Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS: The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS: Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION: With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

Assessment of optimal renin-angiotensin-system inhibition strategy in Asian patients with STEMI after primary myocardial revascularization.

BACKGROUND: For the Asian patients with STEMI undergoing PCI, ACEIs are known to have a better outcome than ARBs. However, there is limited evidence to suggest so. METHODS: Among the STEMI registry consist of 1142 Korean patients, we compared the MACE, the composite of myocardial infarction, stoke, death, admission for heart failure, and target vessel revascularization, between the ACEI and ARB groups (Set 1). Further, we defined adequate medication as the administration of a dose equal to or higher than the initiation dose of ACEI according to the heart failure guideline recommendation with a mandatory addition of beta-blockers, and compared the outcomes between the inadequate and adequate medication groups (Set 2). Propensity score matching was used to eliminate difference. RESULTS: In the Set 1 comparison, patients in the ACEI group had a better outcome than those in the ARB group for both whole and matched populations (whole and matched population: Cox regression hazard ratio [HR], 0.645 and 0.535; 95% confidence interval [CI], 0.440-0.944 and 0.296-0.967; p = 0.024 and p = 0.039, respectively). In the Set 2 comparison for the whole population, patients in the inadequate medication group had more MACE than those in the adequate medication group (HR, 0.673; 95% CI, 0.459-0.985; p = 0.042). However, no difference was observed after propensity score matching (HR, 1.023; 95% CI, 0.654-1.602; p = 0.919). CONCLUSION: ACEIs might be a better choice than ARBs after primary revascularization. However, this study's findings suggest that early ACEI dose escalation combined with beta-blocker use may not improve prognosis.

Prediction of functional results of percutaneous coronary interventions with virtual stenting and quantitative flow ratio.

BACKGROUND: The clinical value of residual quantitative flow ratio (rQFR), a novel function of QFR technique, is unknown. AIM: We investigated the clinical value of rQFR, aimed to predict residual ischemia after virtual percutaneous coronary intervention (vPCI). METHODS: This is a substudy of the COE-PERSPECTIVE registry, which investigated the prognostic value of post-PCI fractional flow reserve (FFR). From pre-PCI angiograms, QFR and rQFR were analyzed and their diagnostic performance was assessed at blinded fashion using pre-PCI FFR and post-PCI FFR as reference, respectively. The prognostic value of rQFR after vPCI was assessed according to vessel-oriented composite outcome (VOCO) at 2 years. RESULTS: We analyzed 274 patients (274 vessels) with FFR-based ischemic causing lesions (49%) from 555 screened patients. Pre-PCI QFR and FFR were 0.63 ± 0.10 and 0.66 ± 0.11 (R = 0.756, p < 0.001). rQFR after vPCI and FFR after real PCI were 0.93 ± 0.06 and 0.86 ± 0.07 (R = 0.528, p < 0.001). The mean difference between rQFR and post-PCI FFR was 0.068 (95% limit of agreement: -0.05 to 0.19). Diagnostic performance of rQFR to predict residual ischemia after PCI was good (area under the curve [AUC]: 0.856 [0.804-0.909], p < 0.001). rQFR predicted well the incidence of 2-year VOCO after index PCI (AUC: 0.712 [0.555-0.869], p = 0.041), being similar to that of actual post-PCI FFR (AUC: 0.691 [0.512-0.870], p = 0.061). rQFR ≤0.89 was associated with increased risk of 2-year VOCO (hazard ratio [HR]: 12.9 [2.32-71.3], p = 0.0035). This difference was mainly driven by a higher rate of target vessel revascularization (HR: 16.98 [2.33-123.29], p = 0.0051). CONCLUSIONS: rQFR estimated from pre-PCI angiography and virtual coronary stenting mildly overestimated functional benefit of PCI. However, it well predicted suboptimal functional result and long-term vessel-related clinical events. CLINICAL TRIAL REGISTRATION: Influence of fractional flow reserve on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (COE-PESPECTIVE) Registry, NCT01873560.

Addition of routine blood biomarkers to TIMI risk score improves predictive performance of 1-year mortality in patients with ST-segment elevation myocardial infarction.

