Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.

Iliac artery angioplasty with stenting is an effective alternative treatment modality for aortoiliac occlusive diseases. Few randomized controlled trials have compared the efficacy and safety between self-expandable stent (SES) and balloon-expandable stent (BES) in atherosclerotic iliac artery disease. In this randomized, multicenter study, patients with common or external iliac artery occlusive disease were randomly assigned in a 1:1 ratio to either BES or SES. The primary end point was the 1-year clinical patency, defined as freedom from any surgical or percutaneous intervention due to restenosis of the target lesion after the index procedure. The secondary end point was a composite event from major adverse clinical events at 1 year. A total of 201 patients were enrolled from 17 major cardiovascular intervention centers in South Korea. The mean age of the enrolled patients was 66.8 ± 8.5 years and 86.2% of the participants were male. The frequency of critical limb ischemia was 15.4%, and the most common target lesion was in the common iliac artery (75.1%). As the primary end point, the 1-year clinical patency as primary end point was 99% in the BES group and 99% in the SES group (p > 0.99). The rate of repeat revascularization at 1 year was 7.8% in the BES group and 7.0% in the SES group (p = 0.985; confidence interval, 1.011 [0.341-2.995]). In our randomized study, the treatment of iliac artery occlusive disease with self-expandable versus balloon-expandable stent was comparable in 12-month clinical outcomes without differences in the procedural success or geographic miss rate regardless of the deployment method in the distal aortoiliac occlusive lesion (ClinicalTrials.gov, NCT01834495).

Effect of delayed hospitalization on patients with non-ST-segment elevation myocardial infarction and complex lesions undergoing successful new-generation drug-eluting stents implantation.

In the absence of available data, we evaluated the effects of delayed hospitalization (symptom-to-door time [SDT] ≥ 24 h) on major clinical outcomes after new-generation drug-eluting stent implantation in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and complex lesions. In total, 4373 patients with NSTEMI were divided into complex (n = 2106) and non-complex (n = 2267) groups. The primary outcome was the 3-year rate of major adverse cardiac events (MACE), defined as all-cause death, recurrent MI, and any repeat revascularization. Secondary outcomes included the individual MACE components. In the complex group, all-cause death (adjusted hazard ratio [aHR], 1.752; p = 0.004) and cardiac death (aHR, 1.966; p = 0.010) rates were significantly higher for patients with SDT ≥ 24 h than for those with SDT < 24 h. In the non-complex group, all patients showed similar clinical outcomes. Patients with SDT < 24 h (aHR, 1.323; p = 0.031) and those with SDT ≥ 24 h (aHR, 1.606; p = 0.027) showed significantly higher rates of any repeat revascularization and all-cause death, respectively, in the complex group than in the non-complex group. Thus, in the complex group, delayed hospitalization was associated with higher 3-year mortalities.

Development and validation of equation for cardiorespiratory fitness in patients with heart failure with preserved ejection fraction.

BACKGROUND/AIMS: Cardiorespiratory fitness (CRF), as measured by maximal oxygen consumption (VO2max), is an important independent predictive factor of cardiovascular outcomes in patients with heart failure (HF). However, it is unclear whether conventional equations for estimating CRF are applicable to patients with HF with preserved ejection fraction (HFpEF). METHODS: This study included 521 patients with HFpEF (EF ≥ 50%) whose CRF was directly measured by cardiopulmonary exercise test using a treadmill. We developed a new equation (Kor-HFpEF) for half of the patients in the HFpEF cohort (group A, n = 253) and validated it for the remaining half (group B, n = 268). The accuracy of the Kor-HFpEF equation was compared to that of the other equations in the validation group. RESULTS: In the total HFpEF cohort, the directly measured VO2max was significantly overestimated by the FRIEND and ACSM equations (p < 0.001) and underestimated by the FRIEND-HF equation (p <0.001) (direct 21.2 ± 5.9 mL/kg/min; FRIEND 29.1 ± 11.8 mL/kg/min; ACSM 32.5 ± 13.4 mL/kg/min; FRIEND-HF 14.1 ± 4.9 mL/kg/min). However, the VO2max estimated by the Kor-HFpEF equation (21.3 ± 4.6 mL/kg/min) was similar to the directly measured VO2max (21.7 ± 5.9 mL/kg/min, p = 0.124), whereas the VO2max estimated by the other three equations was still significantly different from the directly measured VO2max in group B (all p < 0.001). CONCLUSION: Traditional equations used to estimate VO2max were not applicable to patients with HFpEF. We developed and validated a new Kor-HFpEF equation for these patients, which had a high accuracy.

