Optimal strategy for antiplatelet therapy after coronary drug-eluting stent implantation in high-risk "TWILIGHT-like" patients with diabetes mellitus

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
HY Wang ◽  
ZX Cai ◽  
D Yin ◽  
WH Song ◽  
L Feng ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Bleeding Complications ◽  
Diabetic Patients ◽  
Medical Sciences ◽  
Cerebrovascular Events ◽  
Patients With Diabetes ◽  
Effectiveness Endpoint

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Chinese College of Cardiovascular Physicians, CS Optimizing Antithrombotic Research Fund (Grant No. BJUHFCSOARF201801-01), the National Key Research and Development Program of China (Grant No. 2018YFC1315602), the Beijing Municipal Health Commission (Grant No. 2020-1-4032), the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (Grant No. 2016-I2M-1-009), and the National Natural Science Foundation of China (Grant No. 81870277). Background Patients with diabetes mellitus (DM) are known to be at high-risk for both ischemic and bleeding complications post-percutaneous coronary intervention (PCI). The ischemic benefit versus bleeding risk associated with extended dual antiplatelet therapy (DAPT) in high-risk "TWILIGHT-like" patients with diabetes mellitus after PCI has not been established. Methods All consecutive high-risk patients fulfilling the "TWILIGHT-like" criteria undergoing PCI from January 2013 through December 2013 were identified from prospective Fuwai PCI Registry. High-risk "TWILIGHT-like" patients were defined by at least 1 clinical and 1 angiographic feature based on TWILIGHT trial selection criteria. The present analysis evaluated 3425 diabetics patients with concomitant high-risk angiographic features who were event-free at 1 year after PCI. Median follow-up was 2.4 years. The primary effectiveness endpoint was a composite of death, myocardial infarction, or stroke (termed major adverse cardiac and cerebrovascular events) and primary safety endpoint was clinically relevant bleeding according to Bleeding Academic Research Consortium type 2, 3, or 5. Results On inverse probability of treatment weighting (IPTW) analysis, prolonged-term (>1-year) DAPT with aspirin and clopidogrel decreased the risk of primary effectiveness endpoint compared with shorter (≤1-year) DAPT (1.8% vs. 4.3%; hazard ratio [HR]IPTW: 0.381; 95% confidence interval [CI]: 0.252-0.576; P < 0.001) and reduced cardiovascular death (0.1% vs. 1.8%; HRIPTW: 0.056 [0.016-0.193]). Prolonged DAPT was also associated with a reduced risk of definite/probable stent thrombosis (0.2% vs. 0.7%; HRIPTW: 0.258 [0.083-0.802]), and non-significantly lower rate of myocardial infarction (0.5% vs. 0.8%; HRIPTW: 0.676 [0.275-1.661]). There was no significant difference between groups in clinically relevant bleeding (1.1% vs. 1.1%; HRIPTW: 1.078 [0.519-2.241]; P = 0.840). Similar results were observed in multivariable Cox proportional hazards regression model. Conclusion Among high-risk PCI patients with diabetes mellitus without an adverse event through 1 year, extending DAPT > 1-year significantly reduced the risk of major adverse cardiac and cerebrovascular events without an increase in clinically relevant bleeding, suggesting that such high-risk diabetic patients may be good candidates for long-term DAPT. Abstract Figure.

scholarly journals Optimal Strategy for Antiplatelet Therapy After Coronary Drug-Eluting Stent Implantation in High-Risk “TWILIGHT-like” Patients With Diabetes Mellitus

2020 ◽  
Vol 7 ◽  
Author(s):  
Hao-Yu Wang ◽  
Zhong-Xing Cai ◽  
Dong Yin ◽  
Wei-Hua Song ◽  
Lei Feng ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Bleeding Complications ◽  
Diabetic Patients ◽  
Cerebrovascular Events ◽  
Significant Difference ◽  
Patients With Diabetes ◽  
Effectiveness Endpoint

