BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons

Background: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures. Methods: MIMICS 3D is a prospective, European, multi-centre, observational registry to evaluate the BioMimics 3D stent in a real-world population through 3 years. A propensity-matched comparison was performed to investigate the effect of the additional use of drug-coated balloons (DCB). Results: The MIMICS 3D registry enrolled 507 patients (518 lesion, length 125.9 ± 91.0 mm). At 3 years, the overall survival was 85.2%, freedom from major amputation 98.5%, freedom from clinically driven target lesion revascularisation 78.0%, and primary patency 70.2%. The propensity-matched cohort included 195 patients in each cohort. At 3-year follow-up, there was no statistically significant difference in clinical outcomes, such as overall survival (87.9% in the DCB vs. 85.1% in the no DCB group), freedom from major amputation (99.4% vs. 97.2%), clinically driven TLR (76.4% vs. 80.3%), and primary patency (68.5% vs. 74.4%). Conclusion: The MIMICS 3D registry showed good 3-year outcomes of the BioMimics 3D stent in femoropopliteal lesions, demonstrating the safety and performance of this device under real-world conditions, whether used alone or in combination with a DCB

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Pharmacological study of the effect of Clopidogrel and/or Atorvastatin on platelet reactivity after stimulation with different agonists

Titelblatt und Inhaltsverzeichnis Einleitung Grundlagen Methodik Ergebnisse Diskussion Zusammenfassung Literaturverzeichnis AnhangDie Kernpunkte in der Therapie kardiovaskulärer Erkrankungen sind Lipidsenkung und Thrombozyteninhibition. Die Senkung des Serumcholesterols, die Hemmung der Thrombozytenfunktion sowie die Verbesserung der Endotheldysfunktion können die Progression von atherosklerotischen Plaques vermindern. Beobachtungen zur Arzneimittelinteraktion zwischen dem Lipidsenker Atorvastatin und dem Thrombozytenhemmer Clopidogrel sind von besonders hoher klinischer Bedeutung. Es wurde berichtet, dass die Gabe beider Substanzen aufgrund von Wechselwirkungen während der Metabolisierung in der Leber die Wirksamkeit des Clopidogrels beeinträchtigt. Patienten, die Atorvastatin und Clopidogrel einnehmen, würden einem erhöhten Risiko für sekundäre kardiovaskuläre Komplikationen nach perkutaner Koronarintervention und Myokardinfarkt unterliegen. Die vorliegende Arbeit untersuchte, wie sich die Kombinationstherapie von Clopidogrel plus Atorvastatin im Gegensatz zur Clopidogrelmonotherapie auf die Thrombozytenfunktion bei gesunden Probanden auswirkt. Auch bei Patienten mit manifester koronarer Herzkrankheit, die neben Atorvastatin noch weitere Medikamente einnahmen, wurde die thrombozyteninhibierende Wirkung von Clopidogrel analysiert. Die Agonist- induzierte Thrombozytenreaktivität wurde anhand einer durchflusszytometrischen Quantifikation von Plättchenaktivierungsmarkern und der Aggregation im Vollblut evaluiert. Die dreitägige Therapie mit Atorvastatin reduzierte die Degranulation der Blutplättchen bei den gesunden Probanden. Unter der Kombinationstherapie von Clopidogrel und Atorvastatin zeigte sich am Ende der Beobachtung teilweise eine bessere Thrombozytenfunktionshemmung als unter der Monotherapie mit Clopidogrel. 96 Stunden nach Beginn der Clopidogrelgabe waren thrombozytäre Degranulation und Aggregation bei den KHK-Patienten mit begleitender Atorvastatintherapie ebenfalls gehemmt. Somit wurde eine Wirkungsverminderung des Clopidogrels durch Atorvastatin sowohl bei gesunden Probanden als auch bei Patienten mit KHK nicht nachgewiesen. Vielmehr war die Thrombozytenfunktion unter der zusätzlichen Gabe von Atorvastatin teilweise stärker gehemmt. Das Risiko der Patienten mit KHK, an sekundären kardiovaskulären Ereignissen zu erkranken, korreliert deutlich mit der Prothrombogenität der Thrombozyten. Aus diesem Grund ist die Wirksamkeit der medikamentösen antiaggregatorischen Therapie von entscheidender Bedeutung für die klinische Prognose der Patienten. Unsere Untersuchung zeigte, dass die Kombinationstherapie aus einem Statin und Clopidogrel die Thrombozytenreaktivität teilweise wirksamer hemmt als eine Monotherapie. Dies könnte die Prognoseverbesserung erklären, die in der CREDO-Studie bei Patienten mit der kombinierten Gabe von Statin und Clopidogrel beobachtet wurde.Atorvastatin inhibit cholesterol synthesis, lower LDL-cholesterol and therefore reduce cardiovascular morbidity and mortality. Clopidogrel is an irreversible ADP receptor antagonist (P2Y12) on platelets. Clopidogrel inhibits platelet activation and aggregation. Both drugs are frequently combined in patients with coronary artery disease after coronary intervention or acute myocardial infarction. The co-administration with Atorvastatin has been suggested to reduce Clopidogrels platelet inhibitory effects due to shared enzymes in metabolism. We investigated in healthy individuals and patients with coronary artery disease platelet inhibition by Clopidogrel alone and in combination with Atorvastatin. In healthy individuals we observed a reduction of platelet reactivity by Atorvastatin alone. The addition of Clopidogrel to the ongoing Atorvastatin medication led to further platelet inhibition. The effect of Clopidogrel was not impaired by Atorvastatin. Moreover the co-administration of both drugs led to larger platelet inhibition than the therapy with Clopidogrel alone. These results shed additional light on the discussion of a possible drug-drug interaction between Atorvastatin and Clopidogrel

