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2.
JACC Cardiovasc Interv ; 12(20): 2064-2075, 2019 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-31563682

RESUMO

OBJECTIVES: The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI. BACKGROUND: The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined. METHODS: All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value. RESULTS: A total of 968 vessels treated with PCI were screened. Post-PCI QFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurred at 2 years. The mean value of post-PCI QFR was 0.91 ± 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCI QFR <0.91 (n = 284) was significantly higher compared with vessels with post-PCI QFR ≥0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001). CONCLUSIONS: A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of-the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value ≥0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials.

3.
EuroIntervention ; 2019 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-31289016

RESUMO

AIMS: To assess acute performance of the 95-µm ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the Xience metallic drug-eluting stent (DES) in porcine coronary arteries. METHODS AND RESULTS: In 15 nonatherosclerotic Yucatan mini pigs, ArterioSorb in 3.0/14 mm and Xience in 3.0/15 mm were implanted in 25 and 15 vessels, respectively. Acute performance was evaluated by using quantitative coronary angiography (QCA) and optical coherence tomography (OCT). Following three-dimensional reconstruction of coronary arteries, endothelial shear stress (ESS) was quantified using non-Newtonian steady-flow simulation. Acute recoil measured by QCA was comparable in the two arms. Post-procedural flow and scaffold/stent area by OCT did not differ between the two devices. ESS post-procedure was comparable between ArterioSorb and Xience (2.21±1.97 vs. 2.25±1.71 Pa, p=0.314). CONCLUSIONS: Acute recoil, luminal dimensions and ESS in ArterioSorb oriented-PLLA scaffold with thin struts of 95 µm were comparable to Xience metallic DES.

4.
EuroIntervention ; 2019 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-31289018

RESUMO

The aim of this trial is to determine the superiority of on-line three-dimensional optical frequency domain imaging (3D-OFDI) guided percutaneous coronary intervention (PCI) to angiography-guided PCI in bifurcation lesions. The OPTIMUM trial is a randomized, active control, superiority, and multi-center clinical trial. The primary endpoint is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing-balloon-dilatation. A total 106 patients will be randomly allocated to either 3D-OFDI or angiography guidance PCI. OPTIMUM trial will be the first prospective, randomised trial and evaluate the efficacy and safety of the on-line 3D-OFDI guided PCI.

5.
EuroIntervention ; 15(6): e539-e546, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31217143

RESUMO

AIMS: The aim of this study was the external validation of the updated logistic clinical SYNTAX score for two-year all-cause mortality after PCI in the GLOBAL LEADERS trial. METHODS AND RESULTS: The GLOBAL LEADERS trial was an investigator-initiated, prospective randomised, multicentre, open-label trial comparing two strategies of antiplatelet therapy in 15,991 patients undergoing PCI. As a predefined analysis, we studied the first 4,006 consecutive patients enrolled between July 2013 and April 2014 for whom the anatomic SYNTAX scores were calculated by an independent core lab. The updated logistic clinical SYNTAX score was available in 3,271 patients. Patients were divided into quintiles according to the score. The C-statistic of the updated logistic clinical SYNTAX score for two-year all-cause mortality was 0.71 (95% confidence interval [CI]: 0.64-0.77). The updated logistic clinical SYNTAX score identified patients at very high risk for two-year all-cause mortality after PCI. Although it systematically overestimated two-year all-cause mortality, predicted and observed two-year all-cause mortality in the majority of the patients (four out of five quintiles) were in agreement. CONCLUSIONS: Overall discrimination for two-year all-cause mortality of the updated logistic clinical SYNTAX score is either borderline acceptable or possibly helpful. Calibration in the majority of patients is appropriate. The score is potentially useful in selecting enriched high-risk populations.


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Resultado do Tratamento
6.
Artigo em Inglês | MEDLINE | ID: mdl-31215995

