P5615A randomised study comparing FFR-guided paclitaxel-coated balloon angioplasty vs. drug-eluting bioresorbable scaffolds with 9 months invasive follow-up

Abstract

Abstract Background Elimination of a permanent metallic stent from standard PCI techniques is desirable since mid- and longterm adverse reactions are attributed to an intracoronary foreign body. Purpose To investigate two “metal-free” PCI techniques using either drug-coated balloons (DCB) or bioresorbable scaffolds (BRS) in stable coronary artery disease regarding their safety and efficacy (NCT02607241) and clinical course. Methods 59 patients (table 1) were prospectively randomized for elective PCI of de novo stenosis with either BRS implantation (N=28) or with DCB only angioplasty (N=31). The DCB only arm was treated by a previously implemented protocol including sequential balloon predilations and repetitive FFR (fractional flow reserve) measurements. Stenting was deferred if FFR was >0.80 and in the absence of flow-limiting dissections after final DCB dilatation. All BRS were post-dilated using a non-compliant balloon. All BVS were post-dilated (non-compliant balloon). Optical coherence tomography (OCT) was performed during index procedure and at 9-month f/u. Results Both groups were well balanced without significant differences in clinical characteristics (table 1). Procedural success was achieved in 89.3% in the BRS and 77.4% in the DCB group. Parameter of quantitative coronary angiography are shown in the table 2. The predefined primary end point (efficacy) net luminal gain was significantly larger in the DCB group (noninferiority t-Test, margin: 0.2mm, 80% power). Accordingly, the secondary endpoint late lumen loss indicated with −0.20±0.73 vessel enlargement at the stenotic site in the DCB group at 9-month f/u. Target lesion failure during 9-month f/u occurred much more in the BRS group (14.3% (N=4) vs. 3.2% (N=1), p=0.180) but did not reach significance in this small sample size. In detail, there were 2 scaffold thrombosis despite OCT-guided index procedure in the BRS group with subsequent myocardial infarction, and 2 restenosis in the BRS vs. 1 restenosis in the DCB group requiring repeat target lesion revascularization. Due to safety concerns of BRS and the worldwide recall of Absorb BRS the study was prematurely terminated. Conclusion Our data add evidence for FFR-guided “DCB only” PCI as an attractive, safe and feasible alternative by showing a favorable longterm course contrary to the late lumen loss of conventional coronary stents. The Absorb BRS is potentially harmful with a high percentage of target lesion failure including scaffold thrombosis despite OCT-guided implantation and should be avoided.