Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study

Pan, Liang; Liu, Wenjie; Han, Zhanying; Pan, Sancong; Wang, Xi; Shan, Yingguang; Wang, Xule; Zheng, Xiaolin; Li, Ran; Zhou, Yifei; Qin, Peng; Shi, Qiangwei; Zhou, Shuai; Zhang, Wencai; Guo, Sen; Zhang, Peisheng; Qin, Xuda; Sun, Guoju; Qin, Zike; Huang, Zhenwen; Qiu, Chunguang

doi:10.1007/s00392-021-01895-y

“…ISR refers to restenosis of coronary artery in-stent lesions caused by coronary artery endothelial injury and gradual proliferation of intimal tissue caused by percutaneous coronary interventional therapy, and its mechanism includes biological, mechanical, and technical factors [ 5 ]. Relevant studies have pointed out that due to factors such as poor vascular endothelialization, local allergic reactions, and individual differences, there are still a considerable proportion of patients with adverse clinical and anatomical characteristics, and the analysis of risk factors affecting the occurrence of ISR in patients and effective intervention can reduce the risk of ISR [ 6 , 7 ]. Balloon dilation is the main treatment for ISR.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Prediction Model Construction of Drug-Coated Balloon Combined with Cutting Balloon Angioplasty in the Treatment of Drug-Eluting Stent In-Stent Restenosis

Wu

¹

,

Yu

²

,

Tang

³

et al. 2022

Computational and Mathematical Methods in Medicine

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Objective. To investigate the efficacy of drug-coated balloon (DCB) combined with cutting balloon angioplasty (CBA) in the treatment of drug-eluting stent in-stent restenosis (DES-ISR) and to construct a predictive model for the occurrence of DES-ISR. Methods.According to the criteria of diagnosis, inclusion, and exclusion, DES-ISR patients who were treated in the outpatient and inpatient departments of cardiovascular medicine of Second People’s Hospital of Guangdong Province from July 2021 to December 2021 were included. A total of 72 cases were planned to be enrolled, including 36 cases in the control group and 36 cases in the experimental group. The control group was treated with DCB, and the experimental group was combined with CBA. The treatment success rate, coronary angiography results before and after surgery, and the incidence of major adverse cardiovascular events during the follow-up period were compared between the two groups. Seventy-two DES-ISR patients were divided into ISR group and 59 non-ISR patients were divided into non-ISR group. The clinical data of the two groups were compared to analyze the risk factors affecting the occurrence of DES-ISR, and the prediction model was established. Results. The surgical success rate of the experimental group was 94.44% (34/36), which was higher than the 77.78% (28/36) of the control group ( P < 0.05 ). The minimum lumen diameter (MLD) of the experimental group 6 months after operation was greater than that of the control group, the late lumen loss (LL) and lumen stenosis rate were higher than those in the control group, and the incidence of major adverse cardiovascular events was lower than that in the control group ( P < 0.05 ). In the ISR group, the proportion of patients with abnormal BMI, smoking, hypertension, diabetes, and family history of coronary heart disease and multivessel coronary artery disease was higher than that in the non-ISR group, the degree of stenosis target lesion was higher than that in the non-ISR group, the diameter of target lesion and stent diameter were smaller than those in the non-ISR group, and the length of target lesion and stent length were longer than those in the non-ISR group; the number of stents was more than that in the non-ISR group ( P < 0.05 ). Combined hypertension, multiple coronary artery lesions, stenosis target lesion degree ≥85.05%, and target lesion length ≥36.88 mm were risk factors for DES-ISR, and target lesion diameter ≥3.15 mm and stent diameter ≥3.15 mm were protective factors ( P < 0.05 ). The prediction model of DES-ISR was obtained by multiple logistic regression analysis, P = 1 1 + e 2.281 + 3.321 X hypertension + 3.427 X umber of arterial lesions + 3.359 X stenosis target lesion degree − 3.143 X target lesion diameter + 0.650 X target lesion length − 10.159 X stent diameter . The Hosmer-Lemeshow test showed that Hosmer-Lemeshow χ 2 = 0.925, P =0.413; the ROC curve analysis showed that the AUC of the prediction model for the occurrence of DES-ISR was 0.924, the SE value was 0.022, and the 95% CI was 0.880-0.967. Conclusion. DCB combined with CBA has good clinical efficacy in the treatment of DES-ISR, which can reduce the rate of lumen stenosis and the incidence of adverse cardiovascular events. The prediction model established according to risk factors has high predictive value for the occurrence of DES-ISR.

