Objectives This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus ...Liberté, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention. Background Although the efficacy of the drug-eluting stent has been well established, the risk-benefit balance is still suboptimal, and the safety of polymers remains uncertain. Methods Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberté stents. Primary endpoint was 6-month angiographic in-stent late lumen loss (LLL) within a noninferiority scope. Six-month intravascular ultrasound was performed in 20% of the patients. All patients will be clinically followed up to 5 years. Results Out of 323 patients enrolled, 162 received Cre8 and 161 Taxus Liberté stents. In-stent LLL was significantly lower in Cre8 group (0.14 ± 0.36 mm vs. 0.34 ± 0.40 mm, p noninferiority <0.0001, p superiority <0.0001). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis) up to 12 months did not differ significantly between the groups. Conclusions The Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberté stent did, with a trend toward better 12-month clinical safety and efficacy results. (International Randomized Comparison Between DES Limus Carbostent and Taxus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions NEXT; NCT01373502 )
Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a ...polymer-free design versus a permanent-polymer one on the long-term.
Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320–3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112–6.278).
Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.
•Cre8 stent characteristics•Polymer-free drug eluting stent,•Amphilimus formulation allowing high concentration of limus-drug into the cells,•Similar results concerning target lesion revascularisation in diabetic and non diabetic patients.
Chronic heart failure in France is responsible for 160 000 hospitalizations per year. The treatment of chronic heart failure is multidisciplinary. Telemedicine (TLM) reinforces the therapeutic ...arsenal of this chronic pathology by the use of remote monitoring (TLS) on patients followed outside the care structure. This paradigm has proven its effectiveness with the help of digital networks and specific algorithms, which communicate through connected tools with the ICC patient. Clinical signs of worsening can trigger an alert that will be taken into account by the TLS. Early intervention on these warning signs avoids acute decompensation and a new hospitalization of the patient. The analysis of the results shows a rate of alerts that require the intervention of TLS teams, from 20 to 35% depending on the centers. The ETAPES program has set the regulatory framework for the TLS experiment for 4 years. It will end at the end of 2021. The feedback from the TLS centers is between 6 and 18 months. The satisfaction index of patients followed by TLS is 95%. The intermediate results (2018, 2019) and the evaluation of the ETAPES program, are in favor of TLS management of ICC patients. Therapeutic education and TLS improve patients' quality of life. The Ministry of Health plans a transition to the common law for TLS in 2022.
L'insuffisance cardiaque chronique en France, est responsable de 160 000 hospitalisations par an et son traitement est multidisciplinaire.
La télémédecine vient renforcer l'arsenal thérapeutique de ...cette pathologie chronique par l'utilisation de la télésurveillance (TLS) intervenant à distance sur les patients suivis hors de la structure de soins. Ce paradigme a fait la preuve de son efficacité à l'aide de réseaux digitaux et d'algorithmes spécifiques, qui communiquent par des outils connectés avec le patient ICC. Des signes cliniques d'aggravation peuvent déclencher une alerte qui va être prise en compte par la TLS. L'intervention précoce sur ces signes d'alerte évite la décompensation aiguë et une nouvelle hospitalisation du patient. L'analyse des résultats retrouve un taux d'alertes qui nécessitent l'intervention des équipes de TLS, de 20 à 35 % selon les centres. Le programme ETAPES a fixé le cadre réglementaire de l'expérimentation de la TLS pour 4 ans. Elle se termine à la fin de l'année 2021. Le retour d'expériences des centres TLS a un recul de 6 à 18 mois. L'indice de satisfaction des patients suivis par TLS est de 95 %.
Les résultats intermédiaires (2018, 2019) et l’évaluation du programme ETAPES, sont en faveur de la prise en charge par TLS des patients ICC. L’éducation thérapeutique et la TLS améliorent la qualité de vie des patients. Le ministère de la santé prévoit un passage dans le droit commun de la TLS en 2022.
Chronic heart failure in France is responsible for 160 000 hospitalizations per year. The treatment of chronic heart failure is multidisciplinary.
Telemedicine (TLM) reinforces the therapeutic arsenal of this chronic pathology by the use of remote monitoring (TLS) on patients followed outside the care structure. This paradigm has proven its effectiveness with the help of digital networks and specific algorithms, which communicate through connected tools with the ICC patient. Clinical signs of worsening can trigger an alert that will be taken into account by the TLS. Early intervention on these warning signs avoids acute decompensation and a new hospitalization of the patient. The analysis of the results shows a rate of alerts that require the intervention of TLS teams, from 20 to 35% depending on the centers. The ETAPES program has set the regulatory framework for the TLS experiment for 4 years. It will end at the end of 2021. The feedback from the TLS centers is between 6 and 18 months. The satisfaction index of patients followed by TLS is 95%.
