Prospective, Large-Scale Multicenter Trial for the Use of Drug Coated Balloons (DCB) in Coronary Lesions: The DCB-Only All Comer Registry

Aims: The aim of this prospective, multicentre, international registry was to assess the safety and efficacy of a DCB-only strategy for the treatment of de-novo coronary lesions in an unselected all-comer patient population.

Methods and Results: We recruited 1025 patients with 1084 coronary lesions within vessels sized ≥2.0 and ≤4.0 mm and a lesion length of ≤25 mm. The average age of the study population was 64±11.2 years. Noteworthy was a high rate (44.3%) of patients with diabetes, acute coronary syndromes (26.9%) and complex type B2/C lesions (47.5%). DCB angioplasty was done predominantly for de-novo lesions (731 lesions or 67.7%). For comparison 112 lesions (10.3%) with in-stent restenosis (ISR) after bare metal stent (BMS) implantation and 241 lesions (22%) with ISR after treatment with drug eluting stents (DES) were also included. Additional BMS implantation was necessary in 54 patients and mainly occurred in the de-novo and BMS-ISR group (6.0% vs. 5.4% vs. 0.8%; p=0.004). After an average follow up of 8.7±1.8 months 29 patients had Re-PCI of the target lesion which corresponded to a TLR rate of 3.2%. Of note, TLR rate was highest among patients after DCB treatment of a DES-ISR (5.8% vs. 2.3% vs. 2.9 %; p=0.049). In a secondary analysis the MACE rate in the overall population was 6.8% after 9 months. Again there was a trend for more adverse events in the DES-ISR group compared to DCB angioplasty for de-novo or BMS-ISR lesions (9.6% vs. 5.6% vs. 7.8%, p=0.131).

Conclusion: Given the low TLR and MACE rates our registry adds to the accumulating evidence that a DCB only therapy emerges as an attractive alternative to stents for the treatment of suitable de novo coronary lesions.