First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT

Fig. 1. DynamX bioadaptor. The DynamX bioadaptor is comprised of three cobalt-chromium helical strands (denoted in blue, green, yellow) that are temporarily linked together by unique uncaging elements and bioresorbable polymer coating. The polymer coating resorbs over six months and enables the separation of the helical strands from each other (small image). Used with the permission of Elixir Medical Corporation.

Fig. 2. Study Flow Chart. ∗As cardiovascular death is an endpoint, these two patients count into the analysis.

Fig. 3. Late lumen loss at12 months. Fq = frequency, LLL = late lumen loss.

Fig. 4. Neointimal hyperplasia and strut coverage by optical coherence tomographyat 12 months. Data are displayed as mean (SD). NIH = neointimal hyperplasia, ns = not significant, Vol = volume.

Fig. 5. Cyclic pulsatility assessment by intravascular ultrasound. The figures show no difference in % lumen area change measured by IVUS in the proximal vessel, all in-device segments and distal vessel during a cardiac cycle in DynamX versus Resolute Onyx groups post procedure, whereas at 12 month follow up, DynamX shows a significantly higher % change in all in-device segments (p < 0.001) during a cardiac cycle as compared to the Resolute Onyx indicating restoration of pulsatility in treated segments with DynamX (N = 48 paired data for the DynamX group; N = 47 paired data for the Resolute Onyx group). Immediately post-procedure (A), there was a statistically significant difference between the pulsatility of the proximal and distal vessel segments and the in-device segment in both groups (all p < 0.001), whereas at 12 months (B), the difference was not significant anymore with DynamX, but it remained a statistically significant compliance mismatch for Resolute Onyx. Data are displayed as mean (SD). Ns = not significant, prox. = proximal.

Fig. 6. Cyclic pulsatility assessment by optical coherence tomography. The graphs represent the in-device lumen area change and the device-area change at 12 months; both were statistically significant different amongst the groups (p < 0.001). Paired data of 9 patients in the DynamX and 9 patients in the Resolute Onyx group. Data are displayed as mean (SD).