Bioresorbable Vascular Scaffold Deployment Research Articles

299 3-Year results of STEMI patients treated with a pre-specified BVS implantation strategy: BVS SYTEMI strategy-it long term

Abstract Aims Data on Absorb bioresorbable vascular scaffold (BVS) use in patients presenting with ST-segment elevation myocardial infarction (STEMI) are limited. Furthermore, Absorb studies including STEMI patients lacked a prespecified implantation technique to optimize BVS deployment. To assess the 3-year clinical outcomes STEMI patients undergoing primary percutaneous coronary intervention (pPCI) with a pre-specified BVS implantation strategy. Methods and results BVS STEMI STRATEGY-IT (NCT02601781) included 505 STEMI patients undergoing pPCI with BVS following a dedicated implantation protocol. Device-oriented composite endpoint [(DOCE) cardiac death, ischemia-driven target lesion revascularization (ID-TLR) and target vessel myocardial infarction (TV-MI)] and scaffold thrombosis (ScT) at 3-year were evaluated. A subgroup analysis was performed on patients in whom dual antiplatelet therapy (DAPT) was continued 36 months after pPCI (‘longer-term DAPT’), and outcomes of this cohort compared to the remaining population (‘shorter-term DAPT’: <36 months) are also reported. Three-year DOCE and ScT rates were low (2.4% and 1.0%, respectively). In 319 (63.2%) patients DAPT was continued 36 months after pPCI. DOCE rate was significantly lower in the longer- compared to shorter-DAPT group (HR: 0.29; 95% CI: 0.1–0.9; P = 0.03), driven by a lower rate of TV-MI (0% vs. 2.2%, P = 0.018). Significantly lower rate of ScT was observed in longer-DAPT group (0% vs. 2.7%, P = 0.007). Conclusions In STEMI patients undergoing pPCI, a strategy of optimized BVS implantation technique is associated with favourable DOCE and ScT rates at 3 year. DAPT extension up to 36 months further improves long-term clinical outcomes.

Bioresorbable vascular scaffolds versus everolimus-eluting stents: a biomechanical analysis of the ABSORB III Imaging substudy.

The Absorb bioresorbable vascular scaffold (BVS) has high rates of target lesion failure (TLF) at three years. Low wall shear stress (WSS) promotes several mechanisms related to device TLF. We investigated the impact of BVS compared to XIENCE V (XV) on coronary WSS after device deployment. In the prospective, randomised, controlled ABSORB III Imaging study (BVS [n=77] or XV [n=36]), computational fluid dynamics were performed on fused angiographic and intravascular ultrasound (IVUS) images of post-implanted vessels. Low WSS was defined as <1 Pa. There were no differences in demographics, clinical risks, angiographic reference vessel diameter or IVUS minimal lumen diameter between BVS and XV patients. A greater proportion of vessels treated with BVS compared to XV demonstrated low WSS across the whole device (BVS: 17/77 [22%] vs XV: 2/36 [6%], p<0.029). Compared to XV, BVS demonstrated lower median circumferential WSS (1.73 vs 2.21 Pa; p=0.036), outer curvature WSS (p=0.026), and inner curvature WSS (p=0.038). Similarly, BVS had lower proximal third WSS (p=0.024), middle third WSS (p=0.047) and distal third WSS (p=0.028) when compared to XV. In a univariable logistic regression analysis, patients who received BVS were 4.8 times more likely to demonstrate low WSS across the scaffold/stent when compared to XV patients. Importantly, in a multivariable linear regression model, hypertension (beta: 0.186, p=0.023), lower contrast frame count velocity (beta: -0.411, p<0.001), lower post-stent residual plaque burden (beta: -0.338, p<0.001), lower % underexpanded frames (beta: -0.170, p=0.033) and BVS deployment (beta: 0.251, p=0.002) remained independently associated with a greater percentage of stented coronary vessel areas exposed to low WSS. In this randomised controlled study, the Absorb BVS was 4.8 times more likely than the XV metallic stent to demonstrate low WSS. BVS implantation, lower blood velocity and lower residual post-stent plaque burden were independently associated with greater area of low WSS.

Direct Absorb bioresorbable scaffold implantation in acute coronary syndrome.

Direct stent implantation is a preferred technique for primary percutaneous coronary intervention (PCI). For the deployment of a bioresorbable vascular scaffold (BVS), the current guidelines recommend aggressive predilatation. Data about direct BVS implantation in patients with acute coronary syndrome (ACS) are scarce. We sought to assess procedural characteristics and immediate outcomes of direct Absorb BVS implantation in ACS patients. A total of 91 patients with acute myocardial infarction (MI) requiring urgent coronary revascularisation were enrolled. Among them, 50 patients underwent an attempt of direct Absorb implantation. The control group consisted of 41 patients treated with PCI with BVS deployment after elective predilatation. In the direct group BVS deployment was successful in 91% of lesions, and in the remaining 9% of lesions direct implantation failed. In the control group scaffolds were successfully deployed after predilatation in 98% of lesions. In one case Absorb implantation failed even after balloon angioplasty. Type C lesions with severe tortuosity and angulation > 90° were associated with failure in direct Absorb deployment. Quantitative coronary analysis showed similar final percentages of diameter stenosis in the study and control groups. Flow analyses did not show significant differences between both methods. During hospitalisation no recurrent MI, scaffold thrombosis, or target lesion revascularisation was reported in either group. Direct Absorb implantation in ACS patients may be feasible in a suitable lesion anatomy.

