Extranodal NK/T‐cell lymphoma,nasal type: Clinical features,outcome, and prognostic factors in 101 cases

Objectives

We aimed to define the clinical features, outcome, and prognostic factors for extranodal NK/T‐cell lymphoma (ENKTL) patients in Taiwan.

Methods

We retrospectively reviewed 101 ENKTL patients diagnosed between February 1998 and October 2015.

Results

The median age of 101 patients was 52 years old (range 22‐85); 76.2% of patients were Ann Arbor stage I/II disease. The 5‐year progression‐free survival (PFS) and overall survival (OS) were 49.9% and 54.8%, respectively. Patients with log[EBV‐DNA] ≥ 3.8 and bone marrow hemophagocytosis at diagnosis had inferior PFS and OS. Most stage I/II patients received combined chemoradiotherapy with anthracycline‐containing regimen, with overall response rate of 96.7%, complete response rate 86.9%, 5‐year PFS 65%, and OS 72%. The relapse rate was 29.3% with a short median disease‐free survival of 6.2 months. In advanced stage patients, overall response rate was only 13.6%, with median PFS 2.3 months, and OS 4.8 months. Age ≥ 60 (HR 3.773, 95% CI 1.733‐8.215, P = 0.001) and stage III/IV (HR 7.785, 95% CI 2.312‐26.213, P = 0.001) were unfavorable prognostic factors for PFS and OS by multivariate analyses.

Conclusions

Age ≥ 60 and stage III/IV are independent poor prognostic factors for PFS and OS. Early‐stage ENKTL patients had good response to combined chemoradiotherapy with anthracycline‐containing regimen but with a high relapse rate and short disease‐free survival. Anthracycline‐containing regimen in advanced stage had poor response and dismal outcome.

     

Combination of 177Lu‐lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non‐Hodgkin's lymphoma

Objectives

To investigate the therapeutic potential of the next‐generation anti‐CD37 radioimmunoconjugate ¹⁷⁷Lu‐lilotomab satetraxetan (¹⁷⁷Lu‐lilotomab) in combination with the anti‐CD20 antibody rituximab for treatment of mice with non‐Hodgkin's lymphoma (NHL) xenografts.

Methods

Nude mice with subcutaneous (s.c.) Burkitt's lymphoma Daudi xenografts and SCID mice intravenously (i.v.) injected with Mantle cell lymphoma Rec‐1 cells were treated with either ¹⁷⁷Lu‐lilotomab or rituximab alone or with the combination of both treatments. Tumour volume, body weight, blood counts and clinical status were monitored. CD20 expression was measured using flow cytometry with fluorescence‐labelled rituximab.

Results

The combination of ¹⁷⁷Lu‐lilotomab and rituximab was synergistic for treatment of nude mice with s.c. Daudi xenografts while it was additive for treatment of SCID mice with i.v. injected Rec‐1 cells. Binding of rituximab to NHL cells in‐vitro was increased by pretreatment with ¹⁷⁷Lu‐lilotomab.

Conclusions

Treatment of mice with NHL xenografts with ¹⁷⁷Lu‐lilotomab synergistically increased tumour suppression of subsequent anti‐CD20 immunotherapy and improved survival. If the same effect is confirmed in a recently started clinical study, it could change the way radioimmunotherapy and CD20 immunotherapy would be used in the future.

     

Reduced frontal activation during verbal fluency task in chronic hepatitis C patients with interferon‐based therapy as measured by near‐infrared spectroscopy

Aim

Psychiatric side‐effects are the main reason for discontinuation of interferon (IFN)‐based therapy. Recent developments in near‐infrared spectroscopy (NIRS) have enabled non‐invasive clarification of brain functions in psychiatric disorders. We prospectively evaluated brain activation in 20 chronic hepatitis C patients with or without IFN‐based therapy by using NIRS during a verbal fluency task (VFT).

Methods

The relative concentrations of oxygenated hemoglobin were measured while patients completed a questionnaire survey at the start of treatment and at 4 and 12 weeks during treatment, using NIRS.

Results

The VFT performance did not change among the two groups. Patients with IFN‐based therapy showed significantly lower activation during VFT in frontal channels at 12 weeks than those at the start of treatment and control (P < 0.05). Their Center for Epidemiologic Studies Depression Scale scores were significantly higher at 12 weeks than those at the start of treatment, although major depressive symptoms were not found (8.3 ± 7.9 vs. 13.2 ± 6.0, P < 0.001).

