A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan

Abstract

ClinicalTrials.gov, number NCT01844284.

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

“…Recently, bioresorbable vascular scaffolds (BRS) were introduced, which provide temporary vessel scaffolding with drug delivery capacity but do not carry the limitations of a permanent metallic stent in the long term [8,9]. Prospective studies demonstrated BRS safety and efficacy on selected patients [10][11][12], but some studies have reported increased ST rates [13][14][15][16][17][18][19]. However, data on a large sample of ACS patients are still lacking [15,17,[20][21][22][23][24], and only few studies have evaluated the impact of lesion preparation and postdilatation of BRS [25][26][27].…”

Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease?

“…The investigators reported a similar rate of stent thrombosis (1.5%) in both groups (89). In ABSORB China a total of 480 patients were randomized to be implanted with everolimus-eluting An interesting study compared BRS (ABSORB) with second-generation metal drug eluting stent in 100 complex lesions treated under OCT guidance (92).…”

“…Two interesting studies have reported recently: ABSORB Japan and ABSORB China (89,90). The studies were designed to enable approval of the BRS in Japan and China.…”

“…The studies were designed to enable approval of the BRS in Japan and China. The ABSORB Japan study was a prospective, multicenter, randomized clinical trial, which included 400 patients undergoing everolimus-eluting bioresorbable stent (ABSORB) or everolimus-eluting metallic stent (Xience) implantation in 38 investigational site in Japan (89). The ABSORB arm included 56% type B2 and 20% type C coronary lesions according ACC/AHA classification.…”

Overlapping meta-analyses of bioresorbable vascular scaffolds versus everolimus-eluting stents: bringing clarity or confusion?

“…ABSORB Japan used a wide non-inferiority margin for the difference in 1-year TLF (8.6%), based on an agreement with the Japanese Pharmaceutical and Medical Device Agency, which resulted in a small sample size (N=400). The trial showed a 0.4% risk difference in 1-year TLF between BVSs and EESs (4.2% in the BVS group and 3.8% in the EES group), and the upper bound of the confidence interval was 4.0% (8). The sample size of Absorb Japan was sufficient to power a test of non-inferiority for late lumen loss at 13 months, using a 0.20 mm non-inferiority margin, which ultimately showed a difference of 0.01 mm (0.13±0.30 mm in the BVS group and 0.12±0.32 mm in the EES group), with a 0.06 mm upper bound of the 95% confidence interval.…”