Diabetes Mellitus, Type 2; Endothelial Progenitor Cells; Female; Humans; Inflammation Mediators; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Prospective Studies; Purinergic P2Y Receptor Antagonists; Seoul; Stents; Ticagrelor; Time Factors; Treatment Outcome; Vasodilation

Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS.. The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8% had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5%) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5%). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7%; HR = 1.04; 95% CI 0.77-1.42; P = 0.79).. Neoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel.. ClinicalTrials.gov identifier: NCT00699998.

Topics: Acute Coronary Syndrome; Aged; Clopidogrel; Drug Therapy, Combination; Female; Hemorrhage; Humans; Long-Term Care; Male; Neoplasms; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Ticlopidine; Treatment Outcome

This study assessed whether the choice of vascular access site influenced outcomes among non-ST-segment elevation myocardial infarction (NSTEMI) patients enrolled in the ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction NCT01015287).. Transfemoral access (TFA) has been associated with the risk of bleeding and increased mortality that is elevated compared to transradial access (TRA) in acute coronary syndromes, although less consistently in NSTE acute coronary syndrome (NSTE-ACS) than in STE-ACS.. The ACCOAST study evaluated a prasugrel loading dose of 60 mg given at the start of percutaneous coronary intervention (PCI) versus a split loading dose of 30 mg given at the time of diagnosis of NSTE-ACS (prior to coronary angiography), followed by 30 mg given at the start of PCI. In the study, choice of access site was at the investigator's discretion. We compared ischemic and bleeding outcomes with TFA versus those with TRA, using propensity score correction.. Of 4,033 patients, 1,711 (42%) underwent TRA. Use of TRA varied widely by country. TFA was not associated with significant increases in noncoronary bypass graft (CABG)-related thrombolysis in myocardial infarction (TIMI) (hazard ratio [HR] for TFA = 1.46; 95% confidence interval [CI]: 0.59 to 3.62; p = 0.42), nor in GUSTO (Global Utilization Of Streptokinase and Tpa for Occluded arteries) or STEEPLE (Safety and Efficacy of Enoxaparin in PCI) major bleeding after propensity score correction. TFA, however, increased combined non-CABG TIMI major or minor bleeding (HR for TFA = 2.34; 95% CI: 1.17 to 4.69; p = 0.017). Primary ischemic outcomes did not differ by access site, albeit individual endpoint analysis suggested an association between TFA with an increase in urgent revascularizations and reduced risk of procedure-related stroke.. In the ACCOAST trial, TFA did not significantly increase TIMI major bleeding, although TRA was associated with a reduction in TIMI major or minor bleeding. Further study is needed to determine whether wider application of radial approach to NSTE-ACS patients at high risk for bleeding improves overall outcomes. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287).

Topics: Acute Coronary Syndrome; Aged; Catheterization, Peripheral; Coronary Angiography; Databases, Factual; Female; Femoral Artery; Hemorrhage; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Propensity Score; Proportional Hazards Models; Prospective Studies; Punctures; Radial Artery; Recurrence; Risk Factors; Stroke; Time Factors; Treatment Outcome

Low levels of high-density lipoprotein cholesterol (HDL-C; <40 mg/dL) are associated with increased risk of cardiovascular events, but it is unclear whether lower thresholds (<30 mg/dL) are associated with increased hazard.. Very low levels of HDL-C may provide prognostic information in acute coronary syndrome (ACS) patients treated medically without revascularization.. We examined data from 9064/9326 ACS patients enrolled in the TRILOGY ACS trial. Participants were randomized to clopidogrel or prasugrel plus aspirin. Study treatments continued for 6 to 30 months. Relationships between baseline HDL-C and the composite of cardiovascular death, myocardial infarction (MI), or stroke, and individual endpoints of death (cardiovascular and all-cause), MI, and stroke, adjusted for baseline characteristics through 30 months, were analyzed. The HDL-C was evaluated as a dichotomous variable-very low (<30 mg/dL) vs higher (≥30 mg/dL)-and continuously.. Median baseline HDL-C was 42 mg/dL (interquartile range, 34-49 mg/dL) with little variation over time. Frequency of the composite endpoint was similar for very low vs higher baseline HDL-C, with no risk difference between groups (hazard ratio [HR]: 1.13, 95% confidence interval [CI]: 0.95-1.34). Similar findings were seen for MI and stroke. However, risks for cardiovascular (HR: 1.42, 95% CI: 1.13-1.78) and all-cause death (HR: 1.36, 95% CI: 1.11-1.67) were higher in patients with very low baseline HDL-C.. Medically managed ACS patients with very low baseline HDL-C levels have higher risk of long-term cardiovascular and all-cause death but similar risks for nonfatal ischemic outcomes vs patients with higher baseline HDL-C.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Aspirin; Biomarkers; Cholesterol, HDL; Clopidogrel; Down-Regulation; Drug Therapy, Combination; Dyslipidemias; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Risk Assessment; Risk Factors; Stroke; Ticlopidine; Time Factors; Treatment Outcome

