Major Adverse Cardiac Or Cerebrovascular Events Research Articles

Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation

Immediate improvement in left ventricular ejection fraction (LVEF) following transcatheter aortic valve implantation (TAVI) is common; however, data on the pattern and prognostic value of this improvement are limited. To evaluate the incidence, predictors, and clinical impact of immediate improvement in LVEF, we studied 694 consecutive patient who had underwent successful TAVI for severe aortic stenosis (AS) between March 2010 and December 2019. We defined immediate improvement of LVEF as an absolute increase of ≥5% in LVEF at post-procedure echocardiogram. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE), defined as a composite of death from cardiovascular cause, myocardial infarction, stroke, or rehospitalization from cardiovascular cause. Among them, 160 patients showed immediate improvement in LVEF. The independent predictors of immediate LVEF improvement were absence of hypertension and baseline significant aortic regurgitation, and greater baseline LV mass index. Immediate improvement in LVEF was significantly associated with a lower risk of MACCE (adjusted hazard ratio, 0.48; 95% confidence interval, 0.28-0.81; p=0.01). In conclusion, approximately one-fourth of patients with severe AS who underwent TAVI showed immediate improvement in LVEF during index hospitalization. Immediate LVEF recovery was associated with a lower risk of MACCE during follow-up.

10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease

BackgroundThe optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear. ObjectivesThe goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD). MethodsIn the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models. ResultsAmong 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; pinteraction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; pinteraction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: −0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients. ConclusionsElderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972)

Prognostic Value of High-Sensitivity Troponin T After On-Pump Coronary Artery Bypass Graft Surgery

High-sensitivity troponin T (hs-TnT), as a single or serial measurement to predict postoperative mortality and morbidity, appears to be attractive due to its direct relationship in assessing myocardial damage and the widespread availability of hs-TnT testing. Therefore, this study aimed to identify any prognostic value of hs-TnT in predicting in-hospital outcomes after coronary artery bypass graft (CABG) surgery. We identified all consecutive patients who underwent on-pump CABG between July 2011 and December 2018. To evaluate the prognostic value of hs-TnT after CABG, we assessed the probability and odds ratio (OR) of adverse events concerning the maximum value of postoperative hs-TnT (measured within 24 hrs). TnT was routinely collected at 0, 6, 12 and 72 hours postoperatively. Values were categorised into intervals of 200 for analysis. A fully Bayesian logistic regression of the adverse event with the troponin T interval (0-200) as the reference level was used. A subgroup analysis was performed in patients with normal and elevated preoperative hs-TnT (< or ≥30 ng/L). The pre-specified primary outcome was a major adverse cardiac or cerebrovascular event (MACCE), defined as a composite of death within 30 days of operation for any cause, myocardial infection (MI), or stroke. 1,318 people underwent on-pump CABG during this period. One hundred and twenty-three (123) (9.3%) experienced MACCE, 14 (1.1%) experienced death within 30 days, 105 (8.0%) experienced MI and 14 (1.1%) experienced stroke. Compared to the reference category (hs-TnT ≤200 ng/L) we found there was an increase in OR with increasing level of hs-TnT for MACCE (p<0.001), 30-day mortality (p=0.003), MI (p<0.001) and ICU stay >48 hours (p<0.001). However, there was no statistically significant association present between hs-TnT and stroke, readmission to the intensive care unit (ICU), return to theatre for bleeding, or new-onset renal dysfunction. Peak hs-TnT level, greater than 400 ng/L, measured within 24 hours after CABG surgery is associated with MACCE, 30-day mortality, MI and ICU stay >48 hours. Prospectively designed trials, with clear prognostic and outcome variables, may provide further insight into the prognostic value of hs-TnT post-CABG.

Age-Stratified Outcome in Treatment of Left Main Coronary Artery Stenosis: A NOBLE Trial Substudy

