Drug-Coated Balloon Angioplasty With Rescue Stenting Versus Intended Stenting for the ...
The REC-CAGEFREE I trial found that PCI with paclitaxel-coated balloon was inferior to traditional DES PCI for multiple CV outcomes at 2 years among patients with de novo lesions. The trial aimed to assess the safety and efficacy of a paclitaxel-coated balloon (DCB) compared to drug-eluting stent (DES) implantation. The study involved 2,272 patients randomized to either DCB or DES, with follow-up for 734 days. The primary outcome showed DCB was not noninferior to DES (6.4% vs. 3.4%, p for noninferiority = 0.65), with inferior outcomes particularly in larger vessels. Small vessel disease showed comparable outcomes between DCB and DES.
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The REC-CAGEFREE I trial found that PCI with paclitaxel-coated balloon was inferior to traditional DES PCI for multiple CV outcomes at 2 years among patients with de novo lesions. The trial aimed to assess the safety and efficacy of a paclitaxel-coated balloon (DCB) compared to drug-eluting stent (DES) implantation. The study involved 2,272 patients randomized to either DCB or DES, with follow-up for 734 days. The primary outcome showed DCB was not noninferior to DES (6.4% vs. 3.4%, p for noninferiority = 0.65), with inferior outcomes particularly in larger vessels. Small vessel disease showed comparable outcomes between DCB and DES.