RESUMO

AIMS: Scaffold design and plaque characteristics influence implantation outcomes and local flow dynamics in treated coronary segments. Our aim is to assess the impact of strut embedment/protrusion of bioresorbable scaffold on local shear stress distribution in different atherosclerotic plaque types. METHODS AND RESULTS: Fifteen Absorb everolimus-eluting Bioresorbable Vascular Scaffolds were implanted in human epicardial coronary arteries. Optical coherence tomography (OCT) was performed post-scaffold implantation and strut embedment/protrusion were analysed using a dedicated software. OCT data were fused with angiography to reconstruct 3D coronary anatomy. Blood flow simulation was performed and wall shear stress (WSS) was estimated in each scaffolded surface and the relationship between strut embedment/protrusion and WSS was evaluated. There were 9083 struts analysed. Ninety-seven percent of the struts (n = 8840) were well-apposed and 243 (3%) were malapposed. At cross-section level (n = 1289), strut embedment was significantly increased in fibroatheromatous plaques (76 ± 48 µm) and decreased in fibrocalcific plaques (35 ± 52 µm). Compatible with strut embedment, WSS was significantly higher in lipid-rich fibroatheromatous plaques (1.50 ± 0.81 Pa), whereas significantly decreased in fibrocalcified plaques (1.05 ± 0.91 Pa). After categorization of WSS as low (<1.0 Pa) and normal/high WSS (≥1.0 Pa), the percent of low WSS in the plaque subgroups were 30.1%, 31.1%, 25.4%, and 36.2% for non-diseased vessel wall, fibrous plaque, fibroatheromatous plaque, and fibrocalcific plaque, respectively (P-overall < 0.001). CONCLUSION: The composition of the underlying plaque influences strut embedment which seems to have effect on WSS. The struts deeply embedded in lipid-rich fibroatheromas plaques resulted in higher WSS compared with the other plaque types.

7.
EuroIntervention ; 2019 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-31062697

RESUMO

AIMS: DESSOLVE III OCT sub-study compared serially neointimal hyperplasia volume obstruction (%VO) between the thin strut MiStent with early polymer elimination and 9-month sustained drug release from microcrystalline sirolimus and the durable polymer coated everolimus-eluting Xience stent at 6 and 24 months after implantation. METHODS AND RESULTS: The efficacy endpoint was %VO calculated as abluminal neointimal volume/stent volume. Thirty-six patients (MiStent 16 patients, 16 lesions, Xience 20 patients, 22 lesions) underwent serial OCT evaluation at both 6 and 24 months. At 6 months, mean abluminal %VO was significantly lower in the MiStent group than in Xience group (14.54±3.70% vs. 19.11±6.70%; p=0.011), whereas the difference in %VO between the two groups decreased at 24 months (20.88±5.72% vs. 23.50±7.33%; p=0.24). There was no significant difference in percentage malapposed struts and percentage uncovered struts between the two groups at both time points. CONCLUSIONS: In the serial comparative OCT analysis of the MiStent vs. the Xience, the MiStent showed a more favourable efficacy for preventing neointimal formation with comparable strut tissue coverage, as compared with the Xience at 6 months, but this difference in %VO decreased at 24 months so that the difference in neointima at 24 months was no longer significant.

8.
Int J Cardiol ; 286: 43-50, 2019 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-30846254

RESUMO

BACKGROUND: ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population. METHODS: The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles. RESULTS: The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30 days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line. CONCLUSIONS: The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI.

9.
Artigo em Inglês | MEDLINE | ID: mdl-30887024

RESUMO

OBJECTIVES: Invasive coronary angiography has been the preferred diagnostic method to guide the decision-making process between coronary artery bypass grafting (CABG) and percutaneous coronary intervention and plan a surgical revascularization procedure. Guidelines recommend a heart team approach and assessment of coronary artery disease (CAD) complexity, objectively quantified by the anatomical SYNTAX score. Coronary computed tomography angiography (CCTA) and CT-derived fractional flow reserve (FFRCT) are emerging technologies in the diagnosis of stable CAD. In this study, data from patients with left main or 3-vessel CAD who underwent CABG were evaluated to assess the feasibility of developing a surgical plan based on CCTA integrated with FFRCT. The primary objective was to assess the theoretical feasibility of surgical decision-making and treatment planning based only on non-invasive imaging. METHODS: This study represents a survey of surgeons involved in the SYNTAX III Revolution trial. In this trial, heart teams were randomized to make treatment decisions using CTA. CCTAs and FFRCT results of 20 patients were presented to 5 cardiac surgeons. RESULTS: Surgical treatment decision-making based on CCTA with FFRCT was considered feasible by a panel of surgeons in 84% of the cases with an excellent agreement on the number of anastomoses to be made in each patient (intraclass correlation coefficient 0.77, 95% confidence interval 0.35-0.96). CONCLUSIONS: Using non-invasive imaging only in patients with left main or 3-vessel CAD, an excellent agreement on treatment planning and the number of anastomoses was found among cardiac surgeons. Thus, CABG planning based on non-invasive imaging appears feasible. Further investigation is warranted to determine the safety and feasibility in clinical practice.

