1.Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer Ultimaster™ in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry
Soohyung PARK ; Seung-Woon RHA ; Byoung Geol CHOI ; Jae-Bin SEO ; Ik Jun CHOI ; Sung-Il WOO ; Soo-Han KIM ; Tae Hoon AHN ; Jae Sang KIM ; Ae-Young HER ; Ji-Hun AHN ; Han Cheol LEE ; Jaewoong CHOI ; Jin Soo BYON ; Markz RMP SINURAT ; Se Yeon CHOI ; Jinah CHA ; Su Jin HYUN ; Cheol Ung CHOI ; Chang Gyu PARK
Korean Circulation Journal 2024;54(6):339-350
Background and Objectives:
Ultimaster™, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of Ultimaster™ stents in Korean patients with coronary artery disease.
Methods:
This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up.
Results:
A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS).At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint.
Conclusions
The present registry shows that Ultimaster™ stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.
2.Impact of Atrial Fibrillation on Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI): The K-TAVI Registry
Sang Yoon LEE ; Ki Hong CHOI ; Taek Kyu PARK ; Jihoon KIM ; Eun Kyoung KIM ; Sung-Ji PARK ; Seung Woo PARK ; Hyeon-Cheol GWON ; Kiyuk CHANG ; Cheol Woong YU ; JuHan KIM ; Young Jin CHOI ; In-Ho CHAE ; Jae-Hwan LEE ; Jun-Hong KIM ; Jong Seon PARK ; Won-Jang KIM ; Young Won YOON ; Tae Hoon AHN ; Sang Rok LEE ; Byoung Joo CHOI ; Tae-Hyun YANG ; Cheol Ung CHOI ; Seung-Ho HUR ; Seong-Jin OH ; Han Cheol LEE ; HunSik PARK ; Hyo-Soo KIM ; Seung-Hyuk CHOI
Yonsei Medical Journal 2023;64(7):413-422
Purpose:
The incidence and prognostic implications of atrial fibrillation (AF) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) are controversial, especially for Korean patients. Furthermore, the pattern of antithrombotic therapy for these patients is unknown. The present study sought to identify the impact of AF on Korean patients undergoing TAVI and demonstrate the status of antithrombotic therapy for these patients.
Materials and Methods:
A total of 660 patients who underwent TAVI for severe AS were recruited from the nationwide K-TAVI registry in Korea. The enrolled patients were stratified into sinus rhythm (SR) and AF groups. The primary endpoint was all-cause death at 1-year.
Results:
AF was recorded in 135 patients [pre-existing AF 108 (16.4%) and new-onset AF 27 (4.1%)]. The rate of all-cause death at 1 year was significantly higher in patients with AF than in those with SR [16.2% vs. 6.4%, adjusted hazard ratio (HR): 2.207, 95% confidence interval (CI): 1.182–4.120, p=0.013], regardless of the onset timing of AF. The rate of new pacemaker insertion at 1 year was also significantly higher in patients with AF than in those with SR (14.0% vs. 5.5%, adjusted HR: 3.137, 95%CI: 1.621–6.071, p=0.001).Among AF patients, substantial number of patients received the combination of multiple antithrombotic agents (77.8%), and the most common combination was that of aspirin and clopidogrel (38.1%).
Conclusion
AF was an independent predictor of 1-year mortality and new pacemaker insertion in Korean patients undergoing TAVI.
3.A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial
Junsik PARK ; Myong Cheol LIM ; Jae-Kwan LEE ; Dae Hoon JEONG ; Se Ik KIM ; Min Chul CHOI ; Byoung-Gie KIM ; Jung-Yun LEE
Journal of Gynecologic Oncology 2022;33(2):e12-
Background:
Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi.
Methods
The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023.
4.Intranasal Vaccination with OuterMembrane Protein of Orientia tsutsugamushi induces Protective Immunity Against Scrub Typhus
Sung-Moo PARK ; Min Jeong GU ; Young-Jun JU ; In Su CHEON ; Kyu-Jam HWANG ; Byoungchul GILL ; Byoung-Shik SHIM ; Hang-Jin JEONG ; Young Min SON ; Sangho CHOI ; Woonhee JEUNG ; Seung Hyun HAN ; Hyuk CHU ; Cheol-Heui YUN
Immune Network 2021;21(2):e14-
Scrub typhus develops after the individual is bitten by a trombiculid mite infected with Orientia tsutsugamushi. Since it has been reported that pneumonia is frequently observed in patients with scrub typhus, we investigated whether intranasal (i.n.) vaccination with the outer membrane protein of O. tsutsugamushi (OMPOT) would induce a protective immunity against O. tsutsugamushi infection. It was particular interest that when mice were infected with O. tsutsugamushi, the bacteria disseminated into the lungs, causing pneumonia. The i.n. vaccination with OMPOT induced IgG responses in serum and bronchoalveolar lavage (BAL) fluid. The anti-O. tsutsugamushi IgA Abs in BAL fluid after the vaccination showed a high correlation of the protection against O. tsutsugamushi. The vaccination induced strong Ag-specific Th1 and Th17 responses in the both spleen and lungs. In conclusion, the current study demonstrated that i.n. vaccination with OMPOT elicited protective immunity against scrub typhus in mouse with O. tsutsugamushi infection causing subsequent pneumonia.
