Influence of preprocedural glycemic control on clinical outcomes of endovascular therapy in diabetic patients with lower extremity artery disease: an analysis from a Korean multicenter retrospective registry cohort.

BACKGROUND: The influence of intensive glucose control in diabetic patients on the macrovascular outcomes is controversial. Thus, this study aimed to elucidate the effect of preprocedural hemoglobin A1c (HbA1c) on clinical outcomes after endovascular therapy for lower extremity artery disease (LEAD) in diabetic patients. METHODS: Diabetic patients were enrolled from the retrospective cohorts of a Korean multicenter endovascular therapy registry and were divided according to the HbA1c level during index admission into the optimal (< 7.0%) or suboptimal (≥ 7.0%) glycemic control groups. The primary endpoints were major adverse limb events (MALE, a composite of major amputation, minor amputation, and reintervention). RESULTS: Of the 1103 patients enrolled (897 men, mean age 68.2 ± 8.9 years), 432 (39.2%) were classified into the optimal glycemic control group and 671 (60.8%) into the suboptimal glycemic control group. In-hospital events and immediate procedural complications were not different between the two groups. The suboptimal group showed a trend towards a higher incidence of MALE than the optimal group (log-rank p = 0.072). Although no significant differences were found between the two groups in terms of overall survival or amputation, the risk of reintervention was significantly higher in the suboptimal group (log-rank p = 0.048). In the multivariate Cox regression model, suboptimal glycemic control was one of the independent predictors for reintervention. When our data were analyzed according to the initial presentation, suboptimal preprocedural HbA1c significantly increased the incidence of MALE compared with optimal preprocedural HbA1c only in patients with intermittent claudication. CONCLUSION: In diabetic patients undergoing endovascular therapy for LEAD, suboptimal preprocedural HbA1c is associated with an increased risk of adverse limb events, especially in patients with intermittent claudication. Further prospective research will be required to validate the role of more intensive glycemic control on the reduction of adverse limb events in diabetic patients undergoing endovascular therapy for LEAD.

Different association between renal dysfunction and clinical outcomes according to the presence of diabetes in patients undergoing endovascular treatment for peripheral artery disease.

OBJECTIVE: Although chronic kidney disease (CKD) and diabetes are important prognostic factors in patients with peripheral artery disease, there are limited data regarding the outcomes of endovascular treatment (EVT) according to the severity of CKD, especially in the presence of diabetes. This study sought to compare clinical outcomes of lower limb EVT between patients with and patients without CKD according to the presence of diabetes. METHODS: Patients were enrolled from the Korean multicenter EVT registry and were divided according to the presence of diabetes, then further stratified by CKD (estimated glomerular filtration rate <60 mL/min/1.73 m2). The primary outcome was major adverse limb events (MALEs; a composite of reintervention for target limb, reintervention for target vessel, and unplanned major amputation) at 2 years. RESULTS: A total of 3045 patients were eligible for analysis: 1277 nondiabetic patients (944 without CKD, 333 with CKD) and 1768 diabetic patients (951 without CKD, 817 with CKD). CKD was associated with a significantly increased risk of MALEs after EVT in diabetic patients (14.4% vs 9.9%; adjusted hazard ratio, 1.60; 95% confidence interval, 1.28-2.01; P < .001) but not in nondiabetic patients (7.6% vs 9.7%; adjusted hazard ratio, 0.78; 95% confidence interval, 0.53-1.14; P = .203; interaction P = .018). In analysis stratified by the severity of CKD among diabetic patients, end-stage renal disease was significantly associated with an increased risk of MALE. CONCLUSIONS: CKD was associated with a significantly higher risk of MALEs after EVT in diabetic patients but not in nondiabetic patients. The increased risk of MALEs was mainly driven by patients with end-stage renal disease.

Infarcted Myocardium-Primed Dendritic Cells Improve Remodeling and Cardiac Function After Myocardial Infarction by Modulating the Regulatory T Cell and Macrophage Polarization.