We aimed to analyze the 2020 standard of care in certified German chest pain units (CPU) with a special focus on non-ST-segment elevation acute coronary syndrome (NSTE-ACS) through a voluntary survey obtained from all certified units, using a prespecified questionnaire.. The assessment included the collection of information on diagnostic protocols, risk assessment, management and treatment strategies in suspected NSTE-ACS, the timing of invasive therapy in non-ST-segment elevation myocardial infarction (NSTEMI), and the choice of antiplatelet therapy.. The response rate was 75%. Among all CPUs, 77% are currently using the European Society of Cardiology (ESC) 0/3‑h high-sensitive troponin protocol, and only 20% use the ESC 0/1‑h high-sensitive troponin protocol as a default strategy. Conventional ergometry is still the commonly performed stress test with a utilization rate of 47%. Among NSTEMI patients, coronary angiography is planned within 24 h in 96% of all CPUs, irrespective of the day of the week. Prasugrel is the P2Y12 inhibitor of choice in ST-segment elevation myocardial infarction (STEMI), but despite the impact of the ISAR-REACT 5 trial on selection of antiplatelet therapy, ticagrelor is still favored over prasugrel in NSTE-ACS. If triple therapy is used in NSTE-ACS with atrial fibrillation, it is maintained up to 4 weeks in 51% of these patients.. This survey provides evidence that Germany's certified CPUs ensure a high level of guideline adherence and quality of care. The survey also identified areas in need of improvement such as the high utilization rate of stress electrocardiogram (ECG).. HINTERGRUND: Ziel der Arbeit war eine Versorgungsanalyse für das Jahr 2020 im Hinblick auf das akute Koronarsyndrom ohne ST-Strecken-Hebung (NSTE-ACS), welche anhand eines standardisierten Fragebogens in allen zertifizierten Brustschmerzeinheiten (CPU) in Deutschland durchgeführt wurde.. In die Bewertung flossen Diagnoseprotokolle, Risikobewertung, Management- und Behandlungsstrategien bei Verdacht auf NSTE-ACS, Zeitpunkt der invasiven Therapie beim Nicht-ST-Strecken-Hebungs-Myokardinfarkt (NSTEMI) und die Wahl der Thrombozytenaggregationshemmung ein.. Die Rücklaufquote betrug 75 %. Von allen CPU verwenden derzeit 77 % das ESC 0/3-h-high-sensitive-Troponin-Protokoll, und nur 20 % haben das ESC 0/1-h-high-sensitive-Troponin-Protokoll als Standardstrategie. Die konventionelle Ergometrie ist mit einer Durchführungsrate von 47 % nach wie vor der am häufigsten durchgeführte Belastungstest. Bei NSTEMI-Patienten wird in 96 % aller CPU, unabhängig vom Wochentag, eine Koronarangiographie innerhalb von 24 h geplant. Prasugrel ist der P2Y12-Inhibitor der Wahl beim ST-Strecken-Hebungs-Myokardinfarkt. Trotz der Ergebnisse der ISAR-REACT-5-Studie wird Ticagrelor beim NSTE-ACS immer noch gegenüber Prasugrel bevorzugt. Wird eine Tripeltherapie beim NSTE-ACS mit Vorhofflimmern eingeleitet, wird diese in 51 % der CPU bis zu 4 Wochen empfohlen.. Die vorliegende repräsentative Umfrage unter den zertifizierten CPU liefert Belege für ein hohes Maß an Leitlinienkonformität und Versorgungsqualität in diesen Einheiten. Die Analyse deckt jedoch auch Bereiche mit Verbesserungsbedarf (wie die unverändert hohe Rate an Belastungs-EKG) auf.

