Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial

Abstract

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG.

Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

“…Three RCTs to date have assessed the efficacy and safety of DCB versus DES for de novo small‐vessel CAD . The PICCOLETO study compared the effect of a paclitaxel‐eluting balloon (DIOR; Eurocor, Bonn, Germany) with a first‐generation paclitaxel‐eluting stent (Taxus Liberte, Boston Scientific Corporation, Natick, Massachusetts) and was prematurely stopped due to the increase in the primary angiographic endpoint (% diameter stenosis) and the clinical endpoint in the DCB group.…”

“…The MACEs rate was similar in both groups after 6 and 24 months, which was in accordance with the similar rate of primary angiographic endpoint (non‐inferiority of in‐stent or in‐balloon late loss) after 6 months. The BASKET‐SMALL2 study was designed to test the clinical noninferiority of a DCB (SeQuent Please, B. Braun Melsungen AG, Melsungen, Germany) to a DES (Taxus element, Boston Scientific Corporation, Natick, Massachusetts, XIENCE, Abbott Vascular, Santa Clara, California, or Promus, Boston Scientific Corporation, Natick, Massachusetts) in a large all‐comers population of 758 patients undergoing PCI of small coronary vessels (reference diameter <3 mm). After 12 months, the MACE rate was similar in both groups of the full‐analysis population.…”

“…They have shown promising results, enabling high‐concentration, rapid local delivery of paclitaxel without the use of drug reservoirs, thus reducing the inflammation caused by permanent metal implantation . The Balloon Elution and Late Loss Optimization (BELLO) study and the Basel Kosten Effektivitäts Trial‐Drug‐Coated Balloons versus Drug‐eluting Stents in Small Vessel Interventions (BASKET‐SMALL) two trial both showed low major adverse cardiac event (MACE) rates at 1‐year of follow‐up. A previous report from the RESTORE small vessel disease (SVD) China study demonstrated that 9‐month in‐segment percentage diameter stenosis was 29.3 ± 20.2% with the DCB versus 23.9 ± 15.9% with the DES; the one‐sided 97.5% upper confidence limit of the difference was 10.6%, demonstrating noninferiority of the DCB ( p for noninferiority <.001) .…”

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

“…Several studies have suggested that BMS in combination with DCBs are superior to BMS alone . However, the studies comparing the use of DCB alone versus other strategies (i.e., BA, or DES) in de novo SVD are limited . We conducted a systematic review and meta‐analysis to compare the outcomes of DCB‐only strategy with other modalities in the treatment of de novo coronary SVD.…”

Percutaneous transluminal angioplasty using the novel drug-coated balloon catheter SeQuent Please NEO for the treatment of symptomatic intracranial severe stenosis: feasibility and safety study

“…The phenomenon of restenosis caused by neointimal hyperplasia that frequently lowers the mid- and long-term results of ICAD treatment is well recognized. Angioplasty with a drug-coated balloon (DCB) is already well established and frequently used in cardiology, with DCB-PTA recently demonstrating non-inferiority to the current standard DES-PTA 10. Antiproliferative agents, such as the highly lipophilic microtubular stabilizer paclitaxel, prevent neointimal hyperplasia by inhibiting migration and cell division (figure 1).…”