1-Year clinical outcomes of diabeticpatients treated with everolimus-elutingbioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials

Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treatedwith the Absorb bioresorbable vascular scaffold (BVS).Background Clinical outcomes of diabetic patients after BVS implantation have been unreported.Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients werecompared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimuselutingmetal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the AbbottVascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCEV Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus ElutingCoronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V EverolimusEluting Coronary Stent System]) were used for the comparison by applying propensity score matching.The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, targetvessel myocardial infarction, and target lesion revascularization at 1-year follow-up.Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patientstreated with the BVS (3.7% vs. 5.1%, p » 0.64). Diabetic patients treated with the BVS had a similarincidence of the DoCE compared with diabetic patients treated with EES in the matched study group(3.9% for the BVS vs. 6.4% for EES, p » 0.38). There were no differences in the incidence of definite orprobable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0%for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group).Conclusions In the present analyses, diabetic patients treated with the BVS showed...

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results.

AIM: The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent. METHODS: This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents. RESULTS: Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each). CONCLUSION: The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:

Health targets as an instrument for improving the rational framework of healthcare decisions.

There is currently a trend gaining acceptance that explicitly recognizes the need to set priorities for making rational decisions in health policy, respecting at the same time the underlying purpose of health care - to improve people's health. This trend in health policy is referred to as "health targets" although definitions vary considerably. Having been initiated by the World Health Organization in the late 1970s, the international policy on health targets is in the process of renewal to become Health for All in the Twenty-First Century. The new program highlights 10 global targets, from the reduction of worldwide burden of diseases to improvement of access to comprehensive, essential quality care. Countries such as the United Kingdom and Australia have adopted and implemented such programs which basically include cardiovascular, cancer, accidents, and mental health targets. For many countries, however, there are several difficulties in establishing similar programs. One of them is the unavailability of reliable data, although political factors and structure of health systems also play a key role in the creation of health targets. Overall, health targets appear to be a key element in building a strong public health policy, taking into consideration not only the cost of healthcare, but also the outcomes in improving health which is the ultimate goal of health care systems.

A cost-benefit comparison of intensive diabetes management with implantable pumps versus multiple subcutaneous injections in patients with type I diabetes.

OBJECTIVE: To investigate if intraperitoneal (IP) insulin infusion via programmable implantable pumps is a potential alternative to subcutaneous (SC) insulin via multiple injections. RESEARCH DESIGN AND METHODS: We compared the cost-benefits of the two methods using a randomized, prospective, 6-month, crossover design in 10 adult type I diabetic patients. RESULTS: When judged on the last month of IP versus SC periods in the nine patients who completed the study, metabolic data showed better glycemic control (HbA1c: 7.2 +/- 0.2 IP vs. 8.5 +/- 0.7% SC, mean +/- SE, P = 0.02), reduced glycemic fluctuations (SD of capillary glucose values: 3.4 +/- 0.2 IP vs. 4.6 +/- 0.2 mM SC, P < 0.01), and fewer mild hypoglycemic events (5.7 +/- 2.0 IP vs. 10.0 +/- 3.1 events/month SC, P = 0.02). Quality of life, judged by Diabetes Control and Complications Trial questionnaires, was unaffected by pump therapy. Direct costs, including pump acquisition, implantation, and follow-up, were 2.6-fold higher with IP than with SC delivery. CONCLUSIONS: The implantable pump is more effective in the short term, equally accepted, but more costly than multiple injections and should be limited to patients with unsatisfactory glycemic control despite intensive diabetes management with SC insulin. In addition, longer-term, larger-scale, and comparative evaluation is required.

[Cost benefits of intensive insulin therapy using injections, external pumps and implantable pumps]. / Coût-bénéfice de l'insulinothérapie intensive par injections, pompe externe et pompe implantable.

Since feasibility is now proven, cost-efficacy of external sub-cutaneous (EXT) and implantable programmable (IMP) insulin pumps needs to be compared to those of intensified conventional insulin therapy (CONV). Only metabolic efficacy and short-term direct costs are easily evaluable. We (WHO-CSII Study) and others have shown that glycemic control and severe hypoglycemia risk are slightly improved, while ketoacidosis risk and costs are aggravated with EXT vs CONV. We (CEDIT Study) and others have shown that glycemic control, mild and severe hypoglycemic risks are improved, with no increase in ketoacidosis rates although a doubling in costs with IMP vs CONV. Rigid interpretation of the above data would limit indications of insulin pumps to patients experiencing frequent hypoglycemias while on intensified conventional insulin therapy.