Topics: Acute Coronary Syndrome; Cardiology; Chest Pain; Germany; Humans; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Prasugrel Hydrochloride; ST Elevation Myocardial Infarction; Surveys and Questionnaires; Troponin

Introduction: In patients who have survived myocardial infarction, platelet aggregation inhibitor (TAG) treatment plays an important role in preventing recurrent ischemic events. Objective: to investigate the proportion of patients who received aspirin, clopidogrel, prasugrel and ticagrelor during the hospitalization and the proportion of patients who continued taking the recommended therapy during follow-up. All patients treated for myocardial infarction who had a medical ID number were included in the study. Results: 16 273 patients had ST-elevation (STEMI) and 20 305 patients had non-ST-elevation (NSTEMI) infarction. 80% of patients were hypertensive. Diabetes mellitus (35%) and impaired renal function (30%) were demonstrated in one in three patients. The TAG treatment recommendation was analysed in 36 578 patients who left the hospital. Clopidogrel 12.7%, prasugrel 4.3%, ticagrelor, 93.9%, 77.7%, 8.3% and 3.2% were found in the NSTEMI group. For medicines available under special conditions (prasugrel, ticagrelor), there were significant differences between cen­tres: the proposal varied between 1.2–4.3% for prasugrel and 0.3–10.8% for ticagrelor. Drug switching events were monitored using the National Institute of Health Insurance Fund database. Pharmacovigilance data were available for 29 405 patients. We considered the longest period in the adherence study, and the grace period was 2 months. Adherence durations were processed using a standard survival analysis toolkit (Kaplan–Meier method). At 1 year after the first switch, 76.1%, 78.3%, and 80.9% of the patients in clopidogrel, prasugrel and ticagrelor were adherents to the recommended treatment. Conclusion: The frequency of use of certain antiplatelet drugs varies significantly across different intervention centres. More than three-quarters of the patients are adherent to treatment 1 year after starting treatment.. Összefoglaló. Bevezetés: Szívinfarktust túlélt betegeknél a thrombocytaaggregáció-gátló (TAG-) kezelésnek fontos szerepe van az újabb ischaemiás események megelőzése szempontjából. Célkitűzés: Annak vizsgálata, hogy a kórházi távozás idején a betegek milyen arányban részesültek clopidogrel-, prasugrel- és ticagrelorkezelésben, és az utánkövetés ideje alatt milyen arányban folytatták a javasolt terápiát. Módszer: A Nemzeti Szívinfarktus Regiszter adatbázisában 2018. 01. 01. és 2020. 12. 31. között 39 308 olyan, infarktus miatt kezelt beteget tartottunk nyilván, aki egészségügyi azonosító számmal rendelkezett, és szívkatéteres centrumban kapott ellátást. Eredmények: 16 273 betegnél ST-elevációval (STEMI), 20 305 betegnél ST-elevációval nem járó (NSTEMI) infarktus volt. A betegek 80%-a hypertoniás volt, minden harmadik betegnél diabetes mellitus (35%), illetve csökkent vesefunkció (30%) igazolódott. A kórházból távozó betegek 36 578 infarktusos eseményénél elemeztük a távozáskor adott TAG-kezelési javaslatot. A STEMI-betegek 96,2%-a aszpirin-, 78,3%-a clopidogrel-, 12,7%-a prasugrel- és 4,3%-a ticagrelorkezelési javaslatot kapott. Az NSTEMI-betegcsoportban 93,9%, 77,7%, 8,3%, 3,2% értékeket találtuk. A speciális feltételek esetén rendelhető gyógyszerek (prasugrel, ticagrelor) esetén az egyes centrumok között jelentős különbségek voltak: a javaslat a prasugrel esetén 1,2–24,3%, a ticagrelor esetén 0,3–10,8% között változott. A Nemzeti Egészségbiztosítási Alapkezelő (NEAK) adatbázisának felhasználásával követtük a gyógyszerkiváltási eseményeket. A gyógyszertámogatási adatok 29 405 betegnél álltak rendelkezésre. Az adherencia vizsgálatakor a leghosszabb időszakot vettük figyelembe, és a türelmi idő 2 hónap volt. Az adherencia-időtartamokat standard túléléselemzési eszköztárral (Kaplan–Meier-féle eljárás) dolgoztuk fel. Az első gyógyszerkiváltást követő 1 évnél a clopidogrel, a prasugrel és a ticagrelor esetében a betegek 76,1%-a, 78,3%-a és 80,9%-a adherens volt a javasolt kezeléshez. Következtetés: Bizonyos TAG-gyógyszerek alkalmazásának gyakorisága jelentősen eltér a különböző intervenciós centrumokban. 1 évvel a kezelés megkezdése után a betegek több mint háromnegyede adherens a kezeléshez. Orv Hetil. 2022; 163(19): 743–749.

