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.

Home blood pressure measurement for hypertension management in the real world: Do not just measure, but share with your physician.

Introduction: Studies of the effectiveness of home blood pressure (BP) measurement on the treatment of hypertension in the real world are sparse, and the results are controversial. There is an efficacy-effectiveness gap in the treatment of hypertension using home BP measurements. We aimed to investigate the effect of reporting home BP to physicians on ambulatory BP control as a factor contributing to the efficacy-effectiveness gap in treating patients with hypertension. Methods: We recruited patients ≥20 years of age taking antihypertensive drugs. Office and 24-h ambulatory BP were measured. A questionnaire to the measurement of home BP was conducted. Participants were divided into an HBPM(-) group, home BP was not measured (n = 467); HBPM(+)-R(-) group, home BP was measured but not reported (n = 81); and HBPM(+)-R(+) group, home BP was measured and reported (n = 125). Results: The HBPM(+)-R(+) group had significantly lower office systolic BP (SBP, p = 0.035), 24-h SBP (p = 0.009), and daytime SBP (p = 0.016) than the HBPM(-) group, and lower nighttime SBP (p = 0.005) and diastolic BP (DBP, p = 0.008) than the HBPM(+)-R(-) group. In the multivariate analysis, the differences in 24-h SBP, daytime SBP, and nighttime DBP remained significant. There was a significant difference between groups in the target achievement rate of 24-h SBP (p = 0.046), nighttime SBP (p = 0.021), and nighttime DBP (p = 0.023). The nighttime SBP and DBP target achievement rates in the HBPM(+)-R(+) group were higher than those in the HBPM(+)-R(-) group (p = 0.006 and 0.010, respectively). Among patients measuring home BP, the adjusted odds ratio for 24-h and nighttime BP target achievement in the HBPM(+)-R(+) group were 2.233 and 3.658, respectively. Conclusion: Home BP measurements should be reported to the treating physician to effectively manage hypertension. Clinical trial registration: https://clinicaltrials.gov, identifier NCT03868384.

Association of the magnitude of the difference in blood pressure between office and ambulatory measurements with blood pressure variability in untreated individuals.

OBJECTIVES: We evaluated the association between cardiovascular risk factors and the magnitude of the difference in systolic blood pressure (SBP) between office and ambulatory measurements (masked effect) in untreated individuals without apparent hypertension-mediated organ damage (HMOD). METHODS: The inclusion criteria were 1) age ≥ 20 years, 2) blood pressure ≥ 140/90 mmHg at the outpatient clinic, and 3) not receiving antihypertensive medications. The difference between office and ambulatory SBP was calculated by subtracting the ambulatory daytime SBP from the office SBP. The association between the masked effect and SBP variability was analyzed in individuals without HMOD (no electrocardiographic left ventricular hypertrophy, spot urine albumin-to-creatinine ratio < 30 mg/g, and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2, n = 296). RESULTS: Among the cardiovascular risk factors, ambulatory BP variability was significantly correlated with the SBP difference. The standard deviation (SD) and coefficient of variation (cv) of 24-h SBP exhibited a significant negative linear association with the SBP difference in univariate and multivariate analyses adjusted for age, sex, presence of diabetes, and 24-h ambulatory SBP. A significant association was observed in patients with ambulatory daytime hypertension. In the multivariate analysis, individuals with a negative SBP difference > -5 mmHg exhibited a higher SD and cv of 24-h SBP than those with a negative SBP difference ≤ -5 mmHg or a positive SBP difference. CONCLUSIONS: The results of our study suggest that the magnitude of the negative difference in office and ambulatory SBP may be a potential risk factor, even in individuals without apparent HMOD. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov ( NCT03855605 ).

Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial.

