A new study, by researchers from the Intermountain Medical Center Heart Institute (Salt Lake City, USA), indicates that there are no significant differences in the 30-day rate of major bleeding and one-year risk of death, myocardial infarction and urgent repeat percutaneous coronary intervention between patients undergoing PCI who receive heparin and short-term tirofiban (Aggrastat, Medicure) and those who receive bivalirudin (Angiomax, The Medicines Company).
HeartFlow has announced the approval of its HeartFlow FFRCT analysis by the Japanese Ministry of Health, Labour and Welfare. A press release reports that the analysis system is the only non-invasive technology designed to deliver insights on both the extent of a coronary blockage and any impact the blockage has on blood flow to the heart, aiding clinicians in selecting an appropriate treatment.
Two drug regimens involving low doses of rivaroxaban (Xarelto, Bayer)—one with a 15mg once daily dose of the drug and a P2Y12 inhibitor and another with a 2.5mg twice daily dose and dual antiplatelet therapy—are associated with lower rates of clinically significant bleeding in patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI) than is a standard triple therapy drug regimen (dual antiplatelet therapy plus warfarin). Furthermore, these two regimens are associated with a significantly reduced risk of all-cause mortality or recurrent hospitalisation.
The American Heart Association (AHA) awarded its Basic Research Prize for 2016 to Elizabeth M McNally (Chicago, USA) for “Ground-breaking investigations of novel genetic mechanisms responsible for inherited human disorders including heart failure, cardiomyopathy, muscular dystrophy, arrhythmias and aortic aneurysms.”
The results of the MOMENTUM 3 US IDE clinical study, which were presented at a late-breaking clinical trial at the 2016 American Heart Association (AHA) scientific sessions (12–16 November, New Orleans, USA) indicate that St Jude Medical’s HeartMate 3 left ventricular assist device (LVAD) is associated with significantly improved clinical outcomes than is the HeartMate II device. The devices were evaluated in patients with advanced heart failure.
Corvia Medical has announced one-year follow-up data from the REDUCE LAP-HF clinical study of its InterAtrial shunt device. The device is the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction. The data were presented in the late-breaking sessions at the 2016 American Heart Association (AHA) scientific sessions (12–16 November, New Orleans, USA).
Ehrin J Armstrong (Section of Cardiology, Denver VA Medical Center and University of Colorado School of Medicine, Aurora, USA) and others report in JACC: Cardiovascular Interventions that the risk of major adverse cardiac events (MACE) after non-cardiac surgery is significantly increased among patients with incomplete revascularisation post percutaneous coronary intervention (PCI). They add that the risk of postoperative myocardial infarction increases with each additional vessel with incomplete revascularisation.
The Medicines Company and Alnylam Pharmaceuticals have announced positive results from the analysis of day 90 data for 497 patients, as well as analysis of preliminary day 180 data for 189 patients, enrolled in the ORION -1 Phase 2 study of inclisiran. Data from ORION-1 were presented at the 2016 American Heart Association (AHA) scientific sessions (12–16 November, New Orleans, USA). Inclisiran is an investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9 that is being developed for the treatment of hypercholesterolemia.
Mitralign has announced the successful compassionate use treatment of a patient suffering from tricuspid regurgitation due to a cardiac implantable electronic device lead, with their investigational Trialign system. The Trialign system is an investigational device and is limited by US law to investigational use only, and it is designed to offer versatility as a frontline solution to address patients with tricuspid regurgitation.
Amgen has announced that adding its PCSK9 inhibitor evolocumab (Repatha) to optimised statin therapy results in statistically significant regression of atherosclerosis in patients with coronary artery disease. The detailed results from the GLAGOV Phase 3 coronary intravascular ultrasound imaging trial were presented at the 2016 American Heart Association (AHA) scientific sessions (12-16 November, New Orleans, USA) and simultaneously published in the Journal of the American Medical Association.
The Cardiovascular Research Foundation (CRF) is to launch a new international journal focusing on the diagnosis and treatment of structural heart disease and the importance of the heart team in managing these disorders. A CRF press release reports that the first issue of Structural Heart: The Journal of the Heart Team will be published in late spring 2017 with submissions opening in early 2017.
Patient enrolment into the international Phase IIIb RE-DUAL PCI study is complete. The study is evaluating the safety and efficacy of dabigatran (Pradaxa, Boehringer Ingelheim) in patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI). A press release notes that this is the first time that two dosages of a non-vitamin K antagonist oral anticoagulant (NOAC) already approved for stroke prevention in atrial fibrillation have been evaluated in a dual versus triple antithrombotic regimen after PCI.
Terumo Europe has entered into a distribution agreement with New Zealand company Adept Medical to make the STARSystem available to clinicians working across Western Europe. A press release reports that the support for transradial angiography and revascularisation (STAR) system is a combination of the STARBoard and STARTable. It adds that STARBoard is a forearm and hand support that is designed to make performing transradial procedures quicker and easier.
According to the three-year results of the ABSORB II trial, a bioresorbable vascular scaffold (Absorb, Abbott Vascular) does not provide superior vasomotor reactivity than an everolimus-eluting, permanent polymer stent (Xience, Abbott Vascular). These results also indicate that, at three years, late lumen loss is significantly greater with Absorb than it is with Xience. Additionally, the scaffold was associated with significantly higher rates of device thrombosis and target-vessel myocardial infarction.
Two randomised controlled trials have produced what appears to be conflicting results for how left main percutaneous coronary intervention (PCI) compares with coronary artery bypass grafting (CABG), with one (EXCEL; Evaluation of Xience vs. coronary artery bypass grafting surgery for effectiveness of left main revascularisation) suggesting that PCI is non-inferior to surgery and the other (NOBLE; Nordic-Baltic British left main revascularisation study) indicating that it is inferior to surgery. However the studies used different primary endpoints, devices, and follow-up points—which may explain the different outcomes.
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