Is there a need for dedicated bifurcation devices?

Abstract

J123 Introduction Coronary bifurcation disease is one of the outstanding challenges of treatment with percutaneous coronary intervention (PCI), and may be present in up to 20 to 30% of patients with multivessel disease encountered in daily practice. Compared with simple lesions, bifurcations have been associated with lower procedural success rates, higher adverse event rates, and poorer angiographic and clinical outcomes. The less favourable outcomes associated with bifurcation compared with non-bifurcation lesions may in part result from the inability of current devices and techniques to scaffold adequately and preserve the side-branch (SB) ostium, which is a common site for restenosis. Complex strategies are technically demanding and may compromise the main branch (MB) when not carried out properly or when the final result is not optimal in terms of stent apposition and flow dynamic. Furthermore, compromise of the SB during stent implantation is also common as many techniques do not allow the operator to maintain a usable wire in the SB. The use of drug-eluting stents (DES) has resulted in significantly improved outcomes compared with bare metal stents (BMS), with a single digit re-intervention rate in the majority of non-randomised real world studies and also in randomised studies comparing the systematic use of two stents to the strategy of provisional SB stenting. Meta-analyses of these randomised studies, which were performed in selected cases, did not show any advantages associated with the systematic use of two stents compared to the provisional approach. Indeed, the two-stent approach was associated with a higher rate of periprocedural myocardial infraction and a trend towards a higher rate of stent thrombosis. Consequently, there is a common acceptance that provisional SB stenting should be the gold standard approach in the majority of bifurcation lesions and the main question is when we should use two stents to improve procedural safety and long-term efficacy. Although a large variety of dedicated bifurcation stents, both BMS and DES, have been studied none of them has become widely used. An unmet need In the DES era, the most significant independent predictor of clinical outcome is the angiographic success at the level of the main branch and this is a very important point to keep in mind. The acute result achieved in the SB is not a predictive factor of late outcome and this is one of the key reasons why the provisional SB stenting approach is a successful strategy compared to a more complex approach with two stents or more. Dedicated stents are every interventionalist’s dream because they simplify the procedure and make it easy for everybody, improving procedural success rate, decreasing the risk of stent thrombosis and decreasing the risk of SB restenosis. But many questions remain unanswered: How clinically important is it compared to the provisional approach? How cost-effective is it? What about the distal left main trunk?