Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon

Ahmad, Wan Azman Wan; Nuruddin, Amin Ariff; Kader, M.A.S.K. Abdul; Ong, Tiong Kiam; Liew, Houng Bang; Ali, Rosli Mohd; Zuhdi, Ahmad Syadi Mahmood; Ismail, Muhammad Dzafir; Yusof, Ahmad Khairuddin Mohamed; Schwenke, Carsten; Kutschera, Maren; Scheller, Bruno

doi:10.1016/j.jcin.2022.01.012

Cited by 40 publications

(35 citation statements)

References 35 publications

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“…Furthermore, the chosen target lesions were ISR; hence, the findings may not be transferred to other scenarios. The phenomenon of late lumen enlargement seen with paclitaxel in de novo lesions 24,25 could not be confirmed for the sirolimus-coated balloon investigated here 26 and for a biolimus-coated balloon. 27…”

Section: Discussionmentioning

confidence: 64%

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions

Scheller

Kader

Ahmad

et al. 2022

Circ: Cardiovascular Interventions

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Background: Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. Methods: One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Results: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. Conclusions: This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02996318, NCT03242096.

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Section: Discussionmentioning

confidence: 64%

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions

Scheller

Kader

Ahmad

et al. 2022

Circ: Cardiovascular Interventions

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“…Cy5 derived fluorescence of FITC-PEG (2k, 5k, 10k)-Cy5-PC-Latex beads were also evaluated via flow cytometry ( Figure 2 b). Note here that Cy5 was conjugated onto latex surface as a model for low molecular drugs that are intended to be released at the diseased site, e.g., paclitaxel [ 17 , 18 , 19 , 20 ], sirolimus [ 21 , 22 ], or zotarolimus [ 23 , 24 ]. Thus, the intensity of Cy5-derived fluorescence should indirectly indicate the drug load of the photoresponsive platform for DCBs.…”

Section: Resultsmentioning

confidence: 99%

Effect of PEGylation on the Drug Release Performance and Hemocompatibility of Photoresponsive Drug-Loading Platform

Mizuno

Anraku

Sakuma

et al. 2022

IJMS

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Coronary stenosis has been one of the most common heart diseases that drastically increases the risk of fatal disorders such as heart attack. Angioplasty using drug coated balloons (DCB) has been one of the most safe and promising treatments. To minimize the risk of thrombosis of such DCBs during intervention, a different approach that can secure high hemocompatibility under blood flow is necessary. Here we report a method of improving the photoresponsive platform’s hemocompatibility by conjugating polyethylene glycol (PEG), onto the functional groups located at the balloon surface. In this study, latex microbeads were used as models for balloons to enable precise observation of its surface under microscopy. These beads were decorated with PEG polymers of a variety of lengths and grafting densities, along with the Cy5-Photoclevable (PC) linker conjugate to mimic drugs to be loaded onto the platform. Results showed that PEG length and grafting density are both critical factors that alter not only its hemocompatibility, but also the drug load and release efficiency of such platform. Thus, although further investigation is necessary to optimize the tradeoff between hemocompatibility, drug load, and release efficiency, it is safe to conclude that PEGylation of DCB surface is an effective method of enhancing and maintaining high hemocompatibility to minimize the risk of thrombosis during angioplasty.

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“…Previous research has demonstrated LLE after the application of DCB to native coronary vessels ( 29 ). Ahmad et al reported that approximately two-thirds of de novo coronary lesions underwent LLE after treatment with a paclitaxel-coated balloon ( 30 ). However, the mechanism of LLE remains unclear.…”

Section: Discussionmentioning

confidence: 99%

Short-term outcomes of drug-coated balloon versus drug-eluting stent for de novo saphenous vein graft lesions in coronary heart disease

Liu

Liu²,

Wang³

et al. 2023

Front. Cardiovasc. Med.

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BackgroundAs a device for percutaneous coronary intervention, drug-coated balloon (DCB) is widely used to treat in-stent restenosis. However, data regarding the use of DCB in treating de novo saphenous vein graft (SVG) lesions are limited. This study aimed to explore the outcomes of using the DCB in the treatment of de novo SVG lesions of coronary heart disease (CHD).MethodsThis retrospective and observational study analyzed CHD patients with de novo SVG lesions treated with DCB or the new-generation drug-eluting stent (DES) between January 2018 and December 2020. Restenosis was the primary endpoint, whereas target lesion revascularization (TLR), major adverse cardiac events, restenosis, cardiac death, target vessel revascularization, and myocardial infarction were the secondary outcomes.ResultsWe enrolled 31 and 23 patients treated with DCB and DES, respectively. The baseline clinical data, lesion characteristics, and procedural characteristics were similar between the two groups. Twenty-eight (90.3%) patients in the DCB group and 21 (91.3%) in the DES group completed follow-up angiography after 1 year. The quantitative coronary angiography measurements at angiographic follow-up showing late lumen loss were −0.07 ± 0.95 mm for the DCB group and 0.86 ± 0.71 mm for the DES group (P = 0.039), and the rates of restenosis were 13.3% and 21.7% for the DCB and DES groups, respectively (P = 0.470). No significant differences were observed in the rates of MACE (16.7% vs. 26.1%, P = 0.402) and TLR (13.3% vs. 4.3%, P = 0.374) during clinical follow-up.ConclusionOur findings suggest that when pre-dilatation was successful, DCB might be safe and effective in treating de novo SVG lesions.

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Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon

Cited by 40 publications

References 35 publications

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions

Effect of PEGylation on the Drug Release Performance and Hemocompatibility of Photoresponsive Drug-Loading Platform

Short-term outcomes of drug-coated balloon versus drug-eluting stent for de novo saphenous vein graft lesions in coronary heart disease

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