Author + information
- Wan Azman Wan Ahmad1,
- Takaharu Nakayoshi2,
- Ahmad Syadi Mahmood Zuhdi3,
- Yasushi Ino4,
- Takashi Kubo4,
- Takashi Akasaka4 and
- Takafumi Ueno5
Recent clinical trials raised concerns about the safety and the efficacy of bioresorbable Vascular Scaffolds (BVS; ABSORBTM). We reported the 4-month vascular healing comparing to bioabsorbable polymer-coated everolimus-eluting stents (BP-EES; SYNERGY™) at TCT2016. The aim of the ENHANCE study was to compare the vascular healing on the BP-EES versus BVS at 4- and 12-month follow-up.
This is a prospective, non-randomized, single center clinical trial. 13 eligible subjects with multi-vessel-disease were enrolled and deployed in the same patient and on the same time, but in different coronary vessels. Vascular healing was assessed via optical coherence tomography (OCT) and coronary angioscopy to estimate the intra-coronary condition at 4-month and 12-month.
Imaging-follow-up was completed in 11 patients at 12 month. The condition of neointimal coverage was similar between the two groups by OCT at 4-month and 12-month. Intra-stent thrombus was significantly higher in the BVS groups, but thrombus volume was very small at 4 month, which were similar tendency at 12 month follow-up. Angioscopy showed red-thrombus and yellow-plaque more frequently in BVS than in BP-EES group (Thrombus: BP-EES: 33.3% vs. BVS: 81.8%, p =0.02) at 4 month. At 12-month follow-up, the rate of red thrombus in BVS decreased to 50.0%. However, thrombus was not detected in BP-EES. These findings indicate BVS still had instability up to 12 month compared to BP-EES.
Comparing with BP-EES, vascular healing of BVS after deployment was significantly different and was not completed at 12 months follow-up.
CORONARY: Bioresorbable Vascular Scaffolds