scholarly journals Major adverse cardiovascular events after implantation of absorb bioresorbable scaffold: One-year clinical outcomes

2021 ◽  
Vol 52 (4) ◽  
pp. 249-257
Author(s):  
Tanja Šobot ◽  
Nikola Šobot ◽  
Zorislava Bajić ◽  
Nenad Ponorac ◽  
Rade Babić

Background/Aim: Bioresorbable vascular scaffold (BVS) represents a novel generation of intracoronary devices designed to be fully resorbed after healing of the stented lesion, delivering antiproliferative drug to suppress restenosis, providing adequate diameter of the coronary vessel and preserving the vascular endothelial function. It was supposed that BVS will reduce neointimal proliferation and that their late bioresorption will reduce the negative effects of traditional drug-eluting stents, including the late stent thrombosis, local vessel wall inflammation, loss of coronary vasoreactivity and the need for the long-term dual antiplatelet therapy. The purpose of this research was to investigate efficacy and safety of Absorb everolimus-eluting BVS implantation and the prevalence of major adverse cardiovascular events (MACE) at the mid-term follow-up. Methods: The study encompassed 42 patients selected for BVS implantation and fulfilling inclusion criteria - 37 male and 5 female - admitted to the Dedinje Cardiovascular Institute, Belgrade, Serbia over the one-year period (from January 2015 to January 2016) for percutaneous coronary intervention (PCI). Coronary vessel patency before and after stenting was assessed by the Thrombolysis in Myocardial Infarction flow (TIMI) grades. After the index PCI procedure with BVS all patients were clinically followed by regular (prescheduled or event-driven) visits during the next 12-month period. Results: In the intention-to-treat analysis, all Absorb BVS procedures were successful, without the need for conversion to other treatment modalities. The complete reperfusion (TIMI flow grade 3) after the intervention was established in 97.6 % of patients and 100 % of them achieved the TIMI flow grade ≥ 2. The presence of angina pectoris was reduced significantly by the BVS procedure: stable angina 57.1 % to 11.9 %, (p < 0.001) and unstable angina 31 % to 0 %, respectively (p < 0.001). After the one-year follow-up, the MACE rate was 11.9 %. Myocardial infarction occurred in 4.8 % and the need for PCI reintervention in 2.4 % of cases (not influenced by the gender or the age of patients). There were 4 cases of death (all patients were older and had lower values of left ventricular ejection fraction). Conclusion: The results of the current research demonstrated a high interventional success rate of the Absorb BVS implantation, followed by the early improvement of the anginal status. However, that was not translated into the favourable mid-term clinical outcomes, opening debate about the current status of Absorb BVS and the need for future refinements of stent design and implantation techniques.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F A Magamedkerimova ◽  
F A Magamedkerimova ◽  
E N Ivantsov ◽  
N R Khasanov ◽  
E V Valeeva ◽  
...  

Abstract Introduction According to the GRACE registry the largest amount of deaths occurs in the first year after ST elevation myocardial infarction (STEMI). Purpose To investigate the incidence of Major Adverse Cardiovascular Events (MACE), which include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke one year after STEMI and Wall Motion Index Score (WMSI) in patients with different genotypes A/G of rs2891116 polymorphism in CDKN2B gene. Materials and methods A total of 141 patients, diagnosed with STEMI based on the Third Universal Definition of Myocardial Infarction (ESC, 2013) were included in the study, composed of 52 females and 89 males. The study group mean age was 63.8±11.8 years. Informed consent was obtained. During hospitalization echocardiography was performed and a blood sample was taken for genetic testing. Over the one-year period MACE were recorded. 17 patients were lost to follow up. Data was analysed using Kaplan-Meier estimator; to compare differences between groups log-rank test was applied; continuous data analysis was performed by Mann-Whitney test. The measured genotype frequencies fit the Hardy-Weinberg equilibrium (p>0.05). Results Kaplan-Meier survival analysis revealed that in patients with AA genotype the proportion of individuals who experienced MACE over the one year period after STEMI was higher in comparison with AG genotype carriers (log rank p=0.022). Participants with GG genotype did not show significant differences compared to other genotypes carriers (Picture 1). WMSI value in patients with AA genotype was higher (Me = 1.25; Q(0.25) = 1.13; Q(0.75) = 1.56) than in AG genotype carriers (Me = 1.13; Q(0.25) = 1.13; Q(0.75) = 1.25; p=0.037). In participants with GG genotype compared to AA and AG the WMSI value was not significantly different (Me = 1.19; Q(0.25) = 1.13; Q(0.75) = 1.32). Picture 1 Conclusions Genotype AA in CDKN2B gene rs2891168 in patients after STEMI is associated with higher probability of the development of MACE over the one year period after the index event, compared to AG genotype carriers. Participants with AA genotype exhibited a higher WMSI value after STEMI compared to patients with AG genotype.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C X Song ◽  
R Fu ◽  
J G Yang ◽  
K F Dou ◽  
Y J Yang

Abstract Background Controversy exists regarding the use of beta-blockers (BBs) among patients with acute myocardial infarction (AMI) in contemporary reperfusion era. Previous studies predominantly focused on beta-blockers prescribed at discharge, and the effect of long-term adherence to beta-blocker on major adverse cardiovascular events (MACE) remains unclear. Objective To explore the association between long-term beta-blocker use patterns and MACE among contemporary AMI patients. Methods We enrolled 7860 patients with AMI, who were discharged alive and prescribed with BBs based on CAMI registry from January 2013 to September 2014. Patients were divided into two groups according to BBs use pattern: Always users group (n=4476) were defined as patients reporting BBs use at both 6- and 12-month follow-up; Inconsistent users group were defined as patients reporting at least once not using BBs at 6- or 12-month follow-up. Primary outcome was defined as MACE at 24-month follow-up, including all-cause death, non-fatal MI and repeat-revascularization. Multivariable cox proportional hazards regression model was used to assess the association between BBs and MACE. Results Baseline characteristics are shown in table 1. At 2-year follow-up, 518 patients in inconsistent users group (15.6%) and 548 patients in always users group (12.3%) had MACE. After multivariable adjustment, inconsistent use of BBs was associated with higher risk of MACE (HR: 1.323, 95% CI: 1.171–1.493, p<0.001). Table 1 Baseline characteristics Variable Always user (N=4476) Inconsistent user (N=3384) P value Age (years) 60.6±12.0 61.2±12.2 <0.001 Male 3381 (75.7%) 2461 (74.3%) 0.084 Diabetes 892 (20.0%) 610 (18.4%) 0.003 Hypertension 2372 (53.2%) 1543 (46.6%) <0.001 Dyslipidemia 244 (5.5%) 126 (3.8%) <0.001 Prior myocardial infarction 351 (7.9%) 232 (7.0%) <0.001 Heart failure 88 (2.0%) 63 (1.9%) <0.001 Chronic obstructive pulmonary disease 66 (1.5%) 60 (1.8%) <0.001 Current smoker 2054 (46.1%) 1579 (47.8%) 0.179 Left ventricular ejection fraction (%) 53.7±11.48 54.0±10.9 <0.001 Major Adverse Cardiovascular Events 548 (12.3%) 518 (15.6%) <0.001 Conclusions Our results showed consistent BBs use was associated with reduced risk of MACE among patients with AMI managed by contemporary treatment. Acknowledgement/Funding CAMS Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-009)


PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0249338
Author(s):  
Syed Waseem Abbas Sherazi ◽  
Jang-Whan Bae ◽  
Jong Yun Lee

Objective Some researchers have studied about early prediction and diagnosis of major adverse cardiovascular events (MACE), but their accuracies were not high. Therefore, this paper proposes a soft voting ensemble classifier (SVE) using machine learning (ML) algorithms. Methods We used the Korea Acute Myocardial Infarction Registry dataset and selected 11,189 subjects among 13,104 with the 2-year follow-up. It was subdivided into two groups (ST-segment elevation myocardial infarction (STEMI), non ST-segment elevation myocardial infarction NSTEMI), and then subdivided into training (70%) and test dataset (30%). Third, we selected the ranges of hyper-parameters to find the best prediction model from random forest (RF), extra tree (ET), gradient boosting machine (GBM), and SVE. We generated each ML-based model with the best hyper-parameters, evaluated by 5-fold stratified cross-validation, and then verified by test dataset. Lastly, we compared the performance in the area under the ROC curve (AUC), accuracy, precision, recall, and F-score. Results The accuracies for RF, ET, GBM, and SVE were (88.85%, 88.94%, 87.84%, 90.93%) for complete dataset, (84.81%, 85.00%, 83.70%, 89.07%) STEMI, (88.81%, 88.05%, 91.23%, 91.38%) NSTEMI. The AUC values in RF were (98.96%, 98.15%, 98.81%), ET (99.54%, 99.02%, 99.00%), GBM (98.92%, 99.33%, 99.41%), and SVE (99.61%, 99.49%, 99.42%) for complete dataset, STEMI, and NSTEMI, respectively. Consequently, the accuracy and AUC in SVE outperformed other ML models. Conclusions The performance of our SVE was significantly higher than other machine learning models (RF, ET, GBM) and its major prognostic factors were different. This paper will lead to the development of early risk prediction and diagnosis tool of MACE in ACS patients.


2021 ◽  
Author(s):  
Eun-Seok Shin ◽  
Eun Jung jun ◽  
Eu-Vin Teoh ◽  
Youngjune Bhak ◽  
Song Lin Yuan ◽  
...  

Abstract The study aimed to investigate the impact of angiographic and clinical outcomes of the drug-coated balloon (DCB)-only treatment for de novo coronary chronic total occlusion (CTO). One hundred one vessels with de novo CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction (TIMI) flow-grade 3 were assigned. Among them, we analyzed 93-vessel treated using DCB-only treatment. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and target vessel thrombosis. The secondary endpoint was late lumen loss (LLL) on follow-up coronary angiography. All 84-patient were followed up clinically, and 67-vessel underwent scheduled coronary angiography after 6-month. There were no procedural complications, and three vessels required bailout-stenting. MACE occurred in 14 patients, including 2 cardiac deaths, 3 non-fatal MIs, and 11 TVRs. There was no target vessel thrombosis. The mean LLL was 0.03 ± 0.53mm. Binary restenosis occurred in 10 and re-occlusion in 2 vessels. The results from a 2-year follow-up with DCB-only treatment are encouraging, with a low rate of hard endpoints and acceptable MACE rates. It may offer an alternative to the implantation of a drug-eluting stent if the CTO lesions have TIMI flow-grade 3 after pre-dilation.


2020 ◽  
Author(s):  
Yong Hoon Kim ◽  
Ae-Young Her ◽  
Myung Ho Jeong ◽  
Byeong-Keuk Kim ◽  
Sung-Jin Hong ◽  
...  

Abstract Background: Studies comparing long-term clinical outcomes between prediabetes and diabetes based on pre-percutaneous coronary intervention (PCI) Thrombolysis in Myocardial Infarction (TIMI) flow grade in patients with ST-segment elevation myocardial infarction (STEMI) after successful PCI with newer-generation drug-eluting stents are limited. We compared 2-year clinical outcomes of these two groups. Methods: Overall, 6448 STEMI patients were divided into two groups: pre-PCI TIMI 0/1 group (n = 4854) and pre-PCI TIMI 2/3 group (n = 1594). Subsequently, these two groups were further divided into patients with normoglycemia, prediabetes, and type 2 diabetes mellitus (T2DM). The major endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction, or any repeat revascularization. Results: After adjustment, in the pre-PCI TIMI 0/1 group, the cumulative incidence of all-cause death was higher in both prediabetes (adjusted hazard ratio [aHR]: 1.633, p = 0.045) and T2DM (aHR: 2.064, p = 0.002) groups than in the normoglycemia group. In the pre-PCI TIMI 2/3 group, the cumulative incidence of any repeat revascularization was higher in both prediabetes (aHR: 2.511, p = 0.039) and T2DM (aHR: 3.156, p = 0.009) groups than in the normoglycemia group. However, in each group (pre-PCI TIMI 0/1 or 2/3), the cumulative incidences of MACEs and all other clinical outcomes were not significantly different between the prediabetes and T2DM groups. Conclusions: In this retrospective registry study, prediabetes showed worse clinical outcomes similar to those of T2DM regardless of the pre-PCI TIMI flow grade. However, further studies are warranted to confirm these results.


2019 ◽  
Vol 2019 ◽  
pp. 1-9
Author(s):  
Lidija Savic ◽  
Igor Mrdovic ◽  
Milika Asanin ◽  
Sanja Stankovic ◽  
Gordana Krljanac ◽  
...  

Background/Aim. The RISK-PCI is a simple score for the prediction of 30-day major adverse cardiovascular events (MACE) and mortality in patients treated with primary PCI (pPCI). The aim of the present study is to evaluate the prognostic performance of the RISK-PCI score in predicting MACE and mortality in the long-term follow-up of STEMI patients treated with pPCI. Method. The present study enrolled 2,096 STEMI patients treated with pPCI included in the RISK-PCI trial. Patients presenting with cardiogenic shock were excluded. The composite end-point MACE comprising cardiovascular mortality, nonfatal reinfarction and stroke. Patients were followed up at 6 years after enrollment. Results. One-year and 6-year MACE occurred in 229 (10.9%) and 285 (13.6%) patients, respectively; and 1-year and 6-year mortality occurred in 128 (6.2%) and 151 (7.2%) patients, respectively. The RISK-PCI score was an independent predictor for 1-year MACE (HR 1.24, 95% CI 1, 18–1.31, p<0.001), 6-year MACE (HR 1.22, 95% CI 1.16–1.28, p<0.001), 1-year mortality (HR 1.21, 95% CI 1.13–1.29, p<0.001), and 6-year mortality (HR 1.23, 95% CI 1.15–1.31, p<0.001). The discrimination of the RISK-PCI score to predict 1-year and 6-year MACE and mortality was good: for 1-year MACE c-statistic 0.78, for 6-year MACE c-statistic 0.75, for 1-year mortality c-statistic 0.87, and for 6-year mortality c-statistic 0.83. The nonsignificant Hosmer–Lemeshow goodness-of-fit estimates for 1-year MACE (p=0.619), 6-year MACE (p=0.319), 1-year mortality (p=0.258), and 6-year mortality (p=0.540) indicated a good calibration of the model. Conclusion. The RISK-PCI score demonstrates good characteristics in the assessment of the risk for the occurrence of MACE and mortality during long-term follow-up after pPCI.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J W D Shanmuganathan ◽  
K H K Kragholm ◽  
B T Tayal ◽  
L P Poulsen ◽  
T C E G El-Galaly ◽  
...  

Abstract Abstract Background 5-fluorouracil (5-FU) is the third most commonly used chemotherapeutic agent in the treatment of solid malignancies across the world. The most common manifestation of cardiotoxicity associated with 5-FU is chest pain, presenting as atypical chest pain, angina on exertion or rest and acute coronary syndromes including myocardial infarction and in worse case even death. Nevertheless, a widespread appreciation of 5-FU related cardiotoxicity including myocardial infarction is poorly understood. Purpose This study aims to examine risk of myocardial infarction in patients treated with 5-FU compared to age- and sex-matched population controls. Methods and results Methods: Individuals treated with 5-FU between 2004 and 2014 in the Danish National Patient Register were identified and risk set matching was used to find background population controls matched on age and sex in a 1:5 ratio. Furthermore, two years follow-up time were added with total 13 years. Neither 5-FU patients nor controls had prior ischemic disease. Aalen-Johansen and Kaplan-Meier estimates were used to report the cumulative incidence of myocardial infarction and all-cause mortality, respectively. A multivariable Shared Frailty Cox regression analysis (adjusted for patient age, sex, hypertension, hypercholesterolemia, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, heart failure and atrial fibrillation as well as selected anti-anginal medications including nitrates, beta- and calcium-blockers) was used to determine the association between 5-FU treatment and the one-year risk of myocardial infarction. Results A total of 9,012 5-FU patients and 45,060 controls formed the study population. Differences in comorbid conditions (diabetes, chronic obstructive pulmonary disease, chronic kidney disease, heart failure and atrial fibrillation) and selected anti-anginal medications (nitrates, beta- and calcium-blockers) were non-significant (all P>0.05). The one-year cumulative incidence of myocardial infarction is significantly higher for 5-FU patients at 0.8% versus 0.6% among population controls (Figure 1A), with a competing risk of death of 25.1% versus 1.2%. The risk diminishes beyond one year and becomes lower for 5-FU patients with time (Figure 1A), along with an increasing all-cause mortality (Figure 1B). The unadjusted and adjusted hazard ratio for the one-year risk of myocardial infarction were 1.38 [95% CI 1.07–1.78] and 1.54 [95% CI 1.19–1.99]. Conclusions Although the one-year risk of myocardial infarction is higher among 5-FU patients compared with population controls, the absolute risk is small and becomes insignificant beyond one year of follow-up.


2013 ◽  
Vol 109 (04) ◽  
pp. 706-715 ◽  
Author(s):  
Giovanni Spinella ◽  
Sabrina Pagano ◽  
Maria Bertolotto ◽  
Bianca Pane ◽  
Aldo Pende ◽  
...  

SummaryWe aimed at challenging the prognostic accuracies of myeloperoxidase (MPO) and antibodies anti-apolipoprotein A-1 (anti-apoA-1 IgG), alone or in combination, for major adverse cardiovascular events (MACE) prediction, one year after carotid endarterectomy (CEA). In this prospective single centre study, 178 patients undergoing elective CEA were included. Serum anti-apoA-1 IgG and MPO were assessed by enzyme-linked immunosorbent assay prior to the surgery. Post-hoc determination of the MPO cut-off was performed by receiver operating characteristics (ROC) analyses. MACE was defined by the occurrence of fatal or non-fatal acute coronary syndromes or stroke during one year follow-up. Prognostic accuracy of anti-apoA-1 IgG was assessed by ROC curve analyses, survival analyses and reclassification statistics. During follow-up, 5% (9/178) of patients presented a MACE, and 29% (52/178) were positive for anti-apoA-1 IgG. Patients with MACE had higher median MPO and anti-apoA-1 IgG levels at admission (p=0.01), but no difference for the 10-year global Framingham risk score (FRS) was observed (p=0.22). ROC analyses indicated that both MPO and anti-apoA-1 IgG were significant predictors of subsequent MACE (area under the curve [AUC]: 0.75, 95% confidence interval [95%CI]: 0.61–0.89, p=0.01; and 0.74, 95%CI: 0.59–90; p=0.01), but combining anti-apoA-1 IgG positivity and MPO>857 ng/ml displayed the best predictive accuracy (AUC: 0.78, 95%CI: 0.65–0.91; p=0.007). It was associated with a poorer MACE-free survival (98.2% vs. 57.1%; p<0.001, LogRank), with a positive likelihood ratio of 13.67, and provided incremental predictive ability over FRS. In conclusion, combining the assessment of anti-apoA-1 IgG and MPO appears as a promising risk stratification tool in patients with severe carotid stenosis.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Benjamin Miao ◽  
Adrian Hernandez ◽  
Mark Alberts ◽  
Yuani Roman ◽  
Craig Coleman

Introduction: Data on the contemporary risk of major adverse cardiovascular events (MACE) in patients with established cerebrovascular disease (CVD) are needed. Objective: To evaluate the 4-year incidence of MACE in patients with established CVD. Methods: Using US IBM MarketScan claims we identified patients ≥45-years old with billing codes indicating established CVD during the 2013 calendar year (baseline). Starting on January 1, 2014, patients identified as having CVD were followed for the occurrence of MACE (defined as the composite of cardiovascular death, ischemic stroke or myocardial infarction). To be included in this analysis patients had to have a minimum of 4-years (±3-months) of available follow up prior to the end-of-data availability (December 31, 2017). Secondary study outcomes included the incidence of individual MACE components. Results: We identified 48,160 patients with CVD with a minimum 4-years (±3-months) of follow up. At baseline, the median (25%, 75% range) age of patients was 71 years (59, 79), 47.6% were women and 27.9% had disease in at least 1 additional vascular bed (16.9% coronary, 14.9% peripheral, 25.7% carotid). Stroke risk factors included hypertension (90.4%), hypercholesterolemia (68.6%), heart failure (21.6%) and atrial fibrillation (21.0%). During 2013, CVD patients were receiving angiotensin-converting enzyme inhibitor/receptor blockers (57.5%), beta-blockers (50.5%), calcium antagonists (34.9%), diuretics (41.0%), oral anticoagulants (19.1%), P2Y12 inhibitors (27.0%) and statins (65.7%). During the 4-years of follow up, 11.5% of established CVD patients experienced MACE. Of these, 8.3% had an ischemic stroke, 4.9% had a myocardial infarction and 1.2% died of cardiovascular causes. Conclusions: Patients with established CVD possess a substantial 4-year risk of MACE, notably ischemic stroke.


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