Bleeding versus thrombosis: role of short DAPT in complex lesions.

Therapy with dual antiplatelet agents, defined as the combination of a platelet P2Y12 inhibitor and aspirin, is required to prevent thrombotic complications, after percutaneous coronary intervention (PCI) with stent implantation. Usually current guidelines recommend administration of dual antiplatelet therapy (DAPT) following percutaneous revascularization with drug-eluting stent (DES) for a period of at least 12 months or for 6 to 12 months in patients not at high risk. Nevertheless, the treatment of stable/unstable coronary artery disease with DES implantation increasing largely, the optimal duration of DAPT is still unclear. The duration of DAPT after coronary stenting has been evaluated in recent randomized studies with conflicting results. The administration of long period of DAPT is a strategy to reduce thrombosis events but largely increase the hemorrhagic ones. Otherwise, shorter DAPT period is protective about bleeds with consequently increased ischemic events. In addition, as new DES carry a lower risk of stent thrombosis (ST) compared with the first-generation DES and possibly even bare-metal stents, a shift toward better protection from ST may have an effect on the duration and the intensity of DAPT. Whether the duration of DAPT should be shorter or longer than the currently recommended 6 to 12 months is analyzed in this review, drawing on results from the most recent studies and meta-analysis.

Results of the self-expandable BA9 stent for treatment of large angle coronary bifurcation.

Since the advent of coronary angioplasty the treatment of bifurcation lesions has always proved a complex issue resulting in lower angiographic success rates, increased risk of restenosis, higher rates of dissection, myocardial infarction, and acute vessel closure. The advent of coronary stenting reduced the risks, but in-stent restenosis was noted to be frequent at the ostium of the side branch; for this reasons two-stent techniques were developed to try to combat this phenomenon. Novel dedicated stents have recently been developed to provide easier access to the SB and to scaffold more effectively its ostium, matching the stent configuration more closely to the anatomy of the bifurcation. Most of bifurcation lesions that require treatment and which have a wide angle involving the left main coronary artery (LMCA). The impact of the angle and the asymmetry of bifurcation on flow dynamic are very important and may influence clinical outcome. More recently, percutaneous coronary intervention (PCI) to treat wide angle disease has increased in frequency, and is associated with improvements in interventional techniques and adjunctive drug therapy. Several studies have shown that stenting in LMCA, especially using drug-eluting stents (DES), is a safe and effective treatment strategy both at mid- and long-term follow-up. The AXXESS System is a self-expanding, conically-shaped stent from nitinol (nickel-titanium alloy) with strut thickness, specifically designed to conform to the anatomy at the level of the bifurcation carina. A special version of the AXXESS System has been designed for left main bifurcation lesions, allowing for larger diameters (up to 4.75 mm) and distinct bifurcation angles (flare-end diameters of 8, 10 and 12 mm). The AXXENT trial is the first study to evaluate the vascular response of the self-expanding biolimus-eluting AXXESS stent for the treatment of LMCA bifurcation lesions. It was designed to evaluate the safety and efficacy of the AXXESS biolimus-eluting stent for the treatment of LMCA bifurcation lesions, that showed good results in terms of stent thrombosis and TLR at 6 months follow-up. Technical modifications and stent innovations may further improve both the angiographic and clinical outcomes for patients with wide angle bifurcation disease treated by PCI. Moreover a long term follow-up is needful to demonstrate better safety and efficacy of these new dedicated bifurcation devices.

Early, intermediate and late infectious complications after transcatheter or surgical aortic-valve replacement: a prospective cohort study.

Transcatheter aortic valve implantation (TAVI) has been proposed to treat older surgical high-risk patients with severe symptomatic aortic stenosis. There are no data regarding short-term and long-term infectious complications in these patients. The objective of this study was to define the incidence, aetiology and outcome of early and late infectious complications following TAVI compared with patients >65 years old undergoing traditional surgical aortic replacement (SAR). This was a prospective observational study evaluating all consecutive patients who underwent TAVI or SAR. Follow up was performed up to 1 year after the procedure of valve implantation. Fifty-one patients underwent TAVI and were compared with 102 patients who underwent SAR. Compared with SAR patients, those who underwent TAVI had lower incidence of early post-operative (11.7% vs 26.4%, p 0.04), intermediate (5.9% vs 17.6%, p 0.01) and late (7.8% vs 11.7%, p 0.03) infections. Among SAR patients the most common infections were bloodstream infections, pneumonias, urinary tract infections and sternal wound infections. Patients who underwent TAVI had a longer survival without infection (358 days vs 312.9, p 0.006). There were no significant differences in 12-month crude survival between the two study populations. Despite a high frequency of coexisting illnesses, patients undergoing TAVI develop few infectious complications. TAVI appears to be a reasonable and safe option in high-risk patients with severe symptomatic aortic stenosis.

