Is a high calcific burden an indication, or a contraindication for Drug Coated Balloon?

Basavarajaiah, Sandeep; Waduge, Bhagya Harindi Loku; Watkin, Richard; Athukorala, Sampath

doi:10.31083/j.rcm2204120

Cited by 3 publications

(2 citation statements)

References 33 publications

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“…However, literature has supported their use in denovo lesions. 15 Regardless of the strategy used, PCI in SVD is associated with an increased rate of both shortterm and long-term MACE. Bare metal stents cause ISR in a significant number of patients.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Outcomes of Drug-Coated Balloon Angioplasty in The Treatment of Small Vessel Coronary Artery Disease

Ahmed

Satti

Javed

et al. 2023

Ann Pak Inst Med Sci

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Long-Term Outcomes of Drug-Coated Balloon Angioplasty in The Treatment of Small Vessel Coronary Artery Disease Objectives: To determine the outcomes in patients with small-vessel disease (SVD) who underwent percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) and correlate these adverse outcomes with various risk factors. Methodology: The prospective cohort study was conducted at the Rawalpindi Institute of Cardiology (RIC) from January 2020 to December 2022. After being approved by the Hospital Ethics Committee, fifty-four patients who presented with SVD were enrolled using non-probability consecutive sampling. Written informed consent was obtained from the patients. They were treated with DCB and observed clinically on follow-ups at 15, 30, 60, and 90 days, & later after every 6 months for up to 2 years. Only those patients who presented with symptoms underwent repeat angiography. The outcomes assessed were cardiovascular mortality, myocardial infarction (MI), and target lesion revascularization (TLR). Results: Cardiovascular mortality occurred in 2(3.7%), MI in 3(5.6%) and TLR in 2(3.7%) patients. There was a significant association between cardiovascular mortality, MI, and TLR with diabetes mellitus and BMI. Age was only significantly related to cardiovascular mortality. Conclusion: A drug-coated balloon is an effective and feasible treatment modality for small vessel disease. The incidence of outcomes of cardiovascular mortality, MI, and TLR after DCB is low, making it a safe modality. Advanced age, obesity, and diabetes mellitus alone or with hypertension are the predicting factors of adverse outcomes after DCB in patients with SVD. Keywords: Drug-coated balloon, DCB, Small vessel coronary artery disease, SVD

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Section: Discussionmentioning

confidence: 99%

Long-Term Outcomes of Drug-Coated Balloon Angioplasty in The Treatment of Small Vessel Coronary Artery Disease

Ahmed

Satti

Javed

et al. 2023

Ann Pak Inst Med Sci

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“…Drug-coated balloons (DCBs) were developed to avoid a permanent implant, but they don’t support the scaffolding of the vessel, particularly to prevent early recoil, and come with a set of challenges such as drug delivery restricted to the time of inflation, and that only

10% of the coating is transferred to the vessel wall [ 2 ]. At present, DCBs are predominantly used to treat in-stent restenosis, but also in small vessels [ 3 , 4 ]. Newer application modalities might be the combination of DCBs with DES to reduce the amount of implanted metal and the subsequent inhibition of vasomotion and the risk of long-term events [ 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Verheye¹,

Vrolix²,

Montorfano³

et al. 2023

Rev. Cardiovasc. Med.

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Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 1.31 at baseline to 8.46 1.31 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: : NCT03429894.

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Application of Drug‐Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions

Somsen,

Rissanen,

Hoek

et al. 2024

Cathet Cardio Intervent

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There is a growing trend of patients with significant comorbidities among those referred for percutaneous coronary intervention (PCI). Consequently, the number of patients undergoing complex high risk indicated PCI (CHIP) is rising. CHIP patients frequently present with factors predisposing to extensive drug‐eluting stent (DES) implantation, such as bifurcation and/or heavily calcified coronary lesions, which exposes them to the risks associated with an increased stent burden. The drug‐coated balloon (DCB) may overcome some of the limitations of DES, either through a hybrid strategy (DCB and DES combined) or as a leave‐nothing‐behind strategy (DCB‐only). As such, there is a growing interest in extending the application of DCB to the CHIP population. The present review provides an outline of the available evidence on DCB use in CHIP patients, which comprise the elderly, comorbid, and patients with complex coronary anatomy. Although the majority of available data are observational, most studies support a lower threshold for the use of DCBs, particularly when multiple CHIP factors coexist within a single patient. In patients with comorbidities which predispose to bleeding events (such as increasing age, diabetes mellitus, and hemodialysis) DCBs may encourage shorter dual antiplatelet therapy duration—although randomized trials are currently lacking. Further, DCBs may simplify PCI in bifurcation lesions and chronic total coronary occlusions by reducing total stent length, and allow for late lumen enlargement when used in a hybrid fashion. In conclusion, DCBs pose a viable therapeutic option in CHIP patients, either as a complement to DES or as stand‐alone therapy in selected cases.

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Is a high calcific burden an indication, or a contraindication for Drug Coated Balloon?

Cited by 3 publications

References 33 publications

Long-Term Outcomes of Drug-Coated Balloon Angioplasty in The Treatment of Small Vessel Coronary Artery Disease

Long-Term Outcomes of Drug-Coated Balloon Angioplasty in The Treatment of Small Vessel Coronary Artery Disease

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Application of Drug‐Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions

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