Background: In the treatment of left main coronary artery (LMCA) disease, patients’ age may affect the clinical outcome after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). This study stratified the clinical outcome according to the age of patients treated for LMCA stenosis with PCI or CABG in the Nordic-Baltic-British Left Main Revascularization (NOBLE) study. Methods: Patients with LMCA disease were enrolled in 36 centers in northern Europe and randomized 1:1 to treatment by PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST elevation myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCEs), a composite of all-cause mortality, nonprocedural myocardial infarction, any repeat coronary revascularization, and stroke. Age-stratified analysis was performed for the groups younger and older than 67 years and for patients older than 80 years. Results: For patients ≥67 years, the 5-year MACCEs were 35.7 versus 22.3% (hazard ratio [HR] 1.72 [95% confidence interval [CI] 1.27–2.33], p = 0.0004) for PCI versus CABG. The difference in MACCEs was driven by more myocardial infarctions (10.8 vs. 3.8% HR 3.01 [95% CI 1.52–5.96], p = 0.0009) and more repeat revascularizations (19.5 vs. 10.0% HR 2.01 [95% CI 1.29–3.12], p = 0.002). In patients younger than 67 years, MACCE was 20.5 versus 15.3% (HR 1.38 [95% CI 0.93–2.06], p = 0.11 for PCI versus CABG. All-cause mortality was similar after PCI and CABG in both age-groups. On multivariate analysis, age was a predictor of MACCE, along with PCI, diabetes, and SYNTAX score. Conclusions: As the overall NOBLE results show revascularization of LMCA disease, age of 67 years or older was associated with lower 5-year MACCE after CABG compared to PCI. Clinical outcomes were not significantly different in the subgroup younger than 67 years, although no significant interaction was present between age and treatment. Mortality was similar for all subgroups (ClinicalTrials.gov identifier: NCT01496651).

Long-term clinical outcomes in transradial versus transfemoral access for left main percutaneous coronary intervention.

The present study compared 10-year clinical outcomes between transradial access (TRA) and transfemoral access (TFA) for left main (LM) percutaneous coronary intervention (PCI). There are limited data regarding the long-term safety and efficacy of TRA for LM PCI. This retrospective study evaluated consecutive patients who underwent unprotected LM PCI between January 2004 and December 2008 at Fu Wai Hospital. The exclusion criteria were age of less than 18 years and presentation with acute myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), which was defined as a composite of all-cause death, myocardial infarction, stroke, and any revascularization at the 10-year follow-up. Among 913 eligible patients, TRA was used for 417 patients (45.7%) and TFA was used for 496 patients (54.3%). The 30-day clinical outcomes were similar between the two groups. Results from the 10-year follow-up revealed that MACCE occurred in 180 patients (46.7%) from the TRA group and in 239 patients (51.2%) from the TFA group (log-rank p = .3). The TRA and TFA groups also had low and comparable cumulative rates of all-cause death (14.6% vs. 17.3%, log-rank p = .56) and cardiac death (7.9% vs. 9.1%, log-rank p = .7). The present study revealed no significant differences in long-term clinical outcomes when TRA or TFA were used for LM PCI.

Postoperative Hypotension and Adverse Clinical Outcomes in Patients Without Intraoperative Hypotension, After Noncardiac Surgery.

Postoperative hypotension (POH) is associated with major adverse events. However, little is known about the association of blood pressure thresholds and outcomes in postoperative patients without intraoperative hypotension (IOH) on the general-care ward. We evaluated the association of POH with major adverse cardiac or cerebrovascular events (MACCE) in patients without IOH. This retrospective analysis included 67,968 noncardiac patient-procedures (2008-2017) for patients discharged to the ward with postoperative mean arterial pressure (MAP) readings, managed for ≥48 hours postsurgery, with no evidence of IOH. The primary outcome was 30-day MACCE evaluated by postoperative MAP thresholds: ≤75, ≤65, and ≤55 mm Hg (POH defined as a single measurement below threshold). Secondary outcomes included all-cause mortality (30-/90-day), 30-day acute myocardial infarction, 30-day acute ischemic stroke, 30-day readmission, 7-day acute kidney injury, and 30-day readmission. Associations between POH and adverse events were also evaluated in a cohort (#2) of 16,034 patient-procedures with IOH (intraoperative MAP ≤65 mm Hg). In patients without IOH, exposure to POH was not associated with MACCE at any investigated MAP threshold (P < .016 was considered significant: ≤75 mm Hg, hazard ratio [HR] 1.18 [98.4% confidence interval {CI} 0.99-1.39], P = .023; ≤65 mm Hg, HR 1.18 [0.99-1.41], P = .028; ≤55 mm Hg, HR 1.23 [0.90-1.71], P = .121); however, associations were observed at all MAP thresholds for secondary outcomes of acute kidney injury and 30-day readmission, for 30-/90-day mortality for MAP ≤65 mm Hg, and 90-day mortality for MAP ≤55 mm Hg, compared to those without POH. No associations were detected between POH and secondary outcomes of acute ischemic stroke or acute myocardial infarction at any MAP threshold. No interaction between POH and IOH was found when we evaluated the association of POH on outcomes in the data set including all patients, regardless of IOH status (P values for interaction terms nonsignificant). When the interaction term was utilized, the association between POH without IOH and MACCE was significant for MAP ≤75 mm Hg (HR 1.20 [1.01-1.41]) and MAP ≤65 mm Hg (HR 1.21 [1.02-1.45]), but not MAP ≤55 mm Hg. Cohort #2 (POH with IOH) showed largely similar results for MACCE: not significant for MAP ≤75 and ≤65 mm Hg, but significant for MAP ≤55 mm Hg (HR 1.53 [1.05-2.22], P = .006). POH in patients without IOH was not associated with MACCE at any MAP investigated. No interaction was identified between POH and IOH. Large prospective randomized trials are necessary to develop better evidence and inform clinicians the value of postoperative blood pressure management.