BACKGROUND: Several biomarkers have been proposed as independent predictors of poor outcomes in ST-segment elevation myocardial infarction (STEMI). We investigated whether adding information obtained from routine blood tests including hypoxic liver injury (HLI), dysglycemia, anemia, and high neutrophil to lymphocyte ratio (NLR) could improve the prognostic performance of the TIMI risk score for the prediction of 1-year mortality. METHODS: A total of 1057 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) between 2007 and 2014 were retrospectively enrolled from 4-regional hospitals. HLI and dysglycemia were defined as serum transaminase > twice the normal upper limit and glucose < 90 or > 250 mg/dL, respectively. The effect of adding biomarkers to the TIMI risk score on its discriminative ability was assessed using c-statistic, net reclassification improvement (NRI), and integrated discrimination improvement (IDI). RESULTS: The 1-year mortality rate was 7.1%. The best cutoff value of NLR for the prediction of 1-year mortality was 4.3 (sensitivity, 67%; specificity, 65%). HLI (HR 2.019; 95% CI 1.104-3.695), dysglycemia (HR 2.535; 95% CI 1.324-3.923), anemia (HR 2.071; 95% CI 1.093-3.923), and high NLR (HR 3.651; 95% CI 1.927-6.918) were independent predictors of 1-year mortality. When these 4 parameters were added to the TIMI risk score, the c-statistic significantly improved from 0.841 to 0.876 (p < 0.001), and the NRI and IDI were estimated at 0.203 (95% CI 0.130-0.275; p < 0.001) and 0.089 (95% CI 0.060-0.119; p < 0.001), respectively. CONCLUSIONS: The addition of HLI, dysglycemia, anemia, and high NLR to the TIMI risk score may be useful for very early risk stratification in patients with STEMI receiving primary PCI.

The selection of ß-blocker after successful reperfusion in patients with ST-elevation myocardial infarction.

BACKGROUND: The selection of ß-blocker for survivors after primary intervention due to acute ST-elevation myocardial infarction seems crucial to improve the outcomes. However, rare comparison data existed for these patients. We aimed to compare the effectiveness of selective ß-blockers to that of carvedilol in patients treated with primary intervention. METHODS AND RESULTS: Among the 1,485 patients in the "INTERSTELLAR" registry between 2007 and 2015, 238 patients with selective ß-blockers (bisoprolol, nebivolol, atenolol, bevantolol, and betaxolol) and 988 with carvedilol were included and their clinical outcomes were compared for a 2-year observation period. In the clinical baseline characteristics, the unfavorable trends in the carvedilol group were high Killip presentation, lower ejection fractions, smaller diameters, and longer lengths of deployed stents. Although mortality (2.5% vs. 1.7%; p = 0.414) and the rate of stroke (0.8% vs. 0.6%; p = 0.693) were not different between groups, the rate of recurrent myocardial infarction (4.6% vs. 1.2%; p = 0.001) and of target vessel revascularization (4.2% vs. 0.9%; p < 0.001) were lower in the carvedilol group. After eliminating the difference by propensity matching, the similar outcome result was shown (all-cause death, 0.6% vs. 1.0%, p = 0.678; stroke, 0.6% vs. 1.2%, p = 0.479; myocardial infarction, 5.0% vs. 1.2%, p = 0.003; target vessel revascularization, 4.5% vs. 0.7%, p < 0.006) for 595 matched populations. The use of carvedilol was also determined to be an independent predictor for recurrent myocardial infarctions (hazard ratio = 0.305; p = 0.005; 95% confidence interval = 0.13-0.69). CONCLUSION: Use of a carvedilol in ST-segment myocardial infarction survivor is associated with lower recurrent myocardial infarction events. Thus, it might be the better choice of ß-blocker for secondary prevention in ST-elevation myocardial infarction patients treated with primary percutaneous coronary intervention.

Safety and efficacy of a novel hyperaemic agent, intracoronary nicorandil, for invasive physiological assessments in the cardiac catheterization laboratory.

