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      Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon

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          Abstract

          Background

          Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions.

          Methods

          Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization.

          Results

          From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a “DCB only” strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0–12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed.

          Conclusions

          In complex coronary lesions, a “DCB only” strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

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          Most cited references35

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          2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes

          Juhani Knuuti, William Wijns, Antti Saraste … (2019)
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            Clinical end points in coronary stent trials: a case for standardized definitions.

            Donald E Cutlip, Stephan Windecker, Roxana Mehran … (2007)
            Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
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              Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014

              Robert A Byrne, Michael Joner, Adnan Kastrati (2015)
              Modern-day stenting procedures leverage advances in pharmacotherapy and device innovation. Patients treated with contemporary antiplatelet agents, peri-procedural antithrombin therapy and new-generation drug-eluting stents (DES) have excellent outcomes over the short to medium term. Indeed, coupled with the reducing costs of these devices in most countries there remain very few indications where patients should be denied treatment with standard-of-care DES therapy. The two major causes of stent failure are stent thrombosis (ST) and in-stent restenosis (ISR). The incidence of both has reduced considerably in recent years. Current clinical registries and randomized trials with broad inclusion criteria show rates of ST at or <1% after 1 year and ∼0.2–0.4% per year thereafter; rates of clinical ISR are 5% respectively. Angiographic surveillance studies in large cohorts show rates of angiographic ISR of ∼10% with new-generation DES. The advent of high-resolution intracoronary imaging has shown that in many cases of late stent failure neoatherosclerotic change within the stented segment represents a final common pathway for both thrombotic and restenotic events. In future, a better understanding of the pathogenesis of this process may translate into improved late outcomes. Moreover, the predominance of non-stent-related disease as a cause of subsequent myocardial infarction during follow-up highlights the importance of lifestyle and pharmacological interventions targeted at modification of the underlying disease process. Finally, although recent developments focus on strategies which circumvent the need for chronically indwelling stents—such as drug-coated balloons or fully bioresorbable stents—more data are needed before the wider use of these therapies can be advocated.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Cardiol J
                Journal ID (iso-abbrev): Cardiol J
                Title: Cardiology Journal
                Publisher: Via Medica
                ISSN (Print): 1897-5593
                ISSN (Electronic): 1898-018X
                Publication date Collection: 2022
                Publication date (Electronic): 13 December 2022
                Volume: 29
                Issue: 6
                Pages: 906-916
                Affiliations
                [1 ]Cardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland
                [2 ]Departement of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland
                [3 ]Division of Interventional Cardiology — MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Georgetown University, Washington, United States
                Author notes
                Address for correspondence: Prof. Dr. Florim Cuculi, MD, Cardiology Division, Heart Center – Luzerner Kantonsspital, 6000 Luzern 16, Switzerland, tel: +41 41 205 21 34, e-mail: florim.cuculi@ 123456luks.ch
                [*]

                Those two authors contributed equally and should be considered as shared first authors.

                [#]

                Those two authors should be considered as shared last authors.

                Author information
                https://orcid.org/0000-0001-6366-6211
                Article
                Publisher ID: cardj-29-6-906
                DOI: 10.5603/CJ.a2022.0106
                PMC ID: 9788730
                PubMed ID: 36385601
                SO-VID: 06dc37ac-e817-4631-9986-0a9cbdf1803f
                Copyright © Copyright © 2022 Via Medica
                License:

                This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially

                History
                Date received : 24 June 2022
                Date accepted : 29 September 2022
                Categories
                Subject: Interventional Cardiology
                Subject: Original Article

                Keywords: drug-coated balloons,sirolimus,complex coronary lesions,percutaneous coronary interventions,drug-eluting stent
                Data availability:
                Keywords: drug-coated balloons, sirolimus, complex coronary lesions, percutaneous coronary interventions, drug-eluting stent

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