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“…Recent large-scale studies have shown that the clinical and angiographic outcomes of PCB angioplasty for de novo lesions are significantly better than those for ISR. 5,6) The mean magnitudes of late luminal loss after PCB angioplasty for de novo coronary lesions in small vessels were reportedly within 0.1 mm. [7][8][9][10] The International DCB Consensus Group suggested that PCB would be effective for de novo lesions, regardless of vessel size.…”

mentioning

confidence: 97%

Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels

Nakamura

¹

,

Ishikawa

²

,

Mizutani

³

et al. 2023

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We retrospectively examined the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo stenosis in large coronary vessels (LV; pre-or postprocedural reference vessel diameter !2.75 mm) in comparison with placement of drug-eluting stents (DESs).Consecutive de novo stenotic lesions in the LV electively and successfully treated with either PCB (n = 73) or DESs (n = 81) from January 2016 to December 2018 at our center were included. The primary endpoint was the incidence of target lesion failure (TLF), including cardiac death, nonfatal myocardial infarction, and target vessel revascularization. The impact of PCB on TLF was examined using Cox proportional hazards models by including 39 variables. The secondary endpoint, angiographic restenosis, defined as a follow-up percent diameter stenosis > 50, was examined in angiographic follow-up lesions after PCB angioplasty (n = 56) and DES placement (n = 53). This retrospective investigation was conducted in July 2022.The mean PCB size and length were 3.23 ± 0.42 and 18.4 ± 4.3 mm, respectively. The TLF frequency in the PCB group (6.8% during the mean observational interval of 1536 ± 538 days) was not significantly different from that in the DES group (14.6%, 1344 ± 606 days, P = 0.097). PCB was not a significant predictor of TLF in the univariate analysis (hazard ratio: 0.424; 95%CI: 0.15-1.21; P = 0.108). There was no angiographic restenosis after PCB angioplasty.The present observational single-center study showed that PCB for de novo stenosis in the LV had no significant adverse impact on TLF and had favorable angiographic outcomes.

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“…Therefore, the appropriate management of coronary bifurcation lesions remains debatable, especially with LM true bifurcations (23). Drug-coated balloon are emerging devices with established efficacy in ISR, de novo, and small vessels that may provide potential advantages in bifurcation PCI and circumvent the restrictions encountered with this group of lesions (24,25). In the last several years, many clinical trials and registries have studied the efficacy of DCB in treating bifurcation lesions.…”

Section: Discussionmentioning

confidence: 99%

Drug-coated balloon in the treatment of coronary left main true bifurcation lesion: A patient-level propensity-matched analysis

Pan

¹

,

Liu

²

,

Han

³

et al. 2022

Front. Cardiovasc. Med.

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AimsAn increasing body of evidence suggests that drug-coated balloon (DCB) angioplasty represents a valuable option for revascularization in selected patients with coronary bifurcation disease. However, there remains a paucity of real-world observational evidence on the efficacy of DCB in left main (LM) true bifurcation lesion. We compared clinical and angiographic outcomes of hybrid [DCB + drug-eluting stent (DES)] versus DES-only strategy (provisional stenting or two-stent strategies) in de novo LM true bifurcated lesions.MethodsThe primary endpoint was the 2-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularization (CD-TLR). A routine 1-year angiographic follow-up was scheduled. Propensity-score matching was utilized to assemble a cohort of patients with similar baseline characteristics.ResultsAmong 1077 eligible patients, 199 who received DCB treatment and 398 who were assigned to DES therapy had similar propensity scores and were included in the analysis. TLF within 2 years occurred in 13 patients (7.56%) assigned to DCB group, and 52 patients (14.36%) assigned to DES group (odds ratio: 0.487; 95% confidence interval: 0.258–0.922; P = 0.025; Log-rank P = 0.024). Compared with the DES group, the DCB group resulted in a lower rate of CD-TLR (2.91% vs. 9.42%; P = 0.007). Cardiac death, TVMI, all-cause mortality, and stent thrombosis were comparable between both groups. Patients treated with DES-only were associated with a higher late lumen loss (0.42 ± 0.62 mm vs. 0.13 ± 0.42 mm, P < 0.001) compared with the DCB group at 1 year. In sensitivity analysis, the DCB group also presented a lower incidence of TLF, CD-TLR and stent thrombosis both compared to the two-stent strategy and compared to provisional stenting (Ps < 0.05).ConclusionThe 2-year results of PCI utilizing DCB for LM true bifurcation lesions are superior to employing DES alone in terms of safety and effectiveness.

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Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study

Cited by 13 publications

References 33 publications

Efficacy and Prediction Model Construction of Drug-Coated Balloon Combined with Cutting Balloon Angioplasty in the Treatment of Drug-Eluting Stent In-Stent Restenosis

Efficacy and Prediction Model Construction of Drug-Coated Balloon Combined with Cutting Balloon Angioplasty in the Treatment of Drug-Eluting Stent In-Stent Restenosis

Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels

Drug-coated balloon in the treatment of coronary left main true bifurcation lesion: A patient-level propensity-matched analysis

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