AIMS: Maximal hyperaemia is a key element of invasive physiological studies and adenosine is the most commonly used agent. However, infusion of adenosine requires additional venous access and can cause chest discomfort, bronchial hyper-reactivity, and atrioventricular conduction block. The aim of this study was to evaluate the feasibility and efficacy of intracoronary (IC) nicorandil as a novel hyperaemic agent for invasive physiological studies. METHODS AND RESULTS: We enrolled 210 patients who underwent fractional flow reserve (FFR) measurement. Hyperaemic efficacy of the following methods was compared: IC bolus injection of adenosine; intravenous (i.v.) infusion of adenosine (140 µg/kg/min); and IC bolus of nicorandil (1 and 2 mg). In 70 patients, the index of microcirculatory resistance was also measured. Hyperaemic efficacy of IC nicorandil 2 mg was non-inferior to that of i.v. adenosine infusion (FFR: 0.82 ± 0.10 vs. 0.82 ± 0.10; P for non-inferiority < 0.001). There was a strong correlation between FFRs measured by i.v. adenosine and IC nicorandil (R² = 0.934). Nicorandil produced fewer changes in blood pressure, heart rate and PR interval, and less chest pain than adenosine (all P-values < 0.05). Atrioventricular block occurred in 12 patients with IC adenosine, 4 patients with i.v. adenosine and none with IC nicorandil. The index of microcirculatory resistance was 18.3 ± 8.7 with i.v. adenosine and 17.2 ± 7.6 with IC nicorandil (P = 0.126). CONCLUSION: This study suggests that IC bolus injection of nicorandil is a simple, safe, and effective way to induce steady-state hyperaemia for invasive physiological evaluations. Clinicaltrials.gov number: NCT01331902.

Clinical efficacy of angiotensin receptor-neprilysin inhibitor in de novo heart failure with reduced ejection fraction.

BACKGROUND/AIMS: We aimed to analyze the efficacy of angiotensin receptor-neprilysin inhibitor (ARNI) by the disease course of heart failure (HF). METHODS: We evaluated 227 patients with HF in a multi-center retrospective cohort that included those with left ventricular ejection fraction (LVEF) ≤ 40% undergoing ARNI treatment. The patients were divided into patients with newly diagnosed HF with ARNI treatment initiated within 6 months of diagnosis (de novo HF group) and those who were diagnosed or admitted for HF exacerbation for more than 6 months prior to initiation of ARNI treatment (prior HF group). The primary outcome was a composite of cardiovascular death and worsening HF, including hospitalization or an emergency visit for HF aggravation within 12 months. RESULTS: No significant differences in baseline characteristics were reported between the de novo and prior HF groups. The prior HF group was significantly associated with a higher primary outcome (23.9 vs. 9.4%) than the de novo HF group (adjusted hazard ratio 2.52, 95% confidence interval 1.06-5.96, p = 0.036), although on a higher initial dose. The de novo HF group showed better LVEF improvement after 1 year (12.0% vs 7.4%, p = 0.010). Further, the discontinuation rate of diuretics after 1 year was numerically higher in the de novo group than the prior HF group (34.4 vs 18.5%, p = 0.064). CONCLUSION: The de novo HF group had a lower risk of the primary composite outcome than the prior HF group in patients with reduced ejection fraction who were treated with ARNI.

Hemo-metabolic impairment in patients with ST-segment elevation myocardial infarction: Data from the INTERSTELLAR registry.

BACKGROUND: Not only hemo-dynamic (HD) factors but also hemo-metabolic (HM) risk factors reflecting multi-organ injuries are considered as important prognostic factors in ST-segment elevation myocardial infarction (STEMI). However, studies regarding HM risk factors in STEMI patients are currently limited. METHOD: Under analysis were 1,524 patients with STEMI who underwent primary percutaneous coronary intervention in the INTERSTELLAR registry. Patients were divided into HM (≥ 2 risk factors) and non-HM impairment groups. The primary outcome was in-hospital all-cause mortality, and the secondary outcome was 1-year all-cause mortality. RESULTS: Of 1,524 patients, 214 (14.0%) and 1,310 (86.0%) patients were in the HM and non-HM impairment groups, respectively. Patients with HM impairment had a higher incidence of in-hospital mortality than those without (24.3% vs. 2.7%, p < 0.001). After adjusting for confounders, HM impairment was independently associated with in-hospital mortality (inverse probability of treatment weighting [IPTW]-adjusted odds ratio: 1.81, 95% confidence interval: 1.08-3.14). In the third door-to-balloon (DTB) time tertile (≥ 82 min), HM impairment was strongly associated with in-hospital mortality. In the first DTB time tertile ( < 62 min), indicating relatively rapid revascularization, HM impairment was consistently associated with increased in-hospital mortality. CONCLUSIONS: Hemo-metabolic impairment is significantly associated with increased risk of in-hospital and 1-year mortality in patients with STEMI. It remains a significant prognostic factor, regardless of DTB time.

Clinical outcomes of gastrointestinal bleeding management during anticoagulation therapy.

