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Direct Oral Anticoagulants: New Options
Published in Peter Grunwald, Pharmaceutical Biocatalysis, 2020
Rivaroxaban additionally proved benefits in clinical trials on ATE. Its approval for secondary prevention in patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers is based on the ATLAS ACS 2 TIMI 51 study. The low dose of 2.5 mg twice daily (bid) co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine increased the risk of non-fatal bleeding, but significantly reduced the risk of atherothrombotic events as well as of death (Mega et al., 2012). In the large COMPASS trial in 27,395 patients with stable coronary artery disease (CAD) or stable peripheral or carotid artery disease (PAD), the addition of rivaroxaban 2.5 mg bid to ASA significantly reduced the combined risk of stroke, cardiovascular death and myocardial infarction and the net clinical benefit amounted to 20% despite an increase of bleeding (Eikelboom et al., 2017a). The benefit in CAD patients included the reduction of stroke by 42% and that in PAD patients the reduction of major amputation by 70% (Connolly et al., 2018; Anand et al., 2018).
Fibrinolytic Enzymes for Thrombolytic Therapy
Published in Peter Grunwald, Pharmaceutical Biocatalysis, 2019
Swaroop S. Kumar, Sabu Abdulhameed
Tenecteplase is a recombinant mutant variant of t-PA. It is a 65 kDa glycoprotein with 527 amino acids. The mutations include Asp103Thr, Glu117Asn and 4 alanine substitutions (Lys296Ala, His297Ala, Arg298Ala, and Arg299Ala). These point mutations increase the fibrin specificity by 14-fold and resistance to plasminogen activator inhibitor 1 (PAI-1) by 80-fold (Smalling, 1996). Mutations in kringle 1 domain prolongs the renal clearance time and thus increases the half-life to about 10–24 min (Cannon et al., 1997). This makes it suitable for bolus administration. Clinical trials such as TIMI 10B (Thrombolysis in Myocardial Infarction) trial, ASSENT-1 and ASSENT-2 (Assessment of Safety and Efficacy of a New Thrombolytic agent) trials reported similar efficacy and safety while used for treatment of AMI. However, bleeding rate was lesser compared to altepase (Zeymer and Neuhaus, 1999; Cannon et al., 1998; Van de Werf et al., 1999a, 1999b). Trade name of tenectplase is TNKaseTM (Genentech, Inc.) and was approved by USFDA in 2000 for treatment of myocardial infarction.
BVSs in chronic total occlusions: Clinical evidence, tips, and tricks
Published in Yoshinobu Onuma, Patrick W.J.C. Serruys, Bioresorbable Scaffolds, 2017
All registries included true CTO lesions, defined as a complete obstruction of the vessel with thrombolisis in myocardial infarction (TIMI) flow grade 0 through the affected segment of ≥3 months estimated duration [1]. BVS implant was uniformly done following the recommendations of the manufacturer: accurate selection of scaffold diameter, slow progressive increase of dilatation pressure, overlapping by only 1–2 mm, and postdilatation with a shorter NC balloon at nominal pressure with a maximal increase of the balloon above scaffold size of 0.5 mm. Postdilatation was systematically performed in all patients in 4 registries [4–7], but guided by postimplantation OCT analysis in another one [8]. Procedural success was homogeneously defined as achievement of final in-scaffold residual stenosis of <30% with TIMI 3 grade flow, without in-hospital major clinical complications.
Current approaches for treatment of coronary chronic occlusions
Published in Expert Review of Medical Devices, 2019
Giulia Iannaccone, Paola Scarparo, Jeroen Wilschut, Joost Daemen, Wijnand Den Dekker, Peter De Jaegere, Felix Zijlstra, Nicolas M. Van Mieghem, Roberto Diletti
The DECISION CTO trial is a prospective, open-label, randomized trial carried out in 19 centers in Korea, India, Taiwan, and Thailand. Patients eligible for PCI were randomized to receive either PCI or medical therapy in case of CTO-lesions with the option for PCI of significant non-CTO lesions. The study included patients with a coronary chronic total occlusion with TIMI flow 0 of at least 3 months of duration located in a proximal to mid epicardial vessel with a reference diameter >2.5 mm, either causing silent ischemia, stable angina, or acute coronary syndrome. Major exclusion criteria were CTOs located in distal vessels, in venous grafts, in-stent restenosis, left main segment involvement, severe comorbidities, and left ventricular ejection fraction (LVEF) <30% [99]*. The primary composite endpoint was the incidence of death from any cause, repeat revascularization, stroke, periprocedural, or spontaneous MI at 5-year follow-up. As a result, no statistically significant difference was detected between the two groups (PCI + CTO 22.3% vs. PCI + OMT 29.3% after 5 years, p = 0.11), thus suggesting the non-superiority of additional CTO PCI compared with OMT alone.
Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy
Published in Expert Review of Medical Devices, 2020
Moritz Blum, Davide Cao, Roxana Mehran
The most contemporary data on R-Onyx were provided by the Onyx ONE study. Onyx ONE was an international randomized controlled trial investigating the safety and efficacy of R-Onyx as compared to the polymer-free biolimus A9-coated BioFreedom (Biosensors) stent in a HBR population scheduled to receive a 1-month course of DAPT after PCI. For inclusion, patients had to fulfill at least one out of 13 pre-specified criteria indicating HBR or expected noncompliance with long-term DAPT, such as age ≥75 years, concomitant oral anticoagulation, renal dysfunction, anemia, thrombocytopenia, history of bleeding and others. The BioFreedom stent was used as control since it had previously shown superiority over BMS in a similar HBR population [32]. The trial randomized 1,996 patients in a 1:1 fashion to receive either R-Onyx or BioFreedom. The primary safety endpoint at 12 months, a composite of cardiac death, MI and ST occurred in 17.1% and 16.9% of patients with R-Onyx and BioFreedom, respectively, which established non-inferiority based on a margin of 4.1% (p = 0.011). Of note, the R-Onyx group experienced numerically lower rates of ST (1.3% vs. 2.0%, p = 0.22) and significantly lower rates of spontaneous MI (4.6% vs. 7.1%, p = 0.02) at 12-month follow-up. Device success rates, defined as attainment of <30% residual stenosis by QCA and Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 with the assigned device, were higher with R-Onyx (92.8% vs. 89.7%, p = 0.007) and crossover to the alternative device occurred more often in the BioFreedom group (0.2% vs. 4%, p < 0.001). Onyx ONE was the first randomized trial testing two different DES in patients requiring a short DAPT regimen. In summary, results from this trial confirmed the overall safety and efficacy of the R-Onyx stent also after a 1-month DAPT course. Furthermore, compared to the BioFreedom stent, R-Onyx was associated with better angiographic outcomes and greater device success.
First-in-Man trial of a drug-free bioresorbable stent designed to minimize the duration of coronary artery scaffolding
Published in Journal of Biomaterials Science, Polymer Edition, 2021
Jean Fajadet, Marco G. Mennuni, Didier Carrié, Paul Barragan, Pierre Coste, Michel Vert, Antoine Lafont
α) Immediate success. Success appreciation included both device and procedure. Device success was defined from successful scaffold delivery to the target lesion, appropriate scaffold apposition, lesion coverage, removal of delivery system after scaffold deployment, absence of vessel dissection, and final thrombolysis-in-myocardial infarction (TIMI) flow 3.