scholarly journals A prospective multicentre randomized all-comers trial to assess the safety and effectiveness of the ultra-thin-strut sirolimus-eluting coronary stent Supraflex: 2-year results of the TALENT trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Gao ◽  
N Kogame ◽  
P Smits ◽  
P Tonino ◽  
R Moreno ◽  
...  

Abstract Background and purpose Supraflex is a sirolimus-eluting stent with a biodegradable polymeric coating and 60um ultra-thin struts. In the TALENT study, we found the Supraflex stent was non-inferior to the Xience stent for a device-oriented composite endpoint (DOCE, defined as cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation) at 12 months in an all-comer population. Additionally, per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation (CI-TLR) in the Supraflex group than in the Xience group. We now present the 2-year follow-up results. Methods The TALENT study was a prospective, randomised, single-blind, multicentre study across 23 centres in Europe. Eligible participants underwent percutaneous coronary intervention in an all-comers fashion in vessels of 2.25–4.5 mm. Patients were randomized (1:1) to implantation of either Supraflex or Xience (NCT02870140). Results Between October 21, 2016 and July 3, 2017, 720 patients with 1046 lesions were randomly assigned to Supraflex, and 715 patients with 1030 lesions to Xience. At 24 months, DOCE had occurred in 49 patients (6.9%) in the Supraflex group and in 56 patients (7.9%) in the Xience group (absolute difference −1.0% [95% CI: −3.7 to 1.7], Plog-rank=0.491). Per-protocol analysis at 24 months showed CI-TLR occurred in 21 and 30 patients in the Supraflex and Xience, respectively (3.3% versus 4.5%, absolute difference −1.2%, [95% CI: −3.3 to 0.9], Plog-rank=0.267). Conclusion In an all-comer population, at 2-year follow-up, the use of Supraflex stent was at least as safe and efficacious as Xience stent. However, the significantly lower rate of CI-TLR shown in patients treated with Supraflex at 1-year was no longer retained in the 2-year results. Whether theoretical advantage of ultra-thin strut drug eluting stents Supraflex can translate into clinical benefit or not will be further elucidated through a total of 3 years of follow-up. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SMT

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Ploumen ◽  
R.A Buiten ◽  
P Zocca ◽  
A Roguin ◽  
C.J.M Doggen ◽  
...  

Abstract Background/Introduction The novel thin composite-wire strut zotarolimus-eluting stent (ZES) is a drug-eluting stent that is frequently used for treating patients with obstructive coronary artery disease, but so far no clinical outcome data have been published in patients with diabetes. In all-comer patients, the BIONYX trial (NCT02508714) has established non-inferiority of the ZES versus the ultrathin strut biodegradable-polymer sirolimus-eluting stent (SES) regarding the primary composite endpoint of target vessel failure at 1 year follow-up. Purpose To assess in patients with diabetes, the 2-year safety and efficacy of the current generation thin composite-wire strut ZES, compared to the ultrathin strut SES. Methods In the international, multicentre BIONYX trial, randomisation was stratified for sex and the presence of diabetes mellitus. We performed a prespecified subgroup analysis of patients with diabetes. The main endpoint target vessel failure was a composite of safety and efficacy, consisting of cardiac death, target vessel-related myocardial infarction or clinically indicated target vessel revascularisation. Secondary endpoints, such as target lesion revascularisation and stent thrombosis were also assessed. Results A total of 510/2488 (20.5%) BIONYX trial participants had diabetes, and were therefore included in this analysis. Patients were on average 66.4±10.3 years old, and 28.6% were female. Most participants presented with acute coronary syndromes (65.1%), and 182/510 (35.7%) patients were insulin dependent. Two-year follow up was available in 500 of 510 (98.0%) patients. Target vessel failure occurred in 31/260 (12.2%) patients assigned to ZES versus 26/250 (10.7%) patients assigned to SES (HR 1.14, 95%-CI 0.68–1.92; P-logrank=0.63). Kaplan Meier curves of target vessel failure are displayed in Figure 1. There were no significant between-stent differences in the individual components of this endpoint. Target lesion revascularisation occurred in 15/260 (6.0%) patients treated with ZES versus 9/250 (3.7%) patients treated with SES (HR 1.61, 95%-CI 0.71–3.68; P-logrank=0.25). Definite stent thrombosis was an infrequent event and did not differ significantly between stent-arms (0.4% vs. 1.2%; HR 0.32, 95%-CI 0.03–3.06; P-logrank=0.30). Conclusion In patients with diabetes, the novel thin composite-wire strut durable polymer ZES was similarly safe and efficacious as compared to the ultrathin cobalt-chromium strut biodegradable-polymer SES at 2-year follow-up. Figure1. Target vessel failure at 2 years Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The BIONYX trial was equally funded by Biotronik and Medtronic.


