Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial

Rissanen, Tuomas T.; Uskela, Sanna; Eränen, Jaakko; Mäntylä, Pirjo; Olli, Annika; Romppanen, Hannu; Siljander, Antti; Pietilä, Mikko; Minkkinen, Mikko; Tervo, Jerry; Kärkkäinen, Jussi M.; Vatanen, Aija; Perälä, Anssi; Müller, Miriam; Porela, Pekka; Palojoki, Eeva

doi:10.1016/s0140-6736(19)31126-2

Cited by 141 publications

(120 citation statements)

References 31 publications

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“…In the coronary arteries, DES became the therapy of choice for interventional treatment of coronary artery disease due to favorable acute and subacute occlusion rates and low risk of restenosis of new‐generation DES. Meanwhile, DCB are accepted alternatives for the treatment of coronary in‐stent restenosis and under clinical investigation for coronary de novo disease . In peripheral arterial disease, DCB were about to become the standard therapy for the transfemoral region …”

Section: Discussionmentioning

confidence: 99%

Novel, vessel anatomy adjusting drug‐coated balloon—Preclinical evaluation in peripheral porcine arteries

Bienek

Kusmierczuk

Mittag³

et al. 2019

Cathet Cardio Intervent

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Background: The diameter of balloons or stents is selected according to the estimated reference vessel diameter and do not adapt to the vessel anatomy. The aim of the present preclinical studies was to investigate a novel, vessel anatomy adjusting hypercompliant drug-coated balloon catheter (HCDCB). Methods: Hypercompliant balloon membranes were coated in a constricted state with high drug density. Drug adherence was investigated in vitro, transfer to the porcine peripheral arteries and longitudinal distribution in vivo. In young domestic swine, neointimal proliferation was induced by vessel overstretch and continuous irritation by permanent stents. Uncoated hypercompliant balloons (HCB), and standard uncoated balloons and drug-coated balloons (DCB) served as controls. Efficacy was assessed by angiography, optical coherence tomography (OCT), and histomorphometry.Results: HCDCB lost 18.0 ± 3.9% of dose during in vitro simulated delivery to the lesion. Drug transfer to the vessel wall was 13.9 ± 6.4% and drug concentration was 1,044 ± 529 ng/mg tissue. Four weeks after treatment, the histomorphometric neointimal area was smaller with HCDCB versus uncoated HCB (2.39 ± 0.55 mm 2 vs. 3.26 ± 0.72 mm 2 , p = .038) and area stenosis (OCT) was less (11.6 ± 6.9% vs. 24.7 ± 9.7%, p = .022). No premature death occurred and no in-life clinical symptoms or treatment-associated thrombi were observed.Conclusions: HCDCB were found to inhibit excessive neointimal proliferation. Balloon adaption to different vessel diameters and shapes may provide drug-delivery in irregular lumen and facilitate balloon selection. K E Y W O R D S drug transfer, inhibition of neointimal proliferation, vessel anatomy adjusting drug-coated balloon 1 | INTRODUCTION Restenosis after percutaneous transluminal procedures occurs due to the vessel wall trauma induced by balloon dilatation or stent Abbreviations: DCB, drug-coated balloon (=standard drug-coated PTA balloon); FU, followup; HCB, hypercompliant balloon; HCDCB, hypercompliant drug-coated balloon; MLD, minimal lumen diameter; OCT, optical coherence tomography; PTA, percutaneous transluminal angioplasty; QA, quantitative angiography; RFD, reference diameter; SLD, stent struts-to-lumen distance.