Conclusion

The decrease in oxygenated hemoglobin concentrations of the frontal lobe detected using NIRS in this study reflects hypofunction of the frontal lobe. This functional decline that was caused by IFN‐based therapy may be associated with the prodromal phase of depression.

     

High‐volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast‐induced nephropathy: A meta‐analysis of randomized trials

Background

Contrast‐induced nephropathy (CIN) is a well‐recognized complication of coronary angiography that is associated with poor outcomes. Several small randomized controlled trials (RCTs) have recently shown that in patients with chronic kidney disease (CKD), furosemide‐induced forced diuresis with matched hydration using the RenalGuard system can prevent its occurrence. However, individual studies have been underpowered and thus cannot show significant differences in major clinical endpoints.

Hypothesis

Forced diuresis with matched hydration using the RenalGuard system improves clinical outcomes in patients undergoing coronary angiography.

Methods

Scientific databases and websites were searched for relevant RCTs. The pooled risk ratios were calculated using random‐effects models. The primary endpoint was CIN, and the secondary endpoints were major adverse clinical events (MACEs) and the need for renal replacement therapy.

Results

Data from 3 trials including 586 patients were analyzed. High‐volume forced diuresis with matched hydration using the RenalGuard system decreased risk of CIN by 60% (risk ratio: 0.40, 95% confidence interval: 0.25 to 0.65, P < 0.001), MACE rate by 59%, and the need for renal replacement therapy by 78%, compared with the standard of care.

Conclusions

In patients with CKD undergoing coronary angiography, high‐volume forced diuresis with matched hydration using the RenalGuard system significantly reduces the risk of CIN, MACE rate, and the need for renal replacement therapy. Larger RCTs with sufficient power are needed to confirm these findings.

     

Complete versus incomplete revascularization with drug‐eluting stents for multi‐vessel disease in stable,unstable angina or non‐ST‐segment elevation myocardial infarction: A meta‐analysis

Objectives

To determine whether drug‐eluting stent (DES) coronary complete revascularization (CR) confers clinical benefit over incomplete revascularization (IR) in patients with multivessel coronary artery disease (MVD).

Background

Clinical benefit of CR over IR in patients with MVD with angina (both stable and unstable) and non‐ST‐segment elevation myocardial infarction (NSTEMI) in DES has not been well studied.

Methods

We conducted a systematic online literature search of PUBMED and EMBASE. Literatures that compared the clinical outcomes between CR and IR with exclusively or majority (>80%) using DES in patients without or included only small portion (<20%) of ST‐segment elevation myocardial infarction or single‐vessel coronary artery disease were included. Hazards ratio (HR) with 95% confidence interval (CI) was calculated with random‐effects model.

Results

No randomized clinical trials were identified. A total of 14 observational studies with total of 41 687 patients (CR 39.6% and IR 60.4%) were included in this meta‐analysis. CR was associated with lower incident of all‐cause mortality (HR 0.71, P = 0.001), major adverse events (HR 0.75, P < 0.001), cardiovascular mortality (HR 0.39, P < 0.001). Meta‐regression analysis showed that CR significantly reduced the risk of all‐cause mortality in advanced age, triple vessel disease and male sub‐groups.

Conclusions

CR with DES conferred favorable outcomes compared to IR in MVD patients with stable, unstable angina or NTEMI. Further research to achieve higher CR in MVD patients may lead to improvement in prognosis in these cohorts.

     

Aldo‐keto reductase family 1 member B10 is associated with hepatitis B virus‐related hepatocellular carcinoma risk

Aim

Recent reports have indicated that aldo‐keto reductase family 1 member B10 (AKR1B10), a cancer‐related oxidoreductase, was upregulated in some chronic liver diseases. However, few studies have reported AKR1B10 expression in chronic hepatitis B virus (HBV)‐infected patients. The aim of the present study was to analyze AKR1B10 expression and its relevance on hepatocellular carcinoma (HCC) development in patients with chronic HBV infection.

Methods

Expression of AKR1B10 in the liver of 119 chronic HBV‐infected patients was assessed and quantified immunohistochemically. A multivariate Cox model was used to estimate the hazard ratios of AKR1B10 expression for HCC development. The cumulative incidences of HCC were evaluated using Kaplan–Meier analysis.