Background: Drug-coated balloons (DCBs) offer an effective treatment for in-stent restenosis (ISR). The Genoss DCB is a novel paclitaxel-coated balloon with a shellac plus vitamin E excipient that enhances drug delivery to the target lesion, minimizing restenosis. Objectives: This study aimed to investigate the angiographic efficacy, clinical safety, and effectiveness of the novel shellac plus vitamin E-based DCB in a randomized controlled trial designed to enable regulatory approval of this new device in South Korea. Methods: This noninferiority trial randomized patients experiencing their first ISR to the novel shellac plus vitamin E-based DCB or the reference SeQuent Please iopromide-based DCB in a 1:1 ratio. All patients underwent planned angiographic and clinical follow-up at 6 months. The study was powered for the primary endpoint of 6 months in-segment late lumen loss (LLL). Results: A total of 82 patients from 7 centers were randomized to either the novel shellac plus vitamin E-based DCB group (n = 41) or the reference iopromide-based DCB group (n = 41). The 6-month in-segment LLL was 0.15 ± 0.43 mm with the novel DCB compared with 0.24 ± 0.39 mm with the reference device. The 1-sided 97.5% upper confidence limit of the difference was 0.13 mm, lower than the noninferiority limit of 0.29 mm, achieving noninferiority (P for noninferiority = 0.001). Major cardiovascular events were comparable between 2 groups at 6 months (7.7% for the novel DCB vs 10.3% for the reference DCB; P = 0.692). Conclusions: In this multicenter, head-to-head comparison randomized trial, the novel shellac plus vitamin E-based DCB showed a comparable result to the reference iopromide-based device for the primary endpoint of 6-month in-segment LLL for the treatment of coronary ISR. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis; NCT04405063).

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.

Prognostic Impact of Plasma Glucose on Patients With Cardiogenic Shock With or Without Diabetes Mellitus from the SMART RESCUE Trial.

Although the presence of hyperglycemia has been shown to affect the clinical outcome of patients with cardiogenic shock, the extent of hyperglycemia and its association with prognosis have not been fully addressed in a large population. A total of 1,177 consecutive patients with cardiogenic shock were enrolled from January 2014 to December 2018 at 12 hospitals in South Korea. The primary outcome was in-hospital mortality. Patients were divided into 4 groups according to their initial plasma glucose level in patients with diabetes mellitus (DM) (n = 752) and patients without DM (n=425); group 1 (≤8 mmol/L or 144 mg/100 ml), group 2 (8 to 12 mmol/L or 144 to 216 mg/100 ml), group 3 (12 to 16 mmol/L or 216 to 288 mg/100 ml), and group 4 (≥16 mmol/L or 288 mg/100 ml). The groups with higher admission plasma glucose were associated with lower systolic blood pressure and higher lactic acid levels in patients with and without DM. In-hospital mortality increased in groups with higher admission plasma glucose level in patients without DM (group 1:24.2%, group 2: 28.6%, group 3: 38.1%, group 4: 49.0%, p <0.01), whereas in patients with DM, mortality and admission plasma glucose level showed no significant association (group 1: 45%, group 2: 35.4%, group 3: 33.3%, group 4: 43.1%, p = 0.26). Even after multivariate analysis, high plasma glucose was an independent predictor of in-hospital mortality in patients without DM. In patients with cardiogenic shock, plasma glucose obtained at admission was associated with in-hospital mortality in patients without DM.

Influence of individual proton pump inhibitors on clinical outcomes in patients receiving clopidogrel following percutaneous coronary intervention.

BACKGROUND: Data are conflicting on whether proton pump inhibitors (PPIs) diminish the efficacy of clopidogrel. We investigated individual PPIs and adverse cardiovascular events in postpercutaneous coronary intervention (PCI) patients on dual antiplatelet therapy with clopidogrel. METHODS: We searched Ovid-MEDLINE, EMBASE, and Cochrane from inception to March 2020 to identify studies that evaluated the efficacy and safety of clopidogrel added PPIs versus clopidogrel only in post-PCI patient. We extracted data from 28 studies for major adverse cardiovascular endpoints (MACE), myocardial infarction (MI), cardiovascular death, and gastrointestinal bleeding. Risk ratios (RR) and hazard ratios (HR) were pooled separately. RESULTS: Data were extracted on 131,412 patients from the 28 studies included. Concomitant use of PPI with clopidogrel was associated with increased risk of MACE (RR 1.30; 95% confidence interval [CI] 1.15-1.48; P < .001) and MI (RR 1.43; 95% CI 1.25-1.64; P < .001). Random-effects meta-analyses with individual PPIs demonstrated an increased risk of MACE in those taking pantoprazole (RR 1.31; 95% CI 1.07-1.61, P = .01) or lansoprazole (RR 1.35; 95% CI 1.19-1.54, P < .0001) compared with patients not on PPIs. Likewise, in adjusted analyses, the pooled HR of adjusted events for MACEs showed that the increased risk of MACEs was similar for 4 classes of PPIs but not for rabeprazole (HR: 1.32; 95% CI 0.69-2.53, P = .40). CONCLUSION: The post-PCI patients on dual antiplatelet therapy with clopidogrel in the PPI group were associated with higher risk of MACE and MI. Although the results for rabeprazole were not robust, it was the only PPI that did not yield a significantly increased risk of MACE.

