Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score

Ortega‐Paz, Luis; Capodanno, Davide; Gori, Tommaso; Nef, Holger; Latib, Azeem; Caramanno, Giuseppe; Mario, Carlo Di; Naber, Christoph; Lesiak, Maciej; Capranzano, Piera; Wiebe, Jens; Mehilli, Julinda; Araszkiewicz, Aleksander; Pyxaras, Stylianos A.; Mattesini, Alessio; Geraci, Salvatore; Naganuma, Toru; Colombo, Antonio; Münzel, Thomas; Sabaté, Manel; Tamburino, Corrado; Brugaletta, Salvatore

doi:10.4244/eij-d-16-00974

Cited by 121 publications

(99 citation statements)

References 28 publications

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“…This is not equally true in the setting of scaffold, where a careful implantation with some tips and tricks could significantly change the long-term performance. It J Thorac Dis 2017;9(Suppl 9):S887-S897 jtd.amegroups.com Table 1 Sample study characteristics 79 [23] 80 [48] 281 [21] 142 [20] 78 [33] 84 [35] 29 [21] 53 [20] 22 [23] 47 22 [7] 40 [24] 416 [31] 224 [32] 60 [25] 55 [23] 48 [36] 96 [36] 18 [19] 14 [15] 13 [16] 17 [22] 153 [17] 171 [18] Hypertension 48 [14] 93 [56] 150 [22] 282 [21] 38 [16] 40 [17] 32 [23] 42 [16] 3 [3] 2 [2] 14 [18] 11 [14] 172 [19] 166 [18] Previous PCI [%]…”

Section: Discussionmentioning

confidence: 99%

“…5 [1] 14 [8] / / 19 [8] 23 [10] 7 [5] 9 [3] 3 [3] 4 [4] 25 [32] 25 [31] 184 [20] 42 [23] 106 [29] 218 [31] 363 [26] 61 [24] 49 [20] 36 [26)…”

Section: Discussionmentioning

confidence: 99%

“…63 [23] 41 [42] 34 [36] 21 [19] 24 [25] 318 [26] 298 [24] RCA [%] 56 [31] 95 [26] 194 [27] 404 [29] 59 [23] 63 [25] 43 [31) 85 [31] 13 [13] 17 [18] 40 [36] 24 [25] 348 [29] 401 [32] Clinical 16 [20] 13 [17] 192 [21] 185 [20] UA [%] 37 [22] 68 [30] 168 [25] 355 [27] 152 [64] 154 [65] 22 [16] 26 [10] …”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: systematic review and meta-analysis of randomized clinical trials

Pavasini¹,

Serenelli²,

Gallo³

et al. 2017

J. Thorac. Dis.

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randomized clinical trials (RCT) comparing the Absorb BVS versus durable polymer cobalt-chromium Everolimus Eluting Stent. The outcomes analysed were all-cause mortality, cardiac death, ischemia-driven target lesion revascularization, target vessel myocardial infarction (MI), target lesion failure (TLF)/device oriented composite endpoints (DOCE), and device thrombosis. Fixed-effect meta-analysis was performed. Data were expressed as odds ratio (OR). Results

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Section: Discussionmentioning

confidence: 99%

“…5 [1] 14 [8] / / 19 [8] 23 [10] 7 [5] 9 [3] 3 [3] 4 [4] 25 [32] 25 [31] 184 [20] 42 [23] 106 [29] 218 [31] 363 [26] 61 [24] 49 [20] 36 [26)…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: systematic review and meta-analysis of randomized clinical trials

Pavasini¹,

Serenelli²,

Gallo³

et al. 2017

J. Thorac. Dis.

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“…Recently, Ortega-Paz et al published an analysis from the GHOST-EU registry (14), trying to evaluate scaffold implantation by three different scoring model and finding significantly incidence reduction of device oriented composite outcome (DOCE) with fewer cases of definite/ probable scaffold thrombosis in patients in which optimal scaffold implantation was performed compared to those in which there was suboptimal implantation process, highlighting again the importance of a rigorous and accurate approach to scaffold implantation.…”

Section: Discussionmentioning

confidence: 99%

The impact of the 3-year ABSORB II trial results on my clinical practice: an Italian survey

