Author + information
- Satoru Mitomo1,
- Antonio Mangieri2,
- Damiano Regazzoli3,
- Marco Ancona4,
- Francesco Giannini2,
- Alaide Chieffo2,
- Matteo Montorfano5,
- Azeem Latib2 and
- Antonio Colombo6
- 1IRCCS San Raffaele Scientific Institute, Milan, Milan, Italy
- 2Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
- 3San Raffaele Scientific Institute, Milano, Milan, Italy
- 4San Raffaele Hospital, Milan, Italy, Milano, Milan, Italy
- 5San Raffaele Scientific Institute, Milan, Milan, Italy
- 6Interventional Cardiology Institute San Raffaele Hospital - Stamford Hospital - Columbia University - Centro Cuore Columbus, Milan, Milan, Italy
The efficacy of drug-coated balloon (DCB) for the lesion including small vessel and in-stent restenosis (ISR) has been reported. However, suboptimal results of DCB requires bailout stenting, of which clinical outcomes using drug-eluting stent (DES) are limited.
Cases which underwent DES implantation for suboptimal results after DCB (paclitaxel-eluting balloon) in 2 high-volume centers in Milan were analyzed. The suboptimal results after DCB were defined as residual stenosis >30% and/or type C-F dissection. The primary endpoint was target lesion failure (TLF) defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and target lesion revascularization (TLR).
From June 2009 to December 2015, 1460 lesions (1137 patients) were treated with DCB. Of these, 136 lesions (114 patients) were enrolled for this registry. The mean age of the population was 68.1±9.7 years; 36.0% was diabetes mellitus and 50.9% with chronic kidney disease. Regarding the lesions characteristics, left anterior descending artery was the most common (35.3%) and the lesion complexity was high (type B2/C lesions: 85.3%). For these lesions, DCB inflation (diameter: 2.74±0.45 mm, length: 32.3±6.5 mm) was performed and DES implantation was subsequently required due to bailout for dissection (36.8%) and residual stenosis (63.2%). The majority of DES implanted was Xience (Boston Scientific, Natick, MA, USA) (41.9%), followed by SYNERGY (Boston Scientific, Marlborough, MA, USA) (16.9%). The median follow-up period was 804 (IQR: 378-1655) days. The cumulative rate of TLF estimated with Kaplan-Meier method was 4.0% at 1 year, and 16.4% at 2 year, which was mainly driven by TLR (4.0% at 1 year, 16.4% at 2 year, respectively). There were no occurrences of target vessel MI and definite/probable stent thrombosis.
The clinical outcomes of DES implantation for bailout of suboptimal results after DCB were acceptable at 2-year follow-up. TLR rate gradually increased during follow-up. Further investigations with larger number of cases and long-term follow-up are required to confirm the results from this registry.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery