Significant Difference In Major Adverse Cardiac Events Research Articles

Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting for Chronic Total Occlusion of Coronary Arteries: A Systematic Review and Meta-Analysis

Introduction. Chronic total occlusion (CTO) of coronary arteries constitutes a substantial clinical challenge and has historically been managed through medical management and coronary artery bypass grafting (CABG). However, with the advancement in interventional technology, the success rate of percutaneous treatment has been significantly improved, and percutaneous coronary intervention (PCI) has emerged as a primary mode of treatment for CTOs, demonstrating remarkable clinical efficacy. The objective of this systematic review and meta-analysis is to evaluate and contrast the outcomes of PCI and CABG in patients with CTO. Methods and Results. A systematic search was conducted in the databases of PubMed, Embase, and Web of Science. The primary endpoints evaluated in this meta-analysis were the occurrence of major adverse cardiac events (MACE) and all-cause mortality. Secondary endpoints included myocardial infarction (MI), cardiac death, and the need for repeat revascularization. Nine studies, encompassing a total of 8,674 patients, were found to meet the criteria for inclusion and had a mean follow-up duration of 4.3 years. The results of the meta-analysis revealed that compared to CABG, PCI was associated with a lower incidence of all-cause mortality (RR: 0.78, 95% CI: 0.66–0.92; P = 0.003) and cardiac death (RR: 0.55; 95% CI: 0.31–0.96; P < 0.05), but an increased risk of myocardial infarction (MI) (RR: 1.96; 95%CI: 1.07–3.62; P < 0.05) and repeat revascularization (RR: 7.13; 95% CI: 5.69–8.94; P < 0.00001). There was no statistically significant difference in MACE (RR: 1.11; 95% CI: 0.69–1.81; P = 0.66) between the PCI and CABG groups. Conclusion. In the present meta-analysis comparing PCI and CABG in patients with chronic total occlusion of the coronary arteries, the results indicated that PCI was superior to CABG in reducing all-cause mortality and cardiac death but inferior in decreasing myocardial infarction and repeat revascularization. There was no statistically significant difference in MACE between the two groups.

Use of Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Agents for Anemia in Non-Dialysis-Dependent Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Background: Anemia is a common complication associated with chronic kidney disease (CKD), driven by decreased erythropoietin (EPO) production and dysregulated iron metabolism. Anemia is associated with decreased quality of life, as well as increased cardiovascular events, dialysis requirements, and mortality. Treatment classically consists of iron repletion and erythropoietin stimulating agents (ESA). However, use of these agents can be associated with hyporesponsiveness, a need for close monitoring to avoid adverse cardiovascular events, and patient inconvenience due to subcutaneous or intravenous administration. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are novel oral therapeutic agents that promote accumulation of HIF transcription factors and expression of HIF-responsive genes, leading to increased synthesis of EPO and proteins involved in iron metabolism. Multiple large randomized controlled trials (RCTs) investigating the safety and efficacy of HIF-PHIs in the treatment of anemia of non-dialysis dependent CKD (NDD-CKD) have been completed. However, to the best of our knowledge, there have been no recent comprehensive systematic reviews synthesizing this evidence. Aim: The objective of this systematic review is to assess the safety and efficacy of HIF-PHIs in the treatment of anemia caused by NDD-CKD. Methods: A comprehensive search of MEDLINE, Embase, Cochrane (CENTRAL), and the grey literature was done from inception to April 2022. Studies were screened at abstract and full-text level independently and in duplicate. English-language phase three RCTs investigating the use of HIF-PHIs versus placebo or ESAs in anemia of NDD-CKD were included. Baseline characteristics, intervention details, comparator details, and outcome measurement timing were collected. Our primary efficacy outcome measures were mean change in hemoglobin from baseline and proportion of patients achieving a hemoglobin response. Our primary safety outcome was major adverse cardiac events (MACE) defined as a composite of nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. Meta-analysis was done using DerSimonian and Laird random effects model and reported as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI). Results: 14 studies with a total of 12,681 patients were included in the analysis. HIF-PHIs were associated with increased hemoglobin response rate compared to placebo (RR 9.02, 95%CI 6.85,11.86, p<0.005; I2=56%, N=5). There was no significant difference in hemoglobin response rate for HIF-PHIs versus ESAs (RR 0.97, 95%CI 0.9,1.04, p=0.36; I2=76%, N=9). HIF-PHIs were associated with an increased change in hemoglobin from baseline compared to placebo (MD=1.57, 95%CI 1.29,1.85, p<0.05; I2=93%, N=4). There was no significant difference in mean change in hemoglobin from baseline between HIF-PHIs and ESAs (MD -0.06, 95%CI -0.19,0.07, p=0.38; I2=0, N=2). There was no statistically significant difference in MACE between HIF-PHI and placebo (RR 1.14, 95%CI 0.93,1.40, p=0.2; I2=11%, N=4) or ESA (RR 1.03, 95%CI 0.89, 1.19, p=0.70; I2=23%, N=9). Conclusion: HIF-PHIs are associated with increased mean change in hemoglobin and hemoglobin response rate compared to placebo. HIF-PHIs are non-inferior to ESAs for these outcomes. When used to current hemoglobin targets, MACE outcomes are similar to those seen with ESAs.