BACKGROUND: Inflammatory responses play a critical role in left ventricular remodeling after myocardial infarction (MI). Tolerogenic dendritic cells (tDCs) can modulate immune responses, inducing regulatory T cells in a number of inflammatory diseases. METHODS: We generated tDCs by treating bone marrow-derived dendritic cells with tumor necrosis factor-α and cardiac lysate from MI mice. We injected MI mice, induced by a ligation of the left anterior descending coronary artery in C57BL/6 mice, twice with tDCs within 24 hours and at 7 days after the ligation. RESULTS: In vivo cardiac magnetic resonance imaging and ex vivo histology confirmed the beneficial effect on postinfarct left ventricular remodeling in MI mice treated with tDCs. Subcutaneously administered infarct lysate-primed tDCs near the inguinal lymph node migrated to the regional lymph node and induced infarct tissue-specific regulatory T-cell populations in the inguinal and mediastinal lymph nodes, spleen, and infarcted myocardium, indicating that a local injection of tDCs induces a systemic activation of MI-specific regulatory T cells. These events elicited an inflammatory-to-reparative macrophage shift. The altered immune environment in the infarcted heart resulted in a better wound remodeling, preserved left ventricular systolic function after myocardial tissue damage, and improved survival. CONCLUSIONS: This study showed that tDC therapy in a preclinical model of MI was potentially translatable into an antiremodeling therapy for ischemic tissue repair.

Clinical Outcomes of Subintimal vs. Intraluminal Revascularization Approaches for Long Femoropopliteal Occlusions in a Korean Multicenter Retrospective Registry Cohort.

BACKGROUND: There are limited data comparing the outcomes of subintimal vs. intraluminal approach in the treatment of long femoropopliteal artery occlusions. The objective of this study was to investigate the efficacy and safety of the subintimal approach for long femoropopliteal artery occlusions.Methods and Results:From a multicenter retrospective registry cohort, we included a total of 461 patients with 487 femoropopliteal artery occlusions classified as Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II C/D for this analysis. We compared the immediate and mid-term outcomes of subintimal vs. intraluminal approaches. There were 228 patients with 243 limbs in the subintimal group, and 233 patients with 244 limbs in the intraluminal group. Baseline clinical and lesion characteristics were comparable between the 2 groups. The technical success rate was significantly higher in the subintimal group than in the intraluminal group (95.1% vs. 89.8%, P=0.041). The clinical primary patency (67.5% vs. 73.4% at 12 months, 54.0% vs. 61.3% at 24 months; P=0.086) and target lesion revascularization (TLR)-free survival (89.5% vs. 86.3% at 12 months, 77.6% vs. 76.0% at 24 months; P=0.710) did not differ significantly between the subintimal and the intraluminal groups. CONCLUSIONS: In long femoropopliteal occlusions, the subintimal approach achieved a higher technical success rate and similar mid-term primary patency and TLR-free survival compared with intraluminal approach.

Visit-to-visit variability of systolic blood pressure predicts all-cause mortality in patients received percutaneous coronary intervention with drug-eluting stents.

Blood pressure (BP) and its variability are associated with atherosclerotic disease and cardiovascular events. The prognostic implications of outpatient clinic visit-to-visit blood pressure variability (BPV) are unknown in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). A total of 1,463 patients undergoing PCI with DES were consecutively enrolled from January 2009 to December 2013. We analyzed the 1,234 patients, who measured clinic BP more than three times during the first year after PCI. The BPV is determined by standard deviation of systolic and diastolic BP, and coefficient of variation. Median follow-up duration was 905 days (interquartile range 529-1,310 days). All patients were divided into two groups according to the coefficient of variation of systolic BP (CVSBP); high CVSBP group (> 8.78, n = 617) and low CVSBP group (≤ 8.78, n = 617). High CVSBP group had significantly higher all-cause mortality (7.9% versus 3.1%, p < 0.001) and composite of all-cause mortality, myocardial infarction, and stroke (13.1% versus 6.2%, p < 0.001). In multivariate logistic regression analysis for prediction of all-cause mortality, and composite of all-cause mortality, myocardial infarction, and stroke after PCI with DES, hazard ratios of high CVSBP group were 2.441 (95% of confidence interval 1.042-5.718, p = 0.040), and 1.980 (95% of confidence interval 1.125-3.485, p = 0.018). The higher visit-to-visit BPV is associated higher mortality in patients undergoing PCI with DES. The clinic measured visit-to-visit BPV may serve as a predictor of all-cause mortality after PCI with DES.

