Hyun Jong Lee

Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2 A Double-Blind, Placebo-Controlled Study of Extended-Release Niacin on Atherosclerosis Progression in Secondary Prevention Patients Treated With Statins

Background—Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results—This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CIMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20). Conclusions—The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

The effect of 24 months of combination statin and extended-release niacin on carotid intima‐media thickness: ARBITER 3

ABSTRACT Objective: The ARBITER 2 trial showed that extended-release niacin (ERN) when added to statin monotherapy slowed the progression of carotid atherosclerosis over 12 months. Whether longer treatment with ERN would have a greater effect on carotid intima.media thickness (CIMT) is unknown. Research design and methods: We examined the long-term effects of ERN on high density lipoprotein (HDL-C) cholesterol and CIMT during 12.24 months treatment with ERN in ARBITER 2 participants who were either continued or were crossed over (from placebo) to ERN 1000u2009mg daily. Main outcome measures: Among 149 subjects completing ARBITER 2, 130 (88%) enrolled in ARBITER 3. The prespecified primary endpoints were the within-group change in CIMT and HDL.C in patients receiving placebo for 12 months (n = 71), ERN for 12 months (comprised of subjects from ERN treatment during ARBITER 2 (n = 78) and those crossed over to ERN from placebo after ARBITER 2 (n = 47)), and ERN for 24 months spanning ARBITER 2 and 3 (n = 57). Five subjects discontinued the study due to flushing side effects. The study was completed by 104 subjects (47 crossed over from placebo; 57 with ERN continued from ARBITER 2). Results: HDL.C increased in the ERN group from 39.5 ± 6.7 to 48.6 ± 13.3u2009mg/dl (p < 0.001) along with modest reductions in LDL.C and TG. Among 125 participants treated with ERN for 12 months, there was a net regression of CIMT of. 0.027 ± 0.011u2009mm (p < 0.001 vs. placebo). Among 57 participants treated with ERN for 24 months, there was additional significant regression of CIMT of. 0.041 ± 0.021u2009mm (p = 0.001 vs. placebo). Controlling for changes in LDL and triglycerides, only changes in HDL.C were independently associated with regression of CIMT (b =. 0.25; p = 0.001). Conclusion: When added to statin therapy, ERN significantly increases HDL.C and induces atherosclerosis regression measured by CIMT over 24 months. Limitations to this study include its open-label design and the inability to relate CIMT effects to clinical outcomes.

Multivessel vs Single-Vessel Revascularization in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome and Multivessel Disease in the Drug-Eluting Stent Era

We sought to compare long‐term outcomes for multivessel revascularization (MVR) vs single‐vessel revascularization (SVR) with drug‐eluting stents (DES) in patients with non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) and multivessel coronary artery disease (MVD).

Long-Term Clinical Outcomes of Final Kissing Ballooning in Coronary Bifurcation Lesions Treated With the 1-Stent Technique: Results From the COBIS II Registry (Korean Coronary Bifurcation Stenting Registry).

OBJECTIVESnThis study investigated the impact of final kissing ballooning (FKB) after main vessel (MV) stenting on outcomes in patients with coronary bifurcation lesions after application of the 1-stent technique.nnnBACKGROUNDnAlthough FKB has been established as the standard method for bifurcation lesions treated with a 2-stent strategy, its efficacy in a 1-stent approach is highly controversial.nnnMETHODSnThis study enrolled 1,901 patients with a bifurcation lesion with a side branch diameter ≥2.3 mm, treated solely with the 1-stent technique using a drug-eluting stent from 18 centers in Korea between January 1, 2003 and December 31, 2009. The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction, or target lesion revascularization. Propensity score-matching analysis was also performed.nnnRESULTSnFKB was performed in 620 patients and the post minimal lumen diameter of the MV and side branch was larger in the FKB group than in the non-FKB group. During follow-up (median 36 months), the incidence of MACE (adjusted hazard ratio [HR]: 0.68, 95% confidence interval [CI]: 0.46 to 0.99; p = 0.048) was lower in the FKB group than the non-FKB group. After propensity score matching (545 pairs), the FKB group had a lower incidence of MACE (adjusted HR: 0.50, 95% CI: 0.30 to 0.85; p = 0.01), and target lesion revascularization in the MV (adjusted HR: 0.51, 95% CI: 0.28 to 0.93; p = 0.03) and both vessels (adjusted HR: 0.47, 95% CI: 0.25 to 0.90; p = 0.02) than in the non-FKB group.nnnCONCLUSIONSnIn coronary bifurcation lesions, we demonstrated that the 1-stent technique with FKB was associated with a favorable long-term clinical outcome, mainly driven by the reduction of target lesion revascularization in the MV or both vessels as a result of an increase in minimal lumen diameter. (Korean Coronary Bifurcation Stenting Registry II [COBIS II]: NCT01642992).