Effect of delayed hospitalization on 3-year clinical outcomes according to renal function in patients with non-ST-segment elevation myocardial infarction.

BACKGROUND: We evaluated the effect of delayed hospitalization (symptom-to-door time [STD] ≥ 24 h) on 3-year clinical outcomes according to renal function in patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing new-generation drug-eluting stent (DES) implantation. METHODS: A total of 4513 patients with NSTEMI were classified into chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m², n = 1118) and non-CKD (eGFR ≥ 60 mL/min/1.73 m², n = 3395) groups. They were further sub-classified into groups with (STD ≥ 24 h) and without (STD < 24 h) delayed hospitalization. The primary outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, any repeat coronary revascularization, and stroke. The secondary outcome was stent thrombosis (ST). RESULTS: After multivariable-adjusted and propensity score analyses, the primary and secondary clinical outcomes were similar in patients with or without delayed hospitalization in both CKD and non-CKD groups. However, in both the STD < 24 h and STD ≥ 24 h groups, MACCE (p < 0.001 and p < 0.006, respectively) and mortality rates were significantly higher in the CKD group than in the non-CKD group. However, ST rates were similar between the CKD and non-CKD groups and between the STD < 24 h and STD ≥ 24 h groups. CONCLUSIONS: Chronic kidney disease appears to be a much more important determinant of MACCE and mortality rates than STD in patients with NSTEMI.

Effects of delayed hospitalization on the 3-year clinical outcomes of patients with or without diabetes who had non-ST-segment-elevation myocardial infarction and underwent new-generation drug-eluting stent implantation.

Clinical outcomes after non-ST-segment-elevation myocardial infarction (NSTEMI) in patients with (symptom-to-door time [SDT] ≥ 24 h) or without (SDT < 24 h) delayed hospitalization among patients with or without diabetes were compared. From the Korea Acute Myocardial Infarction Registry-National Institute of Health, a total of 4517 patients with NSTEMI who underwent new-generation drug-eluting stents implantation were recruited and they were classified into the diabetes mellitus (DM) and non-DM groups. These two groups were subdivided into groups with and without delayed hospitalization. The primary clinical outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, repeat coronary revascularization, and stroke. The secondary clinical outcome was the occurrence of individual components of MACCE and stent thrombosis. Although after multivariable and propensity score-adjusted analyses in the DM group, the primary and secondary clinical outcomes between the SDT < 24 h and SDT ≥ 24 h groups were similar; in the non-DM group, all-cause (p = 0.003 and p = 0.007, respectively) and cardiac (p = 0.001 and p = 0.008, respectively) death rates were significantly higher in the SDT ≥ 24 h group than in the SDT < 24 h group. Our results suggested that there was no significant difference in prognosis between diabetic patients with and without delayed SDT, but delayed SDT was associated with poor prognosis in nondiabetic patients.

Sex Differences in Delayed Hospitalization in Patients with Non-ST-Segment Elevation Myocardial Infarction Undergoing New-Generation Drug-Eluting Stent Implantation.

We compared the effects of sex differences in delayed hospitalization (symptom-to-door time [SDT], ≥24 h) on major clinical outcomes in patients with non-ST-segment elevation myocardial infarction after new-generation drug-eluting stent implantation. A total of 4593 patients were classified into groups with (n = 1276) and without delayed hospitalization (SDT < 24 h, n = 3317). Thereafter, these two groups were subdivided into male and female groups. The primary clinical outcomes were major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, repeat coronary revascularization, and stroke. The secondary clinical outcome was stent thrombosis. After multivariable- and propensity score-adjusted analyses, in-hospital mortalities were similar between the male and female groups in both the SDT < 24 h and SDT ≥ 24 h groups. However, during a 3-year follow-up period, in the SDT < 24 h group, all-cause death (p = 0.013 and p = 0.005, respectively) and cardiac death (CD, p = 0.015 and p = 0.008, respectively) rates were significantly higher in the female group than those in the male group. This may be related to the lower all-cause death and CD rates (p = 0.022 and p = 0.012, respectively) in the SDT < 24 h group than in the SDT ≥ 24 h group among male patients. Other outcomes were similar between the male and female groups and between the SDT < 24 h and SDT ≥ 24 h groups. In this prospective cohort study, female patients showed higher 3-year mortality, especially in the SDT < 24 h, compared to male patients.

Immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease: results from a prematurely discontinued randomized multicenter trial.

BACKGROUND: We aimed to compare clinical outcomes between immediate and staged complete revascularization in primary percutaneous coronary intervention (PCI) for treating ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). METHODS: A total of 248 patients were enrolled in a prospective, randomized, and multicenter registry. Immediate revascularization was defined as one-time PCI of culprit and non-culprit lesions at the initial procedure. Staged revascularization was defined as PCI of non-culprit lesions at a later date (mean, 4.4 days; interquartile range, 1-11.4), following initial culprit revascularization. The end points were major adverse cardiovascular events (MACE; composite of total death, recurrent myocardial infarction, and revascularization), any individual components of MACE, cardiac death, stent thrombosis, and stroke at 12 months. RESULTS: During a follow-up of 1 year, MACE occurred in 12 patients (11.6%) in the immediate revascularization group and in 8 patients (7.5%) in staged revascularization group (hazard ratio [HR] 1.60, 95% confidence interval [CI] 0.65-3.91). The incidence of total death was numerically higher in the immediate group than in the staged group (9.7% vs 2.8%, HR 3.53, 95% CI 0.97-12.84); There were no significant differences between the 2 groups in risks of any individual component of MACE, cardiac death, stroke, and in-hospital complications, such as need for transfusion, bleeding, acute renal failure, and acute heart failure. This study was prematurely terminated due to halt of production of everolimus-eluting stents (manufactured as PROMUS Element by Boston Scientific, Natick, Massachusetts). CONCLUSIONS: Due to its limited power, no definite conclusion can be drawn regarding complete revascularization strategy from the present study. Further large randomized clinical trials would be warranted to confirm optimal timing of complete revascularization for patients with STEMI and MVD.

Prognostic impact of nitrate therapy in patients with myocardial bridge and coexisting coronary artery spasm.

The aim of this study was to investigate the prognostic impact of nitrate therapy in patients with myocardial bridge (MB) and coexisting coronary artery spasm (CAS). MB often accompanies CAS. Nitrates have been widely used as anti-ischemic drugs in CAS patients, while it is not recommended in MB patients. Thus, we investigated the long-term impact of nitrate on clinical outcomes in patients with both CAS and MB. A retrospective observational study was performed using propensity score matching (PSM) in a total of 757 consecutive MB patients with positive acetylcholine (Ach) provocation test. Patients were divided into two groups according to the regular administration of nitrates (nitrate group: n = 504, No nitrate group; n = 253). The PSM was used to adjust for selection bias and potential confounding factors, and major clinical outcomes were compared between the two groups up to 5 years. Baseline characteristics were well-matched between the two groups following PSM (n = 211 for both groups). There was no significant difference in the incidence of death, myocardial infarction, and major adverse cardiovascular events (MACEs) between the two groups. However, the nitrate group showed a significantly higher rate of recurrent angina which subsequently needed re-evaluation of coronary arteries by follow-up angiography (15.7 vs. 5.7%, Log-rank p = 0.012) compared to the non-nitrate group. Long-term nitrate administration in patients with MB and coexisting CAS did not show benefit in reducing MACE, rather it was associated with a higher incidence of recurrent angina requiring follow-up angiography.

Comparison of Clinical Outcomes after Non-ST-Segment and ST-Segment Elevation Myocardial Infarction in Diabetic and Nondiabetic Populations.