Evaluation of the incremental prognostic value of the combination of CYP2C19 poor metabolizer status and ABCB1 3435 TT polymorphism over conventional risk factors for cardiovascular events after drug-eluting stent implantation in East Asians.

PURPOSE: We evaluated the incremental prognostic value of combining the CYP2C19 poor metabolizer (PM) and ABCB1 3435 TT for adverse clinical outcomes over conventional risk factors in a percutaneous coronary intervention (PCI) cohort. METHODS: We enrolled 2,188 patients. The primary end point was a composite of death from any cause, nonfatal myocardial infarction (MI), and stroke during 1-year follow-up. The population was stratified into the following four groups: CYP2C19 EM/IM+ABCB1 3435 CC/CT, CYP2C19 EM/IM+ABCB1 3435 TT, CYP2C19 PM+ABCB1 3435 CC/CT, and CYP2C19 PM+ABCB1 3435 TT. RESULTS: A total of 87 (3.97%) primary end-point events occurred (64 deaths, 8 non-fatal MIs and 15 strokes). Multivariate Cox analysis indicated that CYP2C19 PM+ABCB1 3435 TT status was a significant predictor of the primary end point (hazard ratio = 4.51, 95% confidence interval (CI) = 1.92-10.58). However, addition of combined genetic status to the clinical risk model did not improve the model discrimination (C-statistic = 0.786 (95% CI = 0.734-0.837) to 0.785 (95% CI = 0.733-0.838)) or risk reclassification (categorical net reclassification improvement (0.040, P = 0.32), integrated discrimination improvement (0.021, P = 0.026)). CONCLUSIONS: In a real-world East Asian PCI population taking clopidogrel, although the concurrent presence of CYP2C19 PM and ABCB1 TT is a strong independent predictor of adverse outcomes, the combined status of two at-risk variants does not have an incremental prognostic value beyond that of the conventional clinical risk factors.Genet Med 18 8, 833-841.

Evaluation of the INNOVANCE PFA P2Y assay and its association with CYP2C19 genotypes.

The purpose of this study was to evaluate associations between INNOVANCE PFA P2Y (PFA P2Y) test results and CYP2C19 genotypes and provide baseline data for PFA P2Y testing to establish a therapeutic monitoring strategy for clopidogrel. A total of 75 new patients with acute coronary syndrome with planned percutaneous coronary intervention were enrolled between June 2012 and September 2012. All patients received clopidogrel at an initial loading dose of 600 mg followed by a 75-mg daily maintenance dose. Blood samples were obtained on the third morning after clopidogrel loading. PFA P2Y, VerifyNow P2Y12 and VASP assays were used to determine platelet inhibition due to clopidogrel, and the Verigene CYP2C19 test was used for CYP2C19 genotyping. The genotype frequency of 75 patients was as follows: CYP2C19 *1/*1 (wild type), 28 (37.3%); *1/*2, 31 (41.3%); *1/*3, 4 (5.3%); *2/*2, 5 (6.7%); *2/*3, 5 (6.7%); *1/*17, 1 (1.3%); and *2/*17, 1 (1.3%). Classified according to CYP2C19 genotypes, there were 29 (38.7%) extensive metabolizers (EM) or ultra rapid metabolizers (UM), 35 (46.7%) intermediate metabolizers (IM), and 10 (13.3%) poor metabolizers (PM). Median (interquartile range) PFA P2Y closure times (seconds) were 119 (101-260), 300 (130-300) and 300 (300-300) in the PM, IM and EM or UM groups, respectively (p < 0.05). Median (interquartile range) VerifyNow PRUs were 294 (213-297), 215 (165-320) and 189 (118-279); and the VASP platelet reactivity index (%) was 52.7 (33.3-91.9), 59.9 (41.4-72.8) and 38.9 (26.8-62.2) in the PM, IM and EM or UM groups, respectively (p > 0.05). Compared with non-carriers, carriers of reduced function CYP2C19 alleles tended to have higher platelet reactivity after clopidogrel treatment. The cut-off for PM versus other groups (IM and EM or UM) was ≤ 141 seconds (AUC 0.704, sensitivity 70%, specificity 76.6%) on the ROC curve. A statistically significant correlation between PFA P2Y (seconds) and VerifyNow (PRU) was found (ρ = -0.47, p < 0.0001). In conclusion, the PFA P2Y test showed a statistically significant association with CYP2C19 metabolizer phenotypes based on CYP2C19 genotyping and effectively determined the risk groups resistant to clopidogrel therapy, including PM.