Do angle and anatomy influence outcomes in bifurcation stenting?

Coronary bifurcation lesions are regarded as complex and their treatment is still the subject of substantial debate. Important elements to consider before approaching a bifurcation include angle and anatomy, in particular the take off angle (proximal angle, A) that is between the proximal MB and SB and the carina angle (distal angle, B) that is between distal main branch (MB) and side branch (SB) and also the extent and distribution of disease on the side branch and its size. Many techniques have been used to treat coronary bifurcation lesions such as provisional stenting or double stenting but no consensus technique has been accepted primarily due to variation of disease severity, angle and anatomy. Angle B is the unique statistically significant independent predictor factor influencing outcomes. Bifurcation angle and anatomy are important predictors of short and long-term outcomes after bifurcation treatment. Moreover we should evaluate it after wiring MB and SB so as after pre-dilatation because of side branch access and carina area angle anatomy variation and plaque shift. Should be investigated if the developing of new dedicated devices for bifurcation lesions could mix the advantages of one and two-stent techniques.

Novel poly(L-lactide) PLLA/SWNTs nanocomposites for biomedical applications: material characterization and biocompatibility evaluation.

Poly(L-lactide) (PLLA)/single-walled carbon nanotubes (SWNTs) nanocomposite films were produced using the solvent casting method, and morphological, thermal and mechanical properties were investigated. Biocompatibility was evaluated by using human bone cells, performing adhesion and proliferation studies. The role of single-walled nanotube incorporation and functionalization on PLLA bio-polymers was investigated. Pristine (SWNTs) and carboxylated (SWNTs-COOH) carbon nanotubes were considered in order to control the interaction between PLLA and nanotubes. SWNTs and SWNTs-COOH showed a good dispersion in the polymer matrix and improved the PLLA crystallinity. Thermal, morphological and dynamic-mechanical analyses revealed that carboxylic groups on the tube sidewalls increased compatibility between PLLA and nanostructures. Mechanical properties demonstrated an enhancement related to introduction and functionalization of carbon nanotubes. Biological investigations showed osteoblasts cultured on PLLA/SWNTs-COOH nanocomposites has higher cell adhesion and proliferation than osteoblasts cultured on PLLA and PLLA/SWNTs nanocomposites. These studies suggest that combination of biodegradable polymers and SWNTs opens a new perspective in the self-assembly of nanomaterials and nanodevices for biomedical applications with tunable properties.

Galactosaminoglucuronoglycan sulphate in the treatment of osteoarthritis: clinical efficacy and tolerance of oral and intra-articular administrations.

The clinical efficacy and the tolerance of galactosaminoglucuronoglycan sulphate (GGGS), administered both orally and intra-articularly were evaluated for the treatment of generalized and localized osteoarthritis (OA). The study included 154 patients: 52 treated orally with GGGS, observed during three periods of three consecutive months of therapy followed by eight weeks of withdrawal, 52 treated only with non-steroidal anti-inflammatory drugs (NSAIDs), and 50 patients treated two times in a year with a total of twelve (6 x 2) knee intra-articular weekly injections. The tolerance to GGGS was excellent, and the monitoring of the clinical measurements revealed a significant improvement of the articular data with a decreasing of NSAID's consumption.

Preliminary observation on the clinical tolerance of interferon-beta in cancer patients.

Nine patients with metastatic solid tumors were given IFN-beta by i.v. bolus injections. Six escalating doses (from 1 to 9 X 10(6) IU) followed by 6 additional injections at the dose of 9 X 10(6) IU were administered every other day (schedule A) in 3 of the 9 patients. IFN dose was also increased to a maximum of 46 X 10(6) IU, and 12 individual injections of 1, 2, 3.3, 5, 7, 9, 12, 16, 21, 27, 34 and 46 X 10(6) IU of IFN were given over a minimum of a 24-day period (schedule B) in 6 of the 9 patients. The single maximal tolerated dose ranged from 9 to 46 X 10(6) IU. The toxicity of IFN-beta given as scheduled in this study was significant but acceptable.