Pannipa Suwannasom

Possible mechanical causes of scaffold thrombosis: Insights from case reports with intracoronary imaging

The advent of intracoronary stents has greatly increased the safety and applicability of percutaneous coronary interventions. One of the drawbacks of drug-eluting stents (DES) is the increased risk of late and very late stent thrombosis (ST). It was anticipated that the risks of ST after DES implantation would be solved with the advent of fully biodegradable scaffolds, which offer the possibility of transient scaffolding of the vessel to prevent acute vessel closure and recoil while also transiently eluting an antiproliferative drug to counteract constrictive remodelling and excessive neointimal hyperplasia. In spite of the enthusiasm for the concept of bioresorbable scaffolds, current clinical data on the Absorb bioresorbable vascular scaffold (BVS) have generated concerns about scaffold thrombosis (ScT) in both the early and late phases. However, the causes of ScT in both the early and late phases have yet to be fully elucidated. This article seeks to provide insights into the possible mechanical causes of ScT in the early and late phases with data stemming from intracoronary imaging (intravascular ultrasound and optical coherence tomography) of the currently published ScT cases following the implantation of BVS and reviews the practical recommendations for implantation of the BVS made by a group of experts.

Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent.

OBJECTIVES This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. METHODS In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise. RESULTS Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002). CONCLUSIONS There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).

Development and Receding of a Coronary Artery Aneurysm After Implantation of a Fully Bioresorbable Scaffold

A 83-year-old man included in the ABSORB cohort B trial underwent successful percutaneous coronary intervention of the middle left anterior descending artery with a 3.0×18-mm bioresorbable scaffold (Absorb, Abbott Vascular, CA) that was postdilated with a 3.0-mm noncompliant balloon at 24 atm (Figure 1A and 1B). The 2-dimensional and 3-dimensional (3D) optical coherence tomography (OCT) confirmed the absence of structural discontinuity after the procedure (Figure 2B and Figure 3A’). At 6 months, the planned angiography showed the absence of restenosis but an ectasia in the scaffolded segment (Figure 1C). Intravascular ultrasound revealed a focal vessel and lumen enlargement (17.93 mm2 [Δ+20.5%] and 6.99 mm2 [Δ+9.6%], respectively, in the matched cross-section analysis; Figure 2C), whereas 3D OCT suggested a deformation of the scaffold in the 2-mm segment of the ectasia (Figure 3B’). At 18 months, the planned multislice computed tomography showed lumen dilatation in the scaffolded segment (Figure 1D). At 2 years, on angiography, the ectatic lesion in the scaffold became aneurysmal (50% increase compared with the …

Single or dual antiplatelet therapy after PCI

The optimal duration and type of antiplatelet therapy after implantation of a drug-eluting stent (DES) remains uncertain. At the time of the first-in-man implantation of the sirolimus DES in 1999, the protocol-defined dual antiplatelet therapy (DAPT) duration was only 2 months. Subsequently, DAPT duration was extended to 1 year on the basis of anecdotal historical data, and this practice was then incorporated into clinical guidelines. For >1 decade, trialists have sought to compare the safety and efficacy of abbreviated (<6 months) and prolonged (>12 months) DAPT regimens. However, the body of evidence is limited by the heterogeneity of end points, time of randomization, and bleeding criteria used in each trial. Pharmaceutical advances led to the introduction of new ADP-receptor antagonists, which are thought to be more effective than clopidogrel. The ADP-receptor antagonists moved the focus from the optimal duration of DAPT to the potential efficacy of single antiplatelet therapy after DES implantation. In this Review, we summarize the current evidence on the duration of DAPT and the risk of bleeding and adverse cardiac events after DES implantation, and describe the pitfalls of trial interpretation. The ongoing, prospective trials to test single antiplatelet therapy after DES implantation are also discussed.

Is quantitative coronary angiography reliable in assessing the lumen gain after treatment with the everolimus-eluting bioresorbable polylactide scaffold?