Procedural Safety and Long-Term Clinical Outcomes in Patients Receiving Ultra-Long Everolimus-Eluting Stent: A Single-Center Real-World Experience.

BackgroundDiffuse long coronary lesions are difficult to treat percutaneously. The aim of the present study was to assess the procedural safety and long-term efficacy of the ultra-long (48-mm) drug-eluting stent Xience Xpedition.MethodsThis was an investigator-initiated, observational, all-comers study. A total of 92 patients with 93 lesions were enrolled in the study from October 2016 to October 2020. The primary outcome of the study was major adverse cardiac events (MACEs). Secondary outcomes were individual components of the primary outcome and procedural success.ResultsThe mean (standard deviation (SD)) age of the participants was 58.8 (10.8) years. More than half of the patients had ST-segment elevation myocardial infarction (STEMI) at presentation (55.4%). Ten patients were in cardiogenic shock (CGS; 10.8%). Most of the lesions were located in the left anterior descending artery (48.3%). American College of Cardiology/American Heart Association (ACC/AHA) type C was the most common lesion type amongst the intervened vessels (46.74%), with a mean syntax score (SD) of 16.99 (8.89). The mean stent diameter used was 2.77 mm (0.25). MACE was observed in 7.6% of patients studied at a median follow-up of 24 months. MACE was significantly lower in the population without CGS, occurring in only 2.4% of the patients; a significant difference in MACE was observed in patients with and without CGS (P < 0.001). Procedural success was obtained in 89.2% of total population; however, 96.3% of patients without CGS had procedural success.ConclusionsThe deployment of the ultra-long 48-mm Xience Xpedition stent is feasible, safe, and effective; and it was associated with a good intermediate-term clinical outcome.

Role of HEART score in prediction of coronary artery disease and major adverse cardiac events in patients presenting with chest pain

Introduction. Chest pain (CP) diagnostics accuracy remains debatable for both general practitioners (GP) or emergency department (ED) physicians for patients in HEART score (HS) low- and intermediate-risk groups which prompted us to review our electronic database for all patients admitted via our center?s ED during 2014 to 2020 for CP and suspect acute coronary syndrome. Methods. Patients were divided in function of low- or intermediate-risk HS and assessed during a three month follow up for angiogram results, major adverse cardiac events (MACE), lab results and echo parameters. Results. Of 585 patients included, low-risk HS group (21,4%, 36% were women) had significant coronary disease on angiogram in 68%, while for intermediate-risk HS group (78.6%, with 32.6% women) it was for 18.4% of patients (p &lt; 0,0005). Area under the ROC curve of HS in detecting patients with ischemic heart disease as a cause of CP was 0.771 (95% CI: 0.772?0.820) with best cut-off point HS was calculated at 3.5. Sensitivity and specificity were 89.2% and 57.6% respectively. Adjusting for sex, lab results and HS, AUROC curve of this model was 0.828 (95% CI: 0.786?0.869; p &lt; 0,0005) with cut-off of 77.95. Sensitivity and specificity were 84.9% and 68% respectively. In the three-month follow-up post-discharge, there was a significant difference in MACE between groups (low- vs. intermediate-risk HS was 3.4 vs. 16.7% p &lt; 0.05). Conclusion. HS for our CP patients admitted via our ED by GP and ED physicians? referral, provides a quick and reliable prediction of ischemic heart disease and MACE.

Impact of target vessel choice on outcomes following percutaneous coronary intervention in patients with a prior coronary artery bypass graft.

To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery. Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown. We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI. Prior CABG patients (n=3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n=2928, 73.5%) followed by venous (n=883, 22.2%) and arterial grafts (n=172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56-8.95; p < 0.001). At 1year, there were no significant differences in MACE or in its individual components. Target vessel choice did not appear to affect MACE at 1year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials.

