The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions

OBJECTIVES: The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. BACKGROUND: Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. METHODS: The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). RESULTS: At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. CONCLUSIONS: Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials

One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial

Objectives: To compare initial and one year costs of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in the stent or surgery trial. Design: Prospective, unblinded, randomised trial. Setting: Multicentre study. Patients: 988 patients with multivessel disease. Interventions: CABG and stent assisted PCI. Main outcome measures: Initial hospitalisation and one year follow up costs. Results: At one year mortality was 2.5% in the PCI arm and 0.8% in the CABG arm (p = 0.05). There was no difference in the composite of death or Q wave myocardial infarction (6.9% for PCI v 8.1% for CABG, p = 0.49). There were more repeat revascularisations with PCI (17.2% v 4.2% for CABG). There was no significant difference in utility between arms at six months or at one year. Quality adjusted life years were similar 0.6938 for PCI v 0.6954 for PCI, = 0.00154, 95% confidence interval (CI) –0.0242 to 0.0273). Initial length of stay was longer with CABG (12.2 v 5.4 days with PCI, p < 0.0001) and initial hospitalisation costs were higher (£7321 v £3884 for PCI, = £3437, 95% CI £3040 to £3848). At one year the cost difference narrowed but costs remained higher for CABG (£8905 v £6296 for PCI, = £2609, 95% CI £1769 to £3314). Conclusions: Over one year, CABG was more expensive and offered greater survival than PCI but little added benefit in terms of quality adjusted life years. The additional cost of CABG can be justified only if it offers continuing benefit at no further increase in cost relative to PCI over several years

Die gewebliche Übertragung mechanisch induzierter Kräfte vom Gebiß auf das Gesicht

Eine sachliche Gliederung der klinischen Kieferorthopädie wird vorgeschlagen. Es wird darauf hingewiesen, daß mechanisch induzierte Kräfte auf allen Teilgebieten des Faches eine bedeutende Rolle spielen. Die von dem kieferorthopädischen Gerät entwickelte Kraft wird als Primärkraft bezeichnet, während Kräfte, die sich beim Auffangen der Primärkraft in den Geweben des Gesichtes entwickeln, Sekundärkräfte genannt werden. Die eigentliche Gewebsreaktion wird von Sekundärkräften ausgelöst. Unterschiede und gegenseitige Beziehungen zwischen mechanische und biologische Gewebsreaktionen werden diskutiert und schematisch dargestellt. The significance of force application in all aspects of clinical orthodontics is stressed. Experimental work is still needed to learn more about the effect of such forces on facial tissues. The increasing attention of modern orthodonties with attempts to influence facial growth and development makes this research also important to the clinician.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/45982/1/56_2005_Article_BF02170928.pd