Clinical significance of chronic kidney disease and atrial fibrillation on morbidity and mortality in patients with acute myocardial infarction.

BACKGROUND/AIMS: Atrial fibrillation (AF) often coexists with acute myocardial infarction (AMI), and chronic kidney disease (CKD) is a major risk for AMI. However, the combined impact of CKD and AF on the mortality and morbidity in AMI population has not been determined. METHODS: Between January 2004 and December 2009, a total of 4,738 AMI patients were enrolled prospectively. Patients were divided into four groups according to the combined status of CKD and AF. The primary endpoint was a combination of 5-year major adverse cardiac and cerebrovascular events (MACCE). RESULTS: The prevalence of AF was significantly higher in CKD patients than in non-CKD patients (6.76 vs. 3.31%, p < 0.001). The highest cumulative event rate of MACCE and death was observed in patients with both CKD and AF (68.5 and 64.0%), respectively. In multivariable analyses, compared with patients with neither AF nor CKD, hazard ratios (HR) for composite of MACCE were 1.66 (95% CI, 1.14-2.41), 1.24 (95% CI, 1.06-1.46), and 2.10 (95% CI, 1.42-3.13) for patients with AF only, those with CKD only, and those with both CKD and AF, respectively (p for interaction = 0.935). Patients with both CKD and AF had a greatest risk for all-cause mortality (HR 2.54; 95% CI, 1.60-4.53), and the significant synergistic interaction was observed between CKD and AF (p for interaction = 0.015). CONCLUSION: The combined effect of AF and CKD on the risk of MACCE after an AMI is stronger than any separate condition, and it confers a synergistic effect on the all-cause mortality risk.

Clinical outcomes and predictors of unprotected left main stem culprit lesions in patients with acute ST segment elevation myocardial infarction.

OBJECTIVES: We aimed at comparing the clinical outcomes of the patients who underwent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI) due to left main coronary arteries (LMCA) and non-LMCA determining the predictors of mortality in the patients. BACKGROUND: There are few data regarding the midterm prognosis of STEMI due to LMCA as compared with them due to non-LMCA. METHODS: A total of 4,697 patients with STEMI (61 patients with LMCA and 4,636 patients with non-LMCA) were enrolled in a nationwide Korea Acute Myocardial Infarction (MI) Registry between November 2005 and September 2009. The primary endpoints was a composite of cardiac death, nonfatal MI, and target lesion and vessel revascularization (TLR/TVR) during a 12-month clinical follow-up. RESULTS: The LMCA group had a higher incidence of total major adverse cardiac events (MACEs) (26.2% vs. 7.8%; P < 0.001) at 12 months, which was largely attributable to cardiac deaths at 1 month (21.3% vs. 3.8%; P < 0.001). Therefore, there was no statistical difference in cardiac deaths, nonfatal MI, TLR/TVR, and MACEs after 1 month between the two groups. Presenting in cardiogenic shock (HR, 4.25; 95% CI, 1.01-17.97; P = 0.049) and heart rate ≥100 bpm (HR, 4.97; 95% CI, 1.18-21.00; P = 0.029) were independent predictors of cardiac death due to LMCA. CONCLUSION: Patients with STEMI and a LMCA had poor clinical outcomes, which is attributable to hemodynamic deterioration during the periprocedural period. However, after that time, midterm MACEs of the survivors following the periprocedural period may not be different between STEMI due to LMCA and non-LMCA.

