Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design

Cortese, Bernardo; Ielasi, Alfonso; Varricchio, Attilio; Tarantini, Giuseppe; Lavecchia, L; Pisano, Francesco; Facchin, Michela; Gistri, Roberto; D’Urbano, Maurizio; Lucci, Valerio; Loi, Bruno; Tumminello, Gabriele; Colombo, Alessandro; Limbruno, Ugo; Nicolino, Annamaria; Calzolari, Diego; Tognoni, Gianni; Defilippi, G; Buccheri, Dario; Tespili, Maurizio; Corrado, Donatella; Steffenino, Giuseppe

doi:10.1016/j.carrev.2015.05.010

Cited by 12 publications

(10 citation statements)

References 17 publications

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“…The ScT rate after BVS delivery was also higher than for metallic stents in other “real-world” registries (3.0% in the AMC registry [23], 1.3% in the Registro Absorb Italiano registry [24] – preliminary data). However, the rate of ScT was not higher in the largest, most recent randomized controlled clinical trial [25]. Higher prevalence of thrombosis was reported in the first 30 days after implantation, similar to the frequency distribution for metallic stents [22].…”

Section: Discussionmentioning

confidence: 85%

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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Section: Discussionmentioning

confidence: 85%

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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“…SVD is a frequently encountered angiographic finding, involving up to 30% of patients treated by PCI . Both the definition of SVD and its optimal treatment remain a matter of debate.…”

Section: Discussionmentioning

confidence: 99%

Absorb bioresorbable vascular scaffold vs. everolimus‐eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD‐ABSORB studies

Tarantini

Masiero

Barioli

et al. 2018

Cathet Cardio Intervent

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“…The rationale and design of the RAI (Registry identified as NCT02298413 at http://clinicaltrials.gov) and the one‐year results were extensively described elsewhere . Briefly, RAI registry is an independent, prospective, multicenter, Italian data collection that enrolled 1,505 consecutive patients who underwent successful BVS implantation between October 2012 and December 2015.…”

Section: Methodsmentioning

confidence: 99%

One‐year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry

Moscarella

Ielasi

Varricchio

et al. 2018

Cathet Cardio Intervent

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Objectives To report 1‐year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. Background BVS use has rapidly extended to high‐risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. Methods RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1‐year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target‐lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1‐year follow‐up. Results Fifty‐nine percent of the patients presented with ACS, of whom 36.5% with ST‐elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in‐stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one‐year follow‐up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device‐oriented composite end‐point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). Conclusions Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

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Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design

Cited by 12 publications

References 17 publications

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

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

Absorb bioresorbable vascular scaffold vs. everolimus‐eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD‐ABSORB studies

One‐year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry

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