1.Clinical impact of drug-coated balloon treatment of coronary artery disease in elderly patients.
Eun-Seok SHIN ; Mi Hee JANG ; Sunwon KIM ; Dong Oh KANG ; Ki-Bum WON ; Bitna KIM ; Ae-Young HER
Journal of Geriatric Cardiology 2025;22(1):150-158
BACKGROUND:
Data on drug-coated balloon (DCB) treatment in elderly patients are limited. This study was to evaluate the efficacy of DCB treatment in percutaneous coronary intervention (PCI) among elderly patients.
METHODS:
A retrospective analysis included 232 patients aged 75 years or older with coronary artery disease who underwent successful PCI using either DCB alone or in combination with drug-eluting stent (DES) based on pre-dilation results (DCB-based PCI). These patients were compared with 1818 elderly patients who underwent second-generation DES implantation (DES-only PCI). The endpoint was major adverse cardiovascular events (MACE) at 2-year follow-up.
RESULTS:
In the DCB-based PCI, 61.2% of patients received DCB-only treatment. Compared to DES-only PCI, the DCB-based PCI group had fewer stents (0.5 ± 0.7 and 1.7 ± 0.8, P < 0.001), shorter stent lengths (13.3 ± 20.9 mm and 37.4 ± 23.0 mm, P < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (15.6% and 28.7%, P = 0.010). The DCB-based PCI group exhibited lower rate of MACE (5.5% and 13.1%, P = 0.003), target vessel revascularization (1.1% and 5.6%, P = 0.017) and major bleeding (0.7% and 5.1%, P = 0.009) at 2-year follow-up. The reduced risk in 2-year MACE was consistently observed across various matching procedures, with the most significant reduction noted in target vessel revascularization and major bleeding.
CONCLUSION
The DCB-based PCI reduced stent burden, particularly in the usage of small diameter stents, and was associated with lower risks of MACE, target vessel revascularization, and major bleeding compared to DES-only PCI in elderly patients.
2.Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives
Korean Circulation Journal 2024;54(9):519-533
The outstanding development in contemporary medicine, highlighted by percutaneous coronary intervention (PCI), was achieved through the adoption of drug-eluting stents (DESs). Although DES is the established therapy for patients undergoing PCI for de novo coronary artery disease (CAD), their drawbacks include restenosis, stent thrombosis, and the requirement for dual antiplatelet therapy (DAPT) with an uncertain duration regarding its optimality. Drug-coated balloon (DCB) treatment leaves nothing behind on the vessel wall, providing the benefit of avoiding stent thrombosis and not necessitating obligatory extended DAPT. After optimizing coronary blood flow, DCB treatment delivers an antiproliferative drug directly coated on a balloon. Although more evidence is needed for the application of DCB treatment in de novo coronary lesions, recent studies suggest the safety and effectiveness of DCB treatment for diverse conditions including small and large vessel diseases, complex lesions like bifurcation lesions or diffuse or multivessel diseases, chronic total occlusion lesions, acute myocardial infarctions, patients at high risk of bleeding, and beyond. Consequently, we will review the current therapeutic choices for managing de novo CAD using DCB and assess the evidence supporting their concurrent application.Additionally, it aims to discuss future important perspectives.
3.Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives
Korean Circulation Journal 2024;54(9):519-533
The outstanding development in contemporary medicine, highlighted by percutaneous coronary intervention (PCI), was achieved through the adoption of drug-eluting stents (DESs). Although DES is the established therapy for patients undergoing PCI for de novo coronary artery disease (CAD), their drawbacks include restenosis, stent thrombosis, and the requirement for dual antiplatelet therapy (DAPT) with an uncertain duration regarding its optimality. Drug-coated balloon (DCB) treatment leaves nothing behind on the vessel wall, providing the benefit of avoiding stent thrombosis and not necessitating obligatory extended DAPT. After optimizing coronary blood flow, DCB treatment delivers an antiproliferative drug directly coated on a balloon. Although more evidence is needed for the application of DCB treatment in de novo coronary lesions, recent studies suggest the safety and effectiveness of DCB treatment for diverse conditions including small and large vessel diseases, complex lesions like bifurcation lesions or diffuse or multivessel diseases, chronic total occlusion lesions, acute myocardial infarctions, patients at high risk of bleeding, and beyond. Consequently, we will review the current therapeutic choices for managing de novo CAD using DCB and assess the evidence supporting their concurrent application.Additionally, it aims to discuss future important perspectives.