Algorithm for diagnosing hypertension using out-of-office blood pressure measurements.

The authors developed and validated a diagnostic algorithm using the optimal upper and lower cut-off values of office and home BP at which ambulatory BP measurements need to be applied. Patients presenting with high BP (≥140/90 mm Hg) at the outpatient clinic were referred to measure office, home, and ambulatory BP. Office and home BP were divided into hypertension, intermediate (requiring diagnosis using ambulatory BP), and normotension zones. The upper and lower BP cut-off levels of intermediate zone were determined corresponding to a level of 95% specificity and 95% sensitivity for detecting daytime ambulatory hypertension by using the receiver operator characteristic curve. A diagnostic algorithm using three methods, OBP-ABP: office BP measurement and subsequent ambulatory BP measurements if office BP is intermediate zone; OBP-HBP-ABP: office BP, subsequent home BP measurement if office BP is within intermediate zone and subsequent ambulatory BP measurement if home BP is within intermediate zone; and HBP-ABP: home BP measurement and subsequent ambulatory BP measurements if home BP is within intermediate zone, were developed and validated. In the development population (n = 256), the developed algorithm yielded better diagnostic accuracies than 75.8% (95%CI 70.1-80.9) for office BP alone and 76.2% (95%CI 70.5-81.3) for home BP alone as follows: 96.5% (95%CI: 93.4-98.4) for OBP-ABP, 93.4% (95%CI: 89.6-96.1) for OBP-HBP-ABP, and 94.9% (95%CI: 91.5-97.3%) for HBP-ABP.  In the validation population (n = 399), the developed algorithm showed similarly improved diagnostic accuracy. The developed algorithm applying ambulatory BP measurement to the intermediate zone of office and home BP improves the diagnostic accuracy for hypertension.

Prevalence and characteristics of isolated nocturnal hypertension in the general population.

BACKGROUND/AIMS: Ascertaining the prevalence of isolated nocturnal hypertension (INHT) in the general population and identifying the characteristics of patients with INHT may be important to determine patients who should receive 24- hour ambulatory blood pressure (BP) measurements. This study aimed to evaluate the prevalence and characteristics of INHT in the general population. METHODS: Of 1,128 participants (aged 20 to 70 years), we analyzed 823 who had valid 24-hour ambulatory BP measurements and were not on antihypertensive drug treatment. RESULTS: The prevalence of INHT in the study was 22.8%. Individuals with INHT had a higher office, 24-hour, and daytime and nighttime ambulatory systolic and diastolic BPs compared to individuals with sustained day-night normotension. INHT was more prevalent in individuals with masked hypertension (MH) than in those with sustained hypertension (59.8% vs. 15.6%, p < 0.001). Among individuals with INHT, 92.6% had MH. Among individuals with office BP-based prehypertension, 34.5% had both INHT and MH. The prevalence of INHT was highest in individuals with office BP-based prehypertension. INHT was an independent determinant of MH after adjustment for age, sex, body mass index, diabetes, low-density-lipoprotein cholesterol, 24-hour systolic and diastolic BP, systolic and diastolic BP dipping, and systolic and diastolic BP non-dipping. CONCLUSION: The present study showed that INHT is not uncommon and is a major determinant of MH. Our findings strongly suggest the use of 24-hour ambulatory BP measurement for individuals within the prehypertension range of office BP owing to the high prevalence of INHT and MH in this population.

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.

Differential clinical impact of chronic total occlusion revascularization based on left ventricular systolic function.