Impact of occluded culprit arteries on long-term clinical outcome in patients with non-ST-elevation myocardial infarction: 48-month follow-up results in the COREA-AMI Registry.

BACKGROUND: The prognostic impact of occluded culprit arteries in non-ST-elevation myocardial infarction (NSTEMI) patients beyond 12 months has not been investigated. OBJECTIVES: The impact of occluded culprit arteries on a composite of cardiac death (CD), recurrent nonfatal MI (RMI), and target vessel revascularization (TVR) in patients who presented with NSTEMI was investigated during a 48-month follow-up using propensity-score (PS) matching. METHODS: A total of 2,878 NSTEMI patients in the COREA-AMI (COnvergent REgistry of cAtholic and chonnAm university for Acute MI) Registry were classified according to the angiographic flow of culprit arteries (occlusion [OC], n = 1,070; nonocclusion, n = 1,808). After PS matching, the incidence of the primary end-point, a composite of CD, RMI, and TVR was compared. RESULTS: The median follow-up duration was 47.3 months (IQR 32.7-66.2). In the PS-matched population, the 48-month cumulative rates of the primary end-point (27.5% vs. 17.9%, P < 0.001) and each event were higher in the OC group (CD: 9.0% vs. 5.4%, RMI: 16.3% vs. 9.4%, TVR: 10.5% vs. 5.6%, respectively, P < 0.05). In multivariate Cox regression analysis, occluded culprit arteries showed the significant statistical impact on the primary end-point (HR 1.689 [1.385-2.059], P < 0.001) and each event (CD: 1.736 [1.218-2.475], RMI: 1.918 [1.468-2.505], TVR: 2.042 [1.453-2.869], respectively, P < 0.05). Furthermore, in the 12-month landmark analysis, occluded culprit arteries were still associated with higher risk of primary end-point beyond 12 months (P < 0.001). CONCLUSIONS: Occluded culprit arteries were independently associated with the higher risk of CD, RMI, and TVR in NSTEMI patients during the 48-month follow-up.

Iliocaval fistula presenting with paradoxical pulmonary embolism combined with high-output heart failure successfully treated by endovascular stent-graft repair: case report.

A 51-yr-old man presented exertional dyspnea as a consequence of iliocaval fistula combined with paradoxical pulmonary embolism and high-output heart failure. Endovascular stent-graft repair was performed to cover iliocaval fistula and restore the heart function. After the procedure, dyspnea was improved and procedure related complication was not seen. A 6-month follow-up computed tomography showed regression of pulmonary thromboembolism and well-positioned stent-graft without graft migration, aortacaval communication or endoleak. Stent graft implantation should be considered an alternative of open repair surgery for treament of abdominal arteriovenous fisula, especially in patient with high risk for surgery.

Impact of the CYP2C19*17 polymorphism on the clinical outcome of clopidogrel therapy in Asian patients undergoing percutaneous coronary intervention.

The impact of the CYP2C19*17 polymorphism on the clinical outcome in Asians undergoing percutaneous coronary intervention (PCI) is unknown. We sought to assess the long-term impact of CYP2C19*17 on the risk for adverse clinical events in 2188 Korean patients taking clopidogrel after PCI. The prevalence of the CYP2C19*17 allele [*wt/*17: 2.4% (n = 53), *17/*17: 0%] was very low. The 2-year cumulative event rates for bleeding [*wt/*17 vs. *wt/*wt: 2 vs. 2.3%; adjusted hazard ratio (HR), 1.23; 95% confidence interval (CI), 0.16-9.45], stent thrombosis (2 vs. 1.1%; HR, 3.98; 95% CI, 0.49-31.6) or composite of any death, and myocardial infarction or stroke (5.4 vs. 7.1%; HR, 1.37; 95% CI, 0.32-5.73) did not differ on the basis of the presence of CYP2C19*17. In conclusion, in our study population of Asian patients, the CYP2C19*17 polymorphism was not associated with adverse clinical outcomes after PCI because of its low prevalence, the rarity of homozygotes, and the relatively low rate of adverse clinical events.