VASA ◽  
2012 ◽  
Vol 41 (2) ◽  
pp. 90-95 ◽  
Author(s):  
Rastan ◽  
Noory ◽  
Zeller

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M De Carlo ◽  
R Liga ◽  
G.M Migaleddu ◽  
M Scatturin ◽  
C Spaccarotella ◽  
...  

Abstract Background Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL. Methods Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up. Results Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up. Conclusions SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Rapezzi ◽  
A.V Kristen ◽  
B Gundapaneni ◽  
M.B Sultan ◽  
M Hanna

Abstract Background In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis was shown to be an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Further assessment of the efficacy of tafamidis in patients with more advanced ATTR-CM would aid treatment decisions. Purpose To characterize the benefits of tafamidis in patients with advanced ATTR-CM. Methods In ATTR-ACT, ATTR-CM patients were randomized to tafamidis (n=264) or placebo (n=177) for 30 months. Efficacy outcomes included all-cause mortality and frequency of cardiovascular (CV)-related hospitalisations. Key secondary endpoints were change from baseline to Month 30 in 6MWT distance and KCCQ-OS score. Efficacy assessments in NYHA Class III patients at baseline (n=141) were a pre-specified analysis. In a post-hoc analysis, mortality and CV-related hospitalizations were assessed in all patients grouped into quartiles of increasing disease severity based on 6MWT distance at baseline. Longer-term all-cause mortality (as of 1 Aug 2019) was assessed in NYHA Class III patients utilizing data from ATTR-ACT patients who enrolled in a long-term, extension study (LTE) and continued treatment with higher dose tafamidis (n=55; median treatment duration 51.6 months); or, if previously treated with placebo, started tafamidis treatment (placebo/tafamidis; n=63 [50.1 months]). Results In advanced ATTR-CM patients (NYHA Class III), tafamidis reduced the risk of death (HR [95% CI] 0.837, [0.541, 1.295], P=0.4253), and the decline in 6MWT distance (LS mean [SE], 31.6 (22.1) m; P=0.1526) and KCCQ-OS score (LS mean [SE], 13.1 (5.0); P=0.0090), vs placebo. Paradoxically, there was a higher frequency of CV-related hospitalizations with tafamidis (RR [95% CI] vs placebo, 1.411 [1.048, 1.900]). In all patients by 6MWT quartile, CV-related hospitalizations/year with tafamidis and placebo increased with disease severity, with the exception that placebo-treated patients in the highest severity quartile had fewer CV-related hospitalisations (0.73) than those in the third quartile (0.92). Mortality with tafamidis and placebo increased, and was greater with placebo, in every quartile (Figure). Survival (NYHA Class III patients in ATTR-ACT and LTE) was improved with high dose tafamidis with longer term follow-up (HR vs placebo/tafamidis [95% CI], 0.6569 [0.4175, 1.0336]; P=0.0692). Conclusions These analyses, including longer-term follow-up, demonstrate that patients with advanced ATTR-CM benefit from tafamidis. The decrease in CV-related hospitalisations in more severe patients treated with placebo suggests that the comparatively greater hospitalisation frequency in NYHA Class III patients treated with tafamidis is a consequence of their lower mortality rate. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Krljanac ◽  
D Trifunovic ◽  
M Asanin ◽  
L Savic ◽  
J Vratonjic ◽  
...  

