In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial.

RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.

Three-year follow-up of the MULTIcentre evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting STEnt or Bare-Metal Stent in Acute Myocardial Infarction StudY (MULTISTRATEGY).

BACKGROUND: The Multicentre Evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study [MULTISTRATEGY]) randomised 745 patients with ST-elevation myocardial infarction to receive high-dose bolus (HDB) tirofiban or abciximab infusion and sirolimus-eluting (SES) or uncoated-stent (BMS) implantation. Tirofiban was non-inferior to abciximab in terms of ST-segment resolution after intervention, whereas 8 month-major adverse cardiac events occurred in 14.5% in the BMS and 7.8% in the SES groups (P = 0.0039), reflecting a reduction of reintervention rates (10.2% vs. 3.2%). A three-year follow-up was performed to extend previous short- to mid-term findings. METHODS AND RESULTS: Complete data at 3 years was available for 736 patients (99%). All-cause mortality was 6.7% in the tirofiban and 7.8% in the abciximab (P = 0.56) and 7.5% in the BMS vs 7.0 in the SES groups, P = 0.79. The composite of all-cause death or MI was identical at 12.9% in tirofiban and abciximab groups, P = 0.99 and it occurred in 13.2% in the BMS vs. 12.6% in the SES groups (P = 0.83). The need for reintervention remained more than twice as common with BMS (13.7%; versus 6.2%, P = 0.0006). The cumulative rate of stent thrombosis (ST) did not differ. This is inspite of a higher very late definite, probable or possible ST thrombosis rate in the SES group. CONCLUSIONS: The 3-year follow-up of MULTISTRATEGY demonstrated comparable outcomes with HDB Tirofiban or abciximab and a sustained efficacy of SES to reduce reintervention with no difference in death, repeat MI or ST.

Emerging drugs for coronary restenosis: the role of systemic oral agents the in stent era.

Introduction of drug eluting stents (DES) during percutaneous coronary interventions significantly reduces the rate of angiographic restenosis, target lesion and vessel revascularization. In spite of these benefits, other clinical hard end points such as death or myocardial infarction were not reduced and, furthermore, new concerns associated with the presence of late and very late stent thrombosis have been raised. The requirement of long-term dual antiplatelet therapy is another limitation associated with DES. Conversely, in this decade, other options to DES have been simultaneously discussed in observational and randomized studies. Several registries and randomized trials using the systemic approach with anti-inflammatory, immunosuppressive or antiplatelet therapies have been identified and discussed in this manuscript. In spite of all randomized studies with oral therapies in the bare metal stent (BMS) era demonstrating positive reductions in coronary restenosis, this practice has not been introduced clinically. Furthermore, a recent randomized trial comparing oral sirolimus plus BMS versus DES demonstrated that the first approach was cost saving and of comparable efficacy to DES. Conclusive evidence of high incidence of late and very late stent thrombosis with DES, together with clinical limitations for its widespread use, has opened up a large opportunity to search for alternative therapies in coronary restenosis prevention.

Correlación arteriográfica en 30 pacientes con patología vascular renal diagnosticada mediante TC multicorte / Arteriographic correlation in 30 patients with renal vascular disease diagnosed with multislice CT

