Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial

Background: We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial. Methods: Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding. Results: Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P <0.001) and were frailer according to the Canadian Study of Health and Aging Clinical Frailty Scale (intermediate, 21.4% versus 14.1%; high, 6.4% versus 2.1%; P <0.001). The cumulative 1-year incidences of the primary outcome measure, all-cause death, and major bleeding were significantly higher in the nonenrolled group than in the enrolled group (7.2% versus 4.5%, P =0.03; 4.1% versus 0.9%, P <0.001; and 4.3% versus 2.1%, P =0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P <0.001; 9.9% versus 3.0%, P <0.001; and 13.5% versus 3.5%, P <0.001, respectively). Conclusions: Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.

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Abstract 18519: Withdrawal of Antiplatelet Therapy Results in Worse Short-term Prognosis in Patients Undergoing Elective Major Noncardiac Surgery

Circulation ◽

10.1161/circ.130.suppl_2.18519 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Jesús álvarez-García ◽

Miquel Vives-Borrás ◽

Joan I Llao ◽

Andreu Ferrero-Gregori ◽

Marc Bausili ◽

...

Keyword(s):

Antiplatelet Therapy ◽

Cardiovascular Events ◽

Primary Outcome ◽

Outcome Measure ◽

Postoperative Mortality ◽

Primary Outcome Measure ◽

Noncardiac Surgery ◽

Concomitant Treatment ◽

Short Term ◽

The Impact

Background: The decision whether to discontinue antiplatelet therapy in patients undergoing major noncardiac surgery can be clinically challenging. There is insufficient clinical evidence to establish comprehensive guidelines and most of recommendations are based on expert consensus. Objective: To evaluate the effectof withdrawal of antiplatelet therapy on 30-day postoperative outcome in subjects undergoing elective major noncardiac surgery. Methods: A retrospective cohort study was performed in 1630 patients, 40 years and older, who underwent major noncardiac surgery. Age, gender, risk factors, previous chronic heart or lung disease, renal function, anemia and concomitant treatment were used in a binary logistic regression to determine the impact of withdrawal of antiplatelet therapy on prognosis. The primary outcome measure was a composite of 30-day postoperative mortality or cardiovascular events (cardiac arrest, myocardial infarction, stroke or pulmonary embolism). Results: Five percent of patients presented the composite primary outcome measure of 30-day postoperative mortality or cardiovascular events. Antiplatelet therapy was withdrawn in 11.4% of patients (table). Discontinuation of antiplatelet therapy was associated with a significant increase in the primary outcome measure (OR 2.27; CI95%: 1.16-4.46). Conclusions: In a contemporary cohort of patients undergoing noncardiac surgery, withdrawal of antiplatelet therapy was associated with a worse short-term prognosis. There is an urgent need for further research in this field.

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Single-session versus staged procedures for elective multivessel percutaneous coronary intervention

Heart ◽

10.1136/heartjnl-2017-312117 ◽

2017 ◽

Vol 104 (11) ◽

pp. 936-944 ◽

Cited By ~ 1

Author(s):

Toshiaki Toyota ◽

Takeshi Morimoto ◽

Hiroki Shiomi ◽

Kyohei Yamaji ◽

Kenji Ando ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Coronary Artery ◽

Clinical Outcomes ◽

Primary Outcome ◽

Outcome Measure ◽

Coronary Intervention ◽

Primary Outcome Measure ◽

Single Session ◽

Coronary Syndrome ◽

Percutaneous Coronary

ObjectivesTo clarify the effect of single-session multivessel percutaneous coronary intervention (PCI) strategy relative to the staged multivessel strategy on clinical outcomes in patients with stable coronary artery disease (CAD) or non-ST-elevation acute coronary syndrome.MethodsIn the Coronary REvascularisation Demonstrating Outcome Study in Kyoto PCI/coronary artery bypass grafting registry cohort-2, there were 2018 patients who underwent elective multivessel PCI. Primary outcome measure was composite of all-cause death, myocardial infarction and stroke at 5-year follow-up.ResultsSingle-session multivessel PCI and staged multivessel PCI were performed in 707 patients (35.0%) and 1311 patients (65.0%), respectively. The cumulative 5-year incidence of and adjusted risk for the primary outcome measure were not significantly different between the single-session and staged groups (26.7% vs 23.0%, p=0.45; HR 0.91, 95% CI 0.72 to 1.16, p=0.47). The 30-day incidence of all-cause death was significantly higher in the single-session group than in the staged group (1.1% vs 0.2%, p=0.009). However, the causes of death in 11 patients who died within 30 days were generally not related to the procedural complications, but related to the serious clinical status before PCI. For the subgroup analyses including age, gender, extent of CAD, severe chronic kidney disease and heart failure, there was no significant interaction between the subgroup factors and the effect of the single-session strategy relative to the staged strategy for the primary outcome measure.ConclusionsThe single-session multivessel PCI strategy was associated with at least comparable 5-year clinical outcomes compared with the staged multivessel PCI, although the prevalence of the single-session strategy was low in the present study.