5.A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01)
Yong Jae LEE ; Myong Cheol LIM ; Byoung-Gie KIM ; Natalie YL NGOI ; Chel Hun CHOI ; Sang-Yoon PARK ; David SP TAN ; Yunjung GO ; Jung-Yun LEE
Journal of Gynecologic Oncology 2021;32(2):e31-
Background:
The optimal treatment of BRCA wild-type patients with platinum-sensitive recurrent ovarian cancer remains unknown. Recently, there is an increase in the evidence to support the role of the combination of a poly(adenosine diphosphate-ribose) polymerase inhibitor, anti-angiogenic agents, and immunotherapy as maintenance therapy in BRCA wild-type patients with platinum-sensitive recurrence. We hypothesized that adding pembrolizumab and bevacizumab to olaparib maintenance can increase progression-free survival (PFS) in BRCA wild-type patients with platinum-sensitive recurrent ovarian cancer.
Methods
BRCA wild-type patients who received two previous courses of platinum-containing therapy, achieved complete or partial response to last treatment, and the treatment-free interval is >6 months after the penultimate platinum-based chemotherapy offered olaparib maintenance with pembrolizumab and bevacizumab. Forty-four patients will be included from 4 sites across Singapore and Korea. The primary endpoint of the study is 6-month PFS rate.
6.Clinical Implications of Preoperative Nonvalvular Atrial Fibrillation with Respect to Postoperative Cardiovascular Outcomes in Patients Undergoing Non-Cardiac Surgery
Min Soo CHO ; Cheol Hyun LEE ; Jun KIM ; Jung Min AHN ; Minkyu HAN ; Gi Byoung NAM ; Kee Joon CHOI ; You Ho KIM
Korean Circulation Journal 2020;50(2):148-159
BACKGROUND AND OBJECTIVES:
Atrial fibrillation (AF) is associated with a higher long-term risk of major cardiovascular events. However, its clinical implications with respect to peri-operative cardiovascular outcomes in patients undergoing non-cardiac surgery is unclear. We tried to examine the association between pre-operative AF and peri-operative cardiovascular outcomes.
METHODS:
We retrospectively analyzed data from 26,501 consecutive patients who underwent comprehensive preoperative cardiac evaluations for risk stratification prior to receiving non-cardiac surgery at our center. Preoperative AF was diagnosed in 1,098 patients (4.1%), and their cardiovascular outcomes were compared with those of patients without AF. The primary outcome was the rate of major adverse cardiac and cerebrovascular events (MACCE) during immediate post-surgery period (<30 days).
RESULTS:
Patients with AF were older and had higher proportion of male sex, higher rate of extra-cardiac comorbidities, higher CHA₂DS₂-VASc score, and higher revised cardiac risk index (RCRI) compared with those without AF. The rate of MACCE was significantly higher in AF patients compared to non-AF patients (4.6% vs. 1.2%, p<0.001). Preoperative AF was associated with higher risk of MACCE, even after multivariable adjustment (odds ratio, 2.97; 95% confidence interval, 2.13–4.07, p<0.001). The relative contribution of AF to MACCE was larger in patients with lower RCRI (p for interaction=0.010). The discriminating performance of RCRI was significantly enhanced by addition of AF.
CONCLUSIONS
In patients undergoing non-cardiac surgery, preoperative AF was associated with a higher risk of peri-operative cardiovascular outcomes.
7.Long-term Clinical Outcomes of Radiofrequency Catheter Ablation versus Permanent Pacemaker Implantation in Patients with Tachycardia-Bradycardia Syndrome
Sang-Cheol CHO ; Eun-Sun JIN ; Sang Yong OM ; Ki Won HWANG ; Hyung Oh CHOI ; Ki-Hun KIM ; Sung-Hwan KIM ; Kyoung-Min PARK ; Jun KIM ; Ki-Joon CHOI ; You-Ho KIM ; Gi-Byoung NAM
Korean Circulation Journal 2020;50(11):998-1009
Background and Objectives:
Pacemaker (PM) implantation is a well-accepted treatment option for patients with paroxysmal atrial fibrillation (AF) and related tachycardiabradycardia syndrome (TBS). Data on the long-term clinical outcomes after radiofrequency catheter ablation (RFCA) or PM implantation are sparse.