Results

Expression of AKR1B10 in the study cohort ranged from 0% to 84%. During the median follow‐up time (6.2 years), 13 patients developed HCC. Multivariate analysis revealed that high AKR1B10 expression (≥15%) was an independent risk factor for HCC (hazard ratio, 10.8; 95% confidence interval, 3.0–38.6; P < 0.001). The 5‐year cumulative incidences of HCC were 20.6% and 2.6% in patients with high and low AKR1B10 expression, respectively (P < 0.001). Patients with high AKR1B10 expression had significantly higher alanine aminotransferase levels during follow‐up than those with low expression, even though antiviral treatment decreased HBV‐DNA levels in both groups.

Conclusion

Chronic HBV‐infected patients with high hepatic AKR1B10 expression had an increased risk of HCC development. This suggests that AKR1B10 upregulation might play a role in the early stages of HBV‐related hepatocarcinogenesis.

     

Incidence and Characteristics of Late Catch‐Up Phenomenon Between Sirolimus‐Eluting Stent and Everolimus‐Eluting Stent: A Propensity Matched Study

Objectives

We evaluated and compared the incidence and characteristics of late catch‐up phenomenon (LCU) between everolimus‐eluting stent (EES) and sirolimus‐eluting stent (SES) implantations.

Background

Late catch‐up phenomenon after everolimus‐eluting stent (EES) implantation has not yet been evaluated sufficiently.

Methods

Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES‐treated patients and 495 ESS‐treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1–3 years]) were compared.

Results

The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different.

Conclusions

EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation. (J Interven Cardiol 2015;28:551–562)

     

Predictors for long‐term survival after transcatheter edge‐to‐edge mitral valve repair

Objectives

To determine predictors for long‐term outcome in high‐risk patients undergoing transcatheter edge‐to‐edge mitral valve repair (TMVR) for severe mitral regurgitation (MR).

Background

There is no data on predictors of long‐term outcome in high‐risk real‐world patients.

Methods

From August 2009 to April 2011, 126 high‐risk patients deemed inoperable were treated with TMVR in two high‐volume university centers.

Results

MR could be successfully reduced to grade ≤2 in 92.1% of patients (116/126 patients). Long‐term clinical follow‐up up to 5 years (95.2% follow‐up rate) revealed a mortality rate of 35.7% (45/126 patients). Repeat mitral valve treatment (surgery or intervention) was needed in 19 patients (15.1%). Long‐term clinical improvement was demonstrated with 69% of patients being in NYHA class ≤II. In a multivariable Cox regression analysis, the post‐procedural grade of MR (hazard ratio [HR] 1.55 per grade, P = 0.035), the left ventricular ejection fraction (HR 0.58 for difference between 75th and 25th percentile, P = 0.031) and the glomerular filtration rate (HR 0.33 for 75th vs 25th percentile, P < 0.001) were independent predictors for long‐term mortality. Patients with primary MR and a post‐procedural MR grade ≤1 had the most favorable long‐term outcome.

Conclusions

This study determines predictors of long‐term clinical outcome after TMVR and demonstrates that the grade of residual MR determines long‐term survival. Our data suggest that it might be of benefit reducing residual MR to the lowest possible MR grade using TMVR—especially in selected high‐risk patients with primary MR who are not considered as candidates for surgical MVR.

     

Second‐Generation Everolimus‐Eluting Stents Compared to First‐Generation Drug‐Eluting Stents in Patients Treated for Multivessel Disease

Objective

This study aimed to compare the safety and efficacy of everolimus‐eluting stents (EES) to first‐generation drug‐eluting stents (DES) in multivessel disease (MVD).

Background

Second‐generation EES have demonstrated superiority over first‐generation DES for single‐vessel disease, although the merits of EES in MVD are less established.

Methods

A cohort of 1,285 patients (3,124 lesions) with ≥2 diseased vessels were treated with either first‐generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non‐fatal myocardial infarction, were compared at 1 year.

Results

Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first‐generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38–0.87]; P = 0.009; 95% confidence interval).

Conclusions

The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first‐generation DES. Randomized trials comparing new‐generation DES to coronary artery bypass grafting surgery are warranted.

     

First‐in‐Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions

Objectives

To describe the first‐in‐man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI.

Background

Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal.

Methods

Prospective, single‐centre, non‐randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria—TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST‐resolution >70% at 90 minutes after vessel reperfusion—was also evaluated.

Results

Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre‐specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration.

