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Drug‐coated balloon angioplasty and 1 month DAPT strategy: Insights from the real world

The use of drug-coated balloon (DCB) during percutaneous coronary interventions (PCI) is an intriguing option with recent interesting results compared with other treatments. It is probable that we will assist to an increasing usage of this device in the future. Indeed, the possibility to perform a safe PCI, even in high bleeding risk patients, is strengthened by the attractive option to avoid metal delivery along coronary arteries. The absence of the implantation of a drug eluting stent (DES), from a pathophysiological point of view, “releases” the cardiologist from starting a dual antiplatelet therapy (DAPT) in stable coronary artery disease. However, the current concept of DAPT duration after the use of DCB is strictly related to studies performed with stent implantation and it was not “per se” investigated. As a consequence, recommendations provided by major societies of cardiology suggested a comparable DAPT regimen as in patients treated with stent implantation. In 2011, thanks to experts opinion, it was reported the first consensus document that allowed patients treated with DCB to start a 1 month DAPT strategy after the procedure. Subsequently, the only randomized trial available with 1 month DAPT strategy, following the use of DCB, was performed considering small vessel disease (vessel diameter <3 mm) and reported similar event rates compared with DES. To date, no adequate powered randomized trials are available to compare the safety of 1 month DAPT regimen to other DAPT strategies after the use of DCB. In this issue of the Journal, Corballis et al performed a retrospective study with the aim to evaluate the occurrence of a major primary composite outcome of cardiac death, myocardial infarction (MI), and target lesion revascularization in patients treated with DCB angioplasty followed by 1 month DAPT. About 303 consecutive patients affected by stable coronary artery disease have been enrolled. No lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death was reported at 6-months follow-up. There were two (0.6%) non-target vessel MIs and one (0.3%) non-cardiac death. We commend the authors for the purpose to investigate the impact of very short DAPT regimen in a small, but significant cohort of patients. In particular, this investigation suggests a favorable safety profile even for patients treated with DCB and specific coronary anatomies which have been few represented in previous studies. Indeed, the reported cohort included patients with relevant vessel diameter (56.5% of the patients with vessel diameter ≥3 mm), high plaque complexity (Ellis C classification in 48.2% of the lesions), and left main involvement (13 patients). This retrospective study could be seen as a first small “proof of concept” of the potential marginal role of DAPT after a successful DCB angioplasty, opening the door to an even shorter DAPT strategy, or directly to a no-DAPT strategy as reported in a small number of patients in a recent study. Compared with other similar retrospective studies in the field, the rate of adverse events was surprisingly low. This result could be related, as the authors pointed out, to the large operator experience in using the DCB conferred by the center policy but it could be also attributable to an eventually accurate patient selection. As a matter of fact, the major limitation of the study, aside from those attributable to an observational single center registry largely unpowered for the proposed end point, is the lack of reported data on bail-out stenting. Indeed, the occurrence of this last issue is different across the available studies, ranging from 0.5 to 22% of the procedures performed by DCB. The bail-out stenting rate is a critical aspect because an high failure rate of DCB could make this attractive option useless due to a weak cost-effective ratio. The correct selection of the lesion to be treated by DCB is therefore critical. Further studies should be addressed to find strong predictors of DCB angioplasty Received: 8 October 2020 Accepted: 8 October 2020