BACKGROUND: The effect of chronic total occlusion (CTO) revascularization on survival remains controversial. Furthermore, data regarding outcome differences for CTO revascularization based on left ventricular systolic function (LVSF) are limited. The differential outcomes from CTO revascularization in patients with preserved LVSF (PLVSF) versus reduced LVSF (RLVSF) were assessed. METHODS: A total of 2,173 CTO patients were divided into either a PLVSF (n = 1661, Ejection fraction ≥ 50%) or RLVSF (n = 512, < 50%) group. Clinical outcomes were compared between successful CTO revascularization (SCR) versus optimal medical therapy (OMT) within each group. The primary endpoint was a composite of all-cause death or non-fatal myocardial infarction. Inverse probability of treatment weighting for endpoint analysis and a contrast test for comparison of survival probability differences according to LVSF were used. RESULTS: Patients with RLVSF had a mean 37% ejection fraction (EF) and 19% had EF < 30%. The median follow-up duration was 1,138 days. Regardless of LVSF, the primary endpoint incidence was significantly lower in patients treated with SCR [RLVSF: 29.7% vs. 49.7%, hazard ratio (HR) = 0.46, 95% confidence interval (CI): 0.36-0.62, p < 0.0001; PLVSF 7.3% vs. 16.9%, HR = 0.68, 95% CI: 0.54-0.93, p = 0.0019], which was mainly driven by a reduction in cardiac death. The difference in survival probability was greater and became more pronounced over time in patients with RLVSF than with PLVSF (1-year, p = 0.197; 3-years, p = 0.048; 5-years, p = 0.036). CONCLUSIONS: SCR was associated with better survival benefit than OMT regardless of LVSF. The benefit was greater and became more significant over time in patients with RLVSF versus PLVSF.

Characteristics of Individuals with Disagreement between Home and Ambulatory Blood Pressure Measurements for the Diagnosis of Hypertension.

Home and ambulatory blood pressure (BP) measurements are recommended for the diagnosis of hypertension. However, the clinical characteristics of individuals showing a diagnostic disagreement between their home and ambulatory BP measurements are unclear. Of the 470 individuals who were not on antihypertensive drug treatment with a BP ≥140/90 mmHg at an outpatient clinic, 399 who had valid office, home, and ambulatory BP results were included. Hypertension was diagnosed based on an average home BP ≥135/85 mmHg and/or an average daytime ambulatory BP ≥135/85 mmHg. The participants were divided into three groups: Agree-NT (home and ambulatory BP normotension), Disagree (home BP normotension and ambulatory BP hypertension, or home BP normotension and ambulatory BP hypertension), and Agree-HT (home and ambulatory BP hypertension). Eighty-four individuals (21.1%) were classified as the Disagree group. The mean serum creatinine, triglycerides, and electrocardiogram voltage in the Disagree group were intermediate between those observed in the Agree-NT and the Agree-HT group. In the Disagree group, the mean levels of office and home diastolic BP, all of the components of ambulatory BP, the aortic systolic BP, and the BP variabilities were found to be intermediate between those of the Agree-NT and the Agree-HT groups. These results indicate that individuals showing a diagnostic disagreement between their home and ambulatory BP may have cardiovascular risks that are intermediate between those with sustained home and ambulatory normotension and hypertension.

Prospective partially randomized comparison of clopidogrel loading versus maintenance dosing to prevent periprocedural myocardial infarction after stenting for stable angina pectoris: Results from the "Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients (MECCA)" study.

WHAT IS KNOWN AND OBJECTIVE: Pre-treatment of clopidogrel 600 mg is better than 300 mg loading for reducing periprocedural myocardial infarction (PMI). We aimed to evaluate pre-treatment methods for preventing PMI among patients undergoing conventional coronary angiography (CAG) for stable angina pectoris. MATERIALS AND METHODS: The study analyzed 402 patients who underwent percutaneous coronary intervention (PCI) during 2010 - 2011 at three Korean hospitals. Clopidogrel-naïve patients received routine maintenance therapy (75 mg/day for ≥ 5 days) and were randomly assigned to a 300-mg reload (RL) or only the maintenance dose (MD). Patients who received a loading dose (LD; 600 mg at 2 - 24 hours before the procedure) were entered into a non-randomized group. RESULTS: After excluding patients who showed an abnormal creatinine kinase myocardial band (CK-MB) level, the study included 233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group. The LD group had a significantly higher rate of PMI (LD: 21, RL: 3, MD: 0 cases; p = 0.007) and a significant increase in the mean CK-MB levels after 8 hours (p = 0.016) and 24 h (p = 0.01). However, there was no difference in PMI between the RL and MD groups. Furthermore, no significant differences between the three groups were observed in the P2Y12 reaction unit (PRU) values (p = 0.57). Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. WHAT IS NEW AND CONCLUSION: Clopidogrel maintenance is better than 600-mg loading for preventing PMI, and the RL protocol did not further prevent PMI.

