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SeQuent® DCBs
Supporting cardiologists with clinical data for both paclitaxel and sirolimus coated balloons.
Cooperation
What role do DCBs play in the modern interventional cardiology toolbox? Dr. Victor Jimenez takes on this and other questions from Cardiovascular News. He discusses how DCBs can address some of the limitations of DES platforms and the clinical scenarios in which balloons are favourable.
Read the article
Early exposure to the use of drug-coated balloons (DCBs) for percutaneous coronary intervention (PCI) “opened my eyes to a whole new world of angioplasty without putting stents in,” Simon Eccleshall (Norwich, UK) tells Cardiovascular News, detailing how the technology has come to play an important role in his practice.
In this interview, Eccleshall offers advice on the fundamentals of adopting DCBs in daily practice, offers insights from his own centre that underscore the safety and efficacy of DCBs in real-world use, and considers what the future holds for DCB-PCI.
What role do DCBs play in the modern interventional cardiology toolbox? Dr. Victor Jimenez takes on this and other questions from Cardiovascular News. He discusses how DCBs can address some of the limitations of DES platforms and the clinical scenarios in which balloons are favourable.
Dr. Marie-Claude Morice (Institute Hospitalier Jacques Cartier, Massy, France) discusses the future role of DCBs in coronary interventions. Learn about the upcoming topic of DCBs in de-novo lesions, the ongoing exciting research and the benefits of leaving nothing behind.
Read the articleDr. Tuomas Rissanen (North Karelia Central Hospital, Joensuu, Finland) speaks to Cardiovascular News about the benefits of using a drug coated balloon, the clinical indications that are most suited and why a wide set of data is key.
Read the articleGlobal Experts
Bruno Scheller, Raban Jeger and Tuomas Rissanen talk about their experiences with DCBs and why there is no need to fear acute vessel closures. In the words of Tuomas Rissanen: "You can sleep tight in the evenings and there's no risk of getting back to the hospital at night."
Paclitaxel and sirolimus coated balloons
Paclitaxel coated balloon
B. Braun's paclitaxel coated balloon SeQuent® Please NEO is the best investigated DCB [1] in the field of percutaneous coronary interventions (PCI). It has demonstrated its performance and efficacy in more than 110 published studies (including more than 35 RCTs) – with over 25,000 documented patients, conducted in more than 20 countries.
2020 | Primary Investigator: Jeger R | Study Aim: SQP vs. DES, Vessel: RD ≤ 3 mm | (Primary) Endpoint: MACE @ 36-month follow-up | Patients: 758
Summary BASKET-SMALL 22017 | Primary Investigator: Funatsu A | Study Aim: DCB vs. POBA, Vessel: RD ≤ 2.75 mm, ≥ 2 mm | (Primary) Endpoint: TVF @ 6-month follow-up | Patients: 135
Summary PEPCAD Japan SVD2017 | Primary Investigator: Gobić D | Study Aim: DCB vs. DES, Patients: STEMI (< 12 h) | (Primary) Endpoint: MACE, LLL @ 6-month follow-up | Patients: 75
Summary AMI Feasibility Study2016 | Primary Investigator: Nishiyama N | Study Aim: DCB vs. DES | (Primary) Endpoint: TLR @ 8-month follow-up | Patients: 60
Summary Clinical Value "Stent-less" PCI2019 | Primary Investigator: Rosenberg M | Study Aim: DCB – ISR & De Novo | (Primary) Endpoint: TLR @ 9-month follow-up | Patients: 1,025
Summary DCB-only All-Comers Registry2016 | Primary Investigator: Shin E | Study Aim: DCB – De Novo, Vessel: RD ≤ 3.5 mm, ≥ 2.5 mm | (Primary) Endpoint: LLL, FFR @ 9-month follow-up, MI, TLR @ 12-month follow-up | Patients: 67
Summary FFR-Guided DCB-Angioplasty2014 | Primary Investigator: Zeymer U | Study Aim: DCB – De Novo, Vessel: RD ≤ 2.75 mm, ≥ 2.0 mm | (Primary) Endpoint: TLR @ 9-month follow-up | Patients: 447
Summary SVD Registry2023 | Primary Investigator: Shin ES | Study Aim: Investigate the impact of DCB-based treatment on PCI for multivessel CAD | (Primary) Endpoint: MACE @ 24-months (cardiac death, MI, TVR, stroke, stent thrombosis and major bleeding) | Patients: 508
Summary DCB-based PCI in Multi-Vessel-DiseaseSirolimus coated balloon
B. Braun's new sirolimus coated balloon is the first SCBsupported by published randomised clinical trials for ISR and de-novo lesions. [2], [3], [4] SeQuent® SCB now offers new implant-free options for treating coronary ISR and de-novo lesions, providing excellent results in targeted drug delivery and sirolimus persistence. The combination of sirolimus and BHT (Butylated Hydroxy Toluol) creates the desired crystalline sirolimus modification to reach best results regarding sirolimus vessel wall content compared to other excipients. [5]
Sirolimus + BHT (Butylated Hydroxy Toluol): Persistence in the vessel wall
Read moreTwo RCTs for SeQuent® SCB vs. SeQuent® Please NEO with angiographic and clinical follow-ups.
Read summaryRCT for SeQuent® SCB vs. SeQuent® Please NEO with angiographic and clinical follow-ups.
Read summaryTreatment methodology
Lesion preparation | |
Acceptable angiographic result
| Unacceptable angiographic result
|
Lesion therapy | |
DCB-only with with SeQuent® Please NEO or SeQuent® SCB
| Stenting
|
[1] All numbers referring to clinical coronary trials on PCBs, patients enrolled therein and countries in which these trials were conducted, are based on a PubMed literature search conducted with due diligence in February/March 2022. (Data on file at B. Braun)
[2] Ali RM et al J Am Coll Cardiol Intv 2019;12:558-66
[3] Scheller B et al. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305.
[4] Ahmad WAW et al. JACC Cardiovasc Interv. 2022 Apr 11;15(7):770-779
[5] Clever et al. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543.
[6] Kleber FX et al. Clin Res Cardiol. 2013 Nov;102(11):785-97.
[7] Jeger RV et JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402.
[8]ACS patients require 12 months of DAPT. In case of HBR, it might be reduced to 6 months according to current guidelines. Jeger R et al. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC: Cardiovascular Interventions; 2020
[9] Neumann FJ et al. ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165.
[10] Date on file at B. Braun
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