Use of NOACs Versus Vitamin K Antagonist in Atrial Fibrillation Catheter Ablation: An Updated Meta-analysis With Subgroup Analysis

Current guidelines give class I recommendations for uninterrupted use of dabigatran rivaroxaban as an alternative to vitamin K antagonist (VKA) in patients of atrial fibrillation (AF) who are undergoing catheter ablation. The recent randomized controlled trials have shown similar efficacy of novel oral anticoagulants when compared to VKA in these patients. We sought to perform a meta-analysis with a focus on subgroup analysis of novel oral anticoagulants. We searched PubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through August 2020. Six RCTs studies (n = 2260) comparing the use of NOACs versus VKA in patients with AF undergoing catheter ablation were included. The odds ratio (OR) with 95% confidence interval was computed and P < 0.05 was considered as a level of significance. Major adverse cardiac events (MACE) were considered as a primary endpoint. Our results showed a significant difference in MACE between NOACs and VKA [OR 0.57 (0.37-0.88); P = 0.01] and in major bleeding events [OR 0.55 (0.35-0.86); P = 0.009], which is mainly derived from the use of dabigatran. No significant difference in MACE or major bleeding events was found on the subgroup analysis of rivaroxaban and apixaban over VKA therapy. Uninterrupted use of NOACs is safe and effective alternative for the prevention of cerebral thromboembolism and reducing the risk of major bleeding in patients undergoing catheter ablation of AF. However, the individual subgroup analysis showed that only dabigatran is superior to VKA in terms of reducing MACE through a reduction in major bleeding. The rivaroxaban, apixaban and edoxaban are non-inferior to VKA therapy based on these results. Further studies are needed to generalize these recommendations in morbidly obese patients.

Cell therapy for nonischemic dilated cardiomyopathy: A systematic review and meta-analysis of randomized controlled trials.

Cell therapy involves transplantation of human cells to promote repair of diseased or injured tissues and/or cells. Only a limited number of mostly small‐scale trials have studied cell therapy in nonischemic cardiomyopathy (NICM). We performed a meta‐analysis of randomized clinical trials (RCTs) to assess the safety and efficacy of cell therapy in NICM. Electronic databases were searched for relevant RCTs from inception until August 2020. Outcomes assessed were left ventricular ejection fraction (LVEF), left ventricular end‐diastolic diameter or volume (LVEDD), quality of life (QoL) indices, and major adverse cardiac events (MACEs). Weighted mean differences (MDs) and standardized mean differences (SMDs) were calculated using random‐effects methods. Eleven RCTs with 574 participants were included in the analysis. There was a significant increase in mean LVEF (MD, 4.17%; 95% confidence interval [CI] = 1.66‐6.69) and modest decrease in LVEDD (SMD, −0.50; 95% CI = −0.95 to −0.06) in patients treated with cell therapy compared with controls. Cell therapy was also associated with improvement in functional capacity, as assessed by the 6‐minute walking distance (MD, 72.49 m; 95% CI = 3.44‐141.53). No significant differences were seen in MACEs and QoL indices between treated and control groups. This meta‐analysis suggests that cell therapy may improve LV systolic function and may be associated with improvement in LVEDD and functional capacity compared with maximal medical therapy. Cell therapy was safe, with no significant difference in MACEs between treatment and control groups. However, given the limitations of current studies, larger well‐designed RCTs are needed to evaluate the efficacy of cell therapy in patients with NICM.

Temporal trends in short and long-term outcomes after percutaneous coronary interventions among cancer patients.

While mortality of acute coronary syndrome (ACS) is known to have steadily decline over the last decades, data are lacking regarding the complex sub-population of patients with both coronary artery disease and cancer. A large single-center percutaneous coronary intervention (PCI) registry was used to retrieve patients who had a known diagnosis of malignancy during PCI. Patients were divided into two groups according to the period in which PCI was performed (period 1: 2006-2011, period 2: 2012-2017). Cox regression hazard models were implemented to compare primary endpoint, defined as the composite outcomes of major adverse cardiac events (MACE) (which include cardiovascular death, myocardial infarction or target vessel revascularization) and secondary endpoint of all-cause mortality, between the two time periods. A total of 3286 patients were included, 1819 (55%) had undergone PCI in period 1, and 1467 (45%) in period 2. Both short- and long-term MACE and overall mortality were significantly lower in patients who underwent PCI at the latter period (2.3% vs. 4.3%, p < 0.001 and 1.1% vs. 3.2%, p < 0.001 after 30days and 24% vs. 30%, p < 0.001 and 12% vs. 22%, p < 0.001 after 2years, respectively). However, in a multivariate analysis, going through PCI in the latter period was still associated with lower rates of overall mortality (HR 0.708, 95% confidence interval [CI] 0.53-0.93, p = 0.014) but there was no significant difference in MACE (HR 0.83, 95% CI 0.75-1.42, p = 0.16). Patients with cancer undergoing PCI during our most contemporary period had an improved overall survival, but no significant differences were observed in the composite cardiovascular endpoints, compared to an earlier PCI period. The management of coronary patients with cancer disease remains challenging.