Abstract Background Malignant arrhythmias, ventricular tachycardia or ventricular fibrillation (VT/VF) in acute myocardial infarction (AIM) carry ominous prognosis including sudden cardiac death (SCD). It is not clear whether the timing of VT/VF occurrence always affects the poor prognosis of patients with AMI. Aim To investigate the prognosis of patients who undergoing primary percutaneous coronary intervention (PCI) in accordance with timing of VT/VF and to find the power predictors of their occurrence. Methods 307 consecutive patients in PREDICT-VT study (NCT03263949), 57.9±10.6 year old, 72.3% males were analysed. Of these patients, 27.7% had VT/VF from the symptoms onset, within 48 hours of AIM (early VT/VF group). 8.1% of patients had VT/VF after 48h, during one year follow up (late VT/VF group). Results The frequency of VT/VF occurrence was high between symptoms onset and the end of 2nd month and during 5th and 6th month of AIM. The parameters of conventional echocardiography were significantly impaired in late VT/VF group, as well as parameters of longitudinal strain (LS) (table). Moreover, the MACE (cardiovascular mortality, SCD, new infarction, emergency revascularisation, and hospitalized heart failure) was the highest in late VT/VF group (p=0.000). The most significant predictor of late VT/VF was systolic LS (cut off −12.72%, ROC 0.680, Sen 71%, Sp 64%, p=0.006). Conclusions Although late VT/VF occurrence after primary PCI were less frequent than early VT/VF occurrence, patients with late VT/VF had a very poor prognosis. The most power predictor of late VT/VF were systolic longitudinal strain. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Clinical Center of Serbia


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.F Watts ◽  
C Schwabe ◽  
R Scott ◽  
P Gladding ◽  
D Sullivan ◽  
...  

Abstract Background Elevated LDL-C and triglyceride rich lipoproteins (TRLs) are independent risk factors for cardiovascular disease (CVD). Genetic deficiency of angiopoietin-like protein 3 (ANGPTL3) is associated with reduced circulating levels of LDL-C, triglycerides (TGs), VLDL-C, HDL-C and reduced CVD risk, with no described adverse phenotype. ARO-ANG3 is a RNA interference drug designed to silence expression of ANGPTL3. Single doses of ARO-ANG3 have been shown to reduce ANGPTL3, TGs, VLDL-C and LDL-C in healthy volunteers (HVs, AHA 2019). We report the effects of multiple doses of ARO-ANG3 in HVs with a focus on the duration of action. Methods ARO-ANG3 was administered subcutaneously to HVs on days 1 and 29 at doses of 100, 200 or 300 mg (n=4 per group). Measured parameters included ANGPTL3, LDL-C, TGs, VLDL-C and HDL-C. Follow up is ongoing. Results All HVs have received both doses and follow-up is currently through week 16 (12 weeks after second dose). Mean nadir for ANGPTL3 levels occurred 2 weeks after the second dose (−83–93%) with minimal change for 200 and 300 mg but 16% recovery for 100 mg at week 16. Mean TGs and VLDL-C reached nadir earlier (3 wks, −61–65%) without apparent dose response and minimal change for any dose at wk 16. LDL-C nadir occurred 4–6 wks after the second dose (−45–54%), again with minimal evidence for dose response or change through wk 16. HDL-C was reduced 14–37% at wk 16. ARO-ANG3 was well tolerated without serious or severe adverse events or dropouts related to drug. The most common adverse events have been headache and upper respiratory infections. Conclusions Genetic deficiency of ANGPTL3 is a cause of familial combined hypolipemia and is associated with a decreased risk of CVD. Using RNAi to selectively suppress ANGPTL3 production reproduces these genetic effects with a duration of at least 12 weeks following a second dose and with good tolerability over 16 wks. ANGPTL3 inhibition results in lowering of LDL-C and TRLs which may confer protection against CVD in patients with atherogenic mixed dyslipidemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Arrowhead Pharmaceuticals


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R De Caterina ◽  
M Gwechenberger ◽  
A Bakhai ◽  
P Monteiro ◽  
P Kelly ◽  
...  