Long-Term Clinical Outcomes of Unprotected Left Main Percutaneous Coronary Intervention: A Large Single-Centre Experience.

Aims This study sought to report the 10-year clinical outcomes of patients who underwent unprotected left main (LM) percutaneous coronary intervention (PCI) in a large centre. Methods and Results A total of 913 consecutive patients who underwent unprotected LM PCI from January 2004 to December 2008 at Fu Wai Hospital were retrospectively analysed; the mean age was 60.0 ± 10.9 years, females accounted for 22% of patients, diabetes was present in 27.7% of patients, and an LM bifurcation lesion occurred in 82.9% of patients. During the median follow-up of 9.7 years, major adverse cardiac or cerebrovascular events (MACCEs) occurred in 25.6% (234) of patients, and the rates of all-cause death, myocardial infarction, and stroke were 14.9%, 11.0%, and 7.1%, respectively. Cardiac death occurred in only 7.9% of patients. The estimated event rate was 41.9% for death/myocardial infarction/any revascularization and 45.9% for death/MI/stroke/any revascularization. Definite/probable stent thrombosis occurred in 4.3% (39) of patients. According to the subgroup analysis, IVUS-guided PCI was associated with less long-term MACCEs. Further multivariate analysis identified that age and LVEF<40% were the only independent predictors for 10-year death. Age, LVEF<40%, creatinine clearance, and incomplete revascularization were independent predictors for death/MI, while a two-stent strategy, diabetes, a transradial approach, and the use of bare metal stents (BMSs) or first-generation drug-eluting stents (DESs) were not. Conclusions Unprotected LM PCI in a large cohort of consecutive patients in a single large centre demonstrated favourable long-term outcomes up to 10 years even with the use of BMSs and first-generation of DESs.

Influence of contralateral carotid artery occlusions on short- and long-term outcomes of carotid artery stenting: a retrospective single-center analysis and review of literature.

In the current literature, correlations between a contralateral carotid artery occlusion (CCO) with mortality and major adverse cardiac or cerebrovascular events (MACCE) rates after carotid artery stenting (CAS) are often described with controversial conclusions. Moreover, long-term results of mortality, MACCE and restenosis rate are scarcely reported. This study examined the association between a CCO and the short- and long-term outcomes after CAS. One hundred and forty-six patients with CCO and without (No-CCO) who underwent between 2010 and 2017 to a CAS procedure in a single institution were retrospectively evaluated. The primary aim of the study was to evaluate mortality and MACCE rates in the short-term (defined as the occurrence during hospitalization and within 30-day) and after 3-year follow-up. The secondary aim of the study was to examine the restenosis rates in the short- and long-term period. The overall success of CAS was 99.3% and the 30-day all-cause mortality rate was 0.7% (one death). About MACCE, there were no major strokes in the CCO groups and 1 (1.4%) in the No-CCO group (P=1.00). The rate of 30-day minor strokes was 1.4% (1 patient) in the CCO group and 2.7% (2 patients) in the No-CCO group (P=1.00). In the 3-year follow-up, death occurred in 11 CCO vs. 6 No-CCO patients, respectively (15.1% vs. 8.2%, P=0.30). Regarding MACCE, major stroke occurred in 6 CCO vs. 2 No-CCO patients (8.2% vs. 2.7%, P=0.27), minor stroke in 6 CCO vs. 6 No-CCO (8.2% vs. 8.2%, P=1.0) and myocardial infarction in 6 CCO (8.2%) vs. 3 No-CCO patients (8.2 vs. 4.1%, P=0.49), respectively. Regarding the 30-day restenosis rate, it was observed in one patient (1.4%) in the CCO group while no cases were recorded in the No-CCO group, respectively (P=1.00). In the 3-year follow-up, greater than >50% restenosis was observed in 7 patients (9.6%) in the CCO group and in one patient (1.4%) in the No-CCO group (P=0.06), respectively. Kaplan-Meier survival analysis revealed that CCO patients had a lower 3-year freedom from restenosis rate with respect to the No-CCO group (87.6% vs. 98.6%, P=0.024). A Cox regression model on 3-year restenosis highlighted female gender and hypertension to be statistically significant predictors of restenosis. Patients with a preexisting CCO did not show a significative increased risk of procedural adverse events after CAS both in the immediate and long-term follow-up, but on the long term they are more likely to experience restenosis. CCO condition should be considered always as a clinical manifestation of a more aggressive carotid atherosclerosis.