Everolimus-eluting bioresorbable vascular scaffolds for treatment of complex chronic total occlusions.

Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO). The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score ≥2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73±0.43 mm. The mean scaffold length was 59.75±25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35±0.44 mm. Post-PCI minimal lumen diameter was 2.50±0.51 mm and percentage diameter stenosis 14.53±10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation. The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

Bioresorbable vascular scaffolds - basic concepts and clinical outcome.

The introduction of percutaneous treatment of coronary artery stenosis with balloon angioplasty was the first revolution in interventional cardiology; the advent of metallic coronary stents (bare and drug-eluting) marked the second and third revolutions. However, the latest generation of drug-eluting stents is limited by several factors. Permanent vessel caging impairs arterial physiology, and the incidence of very late stent thrombosis - although lower with the second generation than with the first generation of drug-eluting stents - remains a major concern. This complication is mainly related to the presence of permanent metallic implants, chronic degeneration triggered by an inflammatory response to the coating polymer, and/or adverse effects of antiproliferative drugs on endothelial regeneration. In 2011, self-degrading coronary stents - the bioresorbable vascular scaffolds (BVS) - were introduced into clinical practice, showing good short-term results owing to their adequate strength. The advantage of these devices is the transient nature of vascular scaffolding, which avoids permanent vessel caging. In this Review, we summarize the latest research on BVS, with a particular emphasis on the implantation technique (which is different from that used with metallic stents) to outline the concept that BVS deployment methods have a major effect on procedural success and prognosis of patients with coronary artery stenosis. Furthermore, the clinical outcome of BVS in randomized clinical trials and in phase IV studies are discussed in different pathophysiological settings, such as stable or acute coronary disease. Finally, all the available data on the safety profile of BVS regarding scaffold thrombosis are discussed.

TCTAP C-118 Unexpected Entrapment of Guidewire by Bioresorbable Vascular Scaffold Deployment at Calcified Coronary Lesion

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The duration of balloon inflation affects the luminal diameter of coronary segments after bioresorbable vascular scaffolds deployment.

BackgroundAdequate expansion is critical to achieve optimal Bioresorbable Vascular Scaffolds (BVS) apposition to the vessel wall. However, compared to metallic stents, BVS present different mechanical properties. Hence, slow deployment and maintenance of balloon inflation for at least 30” is recommended for BVS implantation. However, since no evidences are available demonstrating the superiority of a longer balloon dilatation time, the implantation technique is highly variable among different centers.MethodsA total of 24 BVS-treated lesions were included in the present analysis. After BVS deployment at 12 atmosphere (ATM) the balloon was rapidly deflated and scaffold expansion was documented with an angiogram. The same balloon was then inflated again and kept at 12 ATM for 30”. Finally, a further angiogram was obtained to evaluate BVS expansion. Quantitative coronary angiography (QCA) was performed at each step.ResultsA significant increase of minimal luminal diameter (MLD)-to-reference scaffold diameter (RSD) ratio (MLD to RSD Ration, MR-Ratio) from 0.70 ± 0.10 after initial stent deployment to 0.79 ± 0.10 after the 30”-long balloon dilation was observed (p < 0.001). Of note, this result was consistent across all sub-segments, as well as across almost all lesion subgroups. A substantial reduction in the prevalence of residual stenosis from 29 % to 17 % was registered after the 30”-long dilation.ConclusionsOur results strongly support the maintenance of balloon inflation for at least 30” during BVS deployment to achieve optimal scaffold expansion and minimize the occurrence of residual stenosis.Electronic supplementary materialThe online version of this article (doi:10.1186/s12872-015-0163-5) contains supplementary material, which is available to authorized users.

Short-term outcomes in patients with acute coronary syndrome treated with direct bioresorbable scaffold deployment.

Direct coronary stenting is a validated therapeutic option for coronary lesions. We studied the feasibility of direct deployment with a bioresorbable vascular scaffold (BVS) in acute coronary syndrome (ACS). Demographic, procedural, and survival data were obtained for patients who had direct scaffold deployment with BVS from 1 May 2013 to 1 April 2014. We performed a retrospective review of nine patients which included eight patients having ST-elevation myocardial infarction. There were no cases of worsening coronary flow, scaffold thrombosis, target lesion revascularization or death up to 30 days post intervention. Direct BVS deployment in ACS appears safe and feasible.