Background: Patients with diabetes mellitus (DM) are known to be at high-risk for both ischemic and bleeding complications post-percutaneous coronary intervention (PCI). The ischemic benefit vs. bleeding risk associated with extended dual antiplatelet therapy (DAPT) in high-risk “TWILIGHT-like” patients with diabetes mellitus after PCI has not been established.Methods: All consecutive high-risk patients fulfilling the “TWILIGHT-like” criteria undergoing PCI from January 2013 through December 2013 were identified from the prospective Fuwai PCI Registry. High-risk “TWILIGHT-like” patients were defined by at least one clinical and one angiographic feature based on the TWILIGHT trial selection criteria. The present analysis evaluated 3,425 diabetic patients with concomitant high-risk angiographic features who were event-free at 1 year after PCI. Median follow-up was 2.4 years. The primary effectiveness endpoint was a composite of death, myocardial infarction, or stroke (termed major adverse cardiac and cerebrovascular events), and primary safety endpoint was clinically relevant bleeding according to the Bleeding Academic Research Consortium types 2, 3, or 5.Results: On inverse probability of treatment weighting (IPTW) analysis, prolonged-term (>1-year) DAPT with aspirin and clopidogrel decreased the risk of primary effectiveness endpoint compared with shorter ( ≤ 1-year) DAPT [1.8 vs. 4.3%; hazard ratio (HR)IPTW: 0.381; 95% confidence interval (CI): 0.252–0.576; P < 0.001] and reduced cardiovascular death [0.1% vs. 1.8%; HRIPTW: 0.056 (0.016–0.193)]. Prolonged DAPT was also associated with a reduced risk of definite/probable stent thrombosis [0.2 vs. 0.7%; HRIPTW: 0.258 (0.083–0.802)] and non-significantly lower rate of myocardial infarction [0.5 vs. 0.8%; HRIPTW: 0.676 (0.275–1.661)]. There was no significant difference between groups in clinically relevant bleeding [1.1 vs. 1.1%; HRIPTW: 1.078 (0.519–2.241); P = 0.840). Similar results were observed in multivariable Cox proportional hazards regression model.Conclusion: Among high-risk PCI patients with diabetes mellitus without an adverse event through 1 year, extending DAPT >1-year significantly reduced the risk of major adverse cardiac and cerebrovascular events without an increase in clinically relevant bleeding, suggesting that such high-risk diabetic patients may be good candidates for long-term DAPT.

scholarly journals Ischemic and Bleeding Events of Ticagrelor Monotherapy in Korean Patients With and Without Diabetes Mellitus: Insights From the TICO Trial

2021 ◽  
Vol 11 ◽  
Author(s):  
Kyeong Ho Yun ◽  
Jae Young Cho ◽  
Seung Yul Lee ◽  
Sang Jae Rhee ◽  
Byeong Keuk Kim ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Academic Research ◽  
Bleeding Complications ◽  
Diabetic Patients ◽  
Bleeding Events ◽  
Coronary Syndrome ◽  
Patients With Diabetes ◽  
The Impact ◽  
Ischemic Events

Background: Ticagrelor monotherapy after 3 months dual antiplatelet therapy (DAPT) with aspirin and ticagrelor can reduce bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). However, the impact of this approach among the patient with diabetes remains unknown.Methods: This was a sub-analysis of the Ticagrelor Monotherapy after 3 months in the Patients Treated with New Generation Sirolimus Eluting Stent for Acute Coronary Syndrome (TICO) trial. After successful PCI, the patients were randomly assigned to ticagrelor monotherapy after 3-months DPAT or to ticagrelor-based 12-months DAPT. We compared ischemic events and bleeding events between the patients with diabetes and without diabetes for 12 months. Ischemic events were defined as death, myocardial infarction, ischemic stroke, transient ischemic attack, stent thrombosis, and any revascularizations. Bleeding events were defined according to the Thrombolysis in Myocardial Infarction (TIMI) criteria and Bleeding Academic Research Consortium (BARC) definition.Results: Between August 2015 and October 2018, 3,056 patients were enrolled in the TICO trial, of which 835 (27.3%) had diabetes mellitus. Diabetes mellitus was associated with all evaluated ischemic and bleeding events. No significant differences in any ischemic events were observed in patients with diabetes between ticagrelor monotherapy after 3-months DAPT and ticagrelor-based 12-months DAPT (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.45–1.52, p = 0.540). In patients with diabetes, the overall incidence of bleeding complications during the 12-months follow-up period did not differ between the two treatment groups (HR 0.83, 95% CI 1.48–1.43, p = 0.505). However, ticagrelor monotherapy was significantly reduced both any TIMI bleeding and BARC three or five bleeding events in diabetes patients in the 3-months landmark analysis, after 3-months DAPT period (HR 0.20, 95% CI 0.07–0.59, p = 0.003).Conclusion: In diabetic patients, ticagrelor monotherapy showed a lower incidence of bleeding complications after 3-months DAPT period, without increasing ischemic complications, compared with ticagrelor-based 12-months DAPT (ClinicalTrials.gov Identifier: NCT02494895).