The CatLet score, clinical variables and improved outcome predictions in acute myocardial infarction: a follow-up study of median 4.3-years

Abstract Background The Coronary Artery Tree description and Lesion Evaluation (CatLet) score accommodating the variability in the coronary anatomy is a recently develpoed and comprehensive angiographic scoring system aiming to assist in risk-stratification of coronary artery disease patients. Our preliminary study demonstrated that the CatLet score predicted the clinical outcomes in patients with acute myocardial infaration (AMI) undergoing pirmary percutaneous intervention (PCI). Purpose The current study aimed to identify whether the clinical variables (CVs: age, creatinine and left ventricular ejection fraction) additionally improved the performance of the CatLet score with respect to the outcome predictions in AMI undergoing primary PCI. Methods The CatLet score was calculated retrospectively in consecutively enrolled 308 patients with AMI. The primary end point was major adverse cardiac or cerebrovascular events (MACCEs) at median 4.3-years. Secondary endpoints were all-cause death and cardiac death. Cox regression survival analysis was uesd to identify the associations between the CatLet score, clinical variables and the clinical outcomes. Discrimination was assessed by Harrell's C index, net reclassification improvement (NRI) and calibration was assessed by Hosmer-Lemeshow test and validation plots. Results The CatLet score remained a significant predictor for outcome predictions at a median 4.3-years follow-up after adjusting for the 3 CVs. The model incorporationg the CatLet score and these 3 CVs (CVs-adjusted model) performed better than the stand-alone CatLet model in terms of outcome predictions. Compared with the stand-alone CatLet model, Harrell's C index with the CVs-adjusted model significantly increased by 0.10 (P=0.002) in MACCE, by 0.14 (P&amp;lt;0.001) in all-cause death events and by 0.12 (P=0.001) in cardiac death events. When reclassifying patients with 4.3 year MACCE from the stand-alone CatLet model into the CVs-adjusted model, out of the 244 subjects who remained free of MACCE events, 101 were correctly reclassified to a lower risk category and 42 were reclassified to a higher risk category (categories: ≤10%, 10% to ≤20%, 20% to ≤40%, &amp;gt;40%); out of the 64 subjects who developed MACCE events, 26 were correctly reclassified to a higher risk category and 10 were reclassified to a lower risk category. The category-based overall NRI was 0.49 (P&amp;lt;0.001) and the continuous overall NRI was 0.74 (P&amp;lt;0.001). Hosmer-Lemeshow tested showed a better calibration in MACCE events in the CVs-adjusted model (X2=4.14, P=0.8440) than in the stand-alone CatLet model (X2=5.06, P=0.7515). Similar findings were found both in all-cause death and cardiac death. Conclusion The 3 CVs (age, creatinine and left ventricular ejection fraction) additionally improved the performance of the CatLet score with respect to the outcome predictions in AMI undergoing primary PCI. (ChiCTR-POC-17013536) Reclassification plot Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Sci-Tech Development Program, Grant/Award

Five-year outcomes comparing percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass grafting in patients with left main coronary artery disease: A systematic review and meta-analysis