Conclusions

This first‐in‐man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155–161)

     

Residents from non‐English‐speaking countries of birth in Australian aged care facilities

Objective

To describe the activity of daily living and behavioural and complex care needs of residents born in non‐English‐speaking countries in Australian aged care facilities.

Methods

De‐identified cross‐sectional data were provided by the Australian Institute of Health and Welfare for all residents in government‐funded facilities on 30 June 2015. Analyses included t‐tests, chi‐squared tests and logistic regressions.

Results

A total of 33 168 (19%) residents were born in one of 188 non‐English‐speaking countries. Compared to residents born in English‐speaking countries, they were significantly younger, lived in larger facilities, were more likely to be male and live in an urban area. Their care requirements were greater for activities of daily living and behavioural and complex care. Residents from non‐English‐speaking countries living in ethno‐specific facilities had higher levels of these needs.

Conclusion

The needs of residents born in non‐English‐speaking countries should be considered when planning aged care services.

     

First‐in‐human experience of left atrial appendage occlusion with the steerable FuStar sheath

Background

Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first‐in‐human experience of LAAO with the FuStar sheath.

Methods

Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA₂DS₂‐VASc score: 5.0 ± 2) with non‐valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers.

Results

Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm² ± 3835.3, respectively.

Conclusion

This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

     

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Objectives

We investigated the safety and efficacy of PCI using drug‐coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding.

Background

DCB has been effective in the treatment of in‐stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation.

Methods

82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow‐up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month.

Results

MACE (the composite of cardiovascular death, ischemia‐driven target‐lesion revascularization [TLR] or non‐fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia‐driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months.

Conclusions

This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant.

     

Long‐term use of continuous positive airway pressure therapy in coronary artery disease patients with nonsleepy obstructive sleep apnea

Background

Excessive daytime sleepiness is a frequent symptom of obstructive sleep apnea (OSA) and has been proposed as a motivator for adherence to continuous positive airway pressure (CPAP) therapy. However, excessive daytime sleepiness is absent in many patients with coronary artery disease (CAD) and concomitant OSA. We evaluated long‐term use of CPAP and predictors of CPAP use in nonsleepy and sleepy OSA patients from a CAD cohort.

Hypothesis

Long‐term CPAP use is lower in CAD patients with nonsleepy OSA vs sleepy OSA.

Methods

Nonsleepy (Epworth Sleepiness Scale [ESS] score < 10) OSA patients randomized to CPAP (n = 122) and sleepy (ESS ≥10) OSA patients offered CPAP (n = 155) in the RICCADSA trial in Sweden were included in this substudy. The median follow‐up was 4.8 years for the main trial, with a predefined minimum follow‐up of 2 years.

Results

The probability of remaining on CPAP at 2 years was 60% in nonsleepy patients and 77% in sleepy patients. Multivariate analyses indicated that age and hours of CPAP use per night at 1 month were independently associated with long‐term CPAP use in nonsleepy patients. In the sleepy phenotype, body mass index, acute myocardial infarction at baseline, and hours of CPAP use per night at 1 month were predictors of long‐term CPAP use.

Conclusions

Long‐term use of CPAP is likely to be challenging for CAD patients with nonsleepy OSA. Early CPAP use is an important predictor of continued long‐term use of CPAP, so optimizing patients' initial experience with CPAP could promote adherence.

     

Adherence to Mediterranean Diet Reduces Incident Frailty Risk: Systematic Review and Meta‐Analysis

Objectives

To conduct a systematic review of the literature on prospective cohort studies examining associations between adherence to a Mediterranean diet and incident frailty and to perform a meta‐analysis to synthesize the pooled risk estimates.

Design

Systematic review and meta‐analysis.

Setting

Embase, MEDLINE , CINAHL , PsycINFO , and Cochrane Library were systematically searched on September 14, 2017. We reviewed references of included studies and relevant review papers and performed forward citation tracking for additional studies. Corresponding authors were contacted for additional data necessary for a meta‐analysis.

Participants

Community‐dwelling older adults (mean age ≥60).

Measurements

Incident frailty risk according to adherence to a Mediterranean diet.

