RESUMO
Objectives: The 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 methods: A 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. Results: The 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. Conclusion: The 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.
RESUMO
BACKGROUND: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. METHODS: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. FINDINGS: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. INTERPRETATIONS: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. FUNDING: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.