Using a new-generation drug-eluting stent, we compared the 2-year clinical outcomes of patients with diabetes mellitus (DM) and non-DM concomitant with a non-ST-segment elevation myocardial infarction (NSTEMI) and an ST-segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention. A total of 11,798 patients with acute myocardial infarction were classified into two groups: DM (NSTEMI, n = 2399; STEMI, n = 2693) and non-DM (NSTEMI, n = 2694; STEMI, n = 4012). The primary clinical outcome was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction, or any coronary repeat revascularization. The secondary outcome was the occurrence of definite or probable stent thrombosis. In all the patients, both multivariable and propensity score-adjusted analyses revealed that the incidence rates of MACE (adjusted hazard ratio (aHR), 1.214; p = 0.006 and aHR, 1.298; p = 0.002, respectively), all-cause death, cardiac death (CD), and non-CD rate were significantly higher in the NSTEMI group than in the STEMI group. Additionally, among patients with NSTEMI, there was a higher non-CD rate (aHR, 2.200; p = 0.007 and aHR, 2.484; p = 0.004, respectively) in the DM group and a higher CD rate (aHR, 2.688; p < 0.001 and 2.882; p < 0.001, respectively) in the non-DM group. In this retrospective study, patients with NSTEMI had a significantly higher 2-year mortality rate than those with STEMI did. Furthermore, strategies to reduce the non-CD rate in patients with DM and the CD rate in patients without DM could be beneficial for those with NSTEMI.

Comparison of 3-Year Outcomes between Early and Delayed Invasive Strategies in Older and Younger Adults with Non-ST-Segment Elevation Myocardial Infarction Undergoing New-Generation Drug-Eluting Stent Implantation.

We evaluated the 3-year clinical outcomes of early invasive (EI) and delayed invasive (DI) strategies in older and younger adults with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing successful new-generation drug-eluting stent (DES) implantation to reflect current real-world practice. Overall, 4513 patients with NSTEMI were recruited from the Korea Acute Myocardial Infarction Registry-National Institute of Health and divided into two groups according to age: group A (age ≥ 65 years, n = 2253) and group B (age < 65 years, n = 2260). These two groups were further divided into two subgroups: group EI (A1 and B1) and DI (A2 and B2). The primary clinical outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCEs), defined as all-cause death, recurrent MI (re-MI), any repeat coronary revascularization, or stroke. The secondary clinical outcome was definite or probable stent thrombosis (ST). In both groups A and B, after multivariable-adjusted and propensity score-adjusted analyses, MACCE (group A, p = 0.137 and p = 0.255, respectively; group B, p = 0.171 and p = 0.135, respectively), all-cause death, cardiac death (CD), non-CD, re-MI, any repeat revascularization, stroke, and ST rates were similar between the EI and DI groups. When including only those with complex lesions, the primary and secondary clinical outcomes were not significantly different between the EI and DI groups. In the era of new-generation DESs, major clinical outcomes were not significantly different between the EI and DI strategies in both older and younger adults with NSTEMI.

Outcomes of early versus delayed invasive strategy in older adults with non-ST-segment elevation myocardial infarction.

We evaluated the 3-year clinical outcomes following early invasive (EI) and delayed invasive (DI) strategies in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing successful new-generation drug-eluting stents (DESs) implantation to reflect current real-world practice. Overall, 2437 older adults (age, ≥ 65 years) with NSTEMI were recruited from the Korea Acute Myocardial Infarction Registry-National Institute of Health. They were divided into two groups: EI (n = 1750) and DI (n = 687). The primary clinical outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCEs), defined by all-cause death, recurrent MI, any repeat coronary revascularization, and stroke. The secondary clinical outcome was stent thrombosis (ST). After multivariable-adjusted and propensity score-matched analyses, the primary and secondary clinical outcomes were not significantly different between the EI and DI groups. Even after the analysis was confined to those having complex lesions, these major clinical outcomes were similar between these two groups. The EI and DI strategies in older adults with NSTEMI receiving new-generation DES showed comparable results.Clinical Trial Registration: URL: http://cris.nih.go.kr/cris/en/ ; Unique identifier: KCT0000863.

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.

A Smartphone App (AnSim) With Various Types and Forms of Messages Using the Transtheoretical Model for Cardiac Rehabilitation in Patients With Coronary Artery Disease: Development and Usability Study.

