A Comparison of a Drug Coated Balloon With Drug Eluting Stent Strategy for Treating Coronary Bifurcation Lesions

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Abstract
Background: The treatment of coronary bifurcation lesions (CBL) remains complex and associated with a higher rate of long‐term adverse cardiovascular events due to anatomical and procedural complexity. Aims: We compared procedural outcomes between a drug coated balloon (DCB) only approach and a 2nd generation drug eluting stent (DES) for treating de novo CBLs. Methods: We retrospectively identified all patients with CBL treated with either a DCB only or DES only strategy, including all coronary bifurcations and compared a bifurcation‐oriented composite endpoint (BOCE) of cardiovascular death, target bifurcation‐related myocardial infarction (TB‐MI), and clinically driven target bifurcation revascularization (TBR) using nationally obtained clinical outcome measures from 2015 to 2019. A propensity score matched analysis was undertaken. Results: Of 2113 patients, 1030 patients were treated with a DCB and 1083 with a DES. There was higher lesion complexity in the DCB group, and propensity score‐matched analysis was utilized. This included a total of 2052 patients (1026 in each arm). The median age was 68 (59−75), and all clinical presentations were included. The median follow‐up time was 3.6 (2.5−4.8) years with 501 (48.8%) patients having follow‐up available at 5 years. Propensity matched analysis showed a significant increase in events (14.0% vs. 9.9% respectively) (HR: 1.39 [1.08−1.79], p = 0.01) when using DES compared to DCB, driven predominantly by an increase in TBR (8.9% vs. 5.0%) (HR: 1.79 [1.27−2.50], p ≤ 0.001) and TB‐MI (3.0% vs. 1.6%) (HR: 1.92 [1.05−3.57], p 0.03). Conclusions: The use of DCB‐only in a coronary bifurcation is a safe alternative in treating CBL, within the limitations of a retrospective single center analysis. An appropriately designed RCT is now required.

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