4.Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives
Korean Circulation Journal 2024;54(9):519-533
The outstanding development in contemporary medicine, highlighted by percutaneous coronary intervention (PCI), was achieved through the adoption of drug-eluting stents (DESs). Although DES is the established therapy for patients undergoing PCI for de novo coronary artery disease (CAD), their drawbacks include restenosis, stent thrombosis, and the requirement for dual antiplatelet therapy (DAPT) with an uncertain duration regarding its optimality. Drug-coated balloon (DCB) treatment leaves nothing behind on the vessel wall, providing the benefit of avoiding stent thrombosis and not necessitating obligatory extended DAPT. After optimizing coronary blood flow, DCB treatment delivers an antiproliferative drug directly coated on a balloon. Although more evidence is needed for the application of DCB treatment in de novo coronary lesions, recent studies suggest the safety and effectiveness of DCB treatment for diverse conditions including small and large vessel diseases, complex lesions like bifurcation lesions or diffuse or multivessel diseases, chronic total occlusion lesions, acute myocardial infarctions, patients at high risk of bleeding, and beyond. Consequently, we will review the current therapeutic choices for managing de novo CAD using DCB and assess the evidence supporting their concurrent application.Additionally, it aims to discuss future important perspectives.
5.Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives
Korean Circulation Journal 2024;54(9):519-533
The outstanding development in contemporary medicine, highlighted by percutaneous coronary intervention (PCI), was achieved through the adoption of drug-eluting stents (DESs). Although DES is the established therapy for patients undergoing PCI for de novo coronary artery disease (CAD), their drawbacks include restenosis, stent thrombosis, and the requirement for dual antiplatelet therapy (DAPT) with an uncertain duration regarding its optimality. Drug-coated balloon (DCB) treatment leaves nothing behind on the vessel wall, providing the benefit of avoiding stent thrombosis and not necessitating obligatory extended DAPT. After optimizing coronary blood flow, DCB treatment delivers an antiproliferative drug directly coated on a balloon. Although more evidence is needed for the application of DCB treatment in de novo coronary lesions, recent studies suggest the safety and effectiveness of DCB treatment for diverse conditions including small and large vessel diseases, complex lesions like bifurcation lesions or diffuse or multivessel diseases, chronic total occlusion lesions, acute myocardial infarctions, patients at high risk of bleeding, and beyond. Consequently, we will review the current therapeutic choices for managing de novo CAD using DCB and assess the evidence supporting their concurrent application.Additionally, it aims to discuss future important perspectives.
6.Prognostic Implication of Platelet Reactivity According to Left Ventricular Systolic Dysfunction Status in Patients Treated With Drug-Eluting Stent Implantation:Analysis of the PTRG-DES Consortium
Donghoon HAN ; Sun-Hwa KIM ; Dong Geum SHIN ; Min-Kyung KANG ; Seonghoon CHOI ; Namho LEE ; Byeong-Keuk KIM ; Hyung Joon JOO ; Kiyuk CHANG ; Yongwhi PARK ; Young Bin SONG ; Sung Gyun AHN ; Jung-Won SUH ; Sang Yeub LEE ; Ae-Young HER ; Young-Hoon JEONG ; Hyo-Soo KIM ; Moo Hyun KIM ; Do-Sun LIM ; Eun-Seok SHIN ; Jung Rae CHO ; For the PTRG Investigator
Journal of Korean Medical Science 2024;39(3):e27-
Background:
Coronary artery disease patients undergoing percutaneous coronary intervention (PCI) often exhibit reduced left ventricular ejection fraction (LVEF). However, the impact of LV dysfunction status in conjunction with platelet reactivity on clinical outcomes has not been previously investigated.
Methods:
From the multicenter PTRG-DES (Platelet function and genoType-Related long-term prognosis in DES-treated patients) consortium, the patients were classified as preserved-EF (PEF: LVEF ≥ 50%) and reduced-EF (REF: LVEF< 5 0%) group by echocardiography. Platelet reactivity was measured using VerifyNow P2Y 12 assay and high platelet reactivity (HPR) was defined as PRU ≥ 252. The major adverse cardiac and cerebrovascular events (MACCEs) were a composite of death, myocardial infarction, stent thrombosis and stroke at 5 years after PCI. Major bleeding was defined as Bleeding Academic Research Consortium bleeding types 3–5.
Results:
A total of 13,160 patients from PTRG-DES, 9,319 (79.6%) patients with the results of both PRU and LVEF were analyzed. The incidence of MACCE and major bleeding was higher in REF group as compared with PEF group (MACCEs: hazard ratio [HR] 2.17, P < 0.001, 95% confidence interval [CI] 1.85–2.55; major bleeding: HR 1.78, P < 0.001, 95% CI 1.39–2.78).The highest rate of MACCEs was found in patients with REF and HPR, and the difference between the groups was statistically significant (HR 3.14 in REF(+)/HPR(+) vs. PEF(+)/HPR(-) group,P <0.01, 95% CI 2.51–3.91). The frequency of major bleeding was not associated with the HPR in either group.
Conclusion
LV dysfunction was associated with an increased incidence of MACCEs and major bleeding in patients who underwent PCI. The HPR status further exhibited significant increase of MACCEs in patients with LV dysfunction in a large, real-world registry.Trial Registration: ClinicalTrials.gov Identifier: NCT04734028
7.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.