The intermediate results (2018, 2019) and the evaluation of the ETAPES program, are in favor of TLS management of ICC patients. Therapeutic education and TLS improve patients' quality of life. The Ministry of Health plans a transition to the common law for TLS in 2022.
Background
The polymer‐free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with ...1‐month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all‐comers' population.
Methods
We conducted a prospective single‐arm study of patients undergoing percutaneous coronary intervention with the polymer‐free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target‐vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci‐TLR) at 1‐year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC‐HBR definition.
Results
Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci‐TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non‐HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non‐HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non‐HBR group (relative risk 1.62 95% confidence interval: 1.10–2.41, p = 0015). Compared to the non‐HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci‐TLR. BARC 3–5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non‐HBR group (p < 0.0001).
Conclusion
In this multicenter all‐comers study, HBR patients treated with a polymer‐free biolimus coated stent had, compared to non‐HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3–5 bleeding.
Objectives. Robotic surgery enables to perform coronary surgery totally endoscopically. This report describes our experience using the da Vinci system for coronary artery bypass surgery. Methods. ...Patients requiring single-or-double vessel revascularization were eligible. The procedure was performed without cardiopulmonary bypass on a beating heart. Results. From April 2004 to May 2008, fifty-six patients were enrolled in the study. Twenty-four patients underwent robotic harvesting of the mammary conduit followed by minimal invasive direct coronary artery bypass (MIDCAB), and twenty-three patients had a totally endoscopic coronary artery bypass (TECAB) grafting. Nine patients (16%) were converted to open techniques. The mean total operating time for TECAB was 372±104 minutes and for MIDCAB was 220±69 minutes. Followup was complete for all patients up to one year. There was one hospital death following MIDCAB and two deaths at follow up. Forty-eight patients had an angiogram or CT scan revealing occlusion or anastomotic stenoses (>50%) in 6 patients. Overall permeability was 92%. Conclusions. Robotic surgery can be performed with promising results.
...SAPIEN 3 patients had a higher prevalence of peripheral arterial disease (65.2 vs. 36.8%, p=0.001) and ilio-femoral axis calcifications on scanner (47.9 vs; 26.5 %, p=0.008) than the others. ......SAPIEN 3 patients had a smaller aortic valve area than SAPIEN-XT subjects (0.67±0.9 vs 0.76 ± 0.14 cm2/m2, p=0.007), yet there was no significant difference in aortic annulus diameter (25±4.5 vs 23.8±2 mm, p=ns).
A European, multicenter, prospective, non-randomized, clinical pilot trial was designed to evaluate the feasibility of the Perceval S sutureless aortic valve prosthesis. A clinical and ...echocardiographic follow up was performed at the time of hospital discharge and subsequently after one, three, six, and 12 months.
The valve was implanted following sternotomy, extracorporeal circulation (ECC), aortic cross-clamping, cardioplegic arrest, and removal of the native valve. Implantation suturing was not required. Optimal annular sealing was obtained with brief low-pressure balloon dilation. If coronary bypass was indicated, a distal anastomosis was performed first. Between April 2007 and February 2008, 30 patients (mean age: 81 +/- 4 years) underwent aortic valve replacement. The prevalence of pure aortic stenosis was 76.7%, and that of mixed lesion 23.3%. The mean logistic EuroSCORE was 13.18%, and the NYHA class was III and IV in 93.3% and 6.7% of patients, respectively. The implanted valve size was 21 and 23 mm in 37% and 63% of patients, respectively, and 14 (46.7%) underwent coronary artery bypass grafting (11 internal mammary artery, nine vein grafts).
The mean aortic cross-clamp and ECC times were 34 +/- 15 min and 59 +/- 21 min, respectively. There was one in-hospital death (3.3%), and three deaths occurred within 12 months of follow up (one death was valve-related, and two deaths were independent of the valve implantation). A total of 28 patients was assessed at one month post-implantation, and 23 after 12 months. No migration or dislodgement of the valve had occurred, but there were two mild paravalvular leakages and two mild intravalvular insufficiencies.
The preliminary results of the trial confirmed the safety and efficacy of the Perceval S sutureless aortic valve. In this high-risk subset of patients, shortening the aortic cross-clamp and ECC times may help to reduce mortality and morbidity.
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