ESC 2024 Drug-eluting stent ‘should remain the preferred treatment’ for de novo coronary artery disease

medwireNews: Drug-coated balloon (DCB) angioplasty with rescue stenting is inferior to drug-eluting stent (DES) implantation for adults with de novo, non-complex coronary artery disease irrespective of target vessel diameter, suggests the REC-CAGEFREE I study. “Despite the hypothesised benefit of avoidance of stenting to prevent leaving a scaffold behind, the use of paclitaxel-coated balloons for the treatment of patients with de novo non-complex coronary artery disease in any vessel diameters did not reach non-inferiority compared with an intended DES strategy,” say Ling Tao (Xijing Hospital, Xi’an, China) and co-investigators in The Lancet. At 24 months after surgery, the device-oriented composite endpoint (DoCE), comprising cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically and physiologically indicated target lesion revascularization (CPI-TLR), occurred in 6.4% of 1133 patients in the DCB group and 3.4% of 1139 in the DES group. The between-group difference was 3·04 percentage points favoring DES and the upper boundary of the one-sided 95% confidence interval was 4.52 percentage points, which was above the 2.68 percentage point limit for noninferiority. The open-label trial was conducted at 43 hospitals in China and involved 2272 patients with an indication for percutaneous coronary intervention who were assigned to receive either paclitaxel-coated balloon angioplasty with the option of rescue stenting or second-generation, thin-strut sirolimus-eluting stents, having undergone successful lesion predilatation with balloon angioplasty. The median age of the participants was 62.0 years, 69.3% were men, and all were of Chinese ethnicity. A total of 1225 (48.4%) of the lesions involved small vessel disease (<3.0 mm) and 9.4% of patients in the DCB group needed rescue DES. The researchers note that in subgroup analysis the patients with non-small vessel disease (device diameter ≥3.0 mm) who received DCB had a significantly higher rate of the DoCE than those in the placebo group, occurring in 7.5% of 603 patients compared with 2.5% of 637 in the DES group. This translated to a hazard ratio of 3.04. By contrast, the rate of DoCE was comparable among patients with small-vessel disease, occurring in 5.1% of 530 patients in the DCB group and 4.4% of 502 in the DES group. The findings indicate that “DES implantation should remain the preferred treatment strategy for these patients, especially those with non-small vessel disease,” say the researchers. They acknowledge several limitations to their study, however, including the use of paclitaxel–iopromide coated DCBs, which are not approved globally, the under-representation of women, who accounted for only around 30% of the group, and the east Asian ethnicity of the study population, which precludes extrapolation of the findings to other ethnic groups. Editorialists Margaret McEntegart and Ajay Kirtane, both from Columbia University Irving Medical Center in New York, USA, add that the between-group difference in the full study population was largely driven by a higher rate of the CPI-TLR component of the composite endpoint in patients receiving DCB compared with DES (3.1 vs 1.2%), giving a significant 1.90 percentage point difference favoring DES. However, there were “no significant differences in cardiovascular death or TV-MI seen between the groups,” with respective between-group differences of 1.07 and 0.28 percentage points, they say. Additionally, noting that the risk for ischemic events with DES increased over time, McEntgert and Kirtane emphasize that further follow-up of the trial is needed to assess whether such events can be prevented through avoidance of metallic scaffolds within the vessel. “[L]onger-term follow-up could provide some reassurance that, if there is a desire to avoid DES implantation, DCB might ultimately offer a useful alternative therapeutic option,” they conclude. The study was simultaneously presented at the ESC Congress in London, UK. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group Lancet 2024; doi:10.1016/S0140-6736(24)01594-0 Lancet 2024; doi:10.1016/S0140-6736(24)01696-9 ESC Congress 2024; London, UK: 30 August–2 September

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ESC 2024 Drug-eluting stent ‘should remain the preferred treatment’ for de novo coronary artery disease

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