Objetivo. Determinar la utilidad de la tomografía computarizada multicorte (TCMC) en la valoración de la patología arterial renal, tomando como patrón oro la angiografía con sustracción digital (ASD). Material y métodos. Se evalúan 30 pacientes con hipertensión arterial o insuficiencia renal, a los que se había realizado una TCMC para descartar etiología vascular de su padecimiento, y en los que ante sospecha de la misma, se practicó una ASD de confirmación diagnóstica. Las TCMC se realizaron en un equipo de 10 detectores, con administración intravenosa de 80 ml de contraste yodado (300 mg de yodo/ml) a flujo de 5 ml/s. Se valoraron 71 arterias renales, 56 principales y 15 accesorias. Las estenosis arteriales se clasificaron para su evaluación en: grado 0 (arteria normal), grado I (estenosis < 50%), grado II (>= 50%, pero < 70%), grado III (>= 70%), grado IV (oclusión). Las estenosis de grado II o superior se consideraron hemodinámicamente significativas. Resultados. En 56 arterias renales (78,8%) se realizó una valoración idéntica en TCMC y ASD. En 13 casos (18,3%) la TCMC sobrevaloró el grado de estenosis. Todas las estenosis de grado III fueron detectadas con TCMC. En el diagnóstico de las estenosis hemodinámicamente significativas la TCMC demostró sensibilidad del 96,5%, especificidad del 78,5%, exactitud del 85,9%, valor predictivo positivo del 75,6% y negativo del 97%. Conclusiones. La TCMC es un buen método de imagen no invasivo en la evaluación de los vasos renales, y resulta útil en el cribado de los pacientes con patología nefrológica en los que se busca descartar una etiología vascular potencialmente tratable (AU)

Objective. To determine the usefulness of multislice computed tomography (MSCT) in the evaluation of renal vascular disease against a gold standard of digital subtraction angio -graphy (DSA). Material and methods. We evaluated 30 patients with arterial hypertension and/or kidney failure that underwent MSCT to rule out a vascular cause and DSA to confirm a vascular cause suspected at MSCT. MSCT examinations were performed on a 10-detector scanner with intravenous administration of 80 ml of iodinated contrast (300 mg iodine/ml) at a flow rate of 5 ml/s. A total of 71 renal arteries, 56 main and 15 accessory, were evaluated. Arterial stenoses were classified as: grade 0 (normal artery), grade I (stenosis < 50%), grade II (>= 50% and < 70%), grade III (>= 70%), grade IV (occlusion). Stenosis >= grade II was considered hemodynamically significant. Results. The findings at MSCT and DSA were identical in 56 (78.8%) renal arteries; MSCT overestimated the degree of stenosis in 13 (18.3%) cases. All grade III stenoses were detected at MSCT. In the diagnosis of hemodynamically significant stenosis, MSCT had a sensitivity of 96.5%, specificity 78.5%, accuracy 85.9%, positive predictive value 75.6%, and negative predictive value 97%. Conclusions. MSCT is a good noninvasive imaging technique for the evaluation of renal vessels; it is useful for screening patients with kidney disease to rule out potentially treatable vascular causes (AU)

Design criteria for the ideal drug-eluting stent.

The deployment of drug-eluting stents (DESs) is an integral treatment option for patients with coronary artery disease. Although the development and testing of the first-generation DESs focused to a considerable degree on efficacy parameters, including restenosis, recent concerns over late clinical events have prompted a refinement of the design criteria for succeeding generations of these devices. This review assesses design criteria for the ideal DES from 3 complementary perspectives: deliverability, efficacy, and safety. Most new investigational balloon-expandable DES systems have lowered crossing profiles by thinning stent struts using a cobalt chromium alloy, while investigational self-expanding DESs often use nitinol as the platform material. Stents designed to be fully biodegradable are also being developed, with deliverability and performance to be determined in future clinical trials. Refinements in bifurcation-dedicated stents will secure branch accessibility to offer better deliverability in complex lesion morphologies. Experimentation in stent design is already realizing multiple-lesion stenting and the in situ customization of stent length. Rather than simply targeting further reductions in restenosis rates, efforts to improve efficacy are shifting toward a lesion-specific approach, including the design of stents dedicated to bifurcation lesions. Another future direction is a disease-specific approach, or an approach using DESs as local drug-delivery devices. The identification of long-term safety issues with the first-generation DESs has reignited clinical interest in the development of stents that are more biologically based, including fully biodegradable stents and stents using biomimetic and biodegradable polymers. Important performance criteria for future DES agents include more cell-type specificity, broader safety margins, and greater facility at promoting endothelialization and healing.