BACKGROUND: Despite strong evidence of clinical benefit, cardiac rehabilitation (CR) programs are currently underutilized and smartphone-based CR strategies are thought to address this unmet need. However, data regarding the detailed process of development are scarce. OBJECTIVE: This study focused on the development of a smartphone-based, patient-specific, messaging app for patients who have undergone percutaneous coronary intervention (PCI). METHODS: The AnSim app was developed in collaboration with a multidisciplinary team that included cardiologists, psychiatrists, nurses, pharmacists, nutritionists, and rehabilitation doctors and therapists. First, a focus group interview was conducted, and the narratives of the patients were analyzed to identify their needs and preferences. Based on the results, health care experts and clinicians drafted messages into 5 categories: (1) general information regarding cardiovascular health and medications, (2) nutrition, (3) physical activity, (4) destressing, and (5) smoking cessation. In each category, 90 messages were developed according to 3 simplified steps of the transtheoretical model of behavioral change: (1) precontemplation, (2) contemplation and preparation, and (3) action and maintenance. After an internal review and feedback from potential users, a bank of 450 messages was developed. RESULTS: The focus interview was conducted with 8 patients with PCI within 1 year, and 450 messages, including various forms of multimedia, were developed based on the transtheoretical model of behavioral change in each category. Positive feedback was obtained from the potential users (n=458). The mean Likert scale score was 3.95 (SD 0.39) and 3.91 (SD 0.39) for readability and usefulness, respectively, and several messages were refined based on the feedback. Finally, the patient-specific message delivery system was developed according to the baseline characteristics and stages of behavioral change in each participant. CONCLUSIONS: We developed an app (AnSim), which includes a bank of 450 patient-specific messages, that provides various medical information and CR programs regarding coronary heart disease. The detailed process of multidisciplinary collaboration over the course of the study provides a scientific basis for various medical professionals planning smartphone-based clinical research.

Correction: A randomized, open-label, parallel, multi-center Phase IV study to compare the efficacy and safety of atorvastatin 10 and 20 mg in high-risk Asian patients with hypercholesterolemia.

[This corrects the article DOI: 10.1371/journal.pone.0245481.].

A randomized, open-label, parallel, multi-center Phase IV study to compare the efficacy and safety of atorvastatin 10 and 20 mg in high-risk Asian patients with hypercholesterolemia.

BACKGROUND: Although accumulating evidence suggests a more extensive reduction of low-density lipoprotein cholesterol (LDL-C), it is unclear whether a higher statin dose is more effective and cost-effective in the Asian population. This study compared the efficacy, safety, and cost-effectiveness of atorvastatin 20 and 10 mg in high-risk Asian patients with hypercholesterolemia. METHODS: A 12-week, open-label, parallel, multicenter, Phase IV randomized controlled trial was conducted at ten hospitals in the Republic of Korea between October 2017 and May 2019. High-risk patients with hypercholesterolemia, defined according to 2015 Korean guidelines for dyslipidemia management, were eligible to participate. We randomly assigned 250 patients at risk of atherosclerotic cardiovascular disease to receive 20 mg (n = 124) or 10 mg (n = 126) of atorvastatin. The primary endpoint was the difference in the mean percentage change in LDL-C levels from baseline after 12 weeks. Cost-effectiveness was measured as an exploratory endpoint. RESULTS: LDL-C levels were reduced more significantly by atorvastatin 20 mg than by 10 mg after 12 weeks (42.4% vs. 33.5%, p < 0.0001). Significantly more patients achieved target LDL-C levels (<100 mg/dL for high-risk patients, <70 mg/dL for very high-risk patients) with atorvastatin 20 mg than with 10 mg (40.3% vs. 25.6%, p < 0.05). Apolipoprotein B decreased significantly with atorvastatin 20mg versus 10 mg (-36.2% vs. -29.9%, p < 0.05). Lipid ratios also showed greater improvement with atorvastatin 20 mg than with 10 mg (total cholesterol/high-density lipoprotein cholesterol ratio, -33.3% vs. -29.4%, p < 0.05; apolipoprotein B/apolipoprotein A1 ratio, -36.7% vs. -31.4%, p < 0.05). Atorvastatin 20 mg was more cost-effective than atorvastatin 10 mg in terms of both the average and incremental cost-effectiveness ratios. Safety and tolerability of atorvastatin 20 mg were comparable to those of atorvastatin 10 mg. CONCLUSION: In high-risk Asian patients with hypercholesterolemia, atorvastatin 20 mg was both efficacious in reducing LDL-C and cost-effective compared with atorvastatin 10 mg.

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.

Clinical characteristics and outcomes of patients with coronary artery spasm who initially presented with acute myocardial infarction.