Long-term clinical outcomes of the one-stent technique versus the two-stent technique for non-left main true coronary bifurcation disease in the era of drug-eluting stents.

BACKGROUND: Few studies have compared the long-term major adverse cardiac events (MACEs) between the one-stent technique (stenting only the main branch) and the two-stent technique (stenting of both the main and side branches) for the treatment of true coronary bifurcation lesions in the drug-eluting stent era. Therefore, we investigated this issue using the large nationwide coronary bifurcation registry. METHODS: The 1,147 patients with non-left main coronary true bifurcation lesions underwent percutaneous coronary intervention in the Korea Coronary Bifurcation Stent (COBIS) registry. All patients were stratified based on the stent placement technique: one stent (n = 898) versus two stents (n = 249). MACE, including death, nonfatal myocardial infarction (MI), and repeat vessel and lesion revascularization (TVR and TLR), were evaluated. RESULTS: The median follow-up duration was 20 months. The MACEs did not differ between the 2 groups. Findings from the one-stent group were similar to those of the two-stent group in composite of death, MI, or TVR, based on analysis by crude, multivariate Cox hazard regression model, inverse-probability-of-treatment weighting (hazard ratio [HR] 0.911, 95% confidence interval (CI) 0.614-1.351; HR 0.685 95% CI 0.381-1.232; HR 1.235, 95% CI 0.331-4.605, respectively). In further analysis with propensity score matching, the overall findings were consistent. CONCLUSIONS: The findings of the present study indicate that the one-stent technique was not inferior to the two-stent technique for the treatment of non-left main true coronary bifurcation lesions in terms of long-term MACEs.

Predictors of early and late target lesion revascularization after drug-eluting stent implantation.

INTRODUCTION: Recent studies have suggested the existence of a late catch-up phenomenon after drug-eluting stent (DES) implantation. The aim of this study is to identify predictors of early (≤1 year) and late (>1 year) target lesion revascularization (TLR) in DESs. METHODS: The COACT (CathOlic medical center percutAneous Coronary inTervention) registry was designed to evaluate the clinical outcomes after DES implantation. Data from 9,127 consecutive patients were reviewed, all of whom underwent percutaneous coronary intervention (PCI) with DES between January 2004 and December 2009, including 8,126 patients who received PCI with homogenous DES. RESULTS: During a median follow-up period of 24 months (interquartile range, 11-41), the cumulative incidences of early and late TLR were 4.7% (95% confidence interval [CI], 4.2-5.1) and 3.3% (95% CI, 2.9-3.7). Independent predictors of early TLR were multivessel disease (odds ratio [OR] 1.637; 95% CI 1.241-2.158, P < 0.001) and stent diameter (OR 0.614; 95% CI 0.437-0.862, P = 0.005). Independent predictors of late TLR were stent diameter (OR 0.567; 95% CI 0.367-0.875, P = 0.010), insulin-dependent diabetes mellitus (OR 2.235; 95% CI 1.314-3.802, P = 0.003), first-generation DES (OR 5.104; 95% CI 2.744-9.492, P < 0.001), and elevated levels of high-sensitivity C-reactive protein at follow-up coronary angiography >2 mg/dL (OR 1.616; 95% CI 1.173-2.226, P = 0.003). CONCLUSIONS: Although multivessel disease and stent diameter were associated with early TLR, late TLR was more associated with clinical comorbidities including insulin-dependent diabetes and procedural factors like the generation of the stent used and stent diameter. The risk factors for TLR may be markedly different at different time points during TLR.

Persistent coronary artery spasm documented by follow-up coronary angiography in patients with symptomatic remission of variant angina.