BACKGROUND: Acute gastrointestinal (GI) bleeding is not an uncommon complication of oral anticoagulation (OAC) therapy that requires medication cessation. However, drug cessation may cause fatal stroke or systemic embolization in patients at high thromboembolic risk. Here we sought to find an appropriate anticoagulation cessation strategy in cases of GI bleeding during OAC therapy. METHODS: This single-center retrospective cohort analysis was performed between 2010 and 2018. Patients were enrolled if the following three consecutive conditions were met: 1) electrocardiography electrocardiography-proven atrial fibrillation; 2) OAC therapy; and 3) GI bleeding. We divided the drug cessation strategy into the continuation and discontinuation groups. During 1-year follow-up, the rates of major thromboembolic and rebleeding events were calculated. RESULTS: One hundred and forty-six patients (continuation [n = 54] vs. discontinuation [n = 92] group) were enrolled. Patients in the discontinuation group were more likely to be older (69.8 ± 9.0 yrs vs. 74.9 ± 8.9 yrs, p = 0.001), while patients in the continuation group were more likely to have undergone cardiac valve surgery (51.9% vs. 20.7%, p<0.001). The presence of a mechanical mitral valve was a determinant of continuation strategy (38.9% vs. 7.5%, p<0.001). However, the mean CHA2DS2-VASc (3.4±1.3 vs. 4.1±1.6, p = 0.010) and Glasgow-Blatchford (8.0±2.4 vs. 8.9±2.5, p = 0.037) scores were higher in the discontinuation group. Two major embolic strokes occurred in each group (3.7% vs. 2.2%, p = 0.585). Four of 54 (7.4%) and five of 92 (5.4%) patients had rebleeding events during follow-up (p = 0.632). One embolic event in the continuation group and one rebleeding event in the discontinuation group were fatal. The Glasgow-Blatchford score was a predictor of 1-year rebleeding events (odds ratio [OR], 1.36; 95% confidence interval [CI], 0.68-2.20; p = 0.028). The high CHA2DS2-VASc score showed a strong trend (OR, 1.71; 95% CI, 0.92-3.20; p = 0.089) in 1-year thromboembolic events. CONCLUSION: No single risk factor or drug cessation strategy was attributed to adverse clinical events after GI bleeding. The risk of future thrombotic or rebleeding events should be individualized and controlled for based on a pre-existing stratification system.

Association of height loss and cardiovascular disease: Data from a large Korean cohort.

Background: Height declines with age, and its degree differs among individuals. Despite epidemiologic evidence for the inverse relationship between adult height and cardiovascular disease (CVD) incidence, the clinical significance of height loss in CVD remains to be elucidated. Therefore, this study investigated the association between height loss and CVD incidence. Methods: In total, 127,573 Korean participants were enrolled; their heights were monitored from 2002 to 2011. The annual height loss (cm/year) was the difference between the first and last height measurements within the observation period divided by the number of years. The participants were classified as Group 1 (height loss: <0.3 cm/year; n = 102,554), Group 2 (height loss: 0.3- < 0.6 cm/year; n = 17,324), or Group 3 (height loss: ≥0.6 cm/year; n = 7,695). Results: The cumulative major adverse cardiac and cerebral event (MACCE: cardiac death, non-fatal myocardial infarction, and unplanned hospitalization for heart failure or stroke) incidence rate was 3.6% for Group 1, 4.5% for Group 2, and 5.2% for Group 3. Group 2 (hazard ratio [HR] = 1.27, 95% confidence interval [CI] = 1.17-1.37) and Group 3 (HR = 1.46, 95% CI = 1.32-1.62) had a significantly higher incidence of MACCE than Group 1. In the model adjusted for age, sex, comorbidities, income level, body mass index, smoking, and drinking status, the MACCE risk was higher in Group 2 (HR = 1.11, 95% CI = 1.07-1.20) and Group 3 (HR = 1.25, 95% CI = 1.13-1.39) than in Group 1. Conclusion: The degree of height loss was independently associated with CVD occurrences in the Korean population.

Contrasting haemodynamic effects of exercise and saline infusion in older adults with pulmonary arterial hypertension.

In this study, among patients with pulmonary arterial hypertension, exercise was more potent in eliciting pulmonary vascular abnormalities and demonstrated paradoxical increase in RC-time https://bit.ly/35Mb0dv.

Clinical Implication of Hypoxic Liver Injury for Predicting Hypoxic Hepatitis and In-Hospital Mortality in ST Elevation Myocardial Infarction Patients.

