Technical success, clinical efficacy, and insight into the causes of restenosis after the percutaneous coronary intervention of de novo coronary artery lesions using a paclitaxel-coated balloon with citrate ester excipient

Abstract

ObjectivesThe aim of this all-comers registry study was to investigate the technical success, clinical efficacy, and safety of a drug-coated balloon (DCB) with paclitaxel combined with citrate ester excipient (CEE) in percutaneous coronary intervention (PCI) of de novo coronary lesions in an all-comers population.Materials and methodsA total of 338 consecutive PCIs using the DCB (CEE)-only approach comprising 406 de novo lesions were included in the study. Technical success was determined by the successful delivery of the device and no need for bailout stenting.ResultsThe mean follow-up time was 25 ± 12 months. The mean age of patients was 71 ± 11 years, and 48% had the acute coronary syndrome. A total of 55% of the patients were at risk of factor bleeding. The delivery of DCB was successful in 98% of cases. The overall technical success rate was 83%. Bailout stenting was used in 9% of lesions. Rotational atherectomy was used in 11% of cases before the DCB-only approach. The mean diameter of the DCBs used was 2.7 ± 0.5 mm and 38% of DCBs were large (≥3.0 mm). The 12-month MACE rates were 5.4 ± 1.7 and 18.3 ± 3.1% in stable CAD and in ACS, respectively. The respective target lesion revascularization (TLR) rates were 3.0 ± 1.3 and 8.5 ± 2.3%. Unacceptable acute recoil (>30%) was found in 74% of cases that needed repeat revascularization. No acute vessel closures occurred after DCB treatment.ConclusionThe DCB-only strategy using a paclitaxel-coated (CEE) device was technically feasible, safe, and effective in an all-comers population. Acute recoil was found as a significant cause of restenosis after the DCB-only strategy.

A New Frontier for Drug-Coated Balloons: Treatment of “De Novo” Stenosis in Large Vessel Coronary Artery Disease

“…The mean FFR was 0.92 ± 0.05 in the DCB Group and 0.91 ± 0.06 in the stent group ( p = 0.27). Despite these good results of DCB in the setting of ACS, two observational studies [ 40 , 41 ] have raised some concerns due to a higher risk of cardiovascular events associated with the use of DCB. Uskela et al [ 40 ], in a retrospective, single-center study, enrolled 487 patients treated by Paclitaxel DCB in the novo lesions between September 2009 and December 2013.…”

“…At two years follow-ups, patients presenting with ACS, compared to those with stable CAD, showed higher total mortality (13.0 ± 1.8% and 9.3 ± 1.8%, respectively, p < 0.001) andMACE rates (19.3 ± 3.1% and 12.0 ± 2.0%, respectively, p = 0.012). Likewise, Tervo et al [ 41 ], in a single retrospective study, enrolled 177 patients with stable CAD and 161 patients with ACS treated with paclitaxel-coated DCB between August 2014 and November 2018. The mean age of the patients was 71 ± 11 years, with 37% of diabetic patients and 55% considered at high bleeding risk.…”