scholarly journals Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
T. M. Hommels ◽  
R. S. Hermanides ◽  
B. Berta ◽  
E. Fabris ◽  
G. De Luca ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Clinical Trials ◽  
Target Lesion ◽  
Pooled Analysis ◽  
Diabetic Patients ◽  
Target Vessel ◽  
Bioresorbable Scaffolds ◽  
Patient Level ◽  
Patients With Diabetes

Abstract Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES. Methods We performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77–2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70–2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.

3299Performance of the ESC 0/1h- and 0/3h-algorithm for the early diagnosis of myocardial infarction in patients with diabetes mellitus

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P M Haller ◽  
J T Neumann ◽  
N A Soerensen ◽  
T S Hartikainen ◽  
A Gossling ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Predictive Value ◽  
Diabetic Patients ◽  
Cardiovascular Research ◽  
Diagnostic Strategies ◽  
Patients With Diabetes ◽  
European Society Of Cardiology ◽  
Available Information ◽  
Rule Out

Abstract Background Patients with diabetes mellitus (DM) may have elevated levels of high-sensitive cardiac troponin (hs-Tn) despite acute myocardial ischemia being present. However, it is unclear whether this constrains diagnostic strategies in patients with suspected acute myocardial infarction (MI). Purpose We aimed to assess the diagnostic performance of the European Society of Cardiology (ESC) 0/1 hour (h) and 0/3h-algorithms comparing patients with and without DM and to derive optimized cut-offs. Methods We prospectively enrolled patients with symptoms suggestive of MI in two large clinical cohorts and measured hs-TnI at admission (baseline) and 1 (cohort A) and 3h (cohort A+B) thereafter. Patients with ST-elevation MI were excluded. Patients were stratified based on a diagnosis of DM at baseline. Final diagnoses were adjudicated independently by two cardiologists using all clinically available information, including hs-TnT, but blinded to hs-TnI values. Our primary outcomes of interest were safety of rule-out (defined by sensitivity and negative predictive value [NPV]), accuracy of rule-in (defined by specificity and positive predictive value [PPV]) and the overall performance (% of patients adjudicated to either rule-out or -in). For optimized cut-offs, a NPV >99.0% and a PPV >75.0% were targeted. Results DM was prevalent in 563 (15.29%) of 3683 included patients. MI was more prevalent among patients with DM (137 [24.3%] vs. 498 [16.0%], p<0.001). Using the ESC 0/1h-algorithm (Figure), rule-out was safe in diabetics (p for sensitivity = 1.00) with higher NPV in non-diabetics (p<0.001), while the proportion of patients ruled-out was smaller in diabetics (22.3% vs. 41.8%). Accuracy of rule-in was significantly lower in diabetics (specificity p=0.0035, PPV p=0.48), with a higher rule-in rate of patients with DM (29.5% vs. 21.8%). Using the ESC 0/3h-algorithm, safety of rule-out was lower in both groups compared to the ESC 0/1h-algorithm, with again higher NPV for non-DM (sensitivity p=0.18, NPV p<0.001) and a higher proportion of non-DM ruled-out (65.9% vs. 75.2%). Accuracy of rule-in was significantly lower for patients with DM (specificity p=0.0094, PPV p=0.87). Cut-off adjustment to yield pre-defined accuracy measures resulted in: 4ng/L at baseline or 6ng/L with a delta of 2ng/l for rule–out and 90ng/L or a delta of 10ng/L for rule-in with the ESC 0/1h algorithm; for the ESC 0/3h-algorithm cut-offs were 5ng/L with a delta of 20% for rule-out and 50ng/L with a delta of 20% for rule-in. Conclusion Application of the ESC 0/1h- and 0/3h-algorithms in diabetic patients provided reduced safety and accuracy for rule-out and rule-in of MI, respectively. Use of alternative cut-offs resulted in improved diagnostic safety and accuracy. Acknowledgement/Funding Abbott Diagnostics, German Center of Cardiovascular Research, German Heart Foundation, Else-Kröhner-Stiftung angegeben

scholarly journals Predictive Value of N-Terminal Prohormone of Brain Natriuretic Peptide in Long-Term Remodeling of the Left Ventricle in Diabetic Patients of Young and Middle Age With Acute Coronary Syndrome After Percutaneous Coronary Intervention