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Section: Discussionmentioning

confidence: 99%

Novel, vessel anatomy adjusting drug‐coated balloon—Preclinical evaluation in peripheral porcine arteries

Bienek

Kusmierczuk

Mittag³

et al. 2019

Cathet Cardio Intervent

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“…A recent literature search and subgroup analysis presented by Kleber et al 20 reviewing all published RCTs and registries including de novo coronary disease suggested a 1‐month duration of dual antiplatelet therapy after DCB angioplasty was safe. This has been furthermore consolidated with recent RCTs which gave a 1‐month duration of DAPT for stable CAD 4,5 …”

Section: Discussionmentioning

confidence: 93%

“…DCB angioplasty currently holds a class Ia recommendation for its use in ISR in accordance with the current ESC Guidelines, 11 although there is increasing evidence to support its use for de novo coronary disease 4,5 . With this use of DCB angioplasty predicted to increase, it is important to determine a safe duration for DAPT for elective procedures, a gap in the literature inadvertently highlighted by the ESC Focused Update on DAPT.…”

Section: Discussionmentioning

confidence: 99%

“…A lot of interest has been generated lately about the use and safety of DCB angioplasty focused mainly on peripheral intervention 1–4 . However, the use of drug‐coated balloons (DCB) for coronary intervention has also been steadily increasing over the last few years and as more studies report encouraging results, 5,6 DCB‐only angioplasty for coronary disease is expected to increase further.…”

Section: Introductionmentioning

confidence: 99%

“…Firstly, the Basket‐Small 2 was a randomized control trial comparing DCB with DES for small vessel de novo coronary disease and gave a 1‐month duration of DAPT to the DCB arm in all patients with stable coronary disease 5 . Secondly, Debut, a randomized trial comparing BMS to DCB in patients with high bleeding risk, also gave a 1‐month duration of DAPT for DCB angioplasty; thus suggesting that a full 6‐month course of DAPT might not be necessarily required when a DCB‐only approach is used 4 …”

Section: Introductionmentioning

confidence: 99%

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Duration of dual antiplatelet therapy in elective drug‐coated balloon angioplasty

Corballis

Wickramarachchi

Vassiliou

et al. 2019

Cathet Cardio Intervent

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Objectives We sought to answer whether 1‐month duration of dual antiplatelet therapy (DAPT) is safe after elective drug‐coated balloon only (DCB) angioplasty. Background The duration of DAPT after elective DCB was called into question after the ESC Focused DAPT Update of 2017. Until then, a 1‐month duration of DAPT was considered safe by national consensus groups (German, Italian, and Chinese) supported by data from prospective worldwide registries. The ESC Guidelines recommended a 6‐month duration of DAPT based on evidence from in‐stent restenosis randomized controlled trials only. Methods Retrospective, real‐world population, single‐center analysis conducted from January 1, 2012 to March 31, 2017 in a high‐volume, tertiary PCI center. Consecutive patients receiving 1‐month duration of DAPT after elective DCB angioplasty were included. We identified a primary composite outcome of cardiac death, myocardial infarction and target lesion revascularization at 6‐months. Results A total of 303 patients (78.5% male) with mean age of 67 ± 12.5 were included. This incorporated 86.1% de novo lesions and 56.5% nonsmall (≥3 mm diameter) coronary arteries treated. There were no reported outcomes of lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death at 6‐months. There were two (0.6%) nontarget vessel MIs and one (0.3%) noncardiac death. Conclusion One‐month duration of DAPT appears safe after elective DCB‐only angioplasty, highlighting this strategy for patients at high‐risk of bleeding. These results also show favorable clinical outcomes for de novo coronary artery disease and nonsmall coronary arteries treated with DCB‐only angioplasty. A 1‐month duration of DAPT appears a safe and attractive option.

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Specialized Balloons in Percutaneous Coronary Intervention

Claessen¹,

Henriques²,

Dangas³

2022

Interventional Cardiology

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Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial

Cited by 141 publications

References 31 publications

Novel, vessel anatomy adjusting drug‐coated balloon—Preclinical evaluation in peripheral porcine arteries

Novel, vessel anatomy adjusting drug‐coated balloon—Preclinical evaluation in peripheral porcine arteries

Duration of dual antiplatelet therapy in elective drug‐coated balloon angioplasty

Specialized Balloons in Percutaneous Coronary Intervention

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