Background and aimsIn patients with left main coronary artery disease (LMCAD), long-term outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) remain controversial. We conducted a meta-analysis to compare the efficacy and safety of PCI with DES and CABG in LMCAD patients. MethodsWe comprehensively searched in Web of Science, EMBASE, PubMed, and Cochrane databases for eligible randomised controlled trials (RCTs) comparing the 5-year clinical outcomes between PCI with DES and CABG in LMCAD patients. Random-effect models were applied to analyse risk ratios (RRs) and hazard ratios (HRs) across studies, and I2 to assess heterogeneity. ResultsWe screened 4 RCTs including 4394 patients distributed randomly into PCI (n = 2197) and CABG (n = 2197) groups. In comparison to CABG, PCI showed non-inferiority concerning a composite of death, myocardial infarction, and stroke (HR 1.22, 95% confident interval [CI] 0.84–1.75), death (HR 1.06, 95% CI 0.81–1.40) and stroke (HR 0.80, 95% CI 0.42–1.53). Regarding major adverse cardiac or cerebrovascular events (MACCE) rate, both strategies show clinical equipoise in patients with a low-to-intermediate Synergy Between PCI with TAXUS and Cardiac Surgery (SYNTAX) score (HR 1.20, 95% CI 0.85–1.70), while CABG had an advantage over PCI in those with a high SYNTAX score (HR 1.64, 95% CI 1.20–2.24). ConclusionsCABG showed advantage over PCI with DES for LMCAD patients in MACCE. PCI and CABG showed equivalent 5-year clinical risk of a composite of all-cause mortality, myocardial infarction, and stroke, but the former had higher risk of repeat revascularization.

Clinical Outcomes in Older Patients Undergoing Percutaneous Coronary Intervention for Non-ST-Elevation Acute Coronary Syndromes

Distinguishing the subgroup of older, comorbid patients presenting with non-ST-elevation acute coronary syndromes (NSTEACS) who will benefit from percutaneous coronary intervention (PCI) remains challenging. Identifying risk factors for major adverse cardiac or cerebrovascular events (MACCE) post PCI may help define this cohort. The objective of this study was to describe contemporary outcomes of older patients with NSTEACS undergoing PCI and identify pre-procedural risk factors for MACCE. We retrospectively reviewed data for 1,875 patients aged ≥80 years entered in the Victorian Cardiac Outcomes Registry (VCOR) who underwent PCI for NSTEACS between 1 January 2013 and 31 December 2017. MACCE was a composite outcome comprising 30-day mortality, myocardial infarction, stroke, major bleeding, target lesion revascularisation or target vessel revascularisation; in-hospital cardiogenic shock or stent thrombosis; and new requirement for dialysis. Patient demographic data and pre-procedural comorbidities were compared between the groups with and without a MACCE. The rate of MACCE at 30 days was 8.0% (n=150). Thirty-day (30-day) mortality was 3.0% (n=57). Pre-procedural left ventricular ejection fraction (LVEF)<45% (OR 2.32; 95% CI 1.47-3.68; p<0.001) and eGFR≤30 mL/min/1.73m2 or renal replacement therapy (OR 2.10; 95% CI 1.27-3.46; p<0.01) were independent predictors of a MACCE. Older patients presenting with NSTEACS who have left ventricular systolic dysfunction or renal impairment are at increased risk of MACCE post PCI. Randomised studies are required to determine if invasive management remains beneficial for these patents compared with medical therapy.

Endothelial progenitor cells predict long-term outcome in patients with coronary artery disease: Ten-year follow-up of the PROCREATION extended study

BackgroundLevels of circulating endothelial progenitor cells (EPCs) are associated with the short-term prognosis of patients with coronary artery disease (CAD). No previous study, however, has ascertained if EPCs are related also to long-term outcome. We performed a pre-specified analysis of the PROCREATION (PROgenitor Cells role in Restenosis and progression of coronary ATherosclerosis after percutaneous coronary intervention) study in order to assess if EPCs predict the 10-year prognosis. Methods and resultsConsecutive stable patients with CAD who were included in the PROCREATION study were evaluated. Patients underwent an extended 10-year follow-up to assess major adverse cardiac or cerebrovascular events (MACCE), i.e. death, stroke, myocardial infarction, and revascularization. During follow-up, MACCE occurred in 79 of 149 patients (53%). Most clinical and angiographic baseline variables were similar in patients with or without MACCE, apart from age, diabetes, chronic kidney disease, ejection fraction, and extent of CAD. Comparison of EPCs, conversely, showed that patients with MACCE had greater levels of CD34+/KDR+/CD45- cells (p=0.0002) and CD133+/KDR+/CD45- cells (p=0.0001). Multivariate analysis showed that factors independently associated with 10-year MACCEs were age (p=0.001), ejection fraction (p=0.018), and CD34+/KDR+/CD45- cells (p=0.024). ConclusionSubpopulations of EPCs can improve long-term risk factor characterization in patients with CAD. (ClinicalTrials.gov: NCT01575431)