Infarct characteristics and outcome of patients with transient ST-segment elevation myocardial infarction compared to ST-segment and non-ST-segment elevation myocardial infarction

Abstract Background Up to one out of four patients with signs of ST-segment elevation myocardial infarction (STEMI) express complete normalization of ST elevation before primary revascularization procedure. This condition is commonly referred to as “transient ST-segment elevation myocardial infarction” (TSTEMI) and recent data suggests that this group of patients may have favorable outcome compared to STEMI patients. However, it is currently unknown how these patients compare to both STEMI and non-ST-segment elevation myocardial infarction (NSTEMI) patients with respect to infarct size characteristics and outcome. Objective This study aims to explore cardiac magnetic resonance (CMR) derived scar tissue and 1-year outcome in patients with TSTEMI by comparison to STEMI and NSTEMI. Methods Patients with STEMI were enrolled from two prospective studies (n=170); the patients with TSTEMI were recruited from the TRANSIENT trial (n=141); the patients with NSTEMI were prospectively and consecutively collected from local registries of Amsterdam UMC (n=57) and Maastricht UMC (n=51). All patients underwent CMR examination 2–8 days after the index event. Cine imaging was done for volume and function assessment. Late gadolinium enhancement imaging was performed to identify infarct size (in grams) and the presence of microvascular obstruction (MVO). All CMR images were processed in a single core laboratory (Amsterdam UMC). Clinical outcome after 1 year was measured by the incidence of major adverse cardiac events (MACE), defined as recurrent myocardial infarction (MI), revascularization and all cause death. Results The TSTEMI group demonstrated the lowest end-systolic left ventricular volume and highest left ventricular ejection fraction across the groups (overall p&amp;lt;0.001). Although there was a remarkably lower infarct size in TSTEMI patients compared to STEMI (1.41g [0.00–3.91] vs 13.48g [5.31–26.81], p&amp;lt;0.001), there was only a trend towards lower infarct size compared to NSTEMI patients (1.41g [0.00–3.91] vs 2.13g [0.00–8.64], p=0.06). Whilst MVO was observed less frequently in TSTEMI compared to STEMI patients (5 (4%) vs 53 (31%), p&amp;lt;0.001), no significant difference was seen between TSTEMI and NSTEMI patients (5 (4%) vs 5 (5%), p=0.72). Multivariable linear regression analysis identified infarct type, smoking, peak troponin-T and pre-PCI TIMI flow as predictors for infarct size (p=0.03, p=0.03, p&amp;lt;0.001 and p&amp;lt;0.001, respectively). One-year mortality rate was low in all 3 MI types (TSTEMI 3 (2.2%), NSTEMI 3 (3.1%), 4 (2.4%), log-rank test p=0.91). However, there was a significant difference in MACE at 1 year across the 3 MI types (TSTEMI 18 (13.2%), NSTEMI 19 (19.4%), STEMI 11 (6.7%), overall p&amp;lt;0.01). Conclusion In comparison to NSTEMI and STEMI, TSTEMI yielded favorable cardiac left ventricular function and scar mass. However, this did not lead to benefit in short term (1-year) outcome; further studies are needed with longer follow-up. Funding Acknowledgement Type of funding source: Other. Main funding source(s): European Association of Cardiovascular Imaging (EACVI) Research Grant

P2806A novel sirolimus drug eluting stent for Small-Vessel Disease: results from en-ABL e-registry

Abstract Objective The aim of the study was to assess the clinical outcome of Abluminus DES in patients with small vessels. Background Percutaneous coronary intervention (PCI) of small coronary vessel (≤2.75 mm) associated with more chances of restenosis and repeat revascularization even when drug eluting stent employed. Methods A total of 2,500 patients enrolled in en-ABL e-registry which is a prospective, multicentre observational post market registry. Out of 2,500 patients, 1,253 patients had small vessel (SV, ≤2.75 mm) while 1,247 had large vessel (LV, &gt;3mm) disease. The primary endpoint was major adverse cardiac events (MACE) which is composite of cardiac death, target vessel myocardial infraction (TV-MI) and target lesion/vessel revascularization (TLR) at 1 year follow up. The secondary endpoint were stent thrombosis and MACE up to 2 years. Results Baseline characteristics were well matched in both groups. In the SV group had higher prevalence of diabetes as compared to large vessel 43.0% vs 25.7%. Total 1,400 lesions treated with 1,612 Abluminus DES and 1,569 lesions treated with 1,675 Abluminus DES in SV and LV groups respectively. The mean diameter of stent was 2.61±0.23 and 3.3±0.3 mm in SV and LV groups respectively. There was a significant difference in MACE in treatment groups (3.7% vs. 1.4%, p=0.004 respectively) at 1 year. No significant differences were observed between SV and LV groups in terms of death/myocardial infarction or stent thrombosis. There were increment of only one TLR and no stent thrombosis reported at 2-year follow-up. Conclusion This result suggests the efficacy and safety of novel Abluminus DES in small vessel disease.