Successful treatment with bedtime basal insulin added to metformin without weight gain or hypoglycaemia over three years

The aim of this observational study was to follow-up patients with bedtime basal insulin (NPH insulin) added to metformin. In 285 patients with type 2 diabetes, a therapy with bedtime basal insulin added to metformin was started due to failure to achieve a glycaemic goal. Up until July 2019, 272 patients (95.4%) were followed-up (59.5 y, 92.6 kg, diabetes duration 6.6 y, HbA1c 8.4%/68.6 mmol/mol). HbA1c decreased by −1.2% and bodyweight by −1.7 kg after a duration of 31.7 ± 29.1 (range 2–133) months. Severe hypoglycaemia did not occur. In 144/272 patients (52.9%), the therapeutic goal for HbA1c was achieved over 32.7 months. In 69/272 patients (25.4%), the HbA1c target was achieved over 25.0 months (afterwards, therapy with basal insulin was discontinued because HbA1c was under target). In 36/272 patients (13.2%), the HbA1c goal was achieved until the submission of this manuscript (mean duration of treatment 57.4 ± 28.2 (range 13–121) months). Over 90% of patients with type 2 diabetes and failure of metformin reached their HbA1c goal with additional basal insulin at bedtime over several years in association with a reduction of bodyweight and without any event of severe hypoglycaemia

Effect of concomitant Renal DeNervation and cardiac ablation on Atrial Fibrillation recurrence: RDN+AF study

Background: Renal denervation (RDN) can reduce cardiac sympathetic activity maintained by arterial hypertension (aHT). Its potential antiarrhythmic effect on rhythm outcome in patients with multi-drug resistant aHT undergoing catheter ablation for atrial fibrillation (AF) is unclear. Methods: The RDN+AF study was a prospective, randomized, two-center trial. Patients with paroxysmal or persistent AF and uncontrolled aHT (mean systolic 24-h ambulatory BP > 135 mmHg) despite taking at least three antihypertensive drugs were enrolled. Patients were 1:2 randomized to either RDN+AF ablation or AF-only ablation. Primary endpoint was freedom from any AF episode > 2 min at 12 months assessed by implantable loop recorder (ILR) or 7d-holter electrocardiogram. Secondary endpoints included rhythm outcome at 24 months, blood pressure control, periprocedural complications, and renovascular safety. Results: The study randomized 61 patients (mean age 65 ± 9 years, 53% men). At 12 months, RDN+AF patients tended to have a greater decrease in ambulatory BPs but did not reach statistical significance. No differences in rhythm outcome were observed. Freedom from AF recurrence in the RDN+AF and AF-only group measured 61% versus 53% p = .622 at 12 months and 39% versus 47% p = .927 at 24 months, respectively. Periprocedural complications occurred in 9/61 patients (15%). No patient died. Conclusion: Among patients with multidrug-resistant aHT and paroxysmal or persistent AF, concomitant RDN+AF ablation was not associated with better blood pressure control or rhythm outcome in comparison to AF-only ablation and medical therapy