AIMS The current study aimed to assess the difference in lumen dimension measurements between optical coherence tomography (OCT) and quantitative coronary angiography (QCA) in the polymeric bioresorbable scaffold and metallic stent. METHODS AND RESULTS In the randomised ABSORB Japan trial, 87 lesions in the Absorb arm and 44 lesions in the XIENCE arm were analysed. Post-procedural OCT-QCA lumen dimensions were assessed in matched proximal/distal non-stented/non-scaffolded reference (n=199), scaffolded (n=145) and stented (n=75) cross-sections at the two device edges using the Bland-Altman method. In the non-stented/non-scaffolded reference segments, QCA systematically underestimated lumen diameter (LD) compared with OCT (accuracy, -0.26 mm; precision, 0.47 mm; 95% limits of agreement as a mean bias±1.96 standard deviation, -1.18-0.66 mm). When compared to OCT, QCA of the Absorb led to a more severe underestimation of the LD (-0.30 mm; 0.39 mm; -1.06-0.46 mm) than with the XIENCE (-0.14 mm; 0.31 mm; -0.75-0.46 mm). QCA underestimated LD by 9.1%, 4.9%, and 9.8% in the reference, stented, and scaffolded segments, respectively. The protrusion distance of struts was larger in the Absorb arm than in the XIENCE arm (135±27 µm vs. 18±26 µm, p<0.001), and may have contributed to the observed differences. CONCLUSIONS In-device QCA measurement was differently affected by the presence of a metallic or polymeric scaffold, a fact that had a significant impact on the QCA assessment of acute gain and post-procedural minimum LD.

Edge Vascular Response After Resorption of the Everolimus-Eluting Bioresorbable Vascular Scaffold - A 5-Year Serial Optical Coherence Tomography Study.

BACKGROUND The edge vascular response (EVR) has been linked to important prognostic implications in patients treated with permanent metallic stents. We aimed to investigate the relationship of EVR with the geometric changes in the everolimus-eluting bioresorbable scaffold using serial optical coherence tomography (OCT) analysis. METHODSANDRESULTS In the first-in-man ABSORB trial, 28 patients (29 lesions) underwent serial OCT at 4 different time points (Cohort B1: post-procedure, 6, 24, and 60 months [n=13]; Cohort B2: post-procedure, 12, 36, and 60 months [n=15]) following implantation of the scaffold. In Cohort B1, there was no significant luminal change at the distal or proximal edge segment throughout the entire follow-up. In contrast, there was a significant reduction of the lumen flow area (LFA) of the scaffold between post-procedure and 6 months (-1.03±0.49 mm(2)[P<0.001]), whereas between 6 and 60 months the LFA remained stable (+0.31±1.00 mm(2)[P=0.293]). In Cohort B2, there was a significant luminal reduction of the proximal edge between post-procedure and 12 months (-0.57±0.74 mm(2)[P=0.017]), whereas the lumen area remained stable (-0.26±1.22 mm(2)[P=0.462]) between 12 and 60 months. The scaffold LFA showed a change similar to that observed in Cohort B1. CONCLUSIONS Our study demonstrated a reduction in the scaffold luminal area in the absence of major EVR, suggesting that the physiological continuity of the lumen contour is restored long term. (Circ J 2016; 80: 1131-1141).

Functional Evaluation of Coronary Disease by CT Angiography.

In recent years, several technical developments in the field of cardiac computed tomography (CT) have made possible the extraction of functional information from an anatomy-based examination. Several different lines have been explored and will be reviewed in the present paper, namely: 1) myocardial perfusion imaging; 2) transluminal attenuation gradients and corrected coronary opacification indexes; 3) fractional flow reserve computed from CT; and 4) extrapolation from atherosclerotic plaque characteristics. In view of these developments, cardiac CT has the potential to become in the near future a truly 2-in-1 noninvasive evaluation for coronary artery disease.

Change in lumen eccentricity and asymmetry after treatment with Absorb bioresorbable vascular scaffolds in the ABSORB Cohort B trial: a five-year serial optical coherence tomography imaging study.