10.
Int J Cardiovasc Imaging ; 35(7): 1189-1198, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30911857

RESUMO

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58-1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52-1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19-0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Humanos , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
11.
EuroIntervention ; 2019 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-30719981

RESUMO

AIMS: To assess whether the 9 months cytostatic inhibition by crystalline sirolimus has a beneficial effect in the 2-year follow-up in all-comer population undergoing percutaneous coronary intervention. METHODS AND RESULTS: The DESSOLVE III (n=1398) is a prospective, all-comer, multi-centre, randomized controlled study (NCT02385279) allocating 703 patients to receive MiStent drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall and 695 patients to receive Xience durable polymer everolimus-eluting stent. At 2-year, device-oriented composite endpoint (cardiac death, target-vessel myocardial infarction [TV-MI], and clinically-indicated target lesion revascularization [TLR]) occurred 8.7% and 8.6% (p=0.958) and patient-oriented composite endpoint (all deaths, all MI, and all revascularizations) was observed 18.5% and 19.6% (p=0.598) in the MiStent arm and Xience arm, respectively. The frequency of TV-MI and clinically-indicated TLR was also comparable for both stent types. The rate of definite/probable stent thrombosis was not different in both arms (0.9% vs. 1.3%, p=0.435). CONCLUSIONS: In an all-comer population, at 2-year follow-up, the use of MiStent sirolimus-eluting bioabsorbable polymer-coated stent was at least as safe and efficacious as Xience durable-polymer stent. Through a total of 5 years of follow-up, MiStent's potential long-term clinical benefit will be further elucidated.

12.
Circ J ; 83(3): 556-566, 2019 02 25.
Artigo em Inglês | MEDLINE | ID: mdl-30700665

RESUMO

BACKGROUND: Little is known about serial changes in lumen and device dimensions after bioresorbable scaffold implantation in a growing animal model. Methods and Results: ABSORB (n=14) or bare metal stents (ICROS amg [Abbott Vascular, Santa Clara, CA, USA], Winsen-Luhe, Germany; n=15) were implanted in the coronary arteries of domestic swine (a hybrid of Finnish-Norwegian Landrace swine) weighing 30-35 kg. Angiography and optical coherence tomography (OCT) were performed immediately after implantation and repeated at 7 days, 1, 3, 6 and 12 months after the index procedure. One month after implantation, mean lumen area decreased relative to baseline in both groups (relative area change from baseline, -41.4±15.6% for ABSORB vs. -20.9±18.6% for ICROS) while mean device area decreased only in the ABSORB group (relative area change: -11.1±9.4% vs. +0.14±7.95%, respectively). At 12 months, mean lumen area increased relative to baseline in both groups (relative area change from baseline, +55.6±22.4% vs. +32.3±83.6%, respectively) in accordance with the swine growth weighing up to 260-300 kg. Mean device area in the ICROS group remained stable whereas that in the ABSORB group began to increase between 3 and 6 months along with the vessel growth (relative area change: +107.8±25.7% vs. +0.14±7.95%). CONCLUSIONS: In the growing porcine model, ABSORB was associated with greater extent of recoil 1 month after implantation compared with ICROS but demonstrated substantial adaptability to vessel growth in late phase.

13.
Catheter Cardiovasc Interv ; 93(4): E225-E234, 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30702187

RESUMO

OBJECTIVES: To investigate the impact of minimal stent area (MSA) evaluated by post-procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three-vessel disease (TVD). BACKGROUND: The impact of post-procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD. METHODS: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a state-of-the-art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post-procedural MSA and lesion-level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion-oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. RESULTS: Eight hundred and nineteen lesions with post-procedural MSA available in 367 patients were included in the analysis. The post-procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm2 , intermediate tercile: 5.0-6.7 mm2 , and largest tercile: >6.7 mm2 ). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post-procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR. CONCLUSIONS: In the SYNTAX II trial, larger post-procedural MSA was independently associated with the lower rate of TLR at 2 years.