Abstract Background Edoxaban is an oral factor Xa inhibitor anticoagulant with 50% renal clearance, and proven efficacy and safety in patients (pts) with atrial fibrillation (AF). The post-authorisation, observational, ETNA-AF-Europe registry (NCT02944019) assessed the risks and benefits of edoxaban in pts with AF from 10 European countries. Purpose Evaluate baseline characteristics and event rates in pts categorised by creatinine clearance (CrCl) at 1-year follow-up of the ETNA-AF-Europe registry. Methods In this analysis, pts were divided into three groups according to CrCl: ≤50 ml/min (I), 50–80 mL/min (II) and ≥80 mL/min (III) (calculated using Cockcroft-Gault). Outcomes were descriptively analysed. Results Pts with the lowest CrCl (Group I) were mostly females, and had a higher mean age, lower body weight, higher stroke and bleeding risk scores and were considered more frail than those with higher CrCl (Groups II and III) (Table). Group I experienced higher rates of stroke or SEE, major or CRNM bleeding, cardiovascular death, and had a higher total mortality (Figure). Rates of intracranial haemorrhage (ICH) and haemorrhagic stroke (intracerebral and subarachnoid haemorrhage) were low and similar in pts across the range of CrCl. Conclusions Those with lower CrCl had more comorbidities and higher event rates than those with higher CrCl, with the exception of ICH and haemorrhagic stroke. A steep rise in the proportion of pts perceived as frail and in overall mortality in the lowest renal function tertile, raises the question whether low renal function is a determinant or a correlate of mortality. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH, Munich, Germany


2016 ◽  
Vol 9 (1) ◽  
pp. 49-54
Author(s):  
Afzalur Rahman ◽  
Farhana Ahmed ◽  
Mohammad Arifur Rahman ◽  
Syed Nasir Uddin ◽  
Md Zillur Rahman ◽  
...  

Background: The ostial left anterior descending coronary artery (LAD) lesion is an important target for coronary revascularization because its location subtends a large territory of myocardium. Ostial lesions have a reputation of being fibrotic, calcified, and relatively rigid. Greater degraees of rigidity and recoil resulted in lower acute gain and higher rates of target lesion revascularization (TLR) following percutaneous coronary intervention (PCI). In addition, procedural complications such as dissections, vessel closure and myocardial infarction were more frequent. Aim of the study was to evaluate a simple but innovative technique to deal with significant LAD ostial lesion.Methods: This prospective study was conducted between January 2010 and February 2013. Patients with significant angiographic de novo ostial LAD artery stenoses were identified and screened for study eligibility. An ostial stenosis was defined as an angiographic narrowing of e” 70% located within 3 mm of the vessel origin. Study included all consecutive patients with ostial lesions who underwent elective PCI and stent deployment. The study population consisted of 36 patients.Results: Among 36 patients 27 (75%) were male. mean age was 55.75 ± 8.07 years. 21 (58.3%) had diabetes, 15 (41.7%) hypertension, 21 (58.3%) hypercholesterolemia, 24 (66.66%) were smoker and 18 (50%) had F/H of CAD. Among them 6 (16.7%) had STEMI, 9 (25%) had NSTEMI, 12 (33.3%) had UA and 9 (25%) CSA. CAG showed 15 (41.7%) SVD, 15 (41.7%) DVD and 6 (16.7%) were TVD. LAD ostial stenosis were 83.16 ± 10.14%. Considering procedural characteristics, DES were 33 (91.7%) and BMS were 3 (8.3%). DES polymers were Evarolimus 15 (41.7%), Zotarolimus 12 (33.3%) and Biolimus 6 (16.7%). Mean stent length were 21.75 ± 8.07 mm. Mean stent diameter were 2.83 ± 0.28 mm. Minimum follow up time was 9 months and maximum follow up time was 44 months. There were no MACE but Angina (CCS II) were 2 (5.55%) and LVF (NYHA II) were 1(2.77%).Conclusion: Precise placement of LAD ostial stent is always challenging. Several technique applied but results not always satisfactory. Our strategies were precise location of stent implantation at ostium by adopting special technique of simultaneous balloon placement from distal LM to proximal LCX preventing unwanted stent movement during its placement and also properly guiding us for precise stent placement at the ostium. Parked balloon from distal LM to LCX will also be helpful for quick measure for any plaque shifting into LCX.Cardiovasc. j. 2016; 9(1): 49-54


2019 ◽  
Author(s):  
Tilman Stephan ◽  
Nadine Goldberger ◽  
Mirjam Keßler ◽  
Dominik Felbel ◽  
Manuel Rattka ◽  
...  