Abstract 226: Predicting Major Adverse Cardiac Events Using HEART Score in the Elderly

Background: The HEART score was developed to predict major adverse cardiac events (MACE) within 6 weeks in patients evaluated for chest pain. In the established score, age is scored as &lt;45 years old (y/o) = 0 points, 45-64 y/o = 1 point, and &gt;65 y/o = 2 points. The average age of patients in the original study by Backus et al was 61.2 y/o. Our aim is to evaluate the prognostic value of the HEART score in patients &gt;65 y/o. We hypothesized that elderly patients are at increased risk of MACE unaccounted for by the established age scoring system. Methods: We retrospectively reviewed 668 emergency room visits for chest pain (excluding STEMI) between 2016 to 2018 at a single tertiary, urban medical center. HEART scores were calculated based on presenting data. The primary outcome was MACE (MI, PCI, CABG, or death) within 6 weeks. Patients &gt;65 y/o were stratified to 65-74 y/o, 75-84 y/o, and &gt;85 y/o. Primary outcomes were compared between these age groups. Differences in HEART scores between age groups were controlled by comparing patients within the same HEART score brackets (4-6, 7-8, 9-10). Chi squared analysis was used to determine statistically significant differences in MACE (p&lt;0.01). Results: The average age was 60.2 y/o and average HEART score 5.56. There was statistically significant increase in MACE between &lt;45 y/o (18.5%), 45-64 y/o (36.6%), and &gt;65 y/o (47.4%), as outlined by the established HEART score (p&lt;0.01). However, when comparing 65-74 y/o (45.7%), 75-84 y/o (48.8%) and &gt;85 y/o (48.8%), increasing age did not correlate with increasing rate of MACE (p=0.90). When controlled for differences in HEART scores, there was again no statistically significant increase rates of MACE between 65-74 y/o, 75-84y/o, and &gt;85 y/o across all HEART score brackets (4-6, 7-8, 9-10). Conclusion: In patients &gt;65 y/o, increasing age did not correlate with increasing rate of MACE refuting our hypothesis. This represents that the other components of the HEART score have greater impact on prognosis than age in this elderly patient population. Our findings support the current age stratification of the established HEART score and show that even in the very elderly, the HEART score adequately accounts for age as a contributor to MACE.

Follow-Up Outcomes of Pre-Hospital Thrombolysis and Primary PCI in Outer Metropolitan Management of STEMI

Background: Primary PCI (pPCI) is preferred management with improved outcomes in STEMI [[1]Keeley E.C. et al.Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials.The Lancet. 2006; 367 (doi:10.1016/s0140-6736(06)68148-8): 579-588Abstract Full Text Full Text PDF PubMed Scopus (458) Google Scholar], however previous reviews demonstrate comparable, in-hospital results for early, pre-hospital thrombolysis in regional centres with large catchment zones [[2]May, A. et al. (2016). Review of In-Hospital Outcomes of Thrombolysis and Primary PCI in Outer Metropolitan Management of STEMI. Heart, Lung and Circulation, Volume 25, S63.Google Scholar]. Methods: Retrospective analysis of patients presenting with STEMI at two outer metropolitan centres over a 5-year period (2014–2019), where PCI was available during working hours, with a strategy of pre-hospital thrombolysis otherwise. Patients were excluded if incomplete data precluded follow-up. The primary outcome was a composite of major adverse cardiac events (MACE) including myocardial infarction (MI), unplanned revascularisation, readmission for heart failure and all-cause mortality. Secondary outcomes included severe bleeding, TIMI-III flow rates and death from any cause. Follow up was conducted to 1-year from the index event. Results: 450 consecutive patients presented with STEMI, with 425 analysed after exclusions. 117 (27.5%) underwent pPCI while 308 (72.5%) had initial thrombolysis. Average age was 63.9 years and 76.9% were male. Of the thrombolysis group, 56.5% successfully re-perfused while 43.5% required rescue PCI (rPCI) and 296 (96%) underwent coronary angiography. Rates of TIMI-III flow post angiogram were higher in the thrombolysis group 96.0% vs 85.9% (p = 0.0147). There were no significant differences in MACE at 1-month or 1-year or all-cause mortality. Major bleeding was higher at 1-month after thrombolysis 4.5% vs 2.6% (p = 0.36) but did not reach significance, likely due to inadequate power. Conclusion: Our experience shows pre-hospital thrombolysis remains a safe alternative to pPCI, especially in regional centres, with no clinically significant differences in 1- and 12-month outcomes.