For patients with variant angina it is very important to start medical therapy using calcium-channel blockers. However, the decision of physicians regarding whether to decrease the dose of the drug or discontinue it is controversial. We investigated whether the nature of spasm is remissive and whether the termination of medications is safe. The subjects studied were included in the Vasospastic Angina in Catholic Medical Center Registry from March 2001 to December 2009. We analyzed 37 patients (62 lesions) with variant angina, diagnosed using coronary angiography (CAG) and he acetylcholine provocation test, without any organic coronary stenosis, whose symptoms were well controlled after medication. The follow-up CAG with provocation test was performed at a median interval of 44 months. The characteristics of spasm were analyzed on each pair of CAGs. The study group consisted of 23 men (62.2 %) and 14 women (37.8 %) with a mean age of 59 ± 11.1 years. The follow-up CAG with provocation test showed that the characteristics of the spasmodic nature were consistent with the first test in all patients. Although the patients with variant angina had no chest pain after medical treatment, the spasmodic nature of coronary arteries still remained. We may decrease the drug dosage after carefully checking the patient's symptoms but recommend not discontinuing therapy, even if the patient is asymptomatic.

Effect of Cilostazol on Patients With Diabetes Who Underwent Endovascular Treatment for Peripheral Artery Disease.

Background No large-scale study has compared the clinical impact of triple antiplatelet therapy (TAPT: aspirin, clopidogrel, and cilostazol) and dual antiplatelet therapy (DAPT) on adverse limb events in patients with diabetes after endovascular therapy (EVT) for peripheral artery disease. Thus, we investigate the effect of cilostazol added to a DAPT on the clinical outcomes after EVT in patients with diabetes using a nationwide, multicenter, real-world registry. Methods and Results A total of 990 patients with diabetes who underwent EVT were enrolled from the retrospective cohorts of a Korean multicenter EVT registry and were divided according to the antiplatelet regimen (TAPT [n=350; 35.4%] versus DAPT [n=640; 64.6%]). After propensity score matching based on clinical characteristics, a total of 350 pairs were compared for clinical outcomes. The primary end points were major adverse limb events, a composite of major amputation, minor amputation, and reintervention. For the matched study groups, the lesion length was 125.4±102.0 mm, and severe calcification was observed in 47.4%. The technical success rate (96.9% versus 94.0%; P=0.102) and the complication rate (6.9% versus 6.6%; P>0.999) were similar between the TAPT and DAPT groups. At 2-year follow-up, the incidence of major adverse limb events (16.6% versus 19.4%; P=0.260) did not differ between the 2 groups. However, the TAPT group showed less minor amputation than the DAPT group (2.0% versus 6.3%; P=0.004). In multivariate analysis, TAPT was an independent predictor of minor amputation (adjusted hazard ratio, 0.354 [95% CI, 0.158-0.794]; P=0.012). Conclusions In patients with diabetes undergoing EVT for peripheral artery disease, TAPT did not decrease the incidence of major adverse limb events but may be associated with a decreased risk of minor amputation.

Rates of coronary intervention due to de novo significant atherosclerosis and cardiac death are very low in Korean patients with vasospastic angina: 36-month follow-up results of the Vasospastic Angina in the Catholic Medical Center (VA-CMC) registry.

BACKGROUND: The rate of percutaneous coronary intervention (PCI) due to the development of significant atherosclerosis and the cardiac mortality rate in Korean patients with vasospastic angina (VSA) was estimated. METHODS AND RESULTS: A total of 831 patients with VSA from 8 centers were registered in the Vasospastic Angina in the Catholic Medical Center (VA-CMC) registry. Their provocation tests for VSA showed positive results. The patients with significant atherosclerosis (>50% luminal narrowing) on the baseline angiography were excluded. Subjects were VSA patients without significant atherosclerosis. A total of 745 patients were included in the final analysis. The mean follow-up duration was 36.1±9.8 months. The PCI rate was 2.01% (15/745). Current smoking (odds ratio: 2.31, P<0.05) and high levels of baseline high-sensitivity C-reactive protein (hsCRP) (odds ratio: 1.57, P<0.05) were independent risk factors for PCI. The mortality rate was 2.55% (19/745). Eleven patients died of cardiac causes (1.48%). Cessation of medication was an independent risk factor for cardiac mortality (odds ratio: 1.47, P<0.05). The mean duration from the diagnosis to the cardiac deaths was 10.6±4.3 months. CONCLUSIONS: Korean patients with VSA demonstrated low rates of development of significant atherosclerosis leading to PCI and cardiac mortality. However, cessation of medication, smoking, and high baseline hsCRP were the independent risk factors for unfavorable outcomes.