Serenelli¹,

Biscaglia²,

Tonet³

et al. 2017

J. Thorac. Dis.

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Background: To evaluate how the 3-year results from the "A clinical evaluation to compare the safety, efficacy and performance of ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) 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) trial have influenced clinical practice among Italian interventional cardiologists.Methods: We performed a survey among 95 interventional cardiologists sending a brief questionnaire by electronic mail. We collected 65 replies and analysed the data.Results: The opinion of the operators regarding the two main endpoints of the study ABSORB II was conflicting. However, 66% of the operators considered at least one of the two co-primary endpoints (late lumen loss or vasomotion) unreliable and not reflecting clinical practice. Asking about an explanation for the negative results of the study, we found that the 91% of the operators considered the implantation technique the main limit of the ABSORB II. Furthermore, 74% of the operators affirmed that the results from the study did not decrease the number of scaffold implanted in their cath-lab.Conclusions: Absorb II trial did not influence clinical practice among Italian interventional cardiologists mainly due to the overall idea that the co-primary endpoints were not adequate to provide a robust evidence on device clinical safety and also because the lack of experience on device implantation may have influenced the outcomes.

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“…A specific interventional strategy with adequate lesion preparation and the systematic scaffold post-dilatation may be required to guarantee an optimal scaffold implantation (5). In this context, use of different imaging techniques has been strongly suggested…”

Section: Introductionmentioning

confidence: 99%

Methods to assess bioresorbable vascular scaffold devices behaviour after implantation

et al. 2017

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Bioresorbable vascular scaffolds (BRS) represent a novel approach for coronary revascularization offering several advantages as compared to current generation DES, potentially reducing rate of late adverse events and avoiding permanent vessel caging. Nevertheless, safety concerns have been raised for an increased risk of scaffold thrombosis (ScT) in both early and late phases, probably related to a suboptimal scaffold implantation. In this context, the use of different imaging methodologies has been strongly suggested in order to guarantee an optimal implantation. We herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up. J Thorac Dis 2017;9(Suppl 9):S959-S968 jtd.amegroups.com for BRS implantation in order to confirm optimal scaffold expansion, to exclude edge dissections, struts malapposition or underexpansion. Furthermore, imaging technique may evaluate at follow-up scaffold reabsorption and vessel changes over time. Keywords: Scaffold; intravascular ultrasound (IVUS); echogenicity; virtual histology-IVUS (VH-IVUS); optical coherence tomography (OCT); multislice coronary tomography (MSCT)SubmittedWe herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up. Quantitative coronary angiography (QCA)Coronary angiography is the most important method for assessing BRS implantation. As well as for conventional stent, at least two different projections with at least 30° difference for the right coronary artery and 3 different projections with at least 30° difference for the left coronary artery must be acquired before and after BRS implantation. The treated segment and the 5 mm proximal and distal to scaffold edges should be analyzed. As the bioresorbable devices are radiolucent, the QCA analysis may be performed visualizing the metallic markers of the scaffold.The following parameters can be measured. Acute recoilIt is defined as the difference between the mean diameter of the BRS delivery balloon (or, in case of post-dilatation, mean diameter of post-dilatation balloon) at the highest pressure and the mean lumen diameter (MLD) of the stented segment after balloon deflation. It can be expressed as absolute or relative value. The acute recoil is an important parameter in relation to the success of a PCI in acute and long-time period, as it has a direct impact on minimum stent area (MSA). A MSA less than 5.0 mm 2 is associated with high probability of in-stent restenosis (6).T h e a c u t e r e c o i l o f A b s o r b B V S 1 . 1 ( A b b o t t Laboratories, Abbott park, Illinois, USA) in the Absorb Cohort B trials and DESolve Nx BRS (Elixir Medical, Sunnyvale, California, USA) were 6.7%±6.4% and 6.4%±4.6%, respectively (7,8). These values are not dissimilar to those of metallic stent, showed in a Japanese study of 154 lesions comparing the biolimus eluting stent (Nobori stent, Terumo, Tokyo, Japan), cobalt chromium everolimus eluting stent (Xience V stent, Abbott Vascular, Santa Clara, CA, USA) and pl...

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Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score

Abstract: At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.

Cited by 121 publications

References 28 publications

Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: systematic review and meta-analysis of randomized clinical trials

Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: systematic review and meta-analysis of randomized clinical trials

The impact of the 3-year ABSORB II trial results on my clinical practice: an Italian survey

Methods to assess bioresorbable vascular scaffold devices behaviour after implantation

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