REC-CAGEFREE I: Can we avoid permanent stenting with drug-coated balloons?

A strategy utilising a drug-coated balloon (DCB) with rescue stenting was inferior to standard drug-eluting stenting (DES) in patients with newly diagnosed coronary artery disease (CAD). Although longer follow-up is needed, findings from the REC-CAGEFREE I trial suggested that DES remains the preferred treatment strategy.

“A balloon coated with antiproliferative drugs may be used in patients with CAD to avoid the implant of a permanent scaffold,” argued Dr Ling Tao (Xijing Hospital, China) [1]. To test this hypothesis, the investigator-initiated, multicentre REC-CAGEFREE I trial (NCT04561739) randomised patients with de novo, non-complex CAD who underwent successful pre-dilation (n=2,272) 1:1 to DCB with rescue stenting or to standard DES. The primary endpoint was a composite of cardiac death, target-vessel myocardial infarction (MI), and clinically and physiologically indicated target lesion revascularisation at 2 years.

At 2 years, the DCB arm displayed inferior outcomes to the standard-of-care arm, with primary outcome event rates of 6.4% versus 3.4% (P_{non-inferiority}=0.65) [1,2]. Differences between the 2 arms were seen in cardiac death (2.3% vs 1.2%; P=0.053) and revascularisation (3.1% vs 1.2%; P=0.002) rates, whereas target-vessel MI rates appeared to be similar (1.9% vs 1.6%; P=0.61). “The significant difference between the 2 arms regarding the primary endpoint was mainly present in patients with non-small vessel disease [7.5% vs 2.5%], whereas patients with small vessel disease had comparable outcomes [5.1% vs 4.4%],” added Dr Tao [1].

“DES implantation should remain the preferred treatment strategy for newly diagnosed patients with CAD, especially if they have non-small vessel disease,” concluded Dr Tao. “Longer follow-up will reveal whether the higher revascularisation rates translate into higher MI or mortality rates.”

1. 
   
   1. Tao L, et al. DCB with rescue stenting versus intended stenting for de novo CAD: a multicenter, non-inferiority trial. HOTLINE 11, ESC Congress 2024, 30 Aug–02 Sept, London, UK.
   2. Gao C, et al. Lancet 2024;404(10457):1040-1050.

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Posted on 7 November 20247 November 2024