Topics: Clopidogrel; Humans; Hungary; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; ST Elevation Myocardial Infarction; Ticagrelor

Aim    To study specific features of administering platelet P2Y12 receptor inhibitors to patients with myocardial infarction (MI) in real-life clinical practice; to reveal a possible inconsistency of the therapy with clinical guidelines; to evaluate the patients' compliance with the medication at the outpatient stage; and to outline major direction for improving quality of the antiplatelet treatment.Material and methods    REGION-MI is a multicenter prospective, observational study. The observational period is divided into 3 stages: during the stay in the hospital and at 3 and 12 months following the inclusion into the registry. Information about the drug therapy (used at the time of hospitalization, administered before the hospitalization, received in the hospital, and prescribed at discharge from the hospital) was recorded in the patient's individual registration card. Information about the antiplatelet treatment at 6 months following enrollment into the study was obtain by phone.Results    The study included 4 553 patients. Dual antiplatelet therapy was administered after MI to 94.4 % patients: clopidogrel was administered to 52 %, ticagrelor to 42.2 %, and prasugrel to 11 patients (0.2 %). Ticagrelor was administered significantly more frequently in ST segment elevation myocardial infarction (STEMI) than in NSTEMI, 45 % and 33 %, respectively (p<0.001); clopidogrel was also administered more frequently to patients with STEMI than with NSTEMI, 59 % and 50 %, respectively. According to ARC-HBR criteria, in MI and a high risk of bleeding, clopidogrel was administered more frequently than ticagrelor (p <0.001). Ticagrelor was significantly more frequently administered to patients with MI and a low risk of bleeding than to patients with a high risk (p<0.001). In STEMI and a low risk of bleeding, ticagrelor was administered somewhat more frequently than clopidogrel, 56 % and 44 %, respectively (р<0.05). In NSTEMI and a low risk of bleeding, clopidogrel was administered more frequently than ticagrelor, 53 % and 47 %, respectively (p<0.05). At 6 months post-MI, 94 % of patients continued taking one of the P2Y12 inhibitors.Conclusion    According to data of the REGION-MI registry, the frequency of administering P2Y12 inhibitors to patients with acute MI was high, and the patients' compliance with this therapy was high at 6 months following MI. Although ticagrelor (the most available drug of all powerful platelet P2Y12 receptor inhibitors) has be

Topics: Anticoagulants; Clopidogrel; Hemorrhage; Humans; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Prospective Studies; Purinergic P2Y Receptor Antagonists; ST Elevation Myocardial Infarction; Ticagrelor; Treatment Outcome

After myocardial infarction, guidelines recommend higher-potency P2Y12 receptor inhibitors, namely ticagrelor and prasugrel, over clopidogrel.. We aimed to determine the contemporary use of higher-potency antiplatelet therapy in Canadian patients with non-ST-elevation myocardial infarction (NSTEMI).. A total of 684 moderate-to-high risk NSTEMI patients were enrolled in the prospective Canadian ACS Reflective II registry at 12 Canadian hospitals and three clinics in five provinces between July 2016 and May 2018. Multivariable logistic regression modeling was performed to assess factors independently associated with higher-potency P2Y12 receptor inhibitor use at discharge.. At hospital discharge, 78.3% of patients were treated with a P2Y12 receptor inhibitor. Among patients discharged on a P2Y12 receptor inhibitor, use of higher-potency P2Y12 receptor inhibitor was 61.4%. After adjustment, treatment in-hospital with PCI (OR 4.48, 95%CI 3.34-6.03, p < .0001) was most strongly associated with higher use of higher-potency P2Y12 receptor inhibitor, while oral anticoagulant use at discharge (OR 0.03, 95%CI 0.01-0.12, p < .0001), and atrial fibrillation (OR 0.40, 95%CI 0.17-0.98, p = .046) were most strongly associated with lower use of higher-potency P2Y12 receptor inhibitor. Use of higher-potency P2Y12 receptor inhibitor varied across provinces (range, 21.6%-78.9%).. In contemporary Canadian practice, approximately 60% of moderate-to-high risk NSTEMI patients discharged on a P2Y12 receptor inhibitor are treated with a higher-potency P2Y12 receptor inhibitor. In addition to factors that increase risk of bleeding, interprovincial differences in practice patterns were associated with use of higher-potency P2Y12 receptor inhibitor at discharge. Opportunities remain for further optimization of evidence-based, guideline-recommended antiplatelet therapy use.

Topics: Canada; Cross-Sectional Studies; Humans; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Prospective Studies; Purinergic P2Y Receptor Antagonists; Ticlopidine; Treatment Outcome

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cause of Death; Clinical Trials, Phase IV as Topic; Clopidogrel; Hemorrhage; Humans; Multicenter Studies as Topic; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Randomized Controlled Trials as Topic; ST Elevation Myocardial Infarction; Ticagrelor; Treatment Outcome

To describe from a noninterventional registry (Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Acute Coronary Syndrome), the short-term ischemic and hemorrhagic outcomes in patients with non-ST elevation myocardial infarction (MI) are managed with a loading dose (LD) of a P2Y12 inhibitor (P2Y12i) given at least 4 hours before diagnostic angiography and delineation of coronary anatomy. Prior data on the effects of such "upstream loading" have been inconsistent.. In 53 US hospitals, we evaluated the in-hospital care and outcomes of patients with confirmed non-ST elevation MI managed with an interventional strategy and loaded upstream (at least 4 h before diagnostic angiography) with oral P2Y12i therapy. Patients entered into the database were grouped into 1 of 4 cohorts for analysis: (1) overall cohort, (2) thienopyridine (clopidogrel or prasugrel) load, (3) ticagrelor load, and (4) ticagrelor-consistent. The fourth cohort is a subset of cohort 3 that received ticagrelor throughout the index hospital stay and at discharge. We evaluated in-hospital clinical course and ischemic and bleeding outcomes in all patients and also 30-day outcomes in the ticagrelor-consistent cohort.. A total of 3355 patients were enrolled, of whom 1087 had 30-day follow-up. The mean (±SD) age was 63.3 ± 12.5 years, and 62.6% were male. Thrombolysis in MI and Global Registry of Acute Coronary Events scores placed these patients in the intermediate risk range, and CRUSADE scores were in the moderate risk range. The LD in Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Acute Coronary Syndrome was clopidogrel in 45.6%, ticagrelor in 53.6%, and prasugrel in 0.8%. The median upstream interval (LD to angiography) was 17:27 hours and did not change appreciably over the course of the data collection period (2/15-10/19). Access was radial in 48.6% and femoral in 51.4%. Postangiography management was medical only in 32.3%, percutaneous coronary intervention in 59.4%, and coronary artery bypass grafting in 8.3%. Median length of stay was 2.7 days, and median time from angiography to coronary artery bypass grafting was 3.6 days. In-hospital mortality was 0.51%, and major bleeding (thrombolysis in MI) was 0.24%; the in-hospital major adverse cardiovascular events rate was 0.7%, and stent thrombosis occurred in 0.18%. No significant differences were seen between the ticagrelor and clopidogrel cohorts in hospital, but 16% received more than 1 P2Y12i in-hospital. On follow-up (93.2% response), 86.7% of patients reported taking ticagrelor as directed.. Upstream loading of P2Y12i was associated with very low rates of bleeding and short length of stay in a large cohort of non-ST elevation MI (NSTEMI) patients managed invasively.