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Onyx ONE: outcomes in patients with acute coronary syndrome

European Heart Journal ◽

10.1093/ehjci/ehaa946.1746 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

E.K Kedhi ◽

S.W Windecker ◽

A Latib ◽

D Kandzari ◽

A Kirtane ◽

...

Keyword(s):

Myocardial Infarction ◽

Cardiac Death ◽

Primary Outcome ◽

Bleeding Risk ◽

Funding Source ◽

Coronary Syndrome ◽

Global Study ◽

Risk Patients ◽

St Elevation ◽

High Bleeding Risk

Abstract Background/Introduction The Onyx ONE Global Study (Onyx ONE), a randomized, single-blind, international trial, demonstrated non-inferiority of a zotarolimus-eluting stent (ZES) to a polymer-free drug-coated stent (DCS) in high-bleeding risk patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT). More than half of the Onyx ONE patients presented with an acute coronary syndrome (ACS). The safety and effectiveness of ZES and DCS in ACS patients treated with SAPT after 30 days remains unknown. Purpose To evaluate the safety and effectiveness outcomes for ZES and DCS in Onyx ONE patients presenting with ACS. Methods The primary outcome of the trial was a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year. To align with the time that DAPT is interrupted, we also evaluated the primary endpoint between the 2 stent groups in a landmark analysis between 30 days and 1 year. All analyses were performed in ACS patients (includes unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction). Results Among the 1996 patients randomized in Onyx ONE, 982/1902 (51.6%) presented with ACS, of which 511/982 (52.0%) and 471/982 (48.0%) were treated with ZES and DCS respectively. In a pre-defined subgroup analysis in ACS patients, the event rates between the two stent groups regarding the primary outcome at one year were similar (18.5% ZES; 20.8% DCS; HR: 0.91; 95% CI [0.68, 1.22]; p=0.523). In the landmark analysis beyond day 30, the primary outcome rate tended to be lower among those treated with the ZES (8.4%) compared with the DCS (12.1%) [HR: 0.66 (95% CI: 0.43, 1.01), p=0.055] (Figure). This was primarily driven by lower rates of myocardial infarction with ZES (6.5% ZES; 10.2% DCS; [HR: 0.58 (95% CI: 0.36, 0.93); p=0.025], while other components were similar: cardiac death, 2.6% ZES vs. 2.8% DCS [HR: 1.00 (95% CI: 0.44, 2.27); p>0.99) and stent thrombosis, 1.4% ZES vs. 1.4% DCS [HR: 0.93 (95% CI: 0.27, 3.21); p=0.91]. Conclusions In Onyx ONE, high-bleeding risk patients presenting with ACS had similar safety and efficacy at 1 year in both the ZES and DCS stent groups. However, a trend was present for greater safety with the ZES with SAPT treatment beyond 30 days driven by lower myocardial infarction rates in that time period thus warranting additional confirmatory studies. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic sponsored the Onyx ONE Global Study

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Clinical outcome with NOACs vs VKAs in patients with atrial fibrillation and severe chronic kidney disease: results of a retrospective, multicenter, real-world study

European Heart Journal ◽

10.1093/ehjci/ehaa946.3365 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

V Lio ◽

V Pasceri ◽

L Di Lullo ◽

V Russo ◽

F Fimiani ◽

...

Keyword(s):