Abstract Background: Percutaneous coronary intervention (PCI) of left main coronary artery disease (LMD) is associated with appropriate clinical and angiographic outcomes, resulting in a class I recommendation in patients with less complex coronary anatomy. Due to higher SYNTAX scores and worse clinical outcomes, PCI in distal LMD is accomplished with a lower strength of recommendations for revascularization compared to ostial LM lesions. We compare angiographic and clinical outcomes of ostial/midshaft lesions versus distal lesion in LMD after PCI. Methods: This retrospective study included 176 patients with LMD undergoing PCI with drug-eluting stents. The study population was divided into 34 patients with ostial/midshaft LMD and 142 patients with distal LMD. Patients were routinely scheduled for 9 months of angiographic and 12 months of clinical follow-up. Quantitative coronary analysis (QCA) was performed for all lesions, using an 11-segment model. Primary outcome was MACE (major adverse cardiac events) defined as a composite of cardiac death, myocardial infarction and target lesion revascularization (TLR). Results: The primary outcome measure was comparable in both cohorts after 12 months follow-up (20.6% in ostial/midshaft LMD vs. 17.6% in distal LMD, P=0.71). As expected, TLR rates were increased in distal LM lesions compared to ostial LM lesions, but without reaching statistical significance (14.1% vs. 5.9%, P=0.15). Late lumen loss (LLL) in ostial/midshaft LMD was 0.42±0.33mm. In distal LM lesions value for LLL in the main vessel was 0.42±0.97 mm, with the highest values observed in segments adjacent to the bifurcation (0.37±1.13mm and 0.37±0.73 mm). On cox proportional regression analysis LLL in a bifurcation segment (P=0.03, HR 1.68 [1.1-2.7]) and diabetes mellitus (P=0.046, HR 2.77 [1.0-7.5] were independent correlates for occurrence of MACE. Conclusion: PCI of distal LM lesions result in comparable angiographic and clinical outcomes compared to ostial LM lesions. Highest rates for binary restenosis were observed in segments nearest to the bifurcation.


2020 ◽  
Vol 9 (6) ◽  
pp. 1640 ◽  
Author(s):  
Przemysław Święcki ◽  
Robert Sawicki ◽  
Małgorzata Knapp ◽  
Karol Adam Kamiński ◽  
Katarzyna Ptaszyńska-Kopczyńska ◽  
...  

Galectin-3 (Gal-3) is a new independent risk factor in the development and severity of coronary artery disease (CAD). The aim of the study was to evaluate whether Gal-3 concentration has prognostic value and if it reflects the progression of atherosclerosis in carotid arteries in patients with CAD after acute myocardial infarction (AMI). The analysis included 110 patients who were hospitalized due to AMI, treated with primary coronary intervention (PCI) and further attended a follow-up visit, and 100 healthy volunteers. The Gal-3 concentration and carotid ultrasound were evaluated at baseline and on a follow-up visit. We found that the Gal-3 concentration in the group with hyperlipidemia decreased during the observation (10.7 vs. 7.9 ng/mL, p = 0.00003). Patients rehospitalized during follow up had higher concentration of Gal-3 in the acute phase of myocardial infarction (MI) (10.7 vs. 7.2 ng/mL, p = 0.02; 10.1 vs. 8.0 ng/mL, p = 0.002, respectively). In the group of patients who had none of the following endpoints: subsequent MI, PCI, coronary artery bypass grafting (CABG) or stroke, there was a decrease in Gal-3 concentration at the follow-up visit. Parameters affecting the frequency of a composite endpoint occurrence are: the presence of atheromatous plaque in the carotid artery (p = 0.017), Gal-3 (p = 0.004) and haemoglobin (p = 0.03) concentration. In multivariate analysis, only Gal-3 concentration higher than 9.2 ng/mL at discharge was associated with a nine-fold increase of risk of composite endpoint occurrence (p = 0.0005, OR = 9.47, 95% CI 2.60–34.45). A significant decrease in Gal-3 concentration was observed in the group of patients after AMI without the endpoint occurrence during observation.


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