BackgroundPercutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please® balloon without stenting for elective PCI of de novo lesions.Methods and resultsIn 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: −0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment.ConclusionsFFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months.Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT02120859Electronic supplementary materialThe online version of this article (doi:10.1007/s00392-016-1019-4) contains supplementary material, which is available to authorized users.

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Coronary morphology and functional assessment (4) 483stent during PCI (9.93±7.48 vs. 5.06±4.76, p<0.001). There were 8 cases of TVR (5.1%) during follow-up period. Post-stent IBS was significantly greater in patients with TVR than those without (8.89±4.81 vs. 4.85±4.69, p=0.02), however, baseline IBS was not (11.30±8.67 vs. 9.85±7.44, p=0.58) (Figure). Conclusion: IBS was significantly reduced by PCI with stent implantation, and post-stent IBS was associated with TVR after PCI. Introduction: Intermediate coronary artery stenosis is frequently found in patients diagnosed for angina pectoris. Functional assessment like fractional flow reserve measurement (FFR) is convenient and well standardized method to confirm indication for revascularization. However, for economic reasons, FFR cannot be used routinely in every case. Aim: The aim of our study was to find and explore possible factors influencing the level of concordance between operators visual estimation and invasive functional assessment (FFR). Materials and methods: We investigated 262 consecutive patients, who had undergone functional invasive assessment of stenosis significance with fractional flow reserve in 356 coronary vessels. FFR measurements were made with PreassureWire during continuous intravenous infusion of adenosine. FFR value of 0,80 was used as a cut-off point for revascularization. Each lesion was independently assessed by 3 operators with different experience in PCI, blinded to FFR measurement results, who filled electronic questionnaire. Visual-functional concordance was measured with Cohens kappa coefficient. Results: Mean age of patients was 67,1 years (SD=10,1), 69,8% of patients were men. Main indication for coronary angiography was stable coronary artery disease (60,7% of cases). Measurements were predominantly performed in left anterior descending artery (57,9% of vessels), then in right coronary artery (17,1%) and left circumflex branch (15,7%). Median stenosis of vessels was 60% (IQR 50%; 70%). Median FFR value was 0,83 (IQR: 0,74; 0.89). Subgroup analysis showed no significant differences between patients with significant lesions and those without stenosis in terms of demographics and CAD risk factors profile. Visual-functional concordance was fair. Cohens kappa for 3 operators ranged from 0.297 in less experienced to 0.394 in the most experienced one. Concordance level varied also according to vessel analysed (figure 1. Background: Fractional flow reserve (FFR)-guided angioplasty using paclitaxelcoated balloons without stent implantation (DCB-only PCI) proved feasible and safe in the OCTOPUS-2 trial (NCT02120859). According to the study protocol, dissections were not stented, if postprocedural FFR was greater than 0.8 and no flow impairment was observed. Purpose: To evaluate the extent of residual dissections using the optical coherence tomography (OCT) recordings obtained at 6-month follow-up (f/u) and to compare them with the angiographic acute and 6-month results. Methods: Among 46 consecutive patients (pt) included in the tri...