Prognostic impact of the combination of serum transaminase and alkaline phosphatase determined in the emergency room in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Elevated serum transaminase or alkaline phosphatase (ALP) has been proposed as a novel prognosticator for ST-segment elevation myocardial infarction (STEMI). We evaluated the combined prognostic impact of elevated serum transaminases and ALP on admission in STEMI patients who underwent primary percutaneous coronary intervention (PCI). A total of 1176 patients with STEMI undergoing primary PCI were retrospectively enrolled from the INTERSTELLAR registry. Hypoxic liver injury (HLI) was defined as serum transaminase > twice the upper limit of normal. The cut-off value of high ALP was set at the median level (73 IU/L). Patients were divided into four groups according to their serum transaminase and ALP levels. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven revascularization. Median follow-up duration was 25 months (interquartile range, 10-39 months). The rate of MACCE was highest in patients with HLI (+) and high ALP (25.9%), compared to those in the other groups (8.2% in HLI [-] and low ALP, 11.8% in HLI [-] and high ALP, and 15.0% in HLI [+] and low ALP). Each of HLI or high ALP was an independent predictor for MACCE (HR 1.807, 95% CI 1.191-2.741; HR 1.721, 95% CI 1.179-2.512, respectively). Combined HLI and high ALP was associated with the worst prognosis (HR 3.145, 95% CI 1.794-5.514). Combined HLI and high ALP on admission is associated with poor clinical outcomes in patients with STEMI who have undergone primary PCI.

Statin therapy for reduction of cardiovascular and limb-related events in critical limb ischemia: A systematic review and meta-analysis.

High-intensity statins are recommended for patients with peripheral artery disease (PAD). Critical limb ischemia (CLI) is the most advanced presentation of PAD. The benefit of statins in the CLI population is unclear based on the existent studies. Our objective was to perform a systematic review and meta-analysis regarding the efficacy of statin therapy in patients with CLI. PRISMA guidelines were followed. PubMed, EMBASE, and Cochrane CENTRAL databases were reviewed up to April 30, 2019. The primary outcomes included amputation rates and all-cause mortality. Secondary outcomes included primary patency rates, amputation-free survival and major adverse cardiac or cerebrovascular events (MACCE). Risk of bias was assessed with the Robins-I tool for observational studies. A random-effects model meta-analysis was performed. Heterogeneity was assessed with I2. Funnel plots and Egger's test were used to assess publication bias. Nineteen studies including 26,985 patients with CLI were included in this systematic review. Among patients with known data on statin status, 12,292 (49.6%) were on statins versus 12,513 (50.4%) not on statins. Patients treated with statins were 25% less likely to undergo amputation (HR 0.75; 95% CI: 0.59-0.95; I2 = 79%) and 38% less likely to have a fatal event (HR 0.62; 95% CI: 0.52-0.75; I2 = 41.2%). Statin therapy was also associated with increased overall patency rates and lower incidence of MACCE. There was substantial heterogeneity in the analysis for amputation and amputation-free survival (I2 > 70%). In conclusion, statins are associated with decreased risk for amputation, mortality, and MACCE, as well as increased overall patency rates among patients with CLI. Future studies should assess whether other lipid-lowering medications in addition to high-intensity statins can further improve outcomes among patients with CLI. (PROSPERO registration number: CRD42019134160).

The CatLet score and outcome prediction in acute myocardial infarction for patients undergoing primary percutaneous intervention: A proof-of-concept study.

The Coronary Artery Tree description and Lesion EvaluaTion (CatLet) score accommodating the variability in coronary anatomy is a recently developed and comprehensive angiographic scoring system aimed at assisting in risk-stratification of patients with coronary artery disease. However, a validation of this angiographic scoring system is lacking. The CatLet score was calculated retrospectively in 308 consecutively enrolled patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention. The primary endpoint, major adverse cardiac or cerebrovascular events (MACCEs), was stratified according to CatLet tertiles: CatLetlow ≤14 (n = 124), CatLetmid 15-21 (n = 82) and CatLettop ≥22 (n = 102). The CatLet score alone or after adjusting for a broad spectrum of risk factors, significantly predicted clinical outcomes at a median 4.3-year follow-up. Multivariable-adjusted hazard ratios (95%CI)/unit higher score were 1.05 (1.04-1.07) for MACCE, 1.06 (1.04-1.07) for cardiac death, and 1.05 (1.04-1.07) for all-cause death. When compared to the SYNTAX score, improved discrimination and better calibration of this CatLet score resulted in a significantly refined risk stratification. The overall category-free net reclassification improvement afforded by this CatLet score was as follows: 37.2% (p = .008) for MACCEs, 35.5% (p = .0249) for cardiac death, and 31.8% (p = .0316) for all-cause death. The ability to integrate the variability in coronary anatomy into angiographic scoring makes the CatLet score a more specific tool for outcome predictions in AMI. (http://www.chictr.org.cn. Unique identifiers: ChiCTR-POC-17013536).

Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial

Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009). In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. Biosensors.

P6513Temporal trends in coronary intervention strategies and the impact on one-year clinical events: data from a Japanese multi-center real-world cohort study

Abstract Background While it is clear that device technology of percutaneous coronary intervention (PCI) has advanced over the course of the last 40 years and the evidence for improvements in the efficacy of PCI is clear, it is less clear whether the prognosis following PCI continues to improve year by year. Methods The Kumamoto Intervention Conference Study Real-World Registry is a multi-center registry that enrolls consecutive patients undergoing PCI in 17 centers in Kyushu area, Japan. To elucidate the clinical impact of recent changes in treatment strategies, 8,841 consecutive participants (historical PCI: n=4,038, enrolled between January 2013 and December 2014, and current PCI: n=4,803, between January 2015 and March 2017) with 1-year follow-up data were analysed. Baseline demographic data, cardiovascular risk factors, and the medication being taken at discharge were documented. The primary endpoint was defined as a major adverse cardiac event (MACE), comprising cardiovascular death or non-fatal MI, including stent thrombosis (ST), occurring within 1 year of PCI. Results Regarding the relationships between presenting symptoms and PCI status, ACS, STEMI, NSTEMI, and UAP were similarly common, but the proportion of patients with multi-vessel disease was lower and the proportion with type B2/C lesions was higher in the current PCI group (p=0.004 and p&lt;0.001, respectively). The prevalences of left main trunk lesions and Killip classes III or IV were comparable between the groups, but in-stent restenotic lesions were significantly more frequent in the historical PCI group (p&lt;0.001). In addition to the change in the DAPT regimen, more optimal medical therapy was introduced during this time period, including the use of β-blockers, ACE-Is, and statins. The incidences of MACE were comparable between historical PCI and current PCI (2.2% vs. 2.1%, p=0.693), even though complex lesions were more frequent during the more recent period. During this period, the use of radial approaches, drug eluting stents, and coronary imaging increased, but the use of intra-aortic balloon pumping (IABP) or thromboaspiration decreased. The incidences of major adverse cardiac or cerebrovascular events (MACCE), cardiac death, non-fatal MI, and stent thrombosis were similar between the historical and current periods (Figure). Multivariate analysis for overall patients, after adjustment, showed that multi-vessel disease, type B2/C lesions, ACS, and DES use were significant independent predictors of MACE. Figure 1. Comparison of Clinical Events Conclusion An improvement in the prognosis associated with PCI has not occurred in recent years. However, the lesions being treated are becoming more complex, and the selection of evidence-based approaches, the use of coronary imaging, and the optimal medication treatments may have contributed to comparable outcomes being maintained. Acknowledgement/Funding Daiichi Sankyo Co., Ltd. Japan.

Initial experiences with a centrifugal-pump based minimal invasive extracorporeal circulation system in pediatric congenital cardiac surgery.

Minimal invasive extracorporeal circulation (MiECC) circuits are an established alternative to conventional extracorporeal circulation (CECC). Based on the positive effects and improved perioperative outcomes of MiECC in adult cardiac surgery, this perfusion concept appears particularly attractive to pediatric cardiac surgery. So far, there are no reports on the clinical application of a MiECC system for corrective surgery in neonates and children. We report our initial experiences by using a MiECC system in pediatric cardiac surgery. A total of 38 pediatric patients underwent surgical interventions for a variety of congenital heart disease from March 2017 until August 2018 with a MiECC. Following the classification of MiECC circuits by the Minimal invasive Extra-Corporeal Technologies International Society (MiECTIS), type I and type III perfusion circuits were assembled depending on the planned intervention: type I for closed heart interventions and type III for open heart procedures. Primary outcome was conversion to CECC, secondary endpoints included major adverse cardiac or cerebrovascular events (MACCE). MiECC perfusion was successfully performed in all patients (100%). Median patient age was 9.5 months (range, 0.2-176 months) with a median weight of 8.1 kg (range, 2.3-49 kg). For both MiECC types no system related technical complications were encountered. Beating heart procedures were performed in 23 cases (60%) at normothermia, while in 15 (40%) interventions cardioplegic cardiac arrest was induced at mild hypothermia. All patients had an uneventful perioperative course with no in-hospital mortality. MACCE did not occur during the hospitalization period. MiECC can be performed by using standard techniques for closed and open cardiac procedures for the correction of a variety of malformations in neonates and children with good results and uneventful postoperative course.

