Optical coherence tomography analysis of late lumen enlargement after paclitaxel‐coated balloon angioplasty for de‐novo coronary artery disease

Sogabe, K.; Koide, Masaaki; Fukui, Kuniaki; Kato, Yoshio; Kitajima, Hiroki; Akabame, Satoshi; Zen, Kan; Nakamura, Takeshi; Matoba, Satoaki

doi:10.1002/ccd.29435

Cited by 23 publications

(23 citation statements)

References 22 publications

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“…In our study, LLL was considerably lower in DCB group than in DES group (0.06 ± 0.61 vs. 0.41 ± 0.64 mm, P < 0.001) and QCA results demonstrated that a total of 46.3% of lesions appeared late lumen enlargement. The phenomenon of de novo lesions after DCB angioplasty has also been reported in other studies (21)(22)(23)(24)(25)(26). This phenomenon has positive significance in particular lesions, such as CTO and small-vessel disease.…”

Section: Discussionsupporting

confidence: 74%

Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions

Yang

Liu

Pan

et al. 2022

Front. Cardiovasc. Med.

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BackgroundDrug-coated balloons (DCB), alone or in combination with drug-eluting stents (DES), may be used to treat diffuse coronary lesions. We aimed to explore the efficacy and safety of DCB in patients with diffuse coronary lesions.MethodsConsecutive patients with diffuse coronary lesions (lesion length > 25 mm) who underwent DCB and/or DES between January 2015 and December 2019 were included in this prospective, observational, multicenter study. The DCB group included 355 patients (360 lesions), of which 142 patients (143 lesions, 39.7%) received the DCB-only strategy and 213 patients (217 lesions, 60.3%) received the hybrid strategy (DCB combined with DES). The DES group included 672 patients (831 lesions) treated with DES alone. Target lesion revascularization (TLR) during 3-year follow-up was the primary outcome of interest. The secondary outcome was major adverse cardiac events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, and target vessel revascularization.ResultsThe two groups had comparable baseline clinical and lesion characteristics. Lesion length was similar (43.52 ± 16.46 mm vs. 44.87 ± 15.80 mm, P = 0.181), but the stent length in the DCB group was significantly shorter (24.02 ± 23.62 mm vs. 51.89 ± 15.81 mm, P < 0.001). Ten lesions (2.8%) in the DCB group received bailout stents. Over 3 years of follow-up, no significant difference in TLR incidence between the groups (7.3 vs. 8.3%, log-rank P = 0.636) was observed. Incidence of MACE also did not differ significantly (11.3 vs. 13.7%, log-rank P = 0.324). No thrombosis events occurred in the DCB group, while four patients (0.6%) in the DES group experienced stent thrombosis (log-rank P = 0.193). Moreover, similar TLR and MACE rates were observed between DCB-only and hybrid strategies (TLR: 6.4 vs. 8.0%, log-rank P = 0.651; MACE: 11.4 vs. 11.2%, log-rank P = 0.884).ConclusionLong-term outcomes show that the efficacy and safety of the DCB strategy (DCB alone or combined with DES) are similar to those of DES alone in diffuse coronary lesions. These findings suggest that this strategy is a promising alternative for select patients with diffuse coronary lesions.

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Section: Discussionsupporting

confidence: 74%

Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions

Yang

Liu

Pan

et al. 2022

Front. Cardiovasc. Med.

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“…This form of dissection was termed "therapeutic dissection" [29], which does not significantly compress the coronary lumen, affect blood flow, or cause adverse events, allowing patients to be discharged as scheduled. Studies have shown that restenosis of this dissection type is uncommon [30][31][32]; however, more angiographic follow-up data is required to determine if dissection after DCB is beneficial for positive vascular remodeling.…”

Section: Discussionmentioning

confidence: 99%

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Wang

et al. 2021

Cardiovasc Drugs Ther

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Background Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes. Methods In this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR). Results From July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was −0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was −0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226). Conclusions In this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

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“…Late angiographic findings can also provide important insight into arterial remodeling following a DCB-only approach, even with a small number of patients. Previous angiographic and intravascular imaging analyses [24][25][26] reported late lumen enlargement (LLE) in 50%-70% of cases following DCB angioplasty in non-CTO lesions. In our study, even in CTO lesions, 57.8% (37 of 64 lesions)…”

Section: Discussionmentioning

confidence: 99%

Intraplaque wiring enables drug‐coated balloons to be utilized for percutaneous recanalization of chronically occluded coronary arteries

Terashita

Shimada

Yamanaka

et al. 2023

Cathet Cardio Intervent

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Objectives This study aimed to determine whether drug‐coated balloon (DCB) angioplasty following intraplaque wiring and the use of modified balloons is safe and effective in the percutaneous treatment of coronary chronic total occlusions (CTOs). Background DCB is an alternative therapeutic option without the limitations of permanent vascular implants. However, its efficacy in CTOs has yet to be confirmed. The combination of modified balloons and DCB can be effectively applied when the intraplaque passage of the guidewire is achieved in CTOs. Methods Data from 124 consecutive CTO lesions (105 patients) treated at our hospital between February 2016 and December 2020 were screened for inclusion and retrospectively analyzed. Among the 118 lesions successfully recanalized, intraplaque wiring was achieved in 108, and 85 were treated by the DCB‐only approach following cutting/scoring balloon dilatation. Results Follow‐up data were available for 82 lesions (71 patients). The median occlusion length was 18.5 mm, and the J‐CTO score was 1.7 ± 0.9. No in‐hospital major adverse cardiac events occurred, including abrupt vessel closure. During the median 29‐month follow‐up period, target lesion revascularization was performed for 10 lesions. Follow‐up coronary angiography (8.7 ± 3.9 months after the index procedure) was performed for 64 lesions, demonstrating late lumen loss of −0.15 mm (interquartile range −0.4 to 0.23 mm), binary restenosis (diameter stenosis ≥50%) in 12 lesions (18.8%), and late lumen enlargement in 37 (57.8%). Conclusion The DCB‐only approach following the use of modified balloons is a promising strategy for coronary CTOs when intraplaque wiring is achieved.

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Optical coherence tomography analysis of late lumen enlargement after paclitaxel‐coated balloon angioplasty for de‐novo coronary artery disease

Cited by 23 publications

References 22 publications

Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions

Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Intraplaque wiring enables drug‐coated balloons to be utilized for percutaneous recanalization of chronically occluded coronary arteries

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