Topics: Acute Coronary Syndrome; Aged; Clopidogrel; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Ticagrelor; Treatment Outcome

Topics: Acute Coronary Syndrome; Humans; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Ticagrelor

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.. 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.. 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%. 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.

Topics: Acute Coronary Syndrome; Aged; Aspirin; Drug Administration Schedule; Dual Anti-Platelet Therapy; Europe; Female; Hemorrhage; Humans; Male; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Recurrence; Registries; Risk Assessment; Risk Factors; ST Elevation Myocardial Infarction; Stents; Ticagrelor; Time Factors; Treatment Outcome

Potent P2Y12 blockers are preferred in patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). However, the risk of bleeding remains a major concern. We assessed the association of potent P2Y12 blockers with ischemic and bleeding outcomes in patients with NSTEMI.. From the Korea Acute Myocardial Infarction Registry-National Institute of Health database, 4927 patients with NSTEMI receiving drug-eluting stents (DES) were divided into potent P2Y12 blocker (ticagrelor or prasugrel, n=901) and clopidogrel (n=3180) groups. Propensity-matched 12-month ischemic and bleeding events were compared. Patients who received anticoagulants or who discontinued P2Y12 blockers or switched between potent P2Y12 blockers and clopidogrel were excluded.. In the overall population, patients at higher ischemic and bleeding risks more often received clopidogrel. After propensity matching (n=901 in each group), 12-month rates of major adverse cardiac and cerebrovascular events were lower (7.3% vs. 10.1%, p=0.038), but Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding rates were higher (5.9% vs. 2.2%, p<0.001) with potent P2Y12 blockers. Twelve-month rates of death from any cause, MI, stroke, or TIMI major bleeding were not different. On multivariate analysis, 12-month risk of TIMI major or minor bleeding was higher with B2 or C lesion, potent P2Y12 blocker use, body weight <60kg, and lower with time to PCI <12h and radial artery access.. In patients with NSTEMI receiving DES, potent P2Y12 blockers were associated with reduced ischemic but increased bleeding risk with similar net clinical benefits.

Topics: Aged; Clopidogrel; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Prasugrel Hydrochloride; Propensity Score; Purinergic P2Y Receptor Antagonists; Registries; Republic of Korea; Stroke; Ticagrelor

Topics: Acute Coronary Syndrome; Coronary Angiography; Humans; Non-ST Elevated Myocardial Infarction; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists

We sought to investigate the utilization of prasugrel and its association with outcomes relative to clopidogrel in three typical subgroups of ACS in a real-world setting. Prasugrel is superior to clopidogrel for reducing risk of ischemic events in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), but is associated with an increased risk of bleeding complications. PROMETHEUS was a retrospective multicenter observational study of 19,913 ACS patients undergoing PCI from 8 centers in the United States between 2010 and 2013. Major adverse cardiovascular events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, stroke or unplanned revascularization. The study cohort included 3285 (16.5%) patients with ST-segment elevation myocardial infarction (STEMI), 5412 (27.2%) patients with NSTEMI and 11,216 (56.3%) patients with unstable angina (UA). The frequency of prasugrel use at discharge was highest in STEMI and lowest in UA patients, 27.3% versus 22.2% versus 18.9% (p < 0.001). Use of prasugrel vs clopidogrel was associated with a lower rate of MACE in STEMI, NSTEMI, or UA at 1 year, but the differences were attenuated for all groups except for patients with UA (adjusted HR 0.81, 95% CI 0.69-0.94, p = 0.006) after propensity adjusted analysis. After adjustment, there was no difference in bleeding risk between prasugrel and clopidogrel for all groups at 1 year. STEMI patients were more likely to receive prasugrel compared to NSTEMI and UA patients. Prasugrel was associated with reduced adverse outcomes compared with clopidogrel in unadjusted analyses, findings that were largely attenuated upon adjustment and suggest preferential use of prasugrel in low vs high risk patients.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Cardiovascular Diseases; Clopidogrel; Female; Hemorrhage; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Prasugrel Hydrochloride; Registries; Retrospective Studies; ST Elevation Myocardial Infarction; Treatment Outcome; United States