PURPOSE: In this study, we aimed to determine the value of hypoxic liver injury (HLI) in the emergency room (ER) for predicting hypoxic hepatitis (HH) and in-hospital mortality in ST elevation myocardial infarction (STEMI) patients. MATERIALS AND METHODS: 1537 consecutive STEMI patients were enrolled. HLI in the ER was defined as a ≥2-fold increase in serum aspartate transaminase (AST). HH was defined as a ≥20-fold increase in peak serum transaminase. Patients were divided into four groups according to HLI and HH status (group 1, no HLI or HH; group 2, HLI, but no HH; group 3, no HLI, but HH; group 4, both HLI and HH). RESULTS: The incidences of HLI and HH in the ER were 22% and 2%, respectively. In-hospital mortality rates were 3.1%, 11.8%, 28.6%, and 47.1% for groups 1, 2, 3, and 4, respectively. Patients with HLI and/or HH had worse Killip class, higher cardiac biomarker elevations, and lower left ventricular ejection fraction. Multivariate logistic regression analysis showed that HLI in the ER was an independent predictor of HH [odds ratio 2.572, 95% confidence interval (CI) 1.166-5.675, p=0.019]. The predictive value of HLI in the ER for the development of HH during hospitalization was favorable [area under the curve (AUC) 0.737, 95% CI 0.643-0.830, sensitivity 0.548, specificity 0.805, for cut-off value AST >80]. Furthermore, in terms of in-hospital mortality, predictive values of HLI in the ER and HH during hospitalization were comparable (AUC 0.701 for HLI at ER and AUC 0.674 for HH). CONCLUSION: Among STEMI patients, HLI in the ER is a significant predictor for the development of HH and mortality during hospitalization (INTERSTELLAR ClinicalTrials.gov number, NCT02800421).

Effects of deferred versus immediate stenting on left ventricular function in patients with ST elevation myocardial infarction.

BACKGROUND: Previous studies have shown conflicting results on the benefits of deferred stenting (DS) in infarct size and the incidence of microvascular obstruction in patients with ST elevation myocardial infarction (STEMI). However, effect of DS on left ventricular (LV) function was not known. We aimed to evaluate whether DS improve LV function and relevant clinical outcomes after STEMI, using follow-up data from the INNOVATION study (NCT02324348). METHODS: In total, 114 patients were randomly assigned to DS group or immediate stenting (IS) group at a 1:1 ratio. LV functional remodeling indices and MACE (major adverse cardiac events: a composite of death, non-fatal MI, unplanned target vessel revascularization, or hospitalization due to heart failure) were compared between DS and IS groups. RESULTS: Serial echocardiographic analyses were completed in 89 subjects (78%). There were no significant changes in LV volume in either group. While LV ejection fraction and wall motion score index (WMSI) improved in both groups during follow-up, the increments were not statistically different between the 2 groups (4.3 ±â€Š8.2 vs 3.2 ±â€Š7.1, P = .504 for ΔLV ejection fraction; -0.16 ±â€Š0.25 vs -0.16 ±â€Š0.25, P = .99 for ΔWMSI). However, E/e'' was decreased and e' was increased only in the DS group (-3.31 ±â€Š5.60 vs -0.46 ±â€Š3.10, P = .005 for ΔE/e'; 0.77 ±â€Š1.71 vs -0.22 ±â€Š1.64, P = .009 for Δe'). The incidence of major adverse cardiac events was numerically lower in the DS group than in the IS group without a statistical significance at 1-year follow-up. CONCLUSIONS: Routine DS improved LV diastolic function but not systolic function compared with IS in patients with STEMI.

Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention.

