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. 2024 Jun 18;4(7):519-531.
doi: 10.1016/j.jacasi.2024.04.007. eCollection 2024 Jul.

Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention

Hyun Sung Joh  1 , Woochan Kwon  2 , Doosup Shin  3 , Seung Hun Lee  4 , Young Joon Hong  4 , David Hong  2 , Sang Yoon Lee  2 , Hanbit Park  5 , Sunwon Kim  6 , Sang Yeub Lee  7 , Jin-Sin Koh  8 , Hangyul Kim  8 , Chan Joon Kim  9 , Eun Ho Choo  10 , Hyuck-Jun Yoon  11 , Sang Don Park  12 , Ki-Hyun Jeon  13 , Jang-Whan Bae  14 , Sung Gyun Ahn  15 , Sung Eun Kim  16 , Ki Hong Choi  2 , Taek Kyu Park  2 , Jeong Hoon Yang  2 , Young Bin Song  2 , Joo-Yong Hahn  2 , Seung-Hyuk Choi  2 , Hyeon-Cheol Gwon  2 , Joo Myung Lee  2
Affiliations

Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention

Hyun Sung Joh et al. JACC Asia. .

Abstract

Background: There are limited clinical data on drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients with complex coronary artery lesions.

Objectives: The goal of the current study was to investigate the efficacy of DCB in patients undergoing PCI for complex coronary artery lesions.

Methods: From an institutional registry of patients with de novo complex coronary artery lesions, 126 patients treated with DCB-based PCI were compared with 234 propensity score-matched patients treated with DES-only PCI. Complex coronary artery lesions were defined as the presence of at least 1 of the following: bifurcation, chronic total occlusion, unprotected left main disease, long lesion ≥38 mm, multivessel disease, lesion requiring ≥3 devices, or severe calcification. The primary endpoint was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization.

Results: Baseline characteristics were comparable between the 2 groups. DCB-based PCI showed a comparable risk of TVF vs DES-based PCI (7.6% vs 8.1%; HR: 0.81; 95% CI: 0.33-1.99; P = 0.638). The risks of cardiac death (5.0% vs 5.7%; HR: 0.78; 95% CI: 0.24-2.49), target vessel-related myocardial infarction (0.9% vs 1.3%; HR: 2.65; 95% CI: 0.26-27.06), and target vessel revascularization (3.5% vs 2.0%; HR: 1.30; 95% CI: 0.30-5.67) were also comparable between the 2 groups.

Conclusions: DCB-based PCI showed comparable risks of TVF vs those of DES-only PCI in patients with complex coronary artery lesions. DCB might be considered as a suitable alternative device to DES in patients undergoing complex PCI. (Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815).

Keywords: complex percutaneous coronary intervention; de novo; drug-coated balloon; drug-eluting stent(s).

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Conflict of interest statement

Dr J.M. Lee has received an institutional research grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Zoll Medical, and Donga-ST. Dr Hahn has received an institutional research grant from the National Evidence-based Healthcare Collaborating Agency, Ministry of Health & Welfare of the Republic of Korea, Abbott Vascular, Biosensors, Boston Scientific, Daiichi-Sankyo, Donga-ST, Hanmi Pharmaceutical, and Medtronic Inc. Dr Gwon has received an institutional research grant from Boston Scientific, Genoss, and Medtronic Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Study Flow Study flow is presented. A total of 1,940 patients who had a complex coronary artery lesion were included from a prospective institutional registry. Among them, 324 patients with in-stent restenosis were excluded, leaving 138 patients with drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) and 1,478 patients with drug-eluting stent (DES)-only PCI. Propensity score matching with a 1:2 ratio was used for adjustment of baseline characteristics differences, leaving 126 patients with DCB-based PCI and 234 patients with DES-only PCI for analysis. MI = myocardial infarction.
Figure 2
Figure 2
Proportion of Complex Coronary Artery Lesions in the Study Population Bar graphs show the proportion of complex coronary artery lesions between the DCB-based and DES-only PCI groups. Blue bars denote the proportion of DCB-based PCI, and the red bars denote the proportion of DES-only PCI. CTO = chronic total occlusion; LM = left main; other abbreviations as in Figure 1.
Figure 3
Figure 3
Comparison of Target Vessel Failure Between DCB-Based vs DES-Based PCI Kaplan-Meier curve is presented for cumulative incidence of target vessel failure at 2 years between the DCB-based PCI group and the DES-only PCI group in the original population (A) and in the matched population (B). Stratified multivariable Cox proportional hazards regression was used to calculate adjusted HRs and 95% CIs. The adjusted covariables were age, sex, diabetes mellitus, clinical presentation, target vessel location, multivessel PCI, PCI of CTO lesion, PCI of unprotected LM disease, and concomitant use of aspirin and P2Y12 inhibitor. Abbreviations as in Figures 1 and 2.
Figure 4
Figure 4
Comparison of Target Vessel Failure According to Lesion Characteristics Cumulative incidence and HR with 95% CI of target vessel failure at 2 years are presented between DCB-based and DES-only PCI groups according to various lesion characteristics. The HRs were calculated with the DES-only group as a reference. The risk of target vessel failure at 2 years was comparable between the 2 groups across various complex coronary artery lesions without significant interactions. Abbreviations as in Figures 1 and 2.
Central Illustration
Central Illustration
Efficacy of Drug-Coated Balloon and Drug-Eluting Stent in Percutaneous Coronary Intervention for Complex Lesions The current study evaluated clinical outcomes of drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients undergoing PCI for various complex coronary lesions. DCBs were more frequently used for chronic total occlusion (CTO), multivessel coronary artery disease, and lesions requiring multiple devices. DCB-based PCI showed comparable risk of target vessel failure (TVF) at 2 years with DES-only PCI in patients with de novo complex coronary artery lesions. The comparable risk of TVF was consistently observed in various subgroups of complex coronary artery lesions.
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References

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