Results

Two reviewers independently screened the title, abstract, and full text to ascertain the eligibility of 125 studies that the systematic search of the literature identified, and four studies were included (5,789 older people with mean follow‐up of 3.9 years). Two reviewers extracted data from the studies independently. All four studies provided adjusted odds ratios (OR s) of incident frailty risk according to three Mediterranean diet score (MDS ) groups (0–3, 4–5, and 6–9). Greater adherence to a Mediterranean diet was associated with significantly lower incident frailty risk (pooled OR = 0.62, 95% CI = 0.47–0.82, P  = .001 for MDS 4–5; pooled OR  = 0.44, 95% CI  = 0.31–0.64, P  < .001 for MDS 6–9) than poorer adherence (MDS 0–3). Neither significant heterogeneity (I ² = 0–16%, P  = .30) nor evidence of publication bias was observed.

Conclusion

Greater adherence to a Mediterranean diet is associated with significantly lower risk of incident frailty in community‐dwelling older people. Future studies should confirm these findings and evaluate whether adherence to a Mediterranean diet can reduce the risk of frailty, including in non‐Mediterranean populations.

     

Three‐months optical coherence tomography analysis of a biodegradable polymer,sirolimus‐eluting stent

Objective

We aimed to assess early neointimal healing by optical coherence tomography (OCT) 3 months after implantation of the ultrathin Orsiro® sirolimus‐eluting stent with biodegradable polymer.

Background

New generations of drug‐eluting stents with biodegradable polymer have been developed to avoid the continued vascular irritation of durable polymers.

Methods

In this prospective, open‐label study, 34 patients received an Orsiro® sirolimus‐eluting stent with biodegradable polymer. In a subgroup of patients (n = 15), the intervention was performed under OCT guidance. All patients underwent OCT‐examination at three months. The primary endpoint was 3‐month neointimal healing (NIH) score, calculated by weighing the presence of filling defects, malapposed and uncovered struts. Secondary endpoint was maturity of tissue coverage at 3 months.

Results

At 3 months, NIH score was 13.7 (5.4‐22), covered struts per lesion were 90% (84‐97%), malapposed struts were 2.7% (0.8‐5.4%) and rate of mature tissue coverage was 47% (42‐53%). No target lesion failure occurred up to 12 months. Patients with OCT‐guided stent implantation demonstrated a trend toward earlier stent healing as demonstrated by superior NIH scores (angio guided: 17.6% [8.8‐26.4]; OCT‐guided: 9.8% [4.0‐15.5]; mean difference ?8, [95%CI: ?18.7‐2.9], P = 0.123). This group had significantly more covered struts per lesion (angio‐guided: 86% [82‐90]; 95% [92‐99]; mean difference 9% [95%CI: 3‐15], P = 0.001).

Conclusion

The Orsiro® sirolimus‐eluting stent with biodegradable polymer shows early vascular healing with a high rate of strut coverage at 3‐month follow‐up. OCT guided stent implantation had a positive impact on early vascular healing.

     

Short‐ and Long‐Term Prognostic Value of the TIMI Risk Score after Primary Percutaneous Coronary Intervention for ST‐segment Elevation Myocardial Infarction

Objectives

We investigated the short‐ and long‐term predictive value of the TIMI risk score regarding mortality for patients treated with primary percutaneous coronary intervention (PPCI) for ST‐elevation myocardial infarction (STEMI).

Background

Data on the long‐term predictive value of the TIMI risk score is sparse.

Methods

We used data from 3,609 STEMI patients undergoing PPCI in a high‐volume PCI center in The Netherlands. Cumulative event rates according to TIMI score variables were estimated with the Kaplan‐Meier method and compared with the log‐rank test. The original TIMI risk score was modified based on the availability of the data in the single center registry.

Results

Higher TIMI scores were associated with significantly higher mortality at short‐ and long‐term follow‐up (P < 0.001 for both). Age and Killip Class IV at presentation were significant predictors for both short‐ and long‐term mortality. Patients with an anterior MI, heart frequence >100 beats per minute, or systolic blood pressure <100 mmHG had a worse short‐term prognosis compared to those who had not. However, long‐term mortality was nonsignificantly different. The presence of a history of diabetes/hypertension and weight had only long‐term prognostic value. Time to PPCI did not have any prognostic value.

Conclusions

Our current report shows that the TIMI risk score has both short‐ and long‐term discriminative value. The different variables contained in the TIMI risk score predict short‐term prognosis, others predominantly long‐term mortality, whereas some are predictive for both. (J Interven Cardiol 2013;26:8–13)

     

Low‐Dose Heparin for Elective Percutaneous Coronary Intervention

Objectives

We evaluated the safety and efficacy of low‐dose heparin (40 IU/kg) for elective percutaneous coronary intervention (PCI).