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.

A comparison of procedural success rate and long-term clinical outcomes between in-stent restenosis chronic total occlusion and de novo chronic total occlusion using multicenter registry data.

BACKGROUND: There have been little data about outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusion (CTO) in the drug eluting stent (DES) era. This study aimed to compare the procedural success rate and long-term clinical outcomes of ISR CTO and de novo CTO. METHODS AND RESULTS: Patients who underwent PCI for ISR CTO (n = 164) versus de novo CTO (n = 1208) were enrolled from three centers in Korea between January 2008 and December 2014. Among a total of ISR CTO, a proportion of DES ISR CTO was 79.3% (n = 130). The primary outcome was major adverse cardiac events (MACEs); a composite of all-cause death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR). Following propensity score-matching (1:3), the ISR CTO group (n = 156) had a higher success rate (84.6% vs. 76.0%, p = 0.035), mainly driven by high success rate of PCI for DES ISR CTO (88.6%), but showed a higher incidence of MACEs [hazard ratio (HR): 2.06; 95% confidence interval (CI) 1.37-3.09; p < 0.001], mainly driven by higher prevalence of MI [HR: 9.71; 95% CI 2.06-45.81; p = 0.004] and TLR [HR: 3.04; 95% CI 1.59-5.81; p = 0.001], during 5 years of follow-up after successful revascularization, as compared to the de novo CTO group (n = 408). CONCLUSION: The procedural success rate was higher in the ISR CTO than the de novo CTO, especially in DES ISR CTO. However, irrespective of successful revascularization, the long-term clinical outcomes for the ISR CTO were significantly worse than those for the de novo CTO, in terms of MI and TLR.

Efficacy of postprocedural anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: A post-hoc analysis of the randomized INNOVATION trial.

There exists controversy on whether and for how long anticoagulation is necessary after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).We aimed to study the impact of prolonged (>24 h) or brief (<24 h) postprocedural anticoagulation on infarct size assessed by cardiac magnetic resonance (CMR) after 30 days as well as on left ventricular ejection fraction (LVEF) and left ventricular (LV) remodeling evaluated by 2D-echocardiography after 9 months from the INNOVATION trial (Clinical Trial Registration: NCT02324348).Of the 114 patients (mean age: 59.5 years) enrolled, 76 (66.7%) received prolonged anticoagulation therapy (median duration: 72.6 h) and 38 (33.3%) patients received brief anticoagulation therapy (median duration: 5 h) after primary PCI. There was no significant difference in infarct size (mean size: 15.6% after prolonged anticoagulation versus 19.8% after brief anticoagulation, P = .100) and the incidence of microvascular obstruction (50.7% versus 52.9%, P = .830) between the groups. Even after adjusting, prolonged anticoagulation therapy could not reduce larger infarct (defined as >75 percentile of infarct size; 19.7% versus 35.3%; adjusted odd ratio [OR]: 0.435; 95% confidence interval [CI]: 0.120-1.57; P = .204). Similar results were observed in subanalyses of major high-risk subgroups. Moreover, follow-up LVEF <35% (3.2% versus 7.4%; adjusted OR: 0.383; 95% CI: 0.051-2.884; P = .352) and LV remodeling (defined as >20% increase in LV end-diastolic volume; 37.1% versus 18.5%; adjusted OR: 2.249; 95% CI: 0.593-8.535; P = .234) were similar between groups.These data suggest that prolonged postprocedural anticoagulation may not provide much benefit after successful primary PCI in patients with STEMI. However, further studies are needed.

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.

Clinical outcomes of patients with coronary artery aneurysm after the first generation drug-eluting stent implantation.

