Initial experience in the clinical use of everolimus-eluting bioresorbable vascular scaffold (BVS) in a single institution

Abstract

We read with great interest the recent review article on bioresorbable vascular scaffolds by Bourantas et al. and wish to share our institution's experience with the use of the ABSORB bioresorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, California) [1]. There is currently limited published data on the use of BVS in routine clinical practice andwehaveundertaken a prospective evaluation of this novel device in our institution. All consecutive patients who underwent percutaneous coronary intervention (PCI) with intent for BVS implantation between July 2011 and September 2012were included in the analysis. All patients received dual anti-platelet therapyprior to PCI and this therapywascontinued for at least a year after implantation. This study fulfilled local ethical requirements and written informed consent was obtained from all patients. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. Once a suitable lesion was identified, the pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary analysis (QCA) using the Pie Medical CAAS QCA (quantitative coronary analysis) package in our Xcelera Workstations (Philips Medical Systems, Veenpluis, The Netherlands). Alternative vessel sizing was via the use of commercially available intravascular ultrasound (IVUS) or optical coherence tomography (OCT). A RVD of 2.0 to 3.8 mm and a lesion length of less than 28 mm were considered suitable for BVS (single or overlapping). The availableABSORBBVSwere2.5×18 mm,2.5×28 mm, 3.0×18 mm, 3.0×28 mm, 3.5×12 mm, 3.5×18 mm, or 3.5×28 mm in size. 6 Fr vascular access was used in all patients with a predominant radial access (77.1%). Mandatory predilation with balloon angioplasty using a balloon with a diameter of 0.5 mm smaller or equivalent to the intended BVS size was performed prior to BVS implantation. Device deployment was performed at a rate of ≤2 atm per 5 s up to 16 atm (rated burst pressure). Postdilation was with a non-compliant balloon with diameter≤0.25 mm beyond the implanted BVS if necessary to avoid scaffold damage. For longer lesions or edge dissections, overlapping scaffolds were used. A total of 35 consecutive patients with 41 lesions underwent attempted ABSORB BVS implantation during the study period. Baseline emographics, indications, procedure and quantitative coronary angiography details are summarized in Table 1. The mean age is 54.7± 11.2 years (range 36–86 years) and 85.7% of the patients (n=30) were male. Diabetes mellitus (type I or II) was present in 17.1% (n=6) of the study population. 51.4% of patients presented with an acute coronary syndrome including unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI). Overall, 45 BVS were successfully implanted in 33 (93.3%) patients (1.4 BVS/patient). Of the 41 lesions treated, the success rate was 100% (22/22) for the left anterior descending artery (LAD), 100% (11/11) for the right coronary artery (RCA), and 75% (6/8) for the left circumflex artery (LCX). Two patients had circumflex (LCX) stenosis not crossable by the BVS despite aggressive lesion preparation with multiple balloon predilations. An equivalent metallic drug eluting stent crossed without difficulty in both cases. The majority, 31 (75.6%), of lesions treated were complex (B2 or C). Pre-procedure RVD was assessed by QCA in 28 patients (80.0%), IVUS in 4 patients (11.4%), andOCT in 3 patients (8.6%). Themeanpre-procedural RVDwas 2.7±0.4 mm, diameter stenosiswas 77.7±13.0%, and lesion lengthwas 17.2±6.7 mm. Post-procedural RVD was 3.0±0.3 mmwith residual diameter stenosis of 2.4±2.0%.