1.Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice
Joo Myung LEE ; Hyun Sung JOH ; Ki Hong CHOI ; David HONG ; Taek Kyu PARK ; Jeong Hoon YANG ; Young Bin SONG ; Jin-Ho CHOI ; Seung-Hyuk CHOI ; Jin-Ok JEONG ; Jong-Young LEE ; Young Jin CHOI ; Jei-Keon CHAE ; Seung-Ho HUR ; Jang-Whan BAE ; Ju-Hyeon OH ; Kook-Jin CHUN ; Hyun-Joong KIM ; Byung Ryul CHO ; Doosup SHIN ; Seung Hun LEE ; Doyeon HWANG ; Hyun-Jong LEE ; Ho-Jun JANG ; Hyun Kuk KIM ; Sang Jin HA ; Eun-Seok SHIN ; Joon-Hyung DOH ; Joo-Yong HAHN ; Hyeon-Cheol GWON ; On behalf of the SMART-REWARD Investigators
Journal of Korean Medical Science 2023;38(5):e34-
Background:
The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance.
Methods:
The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patientoriented composite outcome (POCO) at 2 years.
Results:
Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group.Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel.Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487–3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663–3.012,P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups.
Conclusion
With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES.
2.Consensus Document on Perioperative Antithrombotic Management: Part 2. Case Study
Yongwhi PARK ; Ae-Young HER ; Hyun Kuk KIM ; Jae Youn MOON ; Jae Hyoung PARK ; Keun-Ho PARK ; Kyung Hoon LEE ; Hyung Joon JOO ; Ho Yeon WON ; Sung Gyun AHN ; Hong Jun PARK ; Sung-Jin HONG ; Beom Joon KIM ; Seung Pil BAN ; Jung-Won SUH ; Young Bin SONG ; Jung Rae CHO ; Young-Hoon JEONG ; Weon KIM ; Eun-Seok SHIN ;
Korean Journal of Medicine 2022;97(4):204-228
Given the progressive improvements in antithrombotic strategies, management of cardiovascular disease has become sophisticated/refined. However, the optimal perioperative management of antithrombotic therapy in patients with acute coronary syndrome or who are scheduled for percutaneous coronary intervention remains unclear. Assessments of the thrombotic and hemorrhagic risks are essential to reduce the rates of mortality and major cardiac events. However, the existing guidelines do not mention these topics. This case-based consensus document deals with common clinical scenarios and offers evidence-based guidelines for individualized perioperative management of antithrombotic therapy in the real world.
3.Consensus Document on Perioperative Antithrombotic Management: Part 1. A Review
Yongwhi PARK ; Ae-Young HER ; Hyun Kuk KIM ; Jae Youn MOON ; Jae Hyoung PARK ; Keun-Ho PARK ; Kyung Hoon LEE ; Hyung Joon JOO ; Ho Yeon WON ; Sung Gyun AHN ; Hong Jun PARK ; Sung-Jin HONG ; Beom Joon KIM ; Seung Pil BAN ; Jung-Won SUH ; Young Bin SONG ; Jung Rae CHO ; Young-Hoon JEONG ; Weon KIM ; Eun-Seok SHIN ;
Korean Journal of Medicine 2022;97(3):150-163
The prevalence of ischemic heart disease is steadily growing as populations age. Antithrombotic treatment is a key therapeutic modality for the prevention of secondary cerebro-cardiovascular disease. Patients with acute coronary syndrome or who are undergoing percutaneous coronary intervention must be treated with dual antiplatelet therapy for a mandatory period. The optimal perioperative antithrombotic regimen remains debatable; antithrombotics can cause bleeding. Inadequate antithrombotic regimens are associated with perioperative ischemic events, but continuation of therapy may increase the risks of perioperative hemorrhagic complications (including mortality). Many guidelines on the perioperative management of antithrombotic agents have been established by academic societies. However, the existing guidelines do not cover all specialties, nor do they describe the thrombotic and hemorrhagic risks associated with various surgical interventions. Moreover, few practical recommendations on the modification of antithrombotic regimens in patients who require non-deferrable interventions/surgeries or procedures associated with a high risk of hemorrhage have appeared. Therefore, cardiologists, specialists performing invasive procedures, surgeons, dentists, and anesthesiologists have not come to a consensus on optimal perioperative antithrombotic regimens. The Korean Platelet-Thrombosis Research Group presented a positioning paper on perioperative antithrombotic management. We here discuss commonly encountered clinical scenarios and engage in evidence-based discussion to assist individualized, perioperative antithrombotic management in clinical practice.