Ultrasonographic monitoring of implant thickness after augmentation rhinoplasty with expanded polytetrafluoroethylene.

Background Expanded polytetrafluoroethylene (ePTFE), or Gore-Tex (W.L. Gore & Associates, Flagstaff, AZ), is widely used in augmentation rhinoplasty, and the histological changes that it undergoes in the human body have been studied for decades. However, changes in the thickness of ePTFE after its use in augmentation rhinoplasty with a noninvasive object method are not well understood. Methods We report the results of 19 patients (10 male and 9 female patients) who had undergone an uncomplicated augmentation rhinoplasty with Gore-Tex. Ultrasonography was used to evaluate changes in the thickness of Gore-Tex implants and to detect inflammatory reactions around the implants 9-67 months after surgery. Results Gore-Tex implants were clearly distinguishable from the surrounding tissue with ultrasonography. The postoperative thickness of the implant was decreased by 29%. There was no significant correlation between the degree of change in implant thickness and the length of time after surgery. However, the amount of thickness reduction was associated with the implants initial thickness at the time of the surgery (R = 0.448; p = 0.001). In addition, four patients (21%) showed fibrosis or granuloma formation around the implant that was detectable via ultrasonography. Conclusion Gore-Tex implants lost thickness after nasal dorsal augmentation in proportion to their initial thickness, and ultrasonography was useful for evaluating changes in Gore-Tex thickness.

Left atrial appendage occlusion in non-valvular atrial fibrillation in a Korean multi-center registry

BACKGROUNDnThe aim of this study was to evaluate clinical outcome after left atrial appendage (LAA) occlusion in real clinical practice and compare between Amplatzer cardiac plug (ACP) and Watchman.nnnMETHODSANDRESULTSnFrom October 2010 to February 2015, 96 successful LAA occlusion procedures were performed using either ACP (n=50) or Watchman device (n=46) in non-valvular atrial fibrillation (AF) patients (59 male; age, 65.1±9.4 years; CHADS2, 2.5±1.2; CHA2DS2-VASC, 3.9±1.6; HAS-BLED, 2.7±1.3). The procedure success rate was 96.8%. There were serious complications in 4 patients (4.1%; 2 cardiac tamponade, 1 device embolization, and 1 major bleed). The anticoagulation cessation rate after 6 weeks was 92.7%. During mean 21.9-month follow-up, the incidence of death, stroke, systemic embolization and major bleeding was 5.2%, 4.2%, 0% and 1.0%, respectively. On transesophageal echocardiography of 93 patients within 6 months after the procedure, 24 residual leaks were observed (25.8%; 2 mild, 18 moderate, and 4 major). Clinical outcome was similar for the 2 devices, but peridevice leakage was more frequent with the Watchman than the ACP.nnnCONCLUSIONSnLAA occlusion was feasible in non-valvular AF patients with high risk of stroke and hemorrhage. The ACP and Watchman devices were similar in terms of procedural and clinical outcomes. (Circ J 2016; 80: 1123-1130).

Triple antithrombotic therapy versus dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation

BackgroundThe optimal antithrombotic regimen in patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation for complex coronary artery disease is unclear. We compared the net clinical outcomes of triple antithrombotic therapy (TAT; aspirin, thienopyridine, and warfarin) and dual antiplatelet therapy (DAPT; aspirin and thienopyridine) in AF patients who had undergone DES implantation. MethodsA total of 367 patients were enrolled and analyzed retrospectively; 131 patients (35.7%) received TAT and 236 patients (64.3%) received DAPT. DAPT and warfarin were maintained for a minimum of 12 and 24 months, respectively. The primary endpoint was the 2-year net clinical outcomes, a composite of major bleeding and major adverse cardiac and cerebral events (MACCE). Propensity score-matching analysis was carried out in 99 patient pairs. ResultsThe 2-year net clinical outcomes of the TAT group were worse than those of the DAPT group (34.3 vs. 21.1%, P=0.006), which was mainly due to the higher incidence of major bleeding (16.7 vs. 4.6%, P<0.001), without any significant increase in MACCE (22.1 vs. 17.7%, P=0.313). In the multivariate analysis, TAT was an independent predictor of worse net clinical outcomes (odds ratio 1.63, 95% confidence interval 1.06–2.50) and major bleeding (odds ratio 3.54, 95% confidence interval 1.65–7.58). After propensity score matching, the TAT group still had worse net clinical outcomes and a higher incidence of major bleeding compared with the DAPT group. ConclusionIn AF patients undergoing DES implantation, prolonged administration of TAT may be harmful due to the substantial increase in the risk for major bleeding without any reduction in MACCE.

Long-term effects of ischemic postconditioning on clinical outcomes: 1-year follow-up of the POST randomized trial

BACKGROUNDnIn the Effects of Postconditioning on Myocardial Reperfusion in Patients with ST-segment Elevation Myocardial Infarction (POST) trial, ischemic postconditioning failed to improve myocardial reperfusion. However, long-term effects of ischemic postconditioning on clinical outcomes are not known in patients with ST-segment elevation myocardial infarction.nnnMETHODSnA total of 700 patients undergoing primary percutaneous coronary intervention (PCI) were randomly assigned to the postconditioning group or the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow by balloon occlusion 4 times for 1 minute. Complete follow-up data for major clinical events at 1 year were available in 695 patients (99.3%), and analyses were done by the intention to treat principle. The primary outcome was a composite of death, myocardial infarction, severe heart failure, or stent thrombosis at 1 year.nnnRESULTSnAt 1 year, a composite of death, myocardial infarction, severe heart failure, or stent thrombosis occurred in 21 patients (6.1%) in the postconditioning group and 16 patients (4.6%) in the conventional PCI group (hazard ratio [HR] 1.32, 95% CI 0.69-2.53, P = .40). The risk of death (4.9% vs 3.7%, HR 1.32, 95% CI 0.64-2.71, P = .46), heart failure (2.6% vs 2.3%, HR 1.13, 95% CI 0.44-2.94, P = .80), and stent thrombosis (2.3% vs 1.7%, HR 1.34, 95% CI 0.46-3.85, P = .59) did not differ significantly between the 2 groups.nnnCONCLUSIONSnIschemic postconditioning does not seem to improve the 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary PCI.

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.

Impact of final kissing balloon inflation after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome

OBJECTIVESnWe sought to evaluate the impact of final kissing balloon inflation (FKBI) after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome (ACS).nnnBACKGROUNDnWhether FKBI should be mandatory after simple stent implantation for the treatment of coronary bifurcation lesion is controversial. Besides, ACS patients who have undergone bifurcation percutaneous coronary intervention with simple stent implantation may experience worse prognosis compared to stable angina pectoris patients.nnnMETHODSnTwo hundred and fifty one eligible patients (67.7% male, mean age 61.7 ± 10.4 years) were enrolled. The study population was divided into two groups according to the performance of FKBI. The primary end points were major adverse cardiac event (MACE); target lesion revascularization (TLR), non-fatal myocardial infarction (MI) and cardiac death during the follow-up period.nnnRESULTSnOver a mean follow-up period of 3.0 ± 1.9 years, there were 29 MACEs (10 TLR, 6 non-fatal MI, and 13 cardiac deaths), representing an event rate of 11.6%. Kaplan-Meier survival analysis revealed that FBKI group had favorable outcome compared to non-FKBI group with regard to hard events (p = 0.010) as well as composite MACEs (p = 0.008). In multivariable analysis, FKBI was a significant predictor of composite MACEs [hazard ratio 0.398 (95% confidence interval 0.190-0.836, p = 0.015)] and hard events [hazard ratio 0.325 (95% confidence interval 0.130-0.811, p = 0.016)].nnnCONCLUSIONSnIn terms of prognosis, performing FKBI after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions may be mandatory in ACS patients.