2021 ◽  
Vol 9 (4) ◽  
pp. 511-520
Author(s):  
Z. Wang ◽  
E. A. Asaphyeva ◽  
T. I. Makeeva
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Middle Age ◽  
Coronary Intervention ◽  
Diabetic Patients ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Patients With Diabetes ◽  
Long Term Prognosis

Abstract. Recently, quantitative analysis of the level of the N-terminal prohormone of the brain naturetic peptide (NT-proBNP) has been widely used to diagnose heart failure (HF). A statistically significant correlation was found between the serum NT-proBNP concentration and HF stage. It was found that in patients with high cardiovascular risk, NT-proBNP has the highest predictive value in relation to mortality. In young and middle-aged patients with diabetes mellitus (DM) with myocardial infarction (MI) and stents of an infarct-associated artery, the frequency of unfavorable remodeling (UR) of the left ventricle (LV) in the long-term prognosis was studied. The frequency of atherosclerotic lesions of the coronary arteries (CA) in patients with diabetes in acute coronary syndrome (ACS) was determined, the results of echocardiographic parameters were presented in the follow-up dynamics, the value of serum NT-proBNP in predicting LV UR 12 months after myocardial infarction (MI) was determined.Aim of study. To assess the diagnostic capabilities of NT-proBNP in the long-term prediction of the development of LV infarction in patients with MI with diabetes in young and middle age after percutaneous coronary intervention (PCI).Design. Prospective controlled non-randomized trial. The patients were examined twice: on the first day of ACS after PCI with stenting of infarct-associated coronary artery and 12 months after AMI. The study included 191 patients with ACS with / without ST-segment elevation, who were divided into two groups. The main group included 76 patients with ACS with diabetes mellitus, the comparison group included 115 patients with ACS without diabetes mellitus. Patients in both groups were comparable in age, gender, comorbidity, and complications of AMI. The duration of diabetes was, on average, 6 years (from one to 12 years).Material and methods. All patients underwent electrocardiography, echocardiography, tests for the content of troponin I, NT-proBNP, glycosylated hemoglobin, lipids, determined the level of creatinine in the blood and the glomerular filtration rate according to the Modification of diet in renal disease (MDRD). All patients were examined twice: on the first day of ACS after PCI with stenting of infarct-associated coronary artery and 12 months later.Results. In 69% of diabetic patients with anterior myocardial infarction and in 63% of patients with posterolateral MI 12 months after PCI, signs of LV inferiority were revealed in the form of an increase in the indices of end-diastolic and systolic volumes of the LV and low ejection fraction (≤45%). In patients without diabetes, these figures were 18% and 31%, respectively. High concentrations of NT-proBNP on the first day of myocardial infarction after PCI were of the greatest value in the diagnosis and prognosis of LV UR after 12 months.Conclusion. The NT-proBNP level of more than 776 pg/ml on the first day after PCI is an indicator of an unfavorable long-term prognosis in patients with young and middle-aged diabetes in terms of the development of LV systolic dysfunction.

Interaction between expression of angiogenic factors and pathology of the microvasculature and cardiomyocytes in myocardial tissue of patients with diabetes mellitus

2015 ◽  
Vol 1 (1) ◽  
Author(s):  
Dr. Abdulwahab Abuderman
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Sudden Death ◽  
Angiogenic Factors ◽  
Diabetic Patients ◽  
Myocardial Tissue ◽  
Challenging Issue ◽  
Patients With Diabetes

<p>Sudden death with myocardial infarction has always<br />been a challenging issue for the investigators and<br />forensic pathologists. When a person suffering from<br />angina or myocardial infarction is simultaneously<br />suffering from diabetes mellitus issue becomes even<br />more complex for the investigators as usual signs &amp;<br />symptoms of MI may not manifest so as to rouse a<br />suspicion of MI. This study will help the pathologists to<br />understand the microscopic changes of diabetic<br />cardiomyopathy better in a case having MI with<br />diabetes. This study was done in 47 cases to know the<br />pathology of microvasculature and cardiomyocytes in<br />myocardial tissue of diabetic patients and expression of<br />angiogenic factors.</p>

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