Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)

Ishibashi, Yutaka; Nakatani, Shimpei; Sotomi, Yohei; Suwannasom, Pannipa; Grundeken, Maik J.; García‐García, Héctor M.; Bartorelli, Antonio L.; Whitbourn, Robert; Chevalier, Bernard; Abizaid, Alexandre; Ormiston, John A.; Rapoza, Richard; Veldhof, Susan; Onuma, Yoshinobu; Serruys, Patrick W.

doi:10.1016/j.jcin.2015.07.026

Cited by 52 publications

(39 citation statements)

References 17 publications

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“…Conversely, a recent study also reported that implantation of an oversized bioresorbable scaffold in a relatively small vessel appeared to be associated with a higher 1-year adverse event rate, 36 which is inconsistent with our results with metallic DES. It is reasonable that proper implantation methods may vary according to the design and material of device.…”

Section: Long-term Outcomescontrasting

confidence: 99%

Impact of Stent Size Selection on Acute and Long-Term Outcomes After Drug-Eluting Stent Implantation in De Novo Coronary Lesions

Kitahara

Okada

Kimura

et al. 2017

Circ: Cardiovascular Interventions

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In the bare-metal stent era, numerous studies have shown a strong association between small final stent dimensions at post-deployment and in-stent restenosis at follow-up, 1-3 which led to the so-called bigger-is-better strategy for bare-metal stent optimization. After the introduction of drug-eluting stents (DES), several studies have consistently demonstrated that DES have considerably lower optimal thresholds of final stent dimensions to predict subsequent restenosis because of significant suppression of neointimal proliferation within the stent. 4 Combined with the fact that some early DES trials demonstrated a relatively high incidence of restenosis at the stent edge segment, the stenting procedure in the DES era has changed from the aggressive to the adequate strategy. In clinical settings, however, final stent expansion often fails to meet expected stent dimensions after DES implantation. 5 Furthermore, there is compelling clinical evidence that significant stent undersizing of DES often ends up with suboptimal results, particularly stent underexpansion, which can lead to adverse clinical events, such as restenosis and stent thrombosis. [6][7][8] Therefore, selection of proper device size relative to the target vessel may be considered as important as postdeployment optimization strategy. Recently, the importance of accurate device sizing has also gained further attention due to the introduction of bioresorbable scaffold technology into the clinical arena because polymer-based devices cannot be overly dilated after implantation.At the other end of this spectrum, however, potential effects of oversized stent implantation on arterial wall injury and vascular response have not been systematically evaluated. Thus, the aim of this study was to investigate the impact of stent oversizing on acute and long-term outcomes after DES implantation in de novo coronary lesions.Background-Although significant undersizing often results in incomplete stent apposition or underexpansion, the possible impact of oversized stent implantation on arterial wall injury has not been systematically investigated with drug-eluting stents. The aim of this study was to investigate the impact of stent oversizing on acute and long-term outcomes after drugeluting stents implantation in de novo coronary lesions. Methods and Results-Serial (baseline and 6-12 months) coronary angiography and intravascular ultrasound were performed in 2931 lesions treated with drug-eluting stents (355 sirolimus, 846 paclitaxel, 1387 zotarolimus, and 343 everolimus). The percentage of stent oversizing to angiographic reference vessel diameter (RVD) was calculated as (nominal stent diameter-RVD)/RVD×100 (%). Clinical outcomes, including target lesion revascularization and stent thrombosis, were followed for 1 year. Overall, smaller preintervention RVD was associated with higher percentage of stent oversizing (P<0.001). The significant oversizing group underwent less post-dilatation (P=0.002) but achieved greater stent expansion (P<0.001) and less incomplete stent...

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Section: Long-term Outcomescontrasting

confidence: 99%

Impact of Stent Size Selection on Acute and Long-Term Outcomes After Drug-Eluting Stent Implantation in De Novo Coronary Lesions

Kitahara

Okada

Kimura

et al. 2017

Circ: Cardiovascular Interventions

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“…The incidence of MI was low, probably due to inclusion of periprocedural events only. In a recent meta-analysis [28] patients treated with BVS implantation had a similar risk of myocardial infarction (OR = 1.36, 95% CI: 0.98–1.89; p = 0.06) and death (OR = 0.95, 95% CI: 0.45–2.00; p = 0.89) but with higher risk of define/probable ScT (OR = 1.99, 95% CI: 1.00–3.98; p = 0.05), especially between 1 and 30 days after implantation (OR = 3.11, 95% CI: 1.24–7.82; p = 0.02) as compared to the metallic stent group [28]. However, Cassese et al did not evaluate target vessel myocardial infarction (TVMI), which was significantly higher for BVS in comparison to conventional stents in data presented in two other meta-analyses [26, 29, 30].…”

Section: Discussionmentioning

confidence: 99%

Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

Rzeszutko¹,

Tokarek²,

Siudak³

et al. 2016

pwki

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IntroductionThere are limited data on the comparison of bioresorbable vascular scaffold (BVS) and drug-eluting stent (DES)/bare-metal stent (BMS) implantation in an unselected population of patients with coronary artery disease.AimTo compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry.Material and methodsA total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA), DES or BMS (all available types) implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA) or acute coronary syndrome were collected.ResultsBioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; p = 0.001) and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; p = 0.001 for both). The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; p = 0.02), but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; p = 0.01), and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394–18.906; p = 0.001).ConclusionsPatients treated with BVS implantation presented an acceptable safety and efficacy profile in comparison with the DES/BMS group. However, lower risk patients were the most frequent candidates for BVS implantation.

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“…Interestingly, in ABSORB EXTEND, systematic postdilatation did not emerge as a significant treatment modifier . Differently, in an expanded cohort that mostly included patients from ABSORB EXTEND, implantation of an oversized BVS in a relatively small vessel appeared to be associated with a higher 1‐year rate of combined ischemic events, driven by more frequent early MI . In a propensity score matched analysis of BVS and EES, including all patients from ABSORB EXTEND, BVS were associated with comparable rates of TLF and numerically albeit nonsignificantly higher rates of scaffold thrombosis (1.0% vs. 0.3%) compared with EES (Abizaid A, presented at EuroPCR 2015).…”

Section: Multicenter Registriesmentioning

confidence: 83%

Update on clinical evidence (Part II): A summary of the main post market studies

Tamburino

Capranzano

Francaviglia

et al. 2016

Cathet Cardio Intervent

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Bioresorbable vascular scaffolds (BVS, Absorb, Abbott Vascular, Santa Clara, CA) received the CE mark in October 2011, and were approved by the Food and Drug Administration in July 2016. After their introduction in clinical practice a broad amount of post‐marketing clinical experience with BVS has been generated so far in Europe and outside the United States. The available BVS registries differ in many aspects, including their being single‐center or multicenter, single‐arm or controlled, sponsored or investigator‐initiated, published or presented at a large‐scale international meeting. This article provides an overview of clinical results of the main post‐marketing studies of BVS available. © 2016 Wiley Periodicals, Inc.

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Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)

Cited by 52 publications

References 17 publications

Impact of Stent Size Selection on Acute and Long-Term Outcomes After Drug-Eluting Stent Implantation in De Novo Coronary Lesions

Impact of Stent Size Selection on Acute and Long-Term Outcomes After Drug-Eluting Stent Implantation in De Novo Coronary Lesions

Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

Update on clinical evidence (Part II): A summary of the main post market studies

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