Self‐Expanding Dedicated Bifurcation Stent

Interventionists frequently encounter coronary bifurcation lesions during routine percutaneous coronary interventions (PCI). These lesions pose a clinical dilemma due to their increased risk of early and late ischemic complications. Currently, provisional stenting remains the default strategy for bifurcation-PCI. This consensus relates to three large randomized trials that compared provisional stenting versus a two-stent strategy [1–3]. From these trials, only BBC-1 demonstrated lowered major adverse cardiac events (MACE) with provisional stenting strategy [2], which was mainly driven by higher peri-procedural cardiac enzyme elevation, while the other two trials showed benefit only regarding surrogate safety endpoints (radiation exposure, procedural time, and degree of cardiac enzyme elevation). It is noteworthy, that most comparative bifurcation-PCI studies included either bare-metal stent or first-generation drug-eluting stent (DES). Therefore, it is plausible that a more contemporary comparison of these two strategies comprising an unrestrictive use of modern DES, the administration of potent antiplatelet agents (i.e., prasugrel or ticagrelor) and the avoidance of classical crush could lead to different clinical outcomes. The latter is supported by the multicenter randomized DKCRUSH (Double-Kissing Crush vs. Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions) II trial, where the use of a double-kissing crush technique led to lower restenosis and reintervention rates than provisional stenting. Furthermore, in the setting of a true bifurcation with either a large side-branch or a side-branch with extensive disease, there is a high chance of crossover from provisional to a two-stent strategy. While interventionists normally aim to obtain the best results possible with the lowest degree of complexity, bifurcation-PCI strategy is mostly dependent on lesion complexity rather than the operator’s preferences. Optimal handling of a two-stent strategy requires considerable expertise and hence, it becomes evident that the interventional community would profit from a less technically demanding technique, especially in patients with complex bifurcations. The Axxess stent is a self-expanding, dedicated bifurcation stent that has an abluminal biodegradable PLA/BA9 coating eluted with Biolimus (Devax, Lake Forest, and CA). This bifurcated stent is deployed at the level of the carina over one wire (does not need to rotate or align with side-branch), covering only the proximal region of the bifurcation and providing easy access to both distal branches. Importantly, the stent has a conical shape, and thereby conforms graciously to the polygonal of confluence of the bifurcation. In the DIVERGE (DES Intervention for Treating Side Branches Effectively) trial, the stent was deployed successfully in 299/302 patients (99%) and demonstrated encouraging clinical results at 3-year follow-up (MACE 16.1%, bifurcation reinterventions 10% and definite stent thrombosis rates 2%) [4]. In this issue of the Journal, Buysschaert et al. [5] evaluated serial luminal changes in 62 patients who underwent PCI with the Axxess stent, as part of the DIVERGE trial [4]. At 9-month intravascular ultrasound analysis, vessel and stent volumes increased, which led to a reduction in peri-stent plaque, an enlargement in luminal volume and low neointimal growth [5]. Even though acute and persistent stent malposition rates were high (38 and 26%, respectively), definite stent thrombosis rate appears acceptable [4]. In addition, systematic use of kissing balloon inflation