8.Sex-Based Outcomes of P2Y12 Inhibitor Monotherapy After Three Months of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention
Eun-Seok SHIN ; Ae-Young HER ; Bitna KIM ; Joo-Yong HAHN ; Young Bin SONG ; Joo Myung LEE ; Taek Kyu PARK ; Jeong Hoon YANG ; Jin-Ho CHOI ; Seung-Hyuk CHOI ; Sang Hoon LEE ; Hyeon-Cheol GWON ;
Journal of Korean Medical Science 2023;38(45):e383-
Background:
In patients undergoing percutaneous coronary intervention (PCI) in the SMART-CHOICE trial, P2Y12 inhibitor monotherapy after three months of dual antiplatelet therapy (DAPT) achieved clinical outcomes comparable to those of 12 months of DAPT.Nonetheless, the effects of sex on these outcomes remain unknown.
Methods:
This open-label, non-inferiority, randomized study, conducted in 33 hospitals in South Korea, included 2,993 patients undergoing PCI with drug-eluting stents. Patients were randomly assigned to receive DAPT (aspirin plus a P2Y12 inhibitor) for three months then P2Y12 inhibitor alone for nine months, or DAPT for the entire 12 months. The primary endpoints were major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) 12 months after the index procedure. The bleeding endpoints were Bleeding Academic Research Consortium (BARC) bleeding types 2 to 5.
Results:
Of the patients, 795 (26.6%) were women, who were older and had a higher prevalence of hypertension, diabetes, and dyslipidemia than men. The sexes exhibited comparable primary endpoints (adjusted hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.55–1.55; P = 0.770) and bleeding endpoints (adjusted HR, 1.07; 95% CI, 0.63–1.81; P = 0.811). P2Y12 inhibitor monotherapy vs DAPT was associated with lower risk of BARC type 2 to 5 bleeding in women (adjusted HR, 0.40; 95% CI, 0.16–0.98; P = 0.045) but the difference was not statistically significant when using the Bonferroni correction. The primary endpoints were similar between treatment groups in both sexes.
Conclusion
In both sexes undergoing PCI, P2Y12 inhibitor monotherapy after three months of DAPT achieved similar risks of the primary endpoints and the bleeding events compared with prolonged DAPT. Therefore, the benefits of early aspirin withdrawal with ongoing P2Y12 inhibitors may be comparable in women and men.
9.Long-Term Clinical Outcomes of Drug-Coated Balloon Treatment for De Novo Coronary Lesions
Ae-Young HER ; Bitna KIM ; Soe Hee AHN ; Yongwhi PARK ; Jung Rae CHO ; Young-Hoon JEONG ; Eun-Seok SHIN
Yonsei Medical Journal 2023;64(6):359-365
Purpose:
Data are limited on the long-term efficacy and safety of drug-coated balloon (DCB) treatment in comparison to drugeluting stent (DES) for de novo coronary lesions. We investigated the long-term clinical outcomes of DCB treatment in percutaneous coronary intervention (PCI) for de novo coronary lesions.
Materials and Methods:
A total of 103 patients scheduled for elective PCI for de novo non-small coronary lesions (≥2.5 mm) who were successfully treated with DCB alone were retrospectively compared with 103 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n=13160). All patients were followed for 5 years. The primary endpoint was major adverse cardiac events [MACE; cardiac death, myocardial infarction, stroke, target lesion thrombosis, target vessel revascularization (TVR), and major bleeding] at 5 years.
Results:
At 5-year clinical follow-up, Kaplan-Meier estimates of the rate of MACE were significantly lower in the DCB group [2.9% vs. 10.7%; hazard ratio (HR): 0.26; 95% confidence interval (CI): 0.07–0.96; log-rank p=0.027]. There was a significantly lower incidence of TVR in the DCB group (1.0% vs. 7.8%; HR: 0.12; 95% CI: 0.01–0.98; long-rank p=0.015), and there was major bleeding only in the DES group (0.0% vs. 1.9%; log-rank p=0.156).
Conclusion
At 5-year follow-up, DCB treatment was significantly associated with reduced incidences of MACE and TVR, compared with DES implantation, for de novo coronary lesions.
10.Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial
Yong-Joon LEE ; Yongsung SUH ; Jung-Sun KIM ; Yun-Hyeong CHO ; Kyeong Ho YUN ; Yong Hoon KIM ; Jae Young CHO ; Ae-Young HER ; Sungsoo CHO ; Dong Woon JEON ; Sang-Yong YOO ; Deok-Kyu CHO ; Bum-Kee HONG ; Hyuckmoon KWON ; Sung-Jin HONG ; Chul-Min AHN ; Dong-Ho SHIN ; Chung-Mo NAM ; Byeong-Keuk KIM ; Young-Guk KO ; Donghoon CHOI ; Myeong-Ki HONG ; Yangsoo JANG ; For the TICO investigators
Korean Circulation Journal 2022;52(4):324-337
Background and Objectives:
Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs).
Methods:
In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISEDAPT) score ≥25. The primary outcome was a 3–12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events).
Results:
Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76– 4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92–4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178).
Conclusions
In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.Trial Registration: ClinicalTrials.gov Identifier: NCT02494895

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