Methods:
The medical records of 217 patients with TBS were retrospectively assessed.Outcomes in patients who underwent RFCA (n=108, 49.8%) were compared to those with PM implantation (n=109, 50.2%). The clinical outcomes were sinus rhythm maintenance, conversion to persistent AF, additional procedure or crossover, and the composite of cardiovascular hospitalization and death.
Results:
During the follow-up period (mean 3.5±2.0 years), the RFCA group, compared to the PM group, showed better sinus rhythm maintenance (adjusted hazard ratio [aHR], 0.27;95% confidence interval [CI], 0.15–0.46; p=0.002) and less progression to persistent AF (aHR, 0.20; 95% CI, 0.06–0.63; p=0.006). Additional procedure or crossover did not differ significantly between the groups (aHR, 2.07; 95% CI, 0.71–6.06; p=0.185 and aHR, 0.69; 95% CI, 10.8–2.67; p=0.590, respectively). Most RFCA patients (92.6%) did not require pacemaker implantation during long term follow-up period (>3.5 years). The composite endpoint of cardiovascular rehospitalization and death was not significantly different between the groups (aHR, 0.92; 95% CI, 0.50–1.66; p=0.769).Background and Objectives: Pacemaker (PM) implantation is a well-accepted treatment option for patients with paroxysmal atrial fibrillation (AF) and related tachycardiabradycardia syndrome (TBS). Data on the long-term clinical outcomes after radiofrequency catheter ablation (RFCA) or PM implantation are sparse.
Methods:
The medical records of 217 patients with TBS were retrospectively assessed.Outcomes in patients who underwent RFCA (n=108, 49.8%) were compared to those with PM implantation (n=109, 50.2%). The clinical outcomes were sinus rhythm maintenance, conversion to persistent AF, additional procedure or crossover, and the composite of cardiovascular hospitalization and death.
Results:
During the follow-up period (mean 3.5±2.0 years), the RFCA group, compared to the PM group, showed better sinus rhythm maintenance (adjusted hazard ratio [aHR], 0.27;95% confidence interval [CI], 0.15–0.46; p=0.002) and less progression to persistent AF (aHR, 0.20; 95% CI, 0.06–0.63; p=0.006). Additional procedure or crossover did not differ significantly between the groups (aHR, 2.07; 95% CI, 0.71–6.06; p=0.185 and aHR, 0.69; 95% CI, 10.8–2.67; p=0.590, respectively). Most RFCA patients (92.6%) did not require pacemaker implantation during long term follow-up period (>3.5 years). The composite endpoint of cardiovascular rehospitalization and death was not significantly different between the groups (aHR, 0.92; 95% CI, 0.50–1.66; p=0.769).
Conclusions
RFCA is an effective alternative to PM implantation in patients with TBS.In these patients, successful RF ablation of AF is related to a higher rate of sinus rhythm maintenance compared to PM implantation, and the composite outcome of cardiovascular rehospitalization and death is similar.
8.Survival Effects of Cytoreductive Surgery for Refractory Patients after Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer
Wonkyo SHIN ; Joseph J. NOH ; Sang-Soo SEO ; Sokbom KANG ; Chel-Hun CHOI ; Sang-Yoon PARK ; Byoung-Gie KIM ; Myong Cheol LIM
Yonsei Medical Journal 2020;61(11):935-941
Purpose:
Salvage second-line chemotherapy is usually recommended for patients with advanced epithelial ovarian cancer (AEOC) who develop progressive disease (PD) after neoadjuvant chemotherapy (NAC). Herein, we investigated the role of cytoreductive surgery (CRS) for such patients.
Materials and Methods:
We retrospectively reviewed the medical records of 36 patients with AEOC who developed PD after receiving NAC at two tertiary academic centers with different treatment strategies between 2001 and 2016. Patients who developed PD after NAC were consistently treated with CRS at one hospital (group A; n=13) and second-line chemotherapy at another (group B;n=23). The clinical characteristics and treatment outcomes were compared between the groups.
Results:
Overall survival (OS) was longer in group A than in group B (19.4 months vs. 7.9 months; p=0.011). High-grade serous histology was associated with longer OS than non-high-grade serous types. In group A, optimal surgery resection (<1 cm) was achieved after CRS in 6 patients (46%). Multivariate analysis showed that the treatment option was the only independent predictive factor for OS (hazard ratio, 2.30; 95% confidence interval, 1.02–5.17; p=0.044).
