NEUROSCIENTIST 14(5):409-414, 2008. DOI: 10.1177/1073858407309762″
“Background A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer).
Methods We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-eluting (n=857) or sirolimus-eluting
(n=850) stents. The primary endpoint was S63845 price a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis
as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov, number NCT00389220.
Findings SC79 We analysed all randomised patients. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at 9 months (79 [9%] patients vs 89 [11%], rate ratio 0 . 88 [95% Cl 0 . 64-1.19], p for non-inferiority=0.003, p for superiority=0 . 39). Frequency of cardiac death (14 [1.6%] vs 21 [2.5%], p for superiority=0.22), myocardial infarction (49 [5.7%] vs 39 [4.6%], p=0.30), and clinically-indicated target vessel revascularisation (38 [4.4%] vs 47 [5.5%], p= 0. 29) were similar for both stent types. 168 (79%) patients in the biolimus-eluting group and 167 (78%) in the sirolimus-eluting group had data for angiographic follow-up available.
Biolimus-eluting PD184352 (CI-1040) stents were non-inferior to sirolimus-eluting stents in in-stent percentage diameter stenosis (20.9% vs 23.3%, difference -2.2% [95% Cl -6.0 to 1. 6], p for non-inferiority=0. 001, p for superiority=0.26).
Interpretation Our results suggest that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes.
Funding Biosensors Europe SA, Switzerland.”
“This article presents evidence that fibromyalgia patients have alterations in CNS anatomy, physiology, and chemistry that potentially contribute to the symptoms experienced by these patients. There is substantial psychophysical evidence that fibromyalgia patients perceive pain and other noxious stimuli differently than healthy individuals and that normal pain modulatory systems, such as diffuse noxious inhibitory control mechanisms, are compromised in fibromyalgia. Furthermore, functional brain imaging studies revealing enhanced pain-related activations corroborate the patients’ reports of increased pain.