14.
EuroIntervention ; 2019 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-30719976

RESUMO

AIMS: Bioresorbable scaffolds (BRS) were conceived to ensure transient coronary artery support during antiproliferative drug delivery. However, the everolimus-eluting bioresorbable scaffold Absorb (Abbott Vascular, Santa Clara, CA, USA) was found inferior to everolimus-eluting metallic stents (EES) in moderately complex coronary anatomies. We sought to investigate whether the Absorb represents a valuable option for the percutaneous treatment of patients with ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: We pooled individual patient data of two randomized trials designed to investigate the performance of Absorb versus EES in patients with acute myocardial infarction (MI). The primary outcome was lesion diameter stenosis at angiographic follow-up. The main secondary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI and target lesion revascularization at 1 year. A total of 388 patients with STEMI were allocated to Absorb (n=227) or EES (n=161). Angiographic follow-up at 1 year was available for 332 (85.6%) patients. Lesion diameter stenosis was comparable between Absorb and EES (22.8±9.8% versus 23.6±11.2%; mean difference, 95% Confidence intervals= -0.8% [-3.18, 1.48], P= 0.47). DOCE occurred in 21 patients at 1 year, with similar distribution between Absorb and EES groups (5.3% versus 5.6%; hazard ratio, 95% Confidence intervals= 0.95 [0.40, 2.26], P= 0.91). CONCLUSIONS: This pooled analysis provides evidence for a comparable angiographic performance and suggests similar clinical performance of Absorb and EES in STEMI patients undergoing percutaneous revascularization. The long-term durability of Absorb and the extent to which newer BRS platforms might have a potential role in STEMI deserve further investigation.

15.
EuroIntervention ; 15(3): e244-e252, 2019 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-30636684

RESUMO

AIMS: The purpose of the study was to investigate whether the favourable outcomes of state-of-the-art PCI in the SYNTAX II trial, demonstrated at one year, were maintained at two-year follow-up. METHODS AND RESULTS: The SYNTAX II study was a multicentre, single-arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in 454 patients with de novo three-vessel coronary artery disease, without left main disease. Clinical outcomes in SYNTAX II were compared to the predefined PCI (SYNTAX-I PCI) and coronary artery bypass graft (SYNTAX-I CABG) cohorts from the landmark SYNTAX trial (SYNTAX-I), selected on the basis of equipoise for long-term (four-year) mortality utilising the SYNTAX score II. At two years, major adverse cardiac and cerebrovascular events (MACCE: a composite of all-cause death, any stroke, myocardial infarction, or revascularisation) in SYNTAX II were significantly lower compared to SYNTAX-I PCI (13.2% vs. 21.9%, p=0.001). Furthermore, similar two-year outcomes for MACCE were evident between SYNTAX II PCI and SYNTAX-I CABG (13.2% vs. 15.1%, p=0.42). CONCLUSIONS: At two years, clinical outcomes with the SYNTAX II strategy remained superior to the predefined SYNTAX-I PCI cohort, and similar to the predefined SYNTAX-I CABG cohort.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Seguimentos , Humanos , Resultado do Tratamento
16.
Expert Rev Med Devices ; 16(3): 211-228, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30676121

RESUMO

INTRODUCTION: Drug-eluting stents (DES) are still the standard of care in percutaneous coronary intervention (PCI) since the fall of bioresorbable scaffolds with respect to safety. The unbeatable advantage of a metallic stent when compared with a scaffold is a stronger mechanical property and more sustainable vascular support. Recent development of contemporary metallic stent has focused on the reduction of strut thickness. However, there will always be a trade-off between improvement in deliverability, flexibility, and radial strength. AREAS COVERED: This review aims to discuss the designs of metallic stent platform and mechanical properties as well as mechanical performance of contemporary DES from bench studies and clinical trials. EXPERT OPINION: Mechanical properties of stents affect short- and long-term clinical outcomes. Ultrathin-strut DES have become popular and clinical trials have shown impressive results. Thinner struts may improve device flexibility and deliverability but the radial strength and longitudinal integrity might have been compromised as well. Ultrathin-strut cobalt chromium or platinum chromium DES will become standard of care in PCI practice in the near future. Information on the stent design, stent material and mechanical properties of the stent are essential for a rational selection of the appropriate stent in selected lesions and patients.


