Drug-eluting balloon offers a new opportunity in percutaneous bifurcation interventions

Abstract

We read with interest the German Drug-Eluting Balloon Consensus Group recommendations on the use of drug-eluting balloons (DEB), recently published in EuroIntervention.1 When approaching coronary bifurcation lesions, the consensus group advocates to always predilate both the side branch (SB) and the main vessel (MV) with regular balloons. If the result is good, the sequence is repeated with DEB. Otherwise, stenting is favoured with either a drug-eluting stent (DES) alone or a bare metal stent (BMS) in association with DEB; dual antiplatelet therapy (DAPT) is recommended for 12 months in both cases. We believe that the most important feature of DEB technology is the ability to dilate stenoses combined with the effective transfer of a drug successfully inhibiting the vessel response to the dilation itself, without leaving anything behind (metal, polymer, eluting drug) that could trigger a delayed biological reaction. Accordingly, all DEB manufacturers recommend DAPT for only three months. This characteristic offers a new opportunity in percutaneous bifurcation intervention, namely the option to treat, with a result expectably similar to that obtained with a DES, patients that could not assume DAPT for 12 months as required after a DES has been implanted (e.g., patients with low compliance to drug therapy, high bleeding risk, important surgical indications). To date, published follow-up data after DEB treatment of coronary bifurcations are limited to 102 patients who assumed DAPT for three months (Table 1).2-5 Overall, stent thrombosis has been reported in only two patients enrolled in the PEPCAD V study and has been attributed to incomplete stent apposition.4 Therefore, we deem that the recommendation advocating 12 months duration of DAPT if a BMS is implanted after DEB treatment of a bifurcation is not supported by clinical evidence and weakens the advantages offered by DEB over DES, whose use in percutaneous bifurcation interventions is far more documented. Moreover, to warranty effective DEB treatment, any effort has to be pursued to achieve total control of the bifurcation intervention. In that light, we consider that systematic SB predilation is questionable, especially if the vessel is free of disease. Indeed, primary predilation of the SB should be avoided because of the risk of dissection that can increases the need for potentially unnecessary stenting and the risk of rewiring the MV stent through a proximal cell.6 To the contrary, without SB predilation, it is possible to take advantage of the carina shift occurring during MV stenting to rewire the SB through the distal cell.6 Indeed, bench tests of provisional stenting have shown that rewiring through the cell closest to the carina provides far better scaffolding than proximal rewiring.7 Moreover, owing to the specific geometry of bifurcations favouring high atherosclerosis burden,8 success of percutaneous bifurcation interventions appears unlikely, unless adequate vessel scaffolding is provided. To address all those issues, we have developed an approach consisting of stenting the MV with a BMS and then finalising the procedure with kissing inflation with DEB. We have shown that this approach is feasible and safe with all different DEBs.5 However, until a more robust demonstration of the validity of our strategy, we are currently restricting this approach exclusively to patients who could absolutely not be compliant to DAPT. Angiographic followup results accumulate slowly but are extremely encouraging, and our first findings with optical coherence tomography are especially reassuring against possible issues related to our strategy such as drug lost during DEB tracking (Figure 1).