Affiliations 

  • 1 Innere Medizin III, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany
  • 2 Medical Scientific Affairs, B.Braun Melsungen AG, Berlin, Germany
  • 3 Pantai Hospital, Kuala Lumpur, Malaysia
  • 4 Pusat Perubatan Universiti, Kuala Lumpur, Malaysia
  • 5 Ospedale San Giovanni di Dio, Agrigento, Italy
  • 6 The National Heart Institute of Malaysia, Kuala Lumpur, Malaysia
  • 7 Hospital Queen Elizabeth II, Sabah, Malaysia
  • 8 Pusat Perubatan Universiti Kebangsaan, Kuala Lumpur, Malaysia
  • 9 Centre Hospitalier Gonesse, Gonesse, France
  • 10 HIA Toulon, Toulon, France
Catheter Cardiovasc Interv, 2019 02 01;93(2):181-188.
PMID: 30280482 DOI: 10.1002/ccd.27724

Abstract

OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions.

BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited.

METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months.

RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates.

CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.