Switching from ticagrelor to clopidogrel in patients with ST‐segment elevation myocardial infarction undergoing successful percutaneous coronary intervention in real‐world China: Occurrences, reasons, and long‐term clinical outcomes

Although switching between ticagrelor and clopidogrel is common in clinical practice, the efficacy and safety of this de-escalation remain controversial. We assessed the occurrences, reasons, and outcomes of switching from ticagrelor to clopidogrel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing successful primary percutaneous coronary intervention (PCI). A total of 653 patients with STEMI were randomly assigned to receive loading dose of ticagrelor or clopidogrel before PCI and then received maintenance dose, respectively, for 12 months follow-up. The primary outcome was major adverse cardiac events (MACE), including cardiovascular death, nonfatal myocardial infarction, and stroke. The secondary outcome included unexpected rehospitalization for angina, coronary revascularization, and stent thrombosis. The safety outcome was bleeding described by the Bleeding Academic Research Consortium (BARC) criteria. A total of 602 participants completed the study. The rate of switching from ticagrelor to clopidogrel was 48.6% and the main reason was financial burden. The rate of secondary ischemic events in the de-escalation group was higher than that in the ticagrelor group (15.1% vs 5.6%, P = 0.008), but lower than that in the clopidogrel group (15.1% vs 24.6%, P = 0.03), while there were no significant differences in MACE among the three groups (P = 0.16). De-escalation, ticagrelor, and clopidogrel did not cause significant differences in the rates of major bleeding among the three groups (BARC ≥ 2, P = 0.34). Switching from ticagrelor to clopidogrel is very common in patients with STEMI in China. De-escalation might be safe but associated with high risk of ischemic events as compared to ticagrelor.

Drug eluting versus bare metal stents for percutaneous coronary intervention of saphenous vein graft lesions: An updated meta-analysis of randomized controlled trials.

Percutaneous coronary intervention (PCI) is the preferred strategy for treatment of saphenous vein graft (SVG) disease. However, there remains ongoing debate on whether drug-eluting stents (DES) or bare-metal stents (BMS) should be used during SVG-PCI. We performed a meta-analysis of randomized controlled trials (RCTs) comparing DES and BMS for SVG-PCI. The primary end point was major adverse cardiac events (MACE), defined as composite of all-cause death, myocardial infarction (MI) or repeat revascularization. Secondary end points included individual MACE components, cardiac death and stent thrombosis (ST). Six RCTs including 1582 patients (50% receiving DES) met inclusion criteria. MACE occurred in 31% (244/797) patients receiving DES and 36% (281/785) patients receiving BMS (median follow-up, 12-35 months). There was no significant difference in MACE between DES and BMS (Odds Ratio (OR) 0.62, 95%CI 0.36-1.09, p = 0.10, I2 = 77%). However, for individual components of MACE, DES was associated with a significant reduction in repeat revascularization (OR 0.53, 95%CI 0.29-0.97, p = 0.04, I2 = 73%). There was no difference in all-cause death (OR 1.30, 95%CI 0.77-2.20, p = 0.33, I2 = 40%), MI (OR 0.68, 95%CI 0.38-1.25, p = 0.22, I2 = 56%), cardiac death (OR 1.08, 95%CI 0.45-2.64, p = 0.86, I2 = 42%) or ST (OR 0.89, 95%CI 0.37-2.17, p = 0.80, I2 = 35%) between stents. Although there was no significant difference in MACE, DES is associated with a reduction in repeat revascularization compared with BMS in pooled randomized trials for SVG-PCI. The high occurrence of MACE in both stent platforms highlights the need for novel therapeutic approaches to improve clinical outcomes following SVG intervention. We performed a meta-analysis of randomized controlled trials comparing DES and BMS for SVG-PCI. There was no significant difference in MACE between DES and BMS. However, for individual components of MACE, DES was associated with a significant reduction in repeat revascularization. The high occurrence of MACE in both stent platforms highlights the need for novel therapeutic approaches to improve clinical outcomes following SVG intervention.

Short-term application of tocilizumab during myocardial infarction (STAT-MI).

