ESC 2024 | REC-CAGEREE I Trial: Drug Coated Balloon with Bailout Stenting vs. Intended DES for de Novo Lesion Treatment

DES stenting is currently the standard treatment. The development of balloon technology and the coating drugs have reduced adverse effects associated with the maladaptive biologic response, in support of the concept “leave nothing behind”.

The aim of this study was to assess whether drug coated balloons (DCB), with the chance of stenting only if necessary (bailout stenting), resulted non-inferior to intended DES in non-complex de novo lesions, regardless vessel diameter, at 2 year followup. 

It included patients with acute (ACS) or chromic coronary syndrome and non-complex anatomies (with no left main disease, bifurcations, graft lesions, chromic total occlusions (OCT), use of atherectomy or planned angioplasty procedures ≥60 mm), with no shock or restenosis. 

Data from 2272 patients, from 43 centers in China, were gathered. After adequate predilation (with no type D, E or F dissections, with TIMI flow 3 and no residual stenosis) patients were randomized 1:1 to sirolimus DES or paclitaxel DCB (9.4% required stent bailout). Primary non-inferiority outcome was the composite of cardiac death, target vessel MI, and clinical or ischemia driven new revascularization.

Read also: ESC 2024 | The OCCUPI Trial: Guided PCI for OCT in Complex Lesions.

At 2 year followup, the primary outcome was observed in 3.4% patients treated with DES and in 6.4% of the DCB patients (absolute difference 3.04%, with P for non-inferiority = 0.65). There were no significant differences in cardiovascular mortality (P=0.053) or treated vessel MI (P=0.606), but there was higher rate of clinically driven revascularization among DCB patients.

The authors have concluded that DCB + bailout stenting did not reach non-inferiority criteria vs DES at 2 years. 

Presented by Ling Tao at the Hot-Line Sessions, ESC Congress 2024, August 30 thru September 2, London, England