Randomized comparison of the efficacy and safety of zotarolimus-eluting stents vs. sirolimus-eluting stents for percutaneous coronary intervention in chronic total occlusion--CAtholic Total Occlusion Study (CATOS) trial.

BACKGROUND: Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO). METHODS AND RESULTS: A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up. CONCLUSIONS: The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.

Increased risk of coronary heart disease with hysterectomy in young women: A longitudinal follow-up study using a national health screening cohort.

OBJECTIVE: Hysterectomy is one of the most commonly performed gynecological procedures. Several studies have reported an association between hysterectomy and coronary heart disease (CHD), but the conclusions are controversial. This study aimed to evaluate the association between hysterectomy and the occurrence of CHD using a national sample cohort from South Korea. STUDY DESIGN: Using the national cohort from the Korean National Health Insurance Service, we extracted data on patients who had undergone hysterectomy (n = 8,642) and on controls matched at a ratio of 1:4 (n = 34,568) and then analyzed the occurrence of CHD from 2002 to 2013. Patients were matched according to age, income, region of residence, obesity, smoking, alcohol consumption, and medical history. MAIN OUTCOME MEASURES: A Cox proportional hazards model was used to analyze the hazard ratios (HRs) and 95% confidence intervals (CIs). Subgroup analyses were performed based on both age and bilateral salpingo-oophorectomy (BSO) status. The age of the participants was defined as that at the time of hysterectomy. RESULTS: The HR for CHD was 1.05 (95% CI = 0.96-1.16, p = 0.286) in the hysterectomy group. The HRs for CHD according to the different age subgroups were 1.19 (95% CI = 1.03-1.38, p = 0.018) for patients aged < 50 years, 1.05 (95% CI = 0.89-1.25, p = 0.561) for patients aged 50-59 years, and 0.88 (95% CI = 0.73-1.05, p = 0.147) for patients aged ≥ 60 years. CONCLUSION: The incidence of CHD was statistically significantly higher in women who underwent hysterectomy when they were under 50 years of age than in the matched controls.

Long-term Clinical Outcomes and Prognostic Factors After Endovascular Treatment in Patients With Chronic Limb Threatening Ischemia.

BACKGROUND AND OBJECTIVES: Endovascular therapy (EVT) first strategy has been widely adopted for the treatment of chronic limb threatening ischemia (CLTI) patients in real-world practice. This study aimed to investigate long-term outcomes of CLTI patients who underwent EVT and identify prognostic factors. METHODS: From the retrospective cohorts of a Korean multicenter endovascular therapy registry, 1,036 patients with CLTI (792 men, 68.8 ± 9.5 years) were included. The primary endpoint was amputation-free survival (AFS) defined as the absence of major amputation or death. Secondary endpoints were major adverse limb events (MALE; a composite of major amputation, minor amputation, and reintervention). RESULTS: Five-year AFS and freedom from MALE were 69.8% and 61%, respectively. After multivariate analysis, age (hazard ratio [HR], 1.476; p<0.001), end-stage renal disease (ESRD; HR, 2.340; p<0.001), Rutherford category (RC) 6 (HR, 1.456; p=0.036), and suboptimal EVT (HR, 1.798; p=0.005) were identified as predictors of major amputation or death, whereas smoking (HR, 0.594; p=0.007) was protective. Low body mass index (HR, 1.505; p=0.046), ESRD (HR, 1.648; p=0.001), femoropopliteal lesion (HR, 1.877; p=0.004), RC-6 (HR, 1.471; p=0.008), and suboptimal EVT (HR, 1.847; p=0.001) were predictors of MALE. The highest hazard rates were observed during the first 6 months for both major amputation or death and MALE. After that, the hazard rate decreased and rose again after 3-4 years. CONCLUSIONS: In CLTI patients, long-term outcomes of EVT were acceptable. ESRD, RC-6, and suboptimal EVT were common predictors for poor clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02748226.