4.A Multi-Center, Double-Blind Randomized Controlled Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802 (Tenofovir Disoproxil Orotate) and Viread (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients
Hyung Joon KIM ; Ju Hyun KIM ; Jong Eun YEON ; Yeon Seok SEO ; Jeong Won JANG ; Yong Kyun CHO ; Byoung Kuk JANG ; Byung Hoon HAN ; Changhyeong LEE ; Joon Hyeok LEE ; Jung-Hwan YOON ; Kang Mo KIM ; Moon Young KIM ; Do Young KIM ; Neung Hwa PARK ; Eun Young CHO ; June Sung LEE ; Jin-Woo LEE ; In Hee KIM ; Byung-Cheol SONG ; Byung-Seok LEE ; Oh Sang KWON
Journal of Korean Medical Science 2022;37(11):e92-
Background:
Tenofovir disoproxil fumarate (TDF, Viread® ) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF.
Methods:
The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated.
Results:
A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was −5.13 ± 1.40 in the DA-2802 group and −4.97 ± 1.40 log 10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity.
Conclusion
DA-2802 is considered an effective and safe treatment for patients with CHB.
5.KASL clinical practice guidelines: Management of nonalcoholic fatty liver disease
Seong Hee KANG ; Hye Won LEE ; Jeong-Ju YOO ; Yuri CHO ; Seung Up KIM ; Tae Hee LEE ; Byoung Kuk JANG ; Sang Gyune KIM ; Sang Bong AHN ; Haeryoung KIM ; Dae Won JUN ; Joon-Il CHOI ; Do Seon SONG ; Won KIM ; Soung Won JEONG ; Moon Young KIM ; Hong KOH ; Sujin JEONG ; Jin-Woo LEE ; Yong Kyun CHO ;
Clinical and Molecular Hepatology 2021;27(3):363-401
6.Multicenter Analysis of Clinical Features and Prognosis of COVID-19 Patients with Hepatic Impairment
Jeong Eun SONG ; Min Kyu KANG ; Yu Rim LEE ; Chang Hyeong LEE ; Jung Gil PARK ; Young Oh KWEON ; Won Young TAK ; Soo Young PARK ; Se Young JANG ; Jae Seok HWANG ; Byoung Kuk JANG ; Won Young JANG ; Jeong Ill SUH ; Woo Jin CHUNG ; Byung Seok KIM ;
Gut and Liver 2021;15(4):606-615
Background/Aims:
Recent data indicate the presence of liver enzyme abnormalities in patients with coronavirus disease 2019 (COVID-19). We aimed to evaluate the clinical features and treatment outcomes of COVID-19 patients with abnormal liver enzymes.
Methods:
We performed a retrospective, multicenter study of 874 COVID-19 patients admitted to five tertiary hospitals from February 20 to April 14, 2020. Data on clinical features, laboratory parameters, medications, and treatment outcomes were collected until April 30, 2020, and compared between patients with normal and abnormal aminotransferases.
Results:
Abnormal aminotransferase levels were observed in 362 patients (41.1%), of which 94 out of 130 (72.3%) and 268 out of 744 (36.0%) belonged to the severe and non-severe COVID-19 categories, respectively. The odds ratios (95% confidence interval) for male patients, patients with a higher body mass index, patients with severe COVID-19 status, and patients with lower platelet counts were 1.500 (1.029 to 2.184, p=0.035), 1.097 (1.012 to 1.189, p=0.024), 2.377 (1.458 to 3.875, p=0.001), and 0.995 (0.993 to 0.998, p>0.001), respectively, indicating an independent association of these variables with elevated aminotransferase levels. Lopinavir/ ritonavir and antibiotic use increased the odds ratio of abnormal aminotransferase levels after admission (1.832 and 2.646, respectively, both p<0.05). The median time to release from quarantine was longer (22 days vs 26 days, p=0.001) and the mortality rate was higher (13.0% vs 2.9%, p<0.001) in patients with abnormal aminotransferase levels.
Conclusions
Abnormal aminotransferase levels are common in COVID-19 patients and are associated with poor clinical outcomes. Multivariate analysis of patients with normal aminotransferase levels on admission showed that the use of lopinavir/ritonavir and antibiotics was associated with abnormal aminotransferase levels; thus, careful monitoring is needed.
7.KASL clinical practice guidelines: Management of nonalcoholic fatty liver disease
Seong Hee KANG ; Hye Won LEE ; Jeong-Ju YOO ; Yuri CHO ; Seung Up KIM ; Tae Hee LEE ; Byoung Kuk JANG ; Sang Gyune KIM ; Sang Bong AHN ; Haeryoung KIM ; Dae Won JUN ; Joon-Il CHOI ; Do Seon SONG ; Won KIM ; Soung Won JEONG ; Moon Young KIM ; Hong KOH ; Sujin JEONG ; Jin-Woo LEE ; Yong Kyun CHO ;
Clinical and Molecular Hepatology 2021;27(3):363-401
8.Multicenter Analysis of Clinical Features and Prognosis of COVID-19 Patients with Hepatic Impairment
Jeong Eun SONG ; Min Kyu KANG ; Yu Rim LEE ; Chang Hyeong LEE ; Jung Gil PARK ; Young Oh KWEON ; Won Young TAK ; Soo Young PARK ; Se Young JANG ; Jae Seok HWANG ; Byoung Kuk JANG ; Won Young JANG ; Jeong Ill SUH ; Woo Jin CHUNG ; Byung Seok KIM ;
Gut and Liver 2021;15(4):606-615
Background/Aims:
Recent data indicate the presence of liver enzyme abnormalities in patients with coronavirus disease 2019 (COVID-19). We aimed to evaluate the clinical features and treatment outcomes of COVID-19 patients with abnormal liver enzymes.