BACKGROUND: The long-term clinical outcomes of coronary artery spasm (CAS) patients presented with acute myocardial infarction (AMI) compared to those who did not present with AMI has rarely been investigated. METHODS: From November 2004 to May 2014, a total of 3360 patients who were confirmed as CAS by the acetylcholine (Ach) provocation test and without significant coronary lesion were retrospectively analyzed. AMI was an initial presentation in 34 patients [CAS-myocardial infarction (MI) group], and not in other 3326 patients (CAS group). The clinical outcomes up to 5 years were compared between the two groups. RESULTS: Baseline characteristics and cardiovascular risk factors did not differ between the two groups, except the higher smoking rate in CAS-MI group (38.2 vs. 23.5%, P=0.046). During a mean follow-up period of 1211±583 days, the cumulative incidence of recurrent angina [hazard ratio (HR): 2.71; 95% confidence interval (CI): 1.20-6.13; P=0.016], MI (HR: 33.89; 95% CI: 8.76-131.1; P<0.001) and major adverse cardiovascular events (MACE; HR: 10.94; 95% CI: 3.83-31.22; P<0.001) were significantly higher in the CAS-MI group. After propensity score matched analysis (1 : 5 matching; n=186, C-statistic=0.834), the incidences of recurrent angina (HR; 4.68; 95% CI: 1.62-13.5; P=0.004) and MACE (HR: 12.2; 95% CI: 2.23-67.3; P=0.003) remained higher in the CAS-MI group. CONCLUSION: The CAS-MI group patients were associated with higher incidence of recurrent angina, MI, and MACE compared to CAS group patients. More intensive antispastic medication might be needed for these patients, and further study will be necessary to determine which treatment can improve the prognosis of CAS-MI patients.

Intravascular optical imaging of high-risk plaques in vivo by targeting macrophage mannose receptors.

Macrophages mediate atheroma expansion and disruption, and denote high-risk arterial plaques. Therefore, they are substantially gaining importance as a diagnostic imaging target for the detection of rupture-prone plaques. Here, we developed an injectable near-infrared fluorescence (NIRF) probe by chemically conjugating thiolated glycol chitosan with cholesteryl chloroformate, NIRF dye (cyanine 5.5 or 7), and maleimide-polyethylene glycol-mannose as mannose receptor binding ligands to specifically target a subset of macrophages abundant in high-risk plaques. This probe showed high affinity to mannose receptors, low toxicity, and allowed the direct visualization of plaque macrophages in murine carotid atheroma. After the scale-up of the MMR-NIRF probe, the administration of the probe facilitated in vivo intravascular imaging of plaque inflammation in coronary-sized vessels of atheromatous rabbits using a custom-built dual-modal optical coherence tomography (OCT)-NIRF catheter-based imaging system. This novel imaging approach represents a potential imaging strategy enabling the identification of high-risk plaques in vivo and holds promise for future clinical implications.

Impact of Statin Use on Development of New-Onset Diabetes Mellitus in Asian Population.

There have been several reports showing that the statin use is associated with new-onset diabetes mellitus (DM). The aim of the present study was to evaluate the impact of chronic statin use on development of new-onset DM in a series of Asian population. The patients were retrospectively enrolled using the electronic database of Korea University Guro Hospital from January 2004 to February 2010. A total of 10,994 patients without a history of diabetes were analyzed. Baseline lipid profiles, fasting glucose, Hemoglobin (Hb) A1c, and glucose tolerance tests were measured in all patients before statin treatment. Included patients had HbA1c ≤ 5.7% and fasting glucose level ≤ 100 (mg/dl). The patients were divided into 2 groups according to the use of statins (the statin group, n = 2,324 patients and the nonstatin group, n = 8,670 patients). To adjust baseline potential confounders, a propensity score-matched analysis was performed using logistic regression model. After propensity score matching, 2 propensity-matched groups (1,699 pairs, n = 3,398, C statistic = 0.859) were generated and analyzed. After propensity score matching, baseline characteristics of both groups were balanced except that the statin group was older and had higher rate of coronary artery disease compared with the nonstatin group. During a 3-year follow-up, the statin group had higher incidence of new-onset DM compared with the nonstatin group (hazard ratio 1.99, 95% CI 1.36 to 2.92, p <0.001), but the statin group showed lower incidence of major adverse cerebral-cardiovascular events compared with the nonstatin group (hazard ratio 0.40, 95% CI 0.19 to 0.85, p <0.001). In the present study, although the use of statins was associated with higher rate of new-onset DM, it markedly improved 3-year cardiovascular outcomes in Asian population.