Atrial Fibrillation ◽

Chronic Kidney Disease ◽

Real World ◽

Primary Outcome ◽

Outcome Measure ◽

Composite Endpoint ◽

Primary Outcome Measure ◽

Vitamin K Antagonist ◽

Minor Bleeding ◽

Severe Chronic Kidney Disease

Abstract Background Patients with atrial fibrillation (AF) and severe chronic kidney disease (CKD) are at higher risk of both bleeding and thromboembolic events. Non-vitamin K antagonist oral anticoagulants (NOACs) are licensed to be used in these patients, although they were excluded from phase III controlled randomized trials comparing NOACs vs warfarin in AF. Thus, current evidence on NOACs use in such setting of patients is not definitive. Purpose Aim of our multicenter study was to perform a real-world comparison of clinical outcome with NOACs vs vitamin K antagonist anticoagulants (VKAs) also in AF patients having an estimated glomerular filtration rate (eGFR) 15–29 mL/min. Methods We retrospectively included a total of 266 patients receiving NOACs (N=159) or VKAs (N=107). Primary outcome measure was the cumulative incidence of the net composite endpoint including ischemic stroke, systemic thromboembolism or any bleeding. Mean follow-up was 2.6 years. Results CHA2DS2-VASc and HAS-BLED scores at baseline were similar in the two groups (3.4±1.3 with NOACs vs 3.4±0.9 with VKAs and 3.1±1.0 vs 3.0±0.7, respectively); eGFR and hemoglobin values were also comparable (31.8±12.3 vs 32±11.9 mL/min and 10.2±2.1 vs 11.0±2.3 g/dL, respectively). NOACs were not inferior to VKAs for the primary net composite endpoint: incidence 20.7% vs 29.9%, p<0.01 for non-inferiority, p=0.11 for superiority. In proportional Cox regression model, hazard ratio for the primary outcome measure with NOACs use was 0.74 (95% CI 0.45–1.21, p=0.22). In the NOAC group there was a trend towards reduction in minor bleeding complications (p=0.08). Conclusions Our real-world data indicate that in patients with AF and severe renal failure NOACs are not inferior to VKAs for both safety and efficacy. The use of NOACs was associated with a numerically lower incidence of minor bleeding. Funding Acknowledgement Type of funding source: None

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Impact of high bleeding risk criteria on short- and long-term outcomes in patients with acute myocardial infarction

European Heart Journal ◽

10.1093/ehjci/ehaa946.1641 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

K Dai ◽

A.O Okada ◽

Y.H Hyodo ◽

T.N Nakano ◽

S.T Tomomori ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Bleeding Risk ◽

Long Term Outcomes ◽

Kaplan Meier ◽

Short And Long Term ◽

High Bleeding Risk ◽

Minor Criteria ◽

The Impact

Abstract Background The Academic Research Consortium (ARC) proposed the new definition of high bleeding risk (HBR) criteria. It remains unknown about the prevalence and the impact of HBR on clinical outcome after acute myocardial infarction (AMI). Purpose To assess the prevalence and the impact of HBR on short- and long-term outcomes in patients with AMI. Methods Between January 2015 and January 2018, 412 patients with AMI underwent coronary angiography within 24 hours after the onset of chest pain. According to HBR criteria proposed by ARC, we divided patients into 2 groups; HBR and non-HBR group. We considered a patient HBR if the patient met at least 1 major criteria or 2 minor criteria. Major criteria included severe CKD (eGFR<30 ml/min), severe anemia (Hgb<11 g/dl), active cancer, and the use of oral anticoagulant drug. Minor criteria included high age (≥75), moderate CKD (eGFR 30–59 ml/min), moderate anemia (Hgb 11–12.9 g/dl for men and 11–11.9 g/dl for women). Kaplan-meier method was used to compare long-term outcome of HBR and non-HBR group. Major adverse cardiovascular events (MACE) were defined as all-cause death, non-fetal MI, and stroke. Results Patients with HBR were found in 37% of patients with AMI. In-hospital mortality (11.3% vs 4.2%, p=0.008) and MACE rate was significantly higher in HBR than non-HBR group (Figure). HBR group was associated with higher all-cause death (15.7% vs 2.5%, p<0.0001) and intracranial bleeding (4.8% vs 0.5%, p=0.02) than non-HBR group, although the incidence of non-fetal MI was comparable between two groups (7.6% vs 8.5%, p=0.76). Conclusions AMI patients with HBR were associated with worse outcomes both short- and long-term. Kaplan-Meier curves for MACE Funding Acknowledgement Type of funding source: None

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186. Prescriber-Led Antibiotic Timeout Alert Responses: A Retrospective Multicenter Study

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.230 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S99-S99

Author(s):

Steven Smoke ◽

Ellen Secaras ◽

Melissa Crossen ◽

Gargi Patel ◽

Alison Brophy ◽

...

Keyword(s):

Antibiotic Therapy ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Patient Age ◽