Methods:
We performed a retrospective, multicenter study of 874 COVID-19 patients admitted to five tertiary hospitals from February 20 to April 14, 2020. Data on clinical features, laboratory parameters, medications, and treatment outcomes were collected until April 30, 2020, and compared between patients with normal and abnormal aminotransferases.
Results:
Abnormal aminotransferase levels were observed in 362 patients (41.1%), of which 94 out of 130 (72.3%) and 268 out of 744 (36.0%) belonged to the severe and non-severe COVID-19 categories, respectively. The odds ratios (95% confidence interval) for male patients, patients with a higher body mass index, patients with severe COVID-19 status, and patients with lower platelet counts were 1.500 (1.029 to 2.184, p=0.035), 1.097 (1.012 to 1.189, p=0.024), 2.377 (1.458 to 3.875, p=0.001), and 0.995 (0.993 to 0.998, p>0.001), respectively, indicating an independent association of these variables with elevated aminotransferase levels. Lopinavir/ ritonavir and antibiotic use increased the odds ratio of abnormal aminotransferase levels after admission (1.832 and 2.646, respectively, both p<0.05). The median time to release from quarantine was longer (22 days vs 26 days, p=0.001) and the mortality rate was higher (13.0% vs 2.9%, p<0.001) in patients with abnormal aminotransferase levels.
Conclusions
Abnormal aminotransferase levels are common in COVID-19 patients and are associated with poor clinical outcomes. Multivariate analysis of patients with normal aminotransferase levels on admission showed that the use of lopinavir/ritonavir and antibiotics was associated with abnormal aminotransferase levels; thus, careful monitoring is needed.
9.Usefulness of a Vascular Clipping System to Create an Arteriovenous Fistula
Jin Suk LEE ; Kuk-Jin NAM ; Sam-Youl YOON ; Kun Ok LEE ; Hyung Joon HAN ; Sung-Jin CHO ; Jong-Woong PARK ; Tae Jin SONG
Journal of Acute Care Surgery 2020;10(3):101-105
Purpose:
The vascular clipping system (VCS) is beneficial as it is simple and easy to apply for microvascular suturing. Arteriovenous fistula (AVF) creation is a very basic standard technique of microvascular surgery. In this study the VCS and the conventional suture methods were compared in a rabbit model using the carotid artery and vein to create an AVF.
Methods:
There were 28 rabbits assigned equally into 2 groups using the AVF creation method (conventional suturing or the VCS procedure). Histopathology was performed on fixed samples. The procedure time of the 2 methods and changes in histopathology of tissue samples after surgery were compared.
Results:
The VCS procedure showed a lower degree of fibrosis and hyperplasia histologically compared with the conventional suture method. The VCS was quicker to perform and no significant anastomosis stricture was observed.
Conclusion
In a rabbit model of AVF, the VCS has benefits over the conventional suture method. The VCS provides comparable patency rates, produces fewer side effects such as fibrosis and hyperplasia, and takes less operation time than suturing. The VCS is expected to be useful for cases where renal patients need periodic hemodialysis and thus repetitive access to a vessel.
10.Usefulness of a Vascular Clipping System to Create an Arteriovenous Fistula
Jin Suk LEE ; Kuk-Jin NAM ; Sam-Youl YOON ; Kun Ok LEE ; Hyung Joon HAN ; Sung-Jin CHO ; Jong-Woong PARK ; Tae Jin SONG
Journal of Acute Care Surgery 2020;10(3):101-105
Purpose:
The vascular clipping system (VCS) is beneficial as it is simple and easy to apply for microvascular suturing. Arteriovenous fistula (AVF) creation is a very basic standard technique of microvascular surgery. In this study the VCS and the conventional suture methods were compared in a rabbit model using the carotid artery and vein to create an AVF.
Methods:
There were 28 rabbits assigned equally into 2 groups using the AVF creation method (conventional suturing or the VCS procedure). Histopathology was performed on fixed samples. The procedure time of the 2 methods and changes in histopathology of tissue samples after surgery were compared.
Results:
The VCS procedure showed a lower degree of fibrosis and hyperplasia histologically compared with the conventional suture method. The VCS was quicker to perform and no significant anastomosis stricture was observed.
Conclusion
In a rabbit model of AVF, the VCS has benefits over the conventional suture method. The VCS provides comparable patency rates, produces fewer side effects such as fibrosis and hyperplasia, and takes less operation time than suturing. The VCS is expected to be useful for cases where renal patients need periodic hemodialysis and thus repetitive access to a vessel.

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