Conclusion
CRS may result in a survival benefit even in patients with AEOC who develop PD after NAC.
9.Clinical Implications of Preoperative Nonvalvular Atrial Fibrillation with Respect to Postoperative Cardiovascular Outcomes in Patients Undergoing Non-Cardiac Surgery
Min Soo CHO ; Cheol Hyun LEE ; Jun KIM ; Jung Min AHN ; Minkyu HAN ; Gi Byoung NAM ; Kee Joon CHOI ; You Ho KIM
Korean Circulation Journal 2020;50(2):148-159
BACKGROUND AND OBJECTIVES: Atrial fibrillation (AF) is associated with a higher long-term risk of major cardiovascular events. However, its clinical implications with respect to peri-operative cardiovascular outcomes in patients undergoing non-cardiac surgery is unclear. We tried to examine the association between pre-operative AF and peri-operative cardiovascular outcomes.METHODS: We retrospectively analyzed data from 26,501 consecutive patients who underwent comprehensive preoperative cardiac evaluations for risk stratification prior to receiving non-cardiac surgery at our center. Preoperative AF was diagnosed in 1,098 patients (4.1%), and their cardiovascular outcomes were compared with those of patients without AF. The primary outcome was the rate of major adverse cardiac and cerebrovascular events (MACCE) during immediate post-surgery period (<30 days).RESULTS: Patients with AF were older and had higher proportion of male sex, higher rate of extra-cardiac comorbidities, higher CHA₂DS₂-VASc score, and higher revised cardiac risk index (RCRI) compared with those without AF. The rate of MACCE was significantly higher in AF patients compared to non-AF patients (4.6% vs. 1.2%, p<0.001). Preoperative AF was associated with higher risk of MACCE, even after multivariable adjustment (odds ratio, 2.97; 95% confidence interval, 2.13–4.07, p<0.001). The relative contribution of AF to MACCE was larger in patients with lower RCRI (p for interaction=0.010). The discriminating performance of RCRI was significantly enhanced by addition of AF.CONCLUSIONS: In patients undergoing non-cardiac surgery, preoperative AF was associated with a higher risk of peri-operative cardiovascular outcomes.
Atrial Fibrillation
;
Comorbidity
;
Humans
;
Male
;
Retrospective Studies
;
Risk Assessment
;
Stroke
10.Benefit of Four-Dimensional Computed Tomography Derived Ejection Fraction of the Left Atrial Appendage to Predict Thromboembolic Risk in the Patients with Valvular Heart Disease
In Cheol KIM ; Hyuk Jae CHANG ; In Jeong CHO ; Chi Young SHIM ; Geu Ru HONG ; Ji Hoe HEO ; Hyo Suk NAM ; Young Jin KIM ; Byoung Wook CHOI ; Namsik CHUNG
Korean Circulation Journal 2019;49(2):173-180
BACKGROUND AND OBJECTIVES: Decreased left atrial appendage (LAA) emptying velocity in transesophageal echocardiography (TEE) is related with higher incidence of thrombus and increased risk of stroke. Patients with valve disease are at higher risk of thrombus formation before and after surgery. The aim of this study was to investigate the role of 4-dimensional cardiac computed tomography (4DCT) to predict the risk of thrombus formation. METHODS: Between March 2010 to March 2015, total of 62 patients (mean 60±15 years old, male: 53.2%) who underwent 4DCT and TEE for cardiac valve evaluation before surgery were retrospectively included in the current study. Fractional area change in TEE view and emptying velocity at left atrial appendage in TEE view (VeTEE) were measured. Ejection fraction (EF) of left atrial appendage in computed tomography (EFCT) was calculated by 4DCT with full volume analysis. The best cut-off value of EFCT predicting presence of spontaneous echo contrast (SEC) or thrombus was evaluated, and correlation between the parameters were also estimated. RESULTS: SEC or thrombus was observed in 45.2%. EFCT and VeTEE were significantly correlated (r=0.452, p < 0.001). However, fractional area change measured by TEE showed no correlation with VeTEE (r=0.085, p=0.512). EFCT < 37.5% best predicted SEC or thrombus in the patients with valve disease who underwent 4DCT and TEE (area under the curve, 0.654; p=0.038). CONCLUSIONS: In the patients who underwent 4DCT for cardiac valve evaluation before surgery, EFCT by volume analysis might have additional role to evaluate LAA function and estimate the risk of thrombus.
Atrial Appendage
;
Echocardiography, Transesophageal
;
Four-Dimensional Computed Tomography
;
Heart Valve Diseases
;
Heart Valves
;
Humans
;
Incidence
;
Male
;
Retrospective Studies
;
Stroke
;
Thrombosis

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