To understand the optimal timing of adenosine diphosphate (ADP) receptor inhibitor pretreatment prior to percutaneous coronary intervention (PCI) among acute myocardial infarction (MI) patients.. The role of ADP receptor inhibitor pretreatment in this population is unclear.. A total of 9,251 ADP receptor inhibitor-naïve MI patients undergoing PCI at 229 TRANSLATE-ACS sites were evaluated. Adjusted risks of in-hospital major adverse cardiovascular events (MACE) and major bleeding were compared among patients with and without pretreatment using inverse probability-weighted propensity adjustment.. Of 9,251 patients treated with either prasugrel or clopidogrel during the index MI hospitalization, 4,056 (44%) received pretreatment (ST-segment elevation MI [STEMI] 54.9%, non-STEMI 45.1%); pretreatment was used more commonly among those receiving clopidogrel than prasugrel (52% vs. 20%, P < 0.0001). MACE risks were not significantly different between patients with and without pretreatment (clopidogrel 2.1% vs. 2.2%, adjusted hazard ratio [HR] 1.00, 95% confidence interval [CI] 0.70-1.43; prasugrel 2.1% vs. 2.3%, adjusted odds ratio [OR] 0.82, 95% CI 0.42-1.60). No differences in major bleeding were observed among those receiving versus not receiving pretreatment (clopidogrel 3.1% vs. 3.5%, adjusted HR 0.94, 95% CI 0.65-1.36; prasugrel 2.5% vs. 2.7%, adjusted OR 0.93, 95% CI 0.42-2.02); results were similar when stratified by MI type.. ADP receptor inhibitor pretreatment (44%) is commonly used among acute MI patients undergoing PCI in contemporary practice, but no significant differences were found in in-hospital MACE and/or bleeding risks between patients receiving versus not receiving pretreatment, regardless of ADP receptor inhibitor type.

Topics: Aged; Clopidogrel; Community Health Services; Female; Hemorrhage; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Risk Factors; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome; United States

In the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial of patients with non-ST-segment elevation acute coronary syndrome managed medically without revascularization, treated with prasugrel versus clopidogrel for less than or equal to 30 months after index acute coronary syndrome, post-hoc analyses showed a divergence of treatment effect in favor of prasugrel after 12 months. Potential influential factors, including a potential late treatment effect after early study drug discontinuation in the intention-to-treat analysis, have not been explored.. We carried out an exploratory, post-hoc analysis of 1436 patients who received at least one dose of the study drug and discontinued the drug 7-365 days after randomization. Kaplan-Meier event rates were evaluated starting at the landmark timepoint of study discontinuation through 2 years of follow-up, and were compared between prasugrel and clopidogrel.. The unadjusted rates of the primary composite endpoint of cardiovascular death, myocardial infarction, or stroke were 20.1 versus 24.4% in the prasugrel versus clopidogrel groups (log-rank P=0.069). Similar findings were observed for cardiovascular death (13.3 vs. 18.0%, log-rank P=0.022), and cardiovascular death or myocardial infarction (19.3 vs. 23.3%, log-rank P=0.042). In multivariable analyses, there were no significant differences in the adjusted risk of these outcomes between the prasugrel and clopidogrel groups.. In this hypothesis-generating analysis, high rates of ischemic events were observed after study drug discontinuation, with a lower frequency of events among patients treated with prasugrel versus clopidogrel that did not persist after multivariable adjustment. This analysis highlights the complexities of ascertaining downstream effects of antithrombotic therapies after drug discontinuation.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Clopidogrel; Drug Administration Schedule; Female; Hemorrhage; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

