Drug-coated ballons vs drug-eluting stent in de novo coronary lesions, a propensity-score matched cohort study

Background The usage of drug-coated balloons (DCB) in percutaneous coronary interventions (PCI) is increasing due to potential benefits, mainly by avoiding foreign material. However, a widespread application area beyond in-stent restenosis lacks robust clinical data. Purpose Here our aim was to assess the safety and efficacy of DCBs in treating de novo lesions. Methods For this analysis, we included all patients treated with DCB in de novo lesions from 2010 to 2019 at a tertiary care center. We performed a 1:1 propensity score matching to pair each DCB intervention with a comparable DES intervention. The primary study endpoint was target lesion revascularization. Follow-up continued until 09/2022 to assess clinical outcomes. Results A total of 303 patients with de novo lesions were matched to 303 patients with comparable baseline characteristics. The median follow-up time was 5.7 years (IQR 2.7-9.3). Age, sex, comorbidities, and laboratory values were evenly distributed in both matching groups. Differences were found for the variable multivessel disease prior to index PCI, which was slightly higher in the DCB group. In patients with a DCB intervention, the vessel diameter of the matched lesion was somewhat smaller (2.5mm [IQR 2.0-2.5mm] vs 2.5mm [2.25-2.75mm], p-value <0.001) compared to patients with DES intervention. Meanwhile, the total device length used in DCB interventions (41mm [IQR 20-66mm] vs 26mm [IQR [18-48mm]) as well as the proportion of side branch interventions (150 [49.5%] vs 93 [30.7%]) were significantly higher in the DCB group (respectively p-values <0.001). There were no significant differences in cardiovascular (CV) mortality (HR 1.01 [95% CI 0.87-1.19], p-value 0.874), all-cause mortality (HR 1.05 [95% CI 0.91-1.22], p-value 0.491), MACE (HR 1.10 [95% CI 0.96-1.26], p-value 0.170), acute myocardial infarction (HR 1.08 [95% CI 0.90-1.19], p-value 0.308), or any revascularization (HR 1.03 [95% CI 0.90-1.19], p-value 0.671) between both groups. However, we observed a trend toward lower rates of target lesion revascularization in patients with small vessel disease, with 2.6% (n=6) in the DCB group vs. 5.5% (n=12) in the DES group (HR 0.84 [95% CI 0.68-1.02], p-value 0.072). Meanwhile, interventions with a diameter >2.5 mm showed no significant difference (DCB 8.5% [n=6] vs. DES 9.5% [n=8], HR 0.95 [95% CI 0.69-1.30], p-value 0.745, Figure 1). There was a similar trend for target lesion revascularization in side branch interventions, with 1.3% (n=2) in DCB interventions vs 5.4% (n=5, HR 0.79 [IQR 0.58-1.04], p-value 0.096) in DES interventions. Conclusion DCBs demonstrated long-term safety and efficacy in de novo lesions, with promising trends in reducing target lesion revascularization in small vessel disease and side branches.