BASKET BALL: Drug-Coated Balloon (DCB) only strategy versus Drug-Eluting Stents (DES) in complex coronary interventions

BASKET BALL is an international, randomized, multicenter, open-label trial in patients with coronary artery disease and increased clinical or anatomical risk. The trial is designed to create clinical evidence for a sirolimus-coated balloon (SeQuent® SCB) in complex coronary artery disease.

The hypothesis of BASKET BALL is that a sirolimus DCB-only-based approach is non-inferior to a primary DES strategy with respect to the composite endpoint of target vessel failure (TVF) and major bleeding (BARC types 3–5) at 12 and 36 months. A total of 2,184 patients will be enrolled at up to 60 clinical sites across up to 15 countries. The study is led by Prof. Raban Jeger (Zurich, Switzerland) and Prof. Bruno Scheller (Homburg/Saar, Germany).

“BASKET BALL addresses an important clinical question in patients with complex coronary artery disease,” said Prof. Jeger. “The trial will provide valuable evidence on the role of a sirolimus coated balloon-based treatment strategy in this high-risk population.”

“This landmark trial is designed to generate robust evidence on the use of drug-coated balloons in complex coronary interventions,” added Prof. Scheller. “BASKET BALL is a strategy trial comparing a DCB-only approach including cross-over to stenting in case of unsuccessful lesion preparation compared to a 100% full-metal jacket DES strategy. Its findings may help shape the future of interventional cardiology.”

As a pioneer in DCB technology, B. Braun has generated one of the most comprehensive evidence bases in DCB-PCI, with more than 145 clinical studies and publications across the SeQuent® DCB portfolio. Most of this evidence has been established with SeQuent® Please/NEO, the best-investigated coronary DCB worldwide to date. Building on this foundation, the sirolimus-coated SeQuent® SCB has demonstrated non-inferiority to SeQuent® Please/NEO across five randomized clinical trials. The recently presented one-year SCORE results for SeQuent® SCB and the launch of the BASKET BALL trial represent important milestones in the continued expansion of the clinical evidence base supporting DCB treatment in patients with coronary artery disease.