AIMS The aim of the study was to investigate long-term changes in lumen eccentricity and asymmetry at five years after implantation of the Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS Out of 101 patients from the ABSORB cohort B trial, 28 patients (29 lesions) with serial optical coherence tomography (OCT) examination at four different time points (cohort B1: post-procedure, six months, two, and five years [n=13]; cohort B2: post-procedure, one, three, and five years [n=16]) were evaluated. The longitudinal variance in lumen diameter was assessed by asymmetry index (AI). An asymmetric lesion was defined as AI >0.3. The circularity of the lumen or scaffold was evaluated by the eccentricity index calculated as minimal divided by maximal luminal or scaffold diameter per cross-section. The lowest lumen eccentricity index within a scaffold segment (EIL) <0.7 was defined as an eccentric lesion. Post procedure, an eccentric lesion was observed in 72.4% and became concentric in 93.1% at five years (post EIL 0.67±0.05 vs. five-year EIL 0.80±0.10, p=0.03) with a modest reduction of the lumen area from baseline to five years by 0.75±0.32 mm2. Asymmetric lumen morphology was observed in 93.1% (n=27) post implantation and persisted until five-year follow-up. On serial OCT analyses, there was a substantial increase in the scaffold EI during the first two years (post 0.70±0.06, six months 0.76±0.08, two years 0.85±0.07); then, it remained stable whereas the lumen circularity improved further. There were no significant differences in major adverse cardiac events regarding the lumen morphology over the five-year follow-up. CONCLUSIONS In patients treated with the Absorb BVS, the cross-sectional circularity improved over five years while the variance in longitudinal diameters remained. Regaining of lumen circularity is mainly caused by reshaping of the scaffold during the first two years.

Intracoronary optical coherence tomography: Clinical and research applications and intravascular imaging software overview

By providing valuable information about the coronary artery wall and lumen, intravascular imaging may aid in optimizing interventional procedure results and thereby could improve clinical outcomes following percutaneous coronary intervention (PCI). Intravascular optical coherence tomography (OCT) is a light‐based technology with a tissue penetration of approximately 1 to 3 mm and provides near histological resolution. It has emerged as a technological breakthrough in intravascular imaging with multiple clinical and research applications. OCT provides detailed visualization of the vessel following PCI and provides accurate assessment of post‐procedural stent performance including detection of edge dissection, stent struts apposition, tissue prolapse, and healing parameters. Additionally, it can provide accurate characterization of plaque morphology and provides key information to optimize post‐procedural outcomes. This manuscript aims to review the current clinical and research applications of intracoronary OCT and summarize the analytic OCT imaging software packages currently available.

Quantification by optical coherence tomography imaging of the ablation volume obtained with the Orbital Atherectomy System in calcified coronary lesions

AIMS Recently, favourable procedural 30-day and one-year outcomes with the Diamondback 360 Orbital Atherectomy System (OAS) in the treatment of severely calcified lesions have been reported. The purpose of this study was to assess the therapeutic mechanism and efficacy of the OAS with optical coherence tomography (OCT) imaging. METHODS AND RESULTS This was an observational imaging study in 18 patients with complex calcified coro-nary artery lesions who underwent percutaneous coronary intervention with the OAS. Pre-OAS and post-OAS OCT analyses demonstrated that the minimum lumen area (MLA) increased from 2.07±0.66 mm2 to 2.38±0.68 mm2 with a lumen volume increase of 9.68±17.22 mm3 in the ablated segment with a length of 30.7±13.1 mm. The maximal vessel injury (dissection) involved the intima in 39% and the media in 6% of the study population. To eliminate the influence of post-OAS vasoconstriction, the ablation area was measured with the interpolated original lumen surface by comparing the endoluminal border of the pre-OAS image. The ablation area at the maximal ablated cross-section was 0.55±0.41 mm2, and the ablation volume by OAS was 2.68±2.80 mm3. CONCLUSIONS OAS effectively ablated coronary calcified tissue with some degree of intimal dissection. OCT imaging can be used to assess the total ablation volume after orbital atherectomy.