Assuntos
Stents Farmacológicos , Fenômenos Mecânicos , Metais/química , Materiais Biocompatíveis/química , Ensaios Clínicos como Assunto , Humanos , Teste de Materiais
17.
Artigo em Inglês | MEDLINE | ID: mdl-30426299

RESUMO

Optical coherence tomography based computational flow dynamic (CFD) modeling provides detailed information about the local flow behavior in stented/scaffolded vessel segments. Our aim is to investigate the in-vivo effect of strut thickness and strut protrusion on endothelial wall shear stress (ESS) distribution in ArterioSorb Absorbable Drug-Eluting Scaffold (ArterioSorb) and Absorb everolimus-eluting Bioresorbable Vascular Scaffold (Absorb) devices that struts with similar morphology (quadratic structure) but different thickness. In three animals, six coronary arteries were treated with ArterioSorb. At different six animals, six coronary arteries were treated with Absorb. Following three-dimensional(3D) reconstruction of the coronary arteries, Newtonian steady flow simulation was performed and the ESS were estimated. Mixed effects models were used to compare ESS distribution in the two devices. There were 4591 struts in the analyzed 477 cross-sections in Absorb (strut thickness = 157 µm) and 3105 struts in 429 cross-sections in ArterioSorb (strut thickness = 95 µm) for the protrusion analysis. In cross-section level analysis, there was significant difference between the scaffolds in the protrusion distances. The protrusion was higher in Absorb (97% of the strut thickness) than in ArterioSorb (88% of the strut thickness). ESS was significantly higher in ArterioSorb (1.52 ± 0.34 Pa) than in Absorb (0.73 ± 2.19 Pa) (p = 0.001). Low- and very-low ESS data were seen more often in Absorb than in ArterioSorb. ArterioSorb is associated with a more favorable ESS distribution compared to the Absorb. These differences should be attributed to different strut thickness/strut protrusion that has significant effect on shear stress distribution.

18.
EuroIntervention ; 2018 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-30398965

RESUMO

Absorb bioresorbable scaffold (BRS), the most studied device among all BRS, suffered a major setback following the negative results of the ABSORB trials. However, approximately 34 BRSs from 22 companies are currently under development. The potential device specific factors related to increased event rate in Absorb were: 1) weaker mechanical properties, 2) larger strut thickness (less embedment and larger protrusion) and width (larger footprint) predisposing to underexpansion / protrusion of strut, eventually resulting in increased thrombogenicity, and 3) longer bioresorption time combined with failure of encapsulation of struts before dismantling process ensues. Given the diversity of bioresorbable materials (even amongst PLLA), the different mechanical properties and bioresorption profiles of each new BRS, one could expect considerable difference in early and late clinical outcomes. As a matter of fact, data from first-in-man (FIM) and pivotal trials demonstrated variable clinical results. Early clinical evidence from FIM trials indeed does not support class effect. However, the absence of a comparator precludes us from drawing definitive conclusions. Further clinical evidence should confirm the absence (or presence) of a class effect.

20.
Artigo em Inglês | MEDLINE | ID: mdl-30409759

RESUMO

OBJECTIVES: The aims of the present study were to investigate the applicability of quantitative flow ratio (QFR) in patients with 3-vessel disease and to demonstrate the impact of functional SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score derived from QFR (fSSQFR) on clinical outcomes. BACKGROUND: The applicability of QFR in patients with 3-vessel disease and the feasibility of fSSQFR have not yet been investigated. METHODS: All lesions interrogated using instantaneous wave-free ratio and/or fractional flow reserve in the SYNTAX II trial were retrospectively screened and analyzed for QFR. The diagnostic performance of QFR was investigated using hybrid wire-derived pressure assessment (instantaneous wave-free ratio and fractional flow reserve), used in the trial as a reference. Patients with analyzable QFR in 3 vessels were stratified according to fSSQFR to evaluate its clinical prognostic value on the basis of 2-year patient-oriented composite endpoint. RESULTS: QFRs were analyzable in 71.0% of lesions (836 lesions). The diagnostic performance of QFR to predict binary wire-based ischemia was substantial (area under the curve 0.81, accuracy 73.8%), with a positive predictive value of 85.9%. Independent predictors of diagnostic discordance were lesions in side branches, involvement of bifurcation or trifurcation, and small vessel. According to the 2-year patient-oriented composite endpoint, fSSQFR reclassified 26.1% of the patients (36 of 138) in the high- to intermediate-risk group into the low-risk group appropriately (net reclassification improvement 0.32, p < 0.001). The area under the curve for fSSQFR to predict the 2-year patient-oriented composite endpoint was higher than that of the classic anatomic SYNTAX score (0.68 vs 0.56, p = 0.002). CONCLUSIONS: QFR demonstrated substantial applicability in patients with 3-vessel disease. The fSSQFR has the potential to further refine prognostic risk estimation compared with the classic anatomic SYNTAX score.

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