Search

Objectives This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease. Background Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. Methods The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data. Results Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority Conclusions At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348)

SYNERGY stent was designed to improve arterial healing and reduce the risk of stent thrombosis (ST) with thin struts and abluminal everolimus-eluting bioabsorbable polymer. Safety and efficacy of SYNERGY has been established in normal bleeding risk patients treated with standard duration DAPT.

The SYNERGY stent (Boston Scientific) is a thin-strut platinum chromium metal alloy platform eluting everolimus from an ultrathin abluminal layer of poly(DL-lactide-co-glycolide) bioabsorbable polymer. Drug release and polymer degradation are complete within 4 months of implantation. These design

In second-generation bioresorbable scaffolds, thinner struts are often adopted to improve both deliverability and safety profiles, while theoretical concerns remain regarding radial strength and fracture resistance. This analysis aimed to evaluate acute and mid-term performance of the RENUVIA

Durable polymers may contribute to increased risk of late thrombotic events and the need for prolonged DAPT as they have been associated with delayed arterial healing, incomplete endothelialization and hypersensitivity. The SYNERGY stent (Boston Scientific Corporation, Marlborough, MA) designed to

REPRISE III is the first large randomized comparison of 2 TAVR platforms: the mechanically-expanded Lotus valve (Boston Scientific, Marlborough, MA) and self-expanding CoreValve (Medtronic, Dublin, Ireland). In aortic stenosis patients with high/extreme surgical risk, Lotus was noninferior to

The repositionable and fully retrievable Lotus Valve (Boston Scientific, Marlborough, MA, USA) was designed to provide precise positioning and minimize paravalvular leak (PVL) in patients with severe aortic stenosis. This analysis will present the final, 5-year outcomes from the REPRISE II study.

Paravalvular leak (PVL), a common complication of transcatheter aortic valve replacement (TAVR), has been linked to increased mortality risk. The RESPOND post-market study represents the largest population of TAVR patients treated with the Lotus valve (Boston Scientific, Marlborough, MA). Here we

Is it possible to enforce part of an arbitral award? The answer, in principle, is yes. The New York Convention expressly permits partial enforcement in certain circumstances. A number of signatory jurisdictions have interpreted the Convention in a way which extends these circumstances in order to uphold and enforce parts of arbitral awards which might otherwise be frustrated by issues such as national public policy restrictions or challenges to an award at its seat. This article examines the authorities in various jurisdictions on the partial enforcement of arbitral awards and offers practical guidance aimed at increasing the chances of an enforcement-friendly award.

REPRISE III is a multicenter, randomized comparison of the novel mechanically-expanded (Lotus) and self-expanding (CoreValve; CV) TAVI devices. Lotus was superior for primary effectiveness and non-inferior for primary safety endpoints. A detailed analysis of the hemodynamics and paravalvular leak (

In his recent doctoral thesis, the author has undertaken the fundamental research of a close examination of the composition of congregations, to establish the substantial contribution of working-class Church of Ireland immigrants to the nineteenth-century expansion of the Scottish Episcopal Church in the Diocese of Glasgow and Galloway in the west of Scotland. He has thereby supplied a correction to the usual Episcopalian idea that the Scottish Church was the outcome of the interaction between a native Scottish tradition and influences from England. He has also redressed the other emphases in this area, by working-class historians, who tend to neglect working-class religious activity altogether, and by historians of Irish emigration, who concentrate primarily upon Catholic emigrants, or in a secondary sense, stress the role of Presbyterian emigrants at the expense of members of the Church of Ireland. This essay delineates the limits to this Irish influence, in the barriers to working-class participation i...

Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown.This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation.In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging.Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis.At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

The repositionable and fully retrievable Lotus™ Valve (Boston Scientific, Natick, MA, USA) was designed to facilitate accurate positioning and minimize paravalvular regurgitation in patients with severe aortic stenosis who are at high or extreme surgical risk. The device is CE-marked based on

Background: Coronary artery calcification presents multiple challenges to percutaneous revascularization and is associated with suboptimal results and adverse long-term clinical outcomes. Lithoplasty treatment is a balloon-based therapy deploying circumferential lithotripsy to disrupt intimal and

An increased body mass index (BMI) is associated with a high risk of cardiovascular disease and reduction in life expectancy. However, several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases. The aim of the present study is to investigate the impact of BMI on long-term clinical outcomes after implantation of zotarolimus eluting stents.Individual patient data were pooled from the RESOLUTE Clinical Program comprising five trials worldwide. The study population was sorted according to BMI tertiles and clinical outcomes were evaluated at 2-year follow-up.Data from a total of 5,127 patients receiving the R-ZES were included in the present study. BMI tertiles were as follow: I tertile (≤ 25.95 kg/m(2) -Low or normal weight) 1,727 patients; II tertile (25.95 ≤ 29.74 kg/m(2) -overweight) 1,695 patients, and III tertile (29.74 kg/m(2) -obese) 1,705 patients. At 2-years follow-up no difference was found for patients with high BMI (III tertile) compared with patients with normal or low BMI (I tertile) in terms of target lesion failure (I-III tertile, HR [95% CI] = 0.89 [0.69, 1.14], P = 0.341; major adverse cardiac events (I-III tertile, HR [95% CI] = 0.90 [0.72, 1.14], P = 0.389; cardiac death (I-III tertile, HR [95% CI] = 1.20 [0.73, 1.99], P = 0.476); myocardial infarction (I-III tertile, HR [95% CI] = 0.86 [0.55, 1.35], P = 0.509; clinically-driven target lesion revascularization (I-III tertile, HR [95% CI] = 0.75 [0.53, 1.08], P = 0.123; definite or probable stent thrombosis (I-III tertile, HR [95% CI] = 0.98 [0.49, 1.99], P = 0.964.In the present study, the patients' body mass index was found to have no impact on long-term clinical outcomes after coronary artery interventions.

This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months.Fully bioresorbable scaffolds are a novel approach to treatment for coronary narrowing that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. However, a potential drawback of the bioresorbable scaffold is the potential for disruption of the strut network when overexpanded. Conversely, the structural discontinuity of the polymeric struts at a late stage is a biologically programmed fate of the scaffold during the course of bioresorption.The ABSORB cohort B trial is a multicenter single-arm trial assessing the safety and performance of the Absorb BVS in the treatment of 101 patients with de novo native coronary artery lesions. The current analysis included 51 patients with 143 OCT pullbacks who underwent OCT at baseline and follow-up. The presence of acute disruption or late discontinuities was diagnosed by the presence on OCT of stacked, overhung struts or isolated intraluminal struts disconnected from the expected circularity of the device.Of 51 patients with OCT imaging post-procedure, acute scaffold disruption was observed in 2 patients (3.9%), which could be related to overexpansion of the scaffold at the time of implantation. One patient had a target lesion revascularization that was presumably related to the disruption. Of 49 patients without acute disruption, late discontinuities were observed in 21 patients. There were no major adverse cardiac events associated with this finding except for 1 patient who had a non-ischemia-driven target lesion revascularization.Acute scaffold disruption is a rare iatrogenic phenomenon that has been anecdotally associated with anginal symptoms, whereas late strut discontinuity is observed in approximately 40% of patients and could be viewed as a serendipitous OCT finding of a normal bioresorption process without clinical implications. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA).The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined.A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21).Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p0.001).The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.

The Sparrow stent system (Biosensors International) consists of a self-expanding, ultra-thin nitinol stent mounted within a 0.014″ guidewire designed for small or tortuous coronary lesions. We compared the intravascular ultrasound (IVUS) findings between the novel self-expanding sirolimus-eluting stent (Sparrow-SES) and a conventional balloon-expandable sirolimus-eluting stent (Cypher-SES) in patients with small coronary disease.We examined 14 lesions treated with the Sparrow-SES from CARE II, compared with 22 small vessel lesions treated with Cypher-SES. IVUS examination was performed post-procedure and 8 months later. Volumetric data were standardized by length as volume index (VI; mm³/mm).While baseline stent VI trended smaller in Sparrow-SES, follow-up stent VI became similar between the 2 groups due to a significant increase of stent VI in self-expanding Sparrow-SES during the follow-up period. At 8 months, Sparrow-SES showed greater neointima than Cypher-SES (0.8 ± 0.6 mm³/mm vs 0.2 ± 0.2 mm³/mm; P.001). However, the decrease in lumen VI was only 0.3 ± 0.7 mm³/mm in Sparrow-SES, as compared to 0.1 ± 0.3 mm³/mm in Cypher-SES (P=.259), since the late loss due to neointimal hyperplasia was partly counterbalanced by the chronic stent expansion in Sparrow-SES.While 8-month follow-up of Sparrow-SES revealed greater amounts of neointimal hyperplasia compared with conventional Cypher-SES, chronic stent expansion preserved the lumen by increasing stent volume. This novel, guidewire-based, self-expanding stent system designed to be delivered through complex anatomies may be useful to treat patients with small-caliber coronary lesions by offering sufficient lumen preservation at follow-up.

