The Korean Journal of Medicine

The Korean Association of Internal Medicine (대한내과학회)
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Comparison of Clinical Outcomes between Drug-Eluting Balloons and Drug-Eluting Stents in Patients with Small Coronary Artery Disease

작은 관상동맥질환 환자에서 약물 용출 풍선과 약물 용출 스텐트 시술 후 임상 경과의 비교

  • Man Su Kim (Cardiovascular Center, Chonnam National University Hospital) ;
  • Seong Ho Park (Cardiovascular Center, Chonnam National University Hospital) ;
  • Seok Oh (Cardiovascular Center, Chonnam National University Hospital) ;
  • Dae Yong Hyun (Cardiovascular Center, Chonnam National University Hospital) ;
  • Seung Hun Lee (Cardiovascular Center, Chonnam National University Hospital) ;
  • Yong Hwan Lim (Cardiovascular Center, Chonnam National University Hospital) ;
  • Jun Ho Ahn (Cardiovascular Center, Chonnam National University Hospital) ;
  • Kyung Hoon Cho (Cardiovascular Center, Chonnam National University Hospital) ;
  • Min Chul Kim (Cardiovascular Center, Chonnam National University Hospital) ;
  • Doo Sun Sim (Cardiovascular Center, Chonnam National University Hospital) ;
  • Young Joon Hong (Cardiovascular Center, Chonnam National University Hospital) ;
  • Ju Han Kim (Cardiovascular Center, Chonnam National University Hospital) ;
  • Youngkeun Ahn (Cardiovascular Center, Chonnam National University Hospital) ;
  • Myung Ho Jeong (Cardiovascular Center, Chonnam National University Hospital)
  • 김만수 (전남대학교병원 심혈관센터) ;
  • 박성호 (전남대학교병원 심혈관센터) ;
  • 오석 (전남대학교병원 심혈관센터) ;
  • 현대용 (전남대학교병원 심혈관센터) ;
  • 이승헌 (전남대학교병원 심혈관센터) ;
  • 임용환 (전남대학교병원 심혈관센터) ;
  • 안준호 (전남대학교병원 심혈관센터) ;
  • 조경훈 (전남대학교병원 심혈관센터) ;
  • 김민철 (전남대학교병원 심혈관센터) ;
  • 심두선 (전남대학교병원 심혈관센터) ;
  • 홍영준 (전남대학교병원 심혈관센터) ;
  • 김주한 (전남대학교병원 심혈관센터) ;
  • 안영근 (전남대학교병원 심혈관센터) ;
  • 정명호 (전남대학교병원 심혈관센터)
  • Received : 2024.01.05
  • Accepted : 2024.07.09
  • Published : 2024.10.01
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Abstract

Background/Aims: Drug-eluting balloons (DEBs) represent a novel therapeutic approach for patients with small coronary artery disease. However, further studies are needed to compare the clinical efficacy of DEBs versus drug-eluting stents (DESs). Methods: In total, 492 patients (age, 67.9 ± 11.0 years; 339 men) with small coronary artery lesions (diameter < 2.75 mm) were randomly assigned to group I (DEB) (n = 104; age, 67.2 ± 10.7 years; 83 men) and group II (DES) (n = 388; age, 68.0 ± 11.1 years; 254 men). For inverse probability of treatment weighting (IPTW) analysis, the study population was stratified into groups I (n = 269) and II (n = 280). We compared the incidences of major adverse cardiac events (MACE) between the two groups during 12 months of clinical follow-up. Results: Group I had shorter device lengths (22.4 ± 5.8 mm) compared with group II (27.4 ± 9.3 mm; p < 0.001). Additionally, devices in group I were smaller in diameter (2.4 ± 0.1 mm) compared with those in group II (2.6 ± 0.1 mm; p < 0.001). Left ventricular ejection fraction (LVEF) was lower in group I (53.8% ± 12.6%) than in group II (58.6% ± 11.9%; p < 0.001). After IPTW, no significant differences in LVEF were observed between groups I and II. During 12 months of follow-up, the incidence of total MACE did not differ between the two groups. Conclusions: No significant differences were observed in clinical efficacy between DEB and DES for the treatment of small coronary artery disease. Therefore, DEB can be considered a viable alternative to DES in patients with small coronary artery disease.

목적: 약물 용출 풍선(drug-eluting balloon, DEB)은 작은 관상동맥 질환 환자를 위한 새로운 치료 전략이나 약물 용출스텐트(drug-eluting stent, DES)에 비하여 임상적 효과에 관한 연구가 더 많이 필요한 실정이다. 본 연구에서는 작은 혈관 병변을 동반한 환자를 대상으로 DEB와 DES 시술 후 1년간의 임상 효과를 비교 분석하였다. 방법: 2021년 1월부터 2022년 9월까지 2.75 mm 미만의 작은 관상동맥 병변을 가진 492명의 환자(67.9 ± 11.0세; 남자 339명)를 시술 후 1년간 추적 관찰하여 주요 심장 사건(major adverse cardiac events, MACE)을 분석하였다. MACE는 모든 원인 사망, 표적 혈관 재관류(target vessel revascularization, TVR), 표적 병변 재관류(target lesion revascularization, TLR), 스텐트 혈전증(stent thrombosis, ST), 심근경색증(myocardial infarction, MI)으로 하였다. 대상 환자 중 DEB를 사용한 환자를 I군(104명; 67.2 ± 10.7세; 남자 83명), DES를 사용한 환자를 II군(388명; 68.0 ± 11.1세; 남자 254명)으로 분류하여 비교 분석을 하였고 역처리 확률 가중법(inverse probability of treatment weighting, IPTW)을 실시하여 I군 269명과 II군 280명을 추가 분석하였다. 결과: 위험 요인 중 흡연이 I군이 II군보다 많았다(23명 [22.1%] vs. 36명[9.3%]; p < 0.001). 시술 도자의 길이는 I군이 II군보다 짧았고(22.4 ± 5.9 vs. 27.4 ± 9.3 mm; p < 0.001) 시술 도자의 직경도 I군이 II군보다 작았으며(2.4 ± 0.1 vs. 2.6 ± 0.1 mm; p < 0.001) 좌심실 구혈률은 I군이 II군보다 낮았다(53.8% ± 12.6% vs. 58.6% ± 11.9%; p < 0.001). IPTW 시행 후에는 I군과 II군의 좌심실 구혈률의 차이는 보이지 않았고 시술 도자의 길이는 I군이 II군보다 짧았으며(21.9 ± 5.9 vs. 26.9 ± 9.2 mm; p < 0.001) 시술 도자의 직경도 I군이 II군보다 작았다(2.5 ± 0.2 vs. 2.6 ± 0.1 mm; p < 0.001). 일 년간 추적 관찰 시에 모든 원인 사망(0.4% vs. 1.1%; p = 0.450), TLR (2.4% vs. 1.1%; p = 0.444), TVR (2.2% vs. 4.9%; p = 0.333) 및 ST (0.0% vs. 0.4%; p = 0.330)는 I군과 II군에서 차이가 없었으며 MACE 발생률도 I군과 II군 간의 유의한 차이를 보이지 않았다(5.0% vs. 7.5%; p = 0.513). 결론: 작은 관상동맥 질환의 치료에서 DEB의 사용은 DES와 비교하여 1년간 관찰한 임상 경과에 유의한 차이가 없었다.

Keywords

Acknowledgement

This work was supported in part, by the Chonnam National University Hospital Research Fund.

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