With this study, we sought to identify patient characteristics associated with clopidogrel prescription and its relationship with in-hospital adverse events in an unselected cohort of ACSs patients.. We studied all consecutive patients admitted at our institution for ACSs from 2012 to 2014. Patients were divided into two groups based on clopidogrel or novel P2Y12 inhibitors (prasugrel or ticagrelor) prescription and the relationship between clopidogrel use and patient clinical characteristics and in-hospital adverse events was evaluated using logistic regression analysis.. The population median age was 68 years (57-77 year) and clopidogrel was prescribed in 230 patients (46%). Patients characteristics associated with clopidogrel prescription were older age, female sex, non-ST-elevation ACS diagnosis, the presence of diabetes mellitus and anemia, worse renal and left ventricular functions and a higher Killip class. Patients on clopidogrel demonstrated a significantly higher incidence of in-hospital mortality (4.8%) than prasugrel and ticagrelor-treated patients (0.4%), while a nonstatistically significant trend emerged considering bleeding events. However, on multivariable logistic regression analysis female sex, the presence of anemia and Killip class were the only variables independently associated with in-hospital death.. Patients treated with clopidogrel showed a higher in-hospital mortality. However, clinical variables associated with its use identify a population at high risk for adverse events and this seems to play a major role for the higher in-hospital mortality observed in clopidogrel-treated patients.

Topics: Acute Coronary Syndrome; Adenosine; Aged; Aged, 80 and over; Chi-Square Distribution; Clopidogrel; Drug Prescriptions; Drug Therapy, Combination; Drug Utilization Review; Female; Hemorrhage; Hospital Mortality; Humans; Italy; Logistic Models; Male; Middle Aged; Multivariate Analysis; Non-ST Elevated Myocardial Infarction; Patient Selection; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Risk Factors; Ticagrelor; Ticlopidine; Time Factors; Treatment Outcome

Topics: Adenosine; Aged; Female; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Retrospective Studies; Ticagrelor; Treatment Outcome

The relationship between "on-treatment" low platelet reactivity and longitudinal risks of major bleeding dual antiplatelet therapy following acute coronary syndromes remains uncertain, especially for patients who do not undergo percutaneous coronary intervention.. Among medically managed non-ST-segment elevation acute coronary syndromes patients receiving prolonged dual antiplatelet therapy, PRU values were not significantly associated with the long-term risk of major bleeding events, suggesting that low on-treatment platelet reactivity does not independently predict serious bleeding risk.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00699998.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Aspirin; Blood Platelets; Clopidogrel; Drug Therapy, Combination; Female; Hemorrhage; Humans; Longitudinal Studies; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Platelet Aggregation Inhibitors; Platelet Function Tests; Prasugrel Hydrochloride; Proportional Hazards Models; Randomized Controlled Trials as Topic; Ticlopidine

Contemporary use of dual antiplatelet therapy and consistency with guideline recommendations in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) have not been well characterized.. The COAPT was a prospective, observational, multicenter, longitudinal study of patients with myocardial infarction (MI) undergoing PCI. Baseline characteristics, treatment patterns, processes of care, factors associated with switching to and from novel adenosine diphosphate receptor inhibitors (ADPris), and in-hospital outcomes are described.. Among 2,179 MI patients undergoing PCI during their index hospitalization, 1,328 (60.9%) had ST elevation. Initial ADPri use included clopidogrel in 1,812 (83.2%), prasugrel in 125 (5.7%), and ticagrelor in 242 (11.1%). At discharge, 1,597 patients (73.4%) were prescribed clopidogrel, 220 (10.1%) prasugrel, and 358 (16.5%) ticagrelor. Switching between ADPri therapies during the index hospitalization occurred in 15.3%, 22.4%, and 25.2% of patients initially started on clopidogrel, prasugrel, and ticagrelor, respectively. Most switches over the 15-month study period occurred during the index admission (16.8% of patients vs 4.4% switches postdischarge). Major adverse cardiovascular events occurred in 7.5% of patients during the index hospitalization. In-hospital bleeding events occurred in 6.0% of patients and most were mild.. Despite randomized trial evidence and guideline recommendations, only a minority of Canadian MI patients undergoing PCI initially received or were discharged on one of the newer ADPri agents. These findings suggest an opportunity to improve upon the appropriate selection of the ADPris at index hospitalization and discharge in Canadian MI patients undergoing PCI.

Topics: Adenosine; Adult; Aged; Aged, 80 and over; Canada; Clopidogrel; Drug Substitution; Emergency Medical Services; Emergency Service, Hospital; Female; Hemorrhage; Hospitalization; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Prasugrel Hydrochloride; Prospective Studies; Purinergic P2Y Receptor Antagonists; ST Elevation Myocardial Infarction; Ticagrelor; Ticlopidine; Young Adult