Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography

Tudor C Poerner, Corinna Duderstadt, Björn Goebel, Daniel Kretzschmar, Hans R Figulla, Sylvia Otto, Tudor C Poerner, Corinna Duderstadt, Björn Goebel, Daniel Kretzschmar, Hans R Figulla, Sylvia Otto

Abstract

Background: Percutaneous 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 results: In 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.

Conclusions: FFR-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: NCT02120859.

Keywords: Drug-coated balloon; Drug-eluting balloon; Optical coherence tomography; PCI.

Figures

Fig. 1
Fig. 1
Patient flow chart of the different study phases
Fig. 2
Fig. 2
Example of a performed DCB-only PCI of the left anterior descending (LAD) artery with final PCI result showing an angiographically determined type B dissection (left) with complete resolution during re-angiography after 6 months (right-top). However, OCT imaging at 6-months f/u still reveals some minor dissections, which are illustrated with coronary plaque measurements in a spread-out vessel chart of the treated vessel segment (right-bottom)

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