Associations among circulating levels of follistatin-like 1, clinical parameters, and cardiovascular events in patients undergoing elective percutaneous coronary intervention with drug-eluting stents.

ObjectivesFollistatin-like 1 (FSTL1) is a glycoprotein secreted by skeletal muscle cells and cardiac myocytes. Previous studies showed that serum FSTL1 concentrations were increased in acute coronary syndrome and chronic heart failure. The aim of this study was to assess the associations among plasma FSTL1 concentration, clinical parameters, and whether FSTL1 concentration could predict cardiovascular events in patients with elective percutaneous coronary intervention (PCI).Methods and resultsA consecutive series of 410 patients who underwent elective PCI with drug-eluting stents (DES) were enrolled between August 2004 and December 2006 at Juntendo University hospital. We measured plasma FSTL1 levels prior to elective PCI and assessed the association among FSTL1 levels, clinical parameters, and occurrence of major adverse cardiac or cerebrovascular events (MACCE) defined as cardiac death, nonfatal myocardial infarction, unstable angina, stroke, and hospitalization for heart failure. FSTL1 concentration was positively correlated with high-sensitivity C-reactive protein (hsCRP), serum creatinine, and N-terminal pro b-type natriuretic peptide (all P < 0.01). After excluding patients with creatinine clearance < 60 mL/min and hsCRP ≥ 0.2 mg/dL, the remaining 214 were followed for a median of 5.1 years. Twenty (9.3%) patients experienced MACCE. Receiver operating characteristics curve analysis estimated an FSTL1 cutoff of 41.1 ng/mL to predict MACCE occurrence. Kaplan–Meier analysis found a higher MACCE rate in patients with high (≥ 41.1 ng/mL) than with low (< 41.1 ng/mL) FSTL1 (P < 0.01). Multivariate Cox hazard analysis found that high FSTL1 was an independent predictor of MACCE (hazard ratio 4.54, 95% confidence interval: 1.45–20.07, P < 0.01).ConclusionHigh plasma FSTL1 may be a predictor of cardiovascular events in patients who underwent elective PCI with DES, especially with preserved renal function and low hsCRP.

Role of surgical ventricular restoration post surgical treatment of heart failure (STICH) trial.

To compare the outcomes of isolated coronary artery bypass grafting (CABG) versus surgical ventricular restoration (SVR) with or without CABG for patients with ischemic cardiomyopathy (ICM). Retrospectively, 49 patients with ICM and severe LV dysfunction (LVEF < 35%) who underwent SVR with or without CABG from January 2009 to December 2016 at a single institution was compared with 49 patients who underwent isolated CABG. The two groups were matched for preoperative clinical and echocardiographic parameters including left ventricular end-diastolic diameter (LVIDd), left ventricular end-systolic diameter (LVIDs), left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV). Primary outcomes analyzed included early mortality, late mortality, and major adverse cardiac or cerebrovascular events (MACCE). Secondary outcomes analyzed included echocardiographic parameters of left ventricular volume and function-indexed left ventricular end-diastolic volume (LVEDVi), indexed left ventricular end-systolic volume (LVESVi), and LVEF. Cox and survival analysis was performed. Early and late mortality in SVR vs. CABG groups were 4 (8.1%) and 6 (12.2%) vs. 1 (2%) and 5 (10.2%) respectively. Mean improvement in LVEF was 3.39 ± 7.51 compared to 4.97 ± 5.45 between the two groups at 3-month follow-up. Mean improvement in LVEF was 5.1 ± 8.3 in the SVR group vs 5.9 ± 7.1 in the CABG group at the last follow-up. There was no statistically significant improvement between the two groups in terms of LVEF at 3months or the last follow-up. There were statistically significant differences between LVEDVi and LVESVi between the two groups at 3months and the last follow-up. The 5-year rates of survival were 85 ± 6 and 82 ± 9% for SVR and CABG groups respectively. The 5-year rates of freedom from MACCE were 75 ± 7 and 60 ± 11% for SVR and CABG groups respectively. Compared with isolated CABG, SVR plus CABG results in equivalent late mortality and better left ventricular reverse remodeling (as evidenced by LV volume reduction) and better freedom from MACCE at 5-year follow-up.