OBJECTIVES: The aim of this study was to evaluate prognostic implications of physiological 2-dimensional disease patterns on the basis of distribution and local severity of coronary atherosclerosis determined by quantitative flow ratio (QFR) virtual pull back. BACKGROUND: The beneficial effect of percutaneous coronary intervention (PCI) is determined by physiological distribution and local severity of coronary atherosclerosis. METHODS: The study population included 341 patients who underwent angiographically successful PCI and post-PCI fractional flow reserve (FFR) measurement. Using pre-PCI virtual pull backs of QFR, physiological distribution was determined by pull back pressure gradient index, with a cutoff value of 0.78 to define predominant focal versus diffuse disease. Physiological local severity was assessed by instantaneous QFR gradient per unit length, with a cutoff value of ≥0.025/mm to define a major gradient. Suboptimal post-PCI physiological results were defined as both post-PCI FFR ≤0.85 and percentage FFR increase ≤15%. Clinical outcome was assessed by target vessel failure (TVF) at 2 years. RESULTS: QFR pull back pressure gradient index was correlated with post-PCI FFR (R = 0.423; P < 0.001), and instantaneous QFR gradient per unit length was correlated with percentage FFR increase (R = 0.370; P < 0.001). Using the 2 QFR-derived indexes, disease patterns were classified into 4 categories: predominant focal disease with and without major gradient (group 1 [n = 150] and group 2 [n = 21], respectively) and predominant diffuse disease with and without major gradient (group 3 [n = 115] and group 4 [n = 55], respectively). Proportions of suboptimal post-PCI physiological results were significantly different according to the 4 disease patterns (18.7%, 23.8%, 22.6%, and 56.4% from group 1 to group 4, respectively; P < 0.001). Cumulative incidence of TVF after PCI was significantly higher in patients with predominant diffuse disease (8.1% in group 3 and 9.9% in group 4 vs 1.4% in group 1 and 0.0% in group 2; overall P = 0.024). CONCLUSIONS: Both physiological distribution and local severity of coronary atherosclerosis could be characterized without pressure-wire pull backs, which determined post-PCI physiological results. After successful PCI, TVF risk was determined mainly by the physiological distribution of coronary atherosclerosis. (Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes [Algorithm-PCI], NCT04304677; Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention [PERSPECTIVE], NCT01873560).

Clinical and Prognostic Impact From Objective Analysis of Post-Angioplasty Fractional Flow Reserve Pullback.

OBJECTIVES: This study sought to evaluate clinical implications of the residual fractional flow reserve (FFR) gradient after angiographically successful percutaneous coronary intervention (PCI). BACKGROUND: Recent studies have demonstrated FFR measured after PCI is associated with clinical outcome after PCI. Although post-PCI FFR pull back tracings provide clinically relevant information on the residual FFR gradient, there are no objective criteria for assessing post-PCI FFR pull back tracings. METHODS: A total of 492 patients who underwent angiographically successful PCI and post-PCI FFR measurement with pull back tracings were analyzed. The presence of the major residual FFR gradient after PCI was assessed by both conventional visual interpretation of the pull back tracings and objective analysis using the instantaneous FFR gradient per unit time (dFFR(t)/dt) with a cutoff value of dFFR(t)/dt ≥0.035. Classification agreement between 2 independent operators for the presence of the major residual FFR gradient was compared before and after providing dFFR(t)/dt results. Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization at 2 years, was compared according to the presence of the major residual FFR gradient. RESULTS: Among the study population, 33.9% had the major residual FFR gradient defined by dFFR(t)/dt. The classification agreement between operators' assessments for the major residual FFR gradient increased with dFFR(t)/dt results compared with conventional visual assessment (Cohen's kappa = 0.633 to 0.819; P < 0.001; intraclass correlation coefficient: 0.776 to 0.901; P < 0.001). Patients with major residual FFR gradient were associated with a higher risk of TVF at 2 years than those without major residual FFR gradient (9.0% vs 2.2%; P < 0.001). Inclusion of the major residual FFR gradient to a clinical prediction model significantly increased discrimination and reclassification ability (C-index = 0.539 vs 0.771; P = 0.006; net reclassification improvement = 0.668; P = 0.007; integrated discrimination improvement = 0.033; P = 0.017) for TVF at 2 years. The presence of the major residual FFR gradient was independently associated with TVF at 2 years, regardless of post-PCI FFR or percent FFR increase (adjusted hazard ratio: 3.930; 95% confidence interval: 1.353-11.420; P = 0.012). CONCLUSIONS: Objective analysis of post-PCI FFR pull back tracings using dFFR(t)/dt improved classification agreement on the presence of the major residual FFR gradient among operators. Presence of the major residual FFR gradient defined by dFFR(t)/dt after angiographically successful PCI was independently associated with an increased risk of TVF at 2 years. (Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship with Post-PCI Clinical Outcomes [Algorithm-PCI]; NCT04304677; Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention [COE-PERSPECTIVE]; NCT01873560).

Complications of veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock or cardiac arrest.