Background

Current guidelines recommend a 70–100 IU/kg bolus of heparin for elective PCI, but this dose may be associated with increased bleeding risk. Low‐dose heparin may have an advantage in this regard, but has not been well studied.

Methods

From January 2008 to October 2012, 300 patients underwent elective transfemoral PCI and were treated with an initial bolus of 40 IU/kg of heparin at the UCLA Medical Center. Dual antiplatelet therapy with clopidogrel and aspirin was administered prior to or just after diagnostic coronary angiography. The primary end‐point was the composite of cardiac death, myocardial infarction, urgent target vessel revascularization for ischemia, or major bleeding within 30 days after PCI.

Results

The mean activating clotting time was 233 ± 28 seconds. The primary end‐point occurred in 2.3%. The cardiac death rate was 0.3% but was not related to the PCI. The myocardial infarction rate was 1.3%. Urgent target vessel revascularization occurred in 1 patient (0.3%). The major bleeding rate was 0.3%. No stent thrombosis occurred.

Conclusion

Using a lower dose of heparin with dual antiplatelet therapy is safe and is associated with a low bleeding risk after transfemoral PCI while providing suppression of ischemic events. This may also represent a cost savings compared with other antithrombotic strategies. A randomized clinical trial comparing low‐dose heparin with bivalirudin in patients is required to determine the optimal anticoagulation strategy. (J Interven Cardiol 2014;27:58–62)

     

Thrombin‐Induced Platelet‐Fibrin Clot Strength Identified by Thrombelastography

Background and Objective

In‐stent restenosis (ISR) is a limitation of percutaneous coronary intervention and has been linked to specific clinical and angiographic variables. We aimed to simultaneously assess thrombosis biomarkers and lipid levels in patients with and without ISR.

Methods

Consecutive patients (n = 170) with a history of coronary stenting undergoing elective angiography were studied. Blood samples for thrombelastography, light transmittance aggregometry, and lipid levels were obtained prior to cardiac catheterization.

Results

Sixty‐nine patients (41%) had ISR (>50% luminal diameter stenosis). Among patients with ISR, 40 (58%) had ISR in more than one stent bed. Patients with ISR were more often female (37.7% vs. 21.8%, P = 0.04), had higher thrombin‐induced platelet‐fibrin clot strength (TIP‐FCS) (69.9 mm vs. 65.6 mm, P < 0.001), and a higher ApoB/A1 ratio (0.65 vs. 0.59, P = 0.03). In patients on dual antiplatelet therapy (n = 86), there were no differences in ADP‐, arachidonic acid‐, and collagen‐induced platelet aggregation between groups. The frequency of patients with ISR increased with TIP‐FCS quartiles and by ROC analysis, TIP‐FCS = 67.0 mm was the cutpoint for identification of ISR (AUC = 0.80 (95%CI 0.73–0.87, P < 0.0001). By multivariate analysis, TIP‐FCS ≥67.0 mm strongly associated with ISR (OR = 7.3, P = 0.004).

Conclusion

Patients with ISR identified at the time of cardiac catheterization have a prothrombotic phenotype indicated by high TIP‐FCS, a novel marker. Studies to confirm the prognostic utility of high TIP‐FCS for the development of ISR are ongoing. (J Interven Cardiol 2016;29:168–178)

     

First‐in‐Man Study of Dedicated Bifurcation Sirolimus‐eluting Stent: 12‐month Results of BiOSS LIM® Registry

Objectives

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent ‐ sirolimus‐eluting BiOSS LIM® (Balton, Poland) in 12‐month Registry.

Background

The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.

Methods

This was the international, 3‐center registry, which enrolled patients with non‐ST‐elevation acute coronary syndrome (NSTE‐ACS) and stable angina. Provisional T‐stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.

Results

A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE‐ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug‐eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow‐up (11 ± 1 months) there was 1 non‐cardiac death (1.7%), 1 non‐ST‐elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in‐stent thrombosis. Overall TLR was 8.3% (clinically driven TLR – 1.7%, angiographically driven – 6.6%). Mean late lumen loss was as follows: In main vessel – 0.35 ± 0.33 mm, in main branch – 0.34 ± 0.27 mm and in side branch – 0.18 ± 0.38 mm.

Conclusion

Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long‐term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis. (J Interven Cardiol 2015;28:51–60)