The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS).Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain.Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596).Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES.Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES.

The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev.1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months.With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months.Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up.Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p0.001) and 20% (p0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56).The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856).

We studied the Nobori coronary stent coated with a bioabsorbable polymer and the anti-proliferative agent Biolimus A9 which may reduce neointimal formation.Patients undergoing percutaneous coronary intervention for de novo lesions in up to two native coronary arteries, in 29 centres across Europe, Asia and Australia were randomly (2:1) assigned to receive the Biolimus A9 eluting stent Nobori (85 patients) or paclitaxel eluting stent Taxus(R) (35 patients). The two groups were well matched in baseline characteristics. The primary end point of non-inferiority for in-stent late loss of Nobori stent versus Taxus(R) stent, at 9 months, was reached with the values of 0.15+/-0.27 mm with Nobori stent and 0.32+/-0.33 mm with Taxus(R) stent (p=0.006). Neointimal volume obstruction was 2.2+/-6.0% and 8.9+/-9.2% for Nobori and Taxus(R) stent respectively (p=0.017). The rates of death, myocardial infarction and any target vessel revascularisation at 9 months were 0%, 4.7%, and 7.1% respectively for Nobori stent, and 0%, 8.6% and 14.3% respectively for Taxus(R) stent. Clinically-driven target lesion revascularisation rate was 0% for Nobori stent and 2.9% for Taxus(R) stent. Stent thrombosis rates at 9 months were 0% in both groups.In this trial the Nobori Biolimus A9 eluting stent proved to be safe and effective in reducing neointimal proliferation. The long term safety remains to be confirmed during the extended follow-up period of 5 years.

Patients with diabetes mellitus (DM) undergoing percutaneous cardiovascular intervention (PCI) represent a challenging population at higher risk for adverse events including late mortality following drug–eluting stent treatment. Long–term outcomes in patients with DM following PCI with

Patients with acute coronary syndromes (ACS) have been shown to have a local increase in culprit lesion temperature of at least 0.5 degrees Celcius using a specialized thermography catheter. However, this device is unique, not clinically available and unable to provide information other than temperature. The 0.014-inch Radi PressureWire XT (RPW) contains a high-sensitivity thermistor in the sensor that has a sensitivity of 0.1 degrees Celcius. We evaluated the ability of the RPW to detect an increase in plaque temperature in patients with ACS.Patients with ACS and a culprit lesion of70% stenosis and who were candidates for percutaneous coronary intervention (PCI) were eligible (n = 20). Fractional flow reserve (FFR) post-adenosine administration and temperature estimations were performed prior to PCI. All demographic data are presented as mean +/- SD, and temperature data (using delta temperature from baseline) as mean +/- SEM. Fifteen men and 5 women were enrolled (age 59.5 +/- 11.6 years). The FFR pre-PCI was 0.65 +/- 0.06, consistent with hemodynamically significant stenoses. The baseline delta temperature was 0.00 +/- 0.01 degrees Celcius. The delta temperature at the culprit lesion was -0.02 +/- 0.01 degrees Celcius (p = NS), a result below the resolution of the thermistor. Post-PCI, the FFR was 0.95 +/- 0.01 (p0.0001).The RPW was unable to detect any temperature increase in patients with ACS.

Emerging evidence suggest that home BP measurements provide additional information regarding BP control. Most studies reported office and some ambulatory BP changes in renal denervation studies‥ Home BP data are scarce. The EnligHTN-I first-in-human study was designed to assess the safety and