BACKGROUND: The frequency of using veno-arterial extracorporeal membrane oxygenation increased, especially in patients with refractory cardiogenic shock or cardiac arrest. However, data of complications of veno-arterial extracorporeal membrane oxygenation are lacking. This study sought to investigate the incidence of veno-arterial extracorporeal membrane oxygenation complications for acute myocardial infarction patients with refractory cardiogenic shock or cardiac arrest and its relationship with patient survival. METHODS: This study included 151 consecutive patients who underwent veno-arterial extracorporeal membrane oxygenation between 2006 and 2018 at a single referral center. We divided the patients into those who survived for 30 days after veno-arterial extracorporeal membrane oxygenation (n = 57, 38%; group 1) and those who died within 30 days after veno-arterial extracorporeal membrane oxygenation support (n = 94, 62%; group 2). The major adverse clinical events associated with veno-arterial extracorporeal membrane oxygenation were defined as first occurrence of infection, major bleeding, and stroke. RESULTS: Adverse clinical events associated with veno-arterial extracorporeal membrane oxygenation occurred in 34 (59.6%) and 56 (59.6%) patients in groups 1 and 2, respectively. Group 2 had more patients who underwent new renal replacement therapy (21.1% vs 37.2%, p = 0.037). After multivariable analysis, cardiac arrest was independently associated with 30-day mortality (odds ratio = 3.6; 95% confidence interval = 1.7-7.63; p = 0.001). After excluding patients who died within 48 h after undergoing veno-arterial extracorporeal membrane oxygenation, new renal replacement therapy (odds ratio = 4.47; 95% confidence interval = 1.58-12.61; p = 0.005) and major adverse clinical events (odds ratio = 2.66; 95% confidence interval = 1.01-7.03; p = 0.049) were independently associated with 30-day mortality. CONCLUSION: Although veno-arterial extracorporeal membrane oxygenation can improve the survival, it is associated with morbidity. Therefore, risk-benefit analysis for veno-arterial extracorporeal membrane oxygenation and prevention of complications are important to improve prognosis.

Prognostic Implications of Post-Intervention Resting Pd/Pa and Fractional Flow Reserve in Patients With Stent Implantation.

OBJECTIVES: This study sought to investigate the prognostic implications of post-percutaneous coronary intervention (PCI) nonhyperemic pressure ratios compared with that of post-PCI fractional flow reserve (FFR). BACKGROUND: FFR measured after PCI has been shown to possess prognostic implications. However, the prognostic value of post-PCI nonhyperemic pressure ratios has not yet been clarified. METHODS: A total of 588 patients who underwent PCI with available both post-PCI FFR and resting distal coronary pressure-to-aortic pressure ratio (Pd/Pa) were analyzed. Post-PCI FFR and Pd/Pa were measured after successful angiographic stent implantation. The primary outcome was target vessel failure (TVF) up to 2 years, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. Prognosis of patients according to post-PCI Pd/Pa was compared with that of post-PCI FFR. RESULTS: Despite angiographically successful PCI, 18.5% had post-PCI FFR ≤0.80 and 36.9% showed post-PCI Pd/Pa ≤0.92. In post-PCI Pd/Pa >0.92 group, 93.8% of patients showed post-PCI FFR >0.80. Conversely, 60.4% of patients showed post-PCI FFR >0.80 in post-PCI Pd/Pa ≤0.92 group. Although there was significant difference in TVF according to post-PCI FFR (≤0.80 vs. >0.80: 10.3% vs. 2.5%; p < 0.001) and Pd/Pa (≤0.92 vs. >0.92: 6.2% vs. 2.5%; p = 0.029), the reclassification ability of model for TVF was increased only with post-PCI FFR (net reclassification index 0.627; p = 0.003; integrated discrimination index 0.019; p = 0.015), but not with post-PCI Pd/Pa, compared with model including clinical factors. Compared with patients with post-PCI Pd/Pa >0.92, patients with post-PCI Pd/Pa ≤0.92 and FFR ≤0.80 had significantly higher risk of TVF (10.4% vs. 2.5%; adjusted hazard ratio: 4.204; 95% confidence interval: 1.521 to 11.618; p = 0.006); however, those with post-PCI Pd/Pa ≤0.92 but FFR >0.80 showed similar risk of TVF (3.5% vs. 2.5%; adjusted hazard ratio: 1.327; 95% confidence interval: 0.398 to 4.428; p = 0.645). CONCLUSIONS: Over one-half of the patients with abnormal post-PCI Pd/Pa ≤0.92 showed post-PCI FFR >0.80. Compared with post-PCI FFR, post-PCI Pd/Pa showed limited reclassification ability for the occurrence of TVF. Among patients with abnormal post-PCI Pd/Pa, only patients with positive post-PCI FFR showed significantly higher risk of TVF than did those with post-PCI Pd/Pa >0.92. (Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention [PERSPECTIVEPCI]; NCT04265443).

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.

BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: Combined HLI and high ALP on admission is associated with poor clinical outcomes in patients with STEMI who have undergone primary PCI.

Automated Algorithm Using Pre-Intervention Fractional Flow Reserve Pullback Curve to Predict Post-Intervention Physiological Results.

OBJECTIVES: This study sought to develop an automated algorithm using pre-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) pullback recordings to predict post-PCI physiological results in the pre-PCI phase. BACKGROUND: Both FFR and percent FFR increase measured after PCI showed incremental prognostic implications. However, there is no current method to predict post-PCI physiological results using physiological assessment in the pre-PCI phase. METHODS: An automated algorithm that analyzes instantaneous FFR gradient per unit time (dFFR(t)/dt) was developed from the derivation cohort (n = 30). Using dFFR(t)/dt, the pattern of atherosclerotic disease in each patient was classified into 3 groups (major, mixed, and minor FFR gradient groups) in both the internal validation cohort with constant pullback method (n = 234) and the external validation cohort with nonstandardized pullback methods (n = 252). All patients in the validation cohorts underwent PCI on the basis of pre-PCI FFR ≤0.80. Suboptimal post-PCI physiological results were defined as both post-PCI FFR <0.84 and percent FFR increase ≤15%. From the derivation cohort, cutoffs of dFFR(t)/dt for major and minor FFR gradient were 0.035/s and 0.015/s, respectively. RESULTS: In validation cohorts, dFFR(t)/dt showed significant correlations with percent FFR increase (R = 0.801; p < 0.001) and post-PCI FFR (R = 0.099; p = 0.029). In both the internal and external validation cohorts, the major FFR gradient group showed significantly higher post-PCI FFR and percent FFR increase compared with those in the mixed or minor FFR gradient groups (all p values <0.001). The proportions of suboptimal post-PCI physiological results were significantly different among 3 groups (10.4% vs. 25.8% vs. 45.7% for the major, mixed, and minor FFR gradient groups, respectively; p < 0.001) in validation cohorts. Absence of major FFR gradient lesion (odds ratio: 2.435, 95% [CI]: 1.252 to 4.734; p = 0.009) and presence of minor FFR gradient lesion (odds ratio: 2.756, 95% confidence interval: 1.629 to 4.664; p < 0.001) were independent predictors for suboptimal post-PCI physiological results. CONCLUSIONS: The automated algorithm analyzing pre-PCI pullback curve was able to predict post-PCI physiological results. The incidence of suboptimal post-PCI physiological results was significantly different according to algorithm-based classifications in the pre-PCI physiological assessment. (Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship with Post-PCI Clinical Outcomes [Algorithm-PCI]; NCT04304677).

Long-term clinical outcomes after a percutaneous coronary intervention with a drug-eluting stent in patients with unprotected left main coronary artery disease excluded from clinical trials.

BACKGROUND: Major randomized clinical trials assessing clinical outcomes in patients who underwent a percutaneous coronary intervention (PCI) for left main coronary artery disease excluded some high-risk subsets. Whether the effectiveness and safety of a percutaneous approach in this group of patients are comparable with those observed in clinical trials is unclear. We aimed to explore the long-term outcomes of contemporary drug-eluting stent (DES)-based revascularization for left main coronary artery disease in patients presenting with one or more clinical or angiographic characteristics who would have precluded inclusion in randomized trials. PATIENTS AND METHODS: Between April 2003 and December 2011, 340 consecutive patients with unprotected left main coronary artery stenosis of at least 50% who underwent successful PCI with DES at Sejong General Hospital (Bucheon, Republic of Korea) were included in this retrospective study. Patients were classified into the exclusion group (group E; n=120) and the inclusion group (group I; n=220) according to the prespecified inclusion and exclusion criteria utilized in clinical trials. RESULTS: During the median follow-up of 86 (52-114) months, major adverse cardiac or cerebrovascular events occurred in 69 (31.4%) patients in group I and 46 (38.3%) patients in group E (P=0.155). In the propensity score-matched population, group E was not associated with a higher incidence of major adverse cardiac or cerebrovascular events (hazard ratio: 1.42, 95% confidence interval: 0.76-2.65, P=0.758). Definite or probable stent thrombosis occurred in five patients of group I, with no cases in group E. CONCLUSION: In our real-world registry, about a third of patients who underwent PCI for unprotected left main coronary artery stenosis had one or more high-risk characteristics or comorbid conditions that represent exclusion criteria of previous randomized trials. PCI using DES is feasible in these patients.