open access
Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon
, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 3, 3, 12, 12
Affiliations- Cardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland
- Department of Health Sciences and Medicine, Univer sity of Lucerne, Lucerne, Switzerland
- Division of Interventional Cardiology — MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Georgetown University, Washington, United States
open access
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.
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.
Keywords
drug-coated balloons, sirolimus, complex coronary lesions, percutaneous coronary interventions, drug-eluting stent
Supp./Additional Files (3)
About this articleTitle
Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon
Journal
Issue
Article type
Original Article
Pages
906-916
Published online
2022-11-07
Page views
3810
Article views/downloads
1050
DOI
10.5603/CJ.a2022.0106
Pubmed
Bibliographic record
Cardiol J 2022;29(6):906-916.
Keywords
drug-coated balloons
sirolimus
complex coronary lesions
percutaneous coronary interventions
drug-eluting stent
Authors
Mehdi Madanchi
Giacomo M. Cioffi
Adrian Attinger-Toller
Thomas Seiler
Sophie Somm
Tanja Koch
Gregorio Tersalvi
Mathias Wolfrum
Federico Moccetti
Stefan Toggweiler
Richard Kobza
Molly B. Levine
Hector M. Garcia-Garcia
Matthias Bossard
Florim Cuculi
References (36)- Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. The Task Force on myocardial revascularization of the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS)]. G Ital Cardiol (Rome). 2019;20(7-8. (Suppl 1): 1S–61S.
- Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014. Eur Heart J. 2015; 36(47): 3320–3331.
- Ishihara T, Okada K, Kida H, et al. Long-Term outcomes and clinical predictors of mortality following occurrence of stent thrombosis. J Am Heart Assoc. 2022; 11(7): e023276.
- McKavanagh P, Zawadowski G, Ahmed N, et al. The evolution of coronary stents. Expert Rev Cardiovasc Ther. 2018; 16(3): 219–228.
- Jensen LO, Thayssen P, Christiansen EH, et al. Safety and efficacy of everolimus- versus sirolimus-eluting stents: 5-year results from SORT OUT IV. J Am Coll Cardiol. 2016; 67(7): 751–762.
- Hemetsberger R, Abdelghani M, Toelg R, et al. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2022; 111(7): 795–805.
- Kirtane AJ, Gupta A, Iyengar S, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009; 119(25): 3198–3206.
- Picard F, Doucet S, Asgar AW. Contemporary use of drug-coated balloons in coronary artery disease: Where are we now? Arch Cardiovasc Dis. 2017; 110(4): 259–272.
- Jeger RV, Eccleshall S, Wan Ahmad WA, et al. Drug-Coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020; 13(12): 1391–1402.
- Hee L, Terluk A, Thomas L, et al. Late clinical outcomes for SeQuent please paclitaxel-coated balloons in PCI of instent restenosis and de novo lesions: A single-center, real world registry. Catheter Cardiovasc Interv. 2017; 89(3): 375–382.
- Baan J, Claessen BE, Dijk KBv, et al. A randomized comparison of paclitaxel-eluting balloon versus everolimus-eluting stent for the treatment of any in-stent restenosis: the DARE trial. JACC Cardiovasc Interv. 2018; 11(3): 275–283.
- Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009; 119(23): 2986–2994.
- Latib A, Colombo A, Castriota F, et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012; 60(24): 2473–2480.
- Tang Y, Qiao S, Su Xi, et al. Drug-Coated balloon versus drug-eluting stent for small-vessel disease: the RESTORE SVD China randomized trial. JACC Cardiovasc Interv. 2018; 11(23): 2381–2392.
- Cortese B, Di Palma G, Guimaraes MG, et al. Drug-Coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical trial. JACC Cardiovasc Interv. 2020; 13(24): 2840–2849.
- Jeger RV, Farah A, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018; 392(10150): 849–856.
- Cortese B, di Palma G, Latini RA, et al. Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry. Cardiovasc Revasc Med. 2017; 18(7): 487–491.
- Cortese B, Testa L, Di Palma G, et al. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021; 22(2): 94–100.
- Caiazzo G, De Michele M, Golino L, et al. Sirolimus-Eluting balloon for the treatment of coronary lesions in complex ACS patients: the SELFIE registry. J Interv Cardiol. 2020; 2020: 8865223.
- Lemos PA, Farooq V, Takimura CK, et al. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013; 9(1): 148–156.
- MedAlliance. SELUTION SLR™ technical specification, MedAlliance, 2021.
- Böhme T, Noory E, Beschorner U, et al. The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions. Future Cardiol. 2021; 17(2): 257–267.
- Cuculi F, Bossard M, Zasada W, et al. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020; 7(1): e001204.
- Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020; 41(3): 407–77.
- Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988; 78(2): 486–502.
- Medina A. Suárez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006; 59(2): 183.
- Huber MS, Mooney JF, Madison J, et al. Use of a morphologic classification to predict clinical outcome after dissection from coronary angioplasty. Am J Cardiol. 1991; 68(5): 467–471.
- Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
- Kereiakes DJ, Windecker S, Jobe RL, et al. Clinical outcomes following implantation of thin-strut, bioabsorbable polymer-coated, everolimus-eluting SYNERGY stents. Circ Cardiovasc Interv. 2019; 12(9): e008152.
- Mohamed MO, Polad J, Hildick-Smith D, et al. Impact of coronary lesion complexity in percutaneous coronary intervention: one-year outcomes from the large, multicentre e-Ultimaster registry. EuroIntervention. 2020; 16(7): 603–612.
- Park K, Park KW, Rha SW. Comparison of 5-year clinical outcomes between sirolimus-versus paclitaxel-eluting stent. Circulation: Cardiovascular Interventions. 2012; 5(2): 174–84.
- Bossard M, Madanchi M, Avdijaj D, et al. Long-Term outcomes after implantation of magnesium-based bioresorbable scaffolds-insights from an all-comer registry. Front Cardiovasc Med. 2022; 9: 856930.
- Puricel S, Cuculi F, Weissner M, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016; 67(8): 921–931.
- Madanchi M, Cioffi GM, Attinger-Toller A, et al. Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold. Open Heart. 2021; 8(2).
- Jeger RV, Farah A, Ohlow MA, et al. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020; 396(10261): 1504–1510.
- Cioffi GM, Madanchi M, Attinger-Toller A, et al. Pushing the boundaries: drug-coated balloons to treat a calcified and thrombotic lesion in acute coronary syndrome. Am J Case Rep. 2022; 23: e936950.