Time Out ◽

Patient Âgé ◽

Electronic Chart ◽

The Impact ◽

Retrospective Multicenter Study

Abstract Background An antibiotic time out is when a clinician is prompted to reevaluate antibiotic therapy for appropriateness after 48–72 hrs. The purpose of this study is to evaluate the impact of a prescriber-led electronic antibiotic timeout alert. Methods This was a retrospective cohort study conducted at seven hospitals of a health system. The alert prompts prescribers to reevaluate antibiotic therapy after > 72 hours upon opening the electronic chart. Prescribers can then choose to “Continue”, “Renew”, “Discontinue” or “Defer” for each antibiotic. The alert fires for every time the chart is opened, for every prescriber, every time any antibiotic has been active for > 72 hours and no action response (i.e., “Continue”, “Renew”, “Discontinue”) has been selected. This was a 6 month study from November 1, 2018 – April 30, 2019. The primary outcome measure was the percentage of patients having > 1 antibiotic discontinued via the electronic antibiotic timeout alert. Secondary outcomes included frequency of timeout alerts per patient, and percentage of discontinuations per response, by drug, by indication and by patient age. Results A total of 213950 alerts fired for 13263 patients during the study period. 94.2% and 0.4% of responses were “Defer” and “Discontinue”, respectively. The average number of alerts per patient was 16.1. The percentage of patients who had at least one discontinuation was 5.3%. 38.2% of patients had no response other than “Defer”. There were a total of 10306 action responses, 4.8% of which were “Discontinue”. Among action responses, discontinue rates for the indications of “COPD exacerbation”, “Prophylaxis, Surgical/Procedural”, “Prophylaxis, Immunosuppression”, “Osteomyelitis” were 9.6%, 12%, 1.3% and 1%, respectively. Azithromycin and trimethoprim/sulfamethoxazole had discontinuation rates of 9.3% and 0.9%, respectively. Patient age had a significant impact on discontinuation rates with rates of 4.7%, 3.5%, and 10.9% for patients > 18, 2–17 and < 2 years of age (p< 0.001). Conclusion An electronic antibiotic timeout alert implemented at seven hospitals was largely ignored. This alert may be refined by limiting it to antibiotic orders with specific features associated with higher rates of discontinuation. Disclosures All Authors: No reported disclosures

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Exergaming improves functional fitness in MCI patients. Does the APOE genotype moderate the outcome?

International Journal of Aging Research ◽

10.28933/ijoar-2020-11-2105 ◽

2020 ◽

pp. 74

Author(s):

Keyword(s):

Healthy Aging ◽

Primary Outcome ◽

Outcome Measure ◽

Apoe Genotype ◽

Primary Outcome Measure ◽

Considerable Improvement ◽

Functional Fitness ◽

Functional Effect ◽

The Impact ◽

Passive Group

Objectives: Mild cognitive impairment could be defined as the condition between healthy aging and dementia. MCI patients seem to retain the neuroplasticity to benefit from Physical Exercise (PE) interventions delaying the progression to dementia. The present study investigates the impact of PE via “Exergaming” on the functional fitness of MCI adults, depending on the presence of the APOEɛ4 allele. Methods: 159 MCI participants were recruited. They were separated to two groups (performing PE or not). The Fullerton Functional Test was used as a primary outcome measure in two-time points (prior to and after PE). Results: The Active group showed more considerable improvement compared to the Passive group in all Fullerton components despite the presence of APOEε4. Discussion: ΡΕ via exergaming has a beneficial functional effect in MCI patients, whether carrying the APOEɛ4 allele or not.

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Sarcopenia Index as a Predictor of Clinical Outcomes in Older Patients with Coronary Artery Disease

Journal of Clinical Medicine ◽

10.3390/jcm9103121 ◽

2020 ◽

Vol 9 (10) ◽

pp. 3121

Author(s):

Hak Seung Lee ◽

Kyung Woo Park ◽

Jeehoon Kang ◽

You-Jeong Ki ◽

Mineok Chang ◽

...

Keyword(s):

Myocardial Infarction ◽

Clinical Outcomes ◽

Older Patients ◽

Total Population ◽

Bleeding Event ◽

Bleeding Risk ◽

Coronary Intervention ◽

Major Adverse Cardiovascular Events ◽

Minor Bleeding ◽

Serum Cystatin C

To demonstrate the association of the serum creatinine/serum cystatin C ratio (sarcopenia index, SI) with clinical outcomes including cardiovascular and bleeding risk in older patients who underwent percutaneous coronary intervention (PCI), we analyzed a multicenter nation-wide pooled registry. A total of 1086 older patients (65 years or older) who underwent PCI with second-generation drug-eluting stents (DES) were enrolled. The total population was divided into quartiles according to the SI, stratified by sex. The primary clinical outcomes were major adverse cardiovascular events (MACE, all-cause death, myocardial infarction and target lesion revascularization) and thrombolysis in myocardial infarction major and minor bleeding during a 3-year follow-up period. In the total population, MACE occurred within 3 years in 154 (14.2%) patients. The lowest SI quartile group (Q1) had a significantly higher 3-year MACE rate (Q1 vs. Q2–4; 23.1% vs. 11.2%, p < 0.001), while bleeding event rates were similar between the groups (Q1 vs. Q2–4; 2.6% vs. 2.2%, p = 0.656). The Cox proportional hazard model showed that lower SI is an independent predictor for MACE events (HR 2.23, 95% CI 1.62–3.07, p < 0.001). The SI, a surrogate for the degree of muscle mass, is associated with cardiovascular and non-cardiovascular death, but not with bleeding in older patients who underwent PCI.

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