Long‐Term Effectiveness of a Stent‐Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3‐Year Follow‐Up of a Prospective All‐Comers Observational Study

ABSTRACT Introduction Drug‐eluting stent (DES) angioplasty is the gold standard treatment for coronary lesions. Drug‐coated balloon (DCB) is an option for in‐stent restenosis, and has also shown promise for small‐calibre coronary artery disease. We evaluated the 3‐year effectiveness of a decision algorithm for percutaneous coronary intervention (PCI) that favoured a stent‐less strategy (SLS) in primary angioplasty. Methods All patients who underwent angioplasty during 1 year were included in a prospective observational study. Patients eligible for SLS first underwent scoring balloon followed by DCB angioplasty or DES in case of mandatory bailout. Patients not eligible for SLS were unstable patients who underwent conventional drug‐eluting stenting. The metal index, stent burden, was calculated by stent length divided by the total lesion length. A 36‐month follow‐up recorded target lesion revascularization (TLR). Results Patients eligible for SLS represented 85% ( n = 840) of patients who underwent PCI. TLR was required in 2.6% and 6% of patients in the DCB‐only and bailout‐DES groups, respectively. Median metal index was 0.25 (IQR: 0.5) in patients with TLR. There was a difference between TLR–free survival distributions in the DCB‐only and bailout‐DES groups ( p = 0.016). Conclusions The SLS based on a combination of scoring balloon and DCB was effective at 3 years with a low rate of TLR. This rate was higher in patients with stent burden. Trial Registration: This study was registered with clinicaltrials. gov (NCT03893396, first posted on March 28, 2019).