Acute myocardial infarction (MI) occurs when blood supply falls below critical levels and normal cellular maintenance mechanisms fail. Interleukin-6 (IL-6) is a proinflammatory cytokine released in MI and associated with poor clinical outcomes. Tocilizumab (TCZ) is a humanized monoclonal antibody against the IL-6 receptor. In a randomized, double-blinded, placebo controlled trial we assigned subjects admitted with MI a single TCZ dose of 162 mg subcutaneously vs. placebo in addition to standard of care medications and interventions. Primary outcome was a change in major adverse cardiac events (MACE) 30 days after enrollment. Secondary outcomes assessed changes in CRP 30 days after enrollment, changes in QT/QTc, and monitoring for trends in adverse events. Futility analysis was performed as subject enrollment slowed and no trends were noted in either the primary or secondary outcomes. Twenty-eight subjects were enrolled; 12 to TCZ and 16 to placebo. No statistically significant differences were noted between study arms regarding demographics, comorbidities, or medical/interventional therapies received. No statistically significant differences in MACE were observed. CRP increased after administration of TCZ but this was not statistically significant. No adverse events or safety signals were observed. Though futility analysis suggested that the primary outcome was not likely achievable as our recruitment slowed, we did not observe any adverse events or safety trends. Building on this information, future studies should be conducted to assess a true benefit from TCZ as adjunct therapy for MI. The work reported herein was performed under United States Air Force Surgeon General approved Clinical Investigation FKE20140029 and has been registered at ClinicalTrials.gov under identifier NCT02419937.

0234: Drug-eluting stents versus bare-metal stent in large coronary arteries

Although drug-eluting stents (DES) have been shown to dramatically reduce restenosis and improve the rate of event-free survival, the benefit of DES appears to be limited to restenosis. In this retrospective, single-center study we aimed to compare the long-term outcomes of DES versus bare-metal stent (BMS) in large coronary arteries (diameter ≥3.5mm). A total of 164 consecutive patients (mean age 60 years) required percutaneous coronary intervention with stents ≥3.5mm in diameter, 84 were BMS and 80 DES. The primary endpoint was major adverse cardiac events (MACE) defined as angiographically defined in-stent restenosis (ISR), stent thrombosis and death from any cause. A mean clinical follow up of 28 months was obtained. The DES group had higher rates of diabetes (63% vs 37%, p=0.001), previous CAD (74% vs 25%, p=0.001) and previous PCI (69% vs 31%, p=<0.04). There was no significant difference between the two groups regarding the rate of hyper-tension, dyslipidemia, smokers and the mean left ventricular ejection fraction. There was a higher average stent length in the DES group (18.7 vs 16.3, p=0.011) as well as a lower average stent diameter (3.54 vs 3.63, p=0.003). There was a significant difference in MACE between the two groups in favour of DES (11.3% DES vs 23.8% BMS group, p=0.04) at 28 months. The rate of in-stent restenosis (ISR) was significantly reduced among patients receiving DES with ISR rates of 15.8% among patients receiving DES compared to 41.7% among those receiving BMS (p=0.025). There were no significant differences in the rate of death or stent thrombosis. In patients requiring stenting of large coronary arteries, there was reduced MACE in patients treated with DES. This benefit was primarily driven by decreased in-stent restenosis rate.

Drug-eluting stents appear superior to bare metal stents for vein-graft PCI in vessels up to a stent diameter of 4 mm.

Research trials have shown improved short-term outcome with drug-eluting stents (DES) over bare metal stents (BMS) in saphenous vein graft (SVG) percutaneous coronary intervention (PCI), primarily by reducing target vessel revascularization (TVR) for in-stent restenosis. We compared the outcomes in patients undergoing SVG stent implantation treated with DES or BMS. In exploratory analyses we investigated the influence of stent generation and diameter. Data were obtained from a prospective database of 657 patients who underwent PCI for SVG lesions between 2003 and 2011. A total of 344 patients had PCI with BMS and 313 with DES. Propensity scores were developed based on 15 observed baseline covariates in a logistic regression model with stent type as the dependent variable. The nearest-neighbour-matching algorithm with Greedy 5-1 Digit Matching was used to produce two patient cohorts of 313 patients each. We assessed major adverse cardiac events (MACE) out to a median of 3.3 years (interquartile range: 2.1-4.1). MACE was defined as all-cause mortality, myocardial infarction (MI), TVR and stroke. There was a significant difference in MACE between the two groups in favour of DES (17.9% DES vs. 31.2% BMS group; p = 0.0017) over the 5-year follow-up period. MACE was driven by increased TVR in the BMS group. There was no difference in death, MI or stroke. Adjusted Cox analysis confirmed a decreased risk of MACE for DES compared with BMS 0.75 (95% confidence interval (CI) 0.52-0.94), with no difference in the hazard of all-cause mortality (hazard ratio: 1.08; 95% CI: 0.77-1.68). However, when looking at stent diameters greater than 4 mm, no difference was seen in MACE rates between BMS and DES. Overall in our cohort of patients who had PCI for SVG disease, DES use resulted in lower MACE rates compared with BMS over a 5-year follow-up period; however, for stent diameters over 4 mm no difference in MACE rates was seen.