OBJECTIVES: We sought to investigate the long-term clinical outcomes of patients with coronary artery aneurysm (CAA) after drug-eluting stent (DES) implantation, compared with patients without CAA. BACKGROUND: CAA developed after DES implantation is a rare but associated with poor clinical outcome. METHODS: We retrospectively compared 78 patients with CAA after DES implantation with 269 patients without CAA who underwent DES implantation for complex lesions (controls). The primary endpoint was defined as major adverse cardiac events (MACE), the composite of all-cause death, nonfatal myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: Morphologically, CAAs were saccular (32%), fusiform (13%), or microform (55%). The stent types involved were Cypher (n = 56, 71.8%) and Taxus (n = 22, 28.2%). During a median follow-up period of 1164 days, the incidence of MACE was significantly higher in the CAA group (26.9 vs. 2.2%, P < 0.001); the difference was driven mainly by nonfatal MI (11.5 vs. 0%, P < 0.001) and TLR (20.5 vs. 1.9%, P < 0.001). The incidence of stent thrombosis was higher in the CAA group (12.8 vs. 0.74%, P < 0.001), irrespective of the maintenance of dual antiplatelet therapy. In the CAA group, Cox regression analysis showed significantly higher hazard ratios of CAA for MACE during the follow-up period. Further analyses after propensity-score matching of 65 pairs also showed similar results. CONCLUSIONS: The incidence of MACE was higher in patients with CAA compared with patients without CAA after DES implantation. This difference was driven by TLR and nonfatal MI and widened over time.

Prognostic Impact of Combined Dysglycemia and Hypoxic Liver Injury on Admission in Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (from the INTERSTELLAR Cohort).

Dysglycemia on admission is known to predict the prognosis of ST-segment elevation myocardial infarction (STEMI). Recently, hypoxic liver injury (HLI) has been proposed as a novel prognosticator for STEMI. We evaluated the prognostic impact of combined dysglycemia and HLI at the time of presentation in patients with STEMI who underwent primary percutaneous coronary intervention. From 2007 to 2014, 1,525 consecutive patients (79% men, mean age 61 years) who underwent primary percutaneous coronary intervention for STEMI in the INTERSTELLAR (Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute ST-Elevation Myocardial Infarction) cohort were analyzed retrospectively. Dysglycemia was defined as either hypoglycemia (serum glucose <90 mg/dl) or hyperglycemia (serum glucose >250 mg/dl). HLI was defined as more than twofold increase of any serum aminotransferases above the upper normal limit. Patients were divided into 4 groups according to their dysglycemia and HLI status on admission: group 1, normoglycemia without HLI; group 2, dysglycemia without HLI; group 3, normoglycemia with HLI; and group 4, dysglycemia with HLI. Primary end point was inhospital death and secondary end point was all-cause mortality at 12 months after the index procedure. Of the 1,525 patients, there were 87 inhospital deaths (5.7%) and 113 all-cause deaths (7.4%) at 12 months after the index procedure. Both dysglycemia and HLI on admission were independent predictors of inhospital death. Inhospital mortality rate was the highest in group 4 (32.1%), followed by groups 2 and 3. Kaplan-Meier survival analysis at 12 months showed similar trends among the 4 groups. In conclusion, combined dysglycemia and HLI on admission predicts early prognosis for STEMI.

INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction).

BACKGROUND: The aim of this study was to assess whether deferred stenting (DS) reduces infarct size and microvascular obstruction (MVO) compared with immediate stenting (IS) in primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction. METHODS AND RESULTS: From February 2013 to August 2015, 114 patients (mean age: 69 years) were randomized into the following 2 groups: DS with an intention to stent 3 to 7 days later or IS after primary reperfusion in 2 centers. The primary and secondary end points were infarct size and the incidence of MVO, respectively, assessed by cardiac magnetic resonance imaging at 30 days after primary reperfusion. The median time to the second procedure in the DS was 72.8 hours. Six patients in the DS group were crossed over to the IS group because of progression of dissection or safety concerns after randomization. In the intention-to-treat analysis, DS did not significantly reduce infarct size (15.0% versus 19.4%; P=0.112) and the incidence of MVO (42.6% versus 57.4%; P=0.196), compared with IS. However, in anterior wall myocardial infarction, infarct size (16.1% versus 22.7%; P=0.017) and the incidence of MVO (43.8% versus 70.3%; P=0.047) were significantly reduced in the DS group. There was no urgent revascularization event during deferral period. CONCLUSIONS: A routine DS did not significantly reduce infarct size and MVO compared with IS, although it was safe. The beneficial effect of DS in patients with anterior myocardial infarction should be confirmed by larger randomized studies. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02324348.