Clinical outcomes of chronic kidney disease patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES)

BackgroundThe target lesion revascularization of paclitaxel-eluting stents (PES) has been reported to be lower than that of sirolimus-eluting stents in patients on hemodialysis (HD). However, the comparison of PES and second generation drug-eluting stents in CKD patients has not been fully investigated. We compared clinical outcomes of everolimus-eluting stents (EES) and PES in CKD patients. MethodsHundred and forty seven CKD patients (eGFR<60mLmin−11.73m−2) treated with PES (n=74, from May 2007 to December 2009) and EES (n=73, from January 2010 to January 2013) were enrolled in the study. Major adverse cardiac events (MACEs) were defined as death, non-fatal myocardial infarction, and ischemia driven target lesion revascularization. ResultsThe incidence of 36-month MACE was significantly lower in EES, non-HD group compared to PES, non HD group (0% in EES group and 13.5% in PES group, respectively, P<0.01). There was no significant difference in MACE between EES and PES in HD patients (5.4% in PES group and 5.5% in EES group, P=0.98). In multivariate analysis, PES group and PES ISR were independent factors for worse incidence of MACE. ConclusionsIn CKD patients, PES was associated with worse clinical outcomes in non-HD patients as compared with EES.

Abstract 13408: Successful Prediction of MACE by not Occurrence of Non Sustained Ventricular Tachycardia but Presence of Myocardial Fibrosis on CT in HCM Cases without Obstructed Coronary Arteries. a Long Follow-Up Study with a Median of 69 Months

Introduction: Hypertrophic cardiomyopathy (HCM) presents several risk factors for sudden cardiac death and the presence of myocardial fibrosis (MF) on CT is a novel candidate to predict prognosis in HCM patients. Aim: To compare the value of non sustained ventricular tachycardia (NSVT) and MF in risk stratification for major adverse cardiac events (MACE) in HCM patients without obstructed coronary arteries. Methods: We selected 48 consecutive HCM patients (33 males, 61±14 y) who underwent cardiac CT and 24 h of ECG monitoring within 12 mo between 2002 and 2009. Patients had no significant luminal coronary artery stenosis (&gt;50%) on CT or previous myocardial infarction. On CT, if a contrast defect was observed in the early phase and abnormal late enhancement was observed at a corresponding site, we diagnosed MF. NSVT was defined as ≥3 consecutive premature ventricular beats. Follow-up after CT for MACE was a median of 69 mo. MACE included cardiac death, cardiac arrest, 2 or more hospitalizations for heart failure, sustained ventricular tachycardia (VT) (continued &gt;30 s), ventricular fibrillation and appropriate discharge of Implantable cardioverter defibrillators. Result: NSVT was detected in 24 patients. There was no significant difference in MACE between patients with and without NSVT (13% and 8%; P=1.00, respectively). No significant differences between HCM patients with and without NSVT, were seen at each time point and when the entire follow-up period was compared with Kaplan-Meier and log rank tests (P=0.60). MF was detected by CT in 29 patients. Patients with MF had a higher risk of MACE (17%) than those without (0%; P=0.07, n.s.). Significant differences between HCM patients with and without MF were seen at each time point and when the entire follow-up period was compared with Kaplan-Meier and log rank tests (P=0.04). Conclusions: MF is a stronger predictor of MACE than NSVT in HCM patients without obstructed coronary arteries following a median of 69 mo.

Safety and feasibility of transulnar versus transradial artery approach for coronary catheterization in non-selective patients

Background Transradial approach catheterization is now widely used in coronary angiography and angioplasty. The ulnar artery, which is one of the two terminal branches of the brachial artery, may be a potential approach for cardiac catheterization. The aim of this study was to evaluate the safety and feasibility of a transulnar approach for coronary catheterization in non-selective patients. Methods A total of 535 consecutive patients were randomly assigned to transulnar approach (TUA) group (n=271) or transradial approach (TRA) group (n=264) upon arrival at the catheterization laboratory. Allen's test and inverse Allen's test were not routinely performed. Ultrasound-Doppler assessment of the forearm artery was performed before the procedure, two days after the procedure, and 30 days after the procedure. The primary endpoints of study were the rate of successful artery cannulation and the access-site related complications. The secondary endpoints included the number of needle punctures, total time for the procedure, and major adverse cardiac events (MACE). Results Successful puncture of the objective artery was obtained in 91.5% of the patients in the TUA group, and 95.1% of the patients in the TRA group (P &gt;0.05). There was no significant difference in hematoma complications between the two groups (7.7% vs. 4.2%, P=0.100). A motor abnormality of the hand was observed in one patient in the TUA group. There were no arteriovenous fistula or pseudoaneurysm observed in our study. Three (1.1%) patients in the TUA group and 8 (3.0%) patients in the TRA group had occlusion of the access artery (P=0.137), but none of the patients had symptoms or signs of hand ischemia. There were no significant differences in MACE between the two groups during follow-up. Conclusion The transulnar approach is an effective and safe technique for coronary catheterization in non-selective patients.