The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution.

Background: New paclitaxel coated balloons (PCB) developments have been proposed to maintain therapeutic levels of drug in the tissue while decreasing particle release. In this series of studies, we evaluated the pharmacokinetic profile and biological effects after paclitaxel delivery via novel microcrystalline PCB coating (mcPCB, Pax V R , Balton) in porcine iliofemoral arteries. Methods: Ten domestic swine were enrolled yielding 24 iliofemoral segments for evaluation. In the pharmacokinetic study, nine mcPCBs were dilated for 60 sec and animals sacrificed after 1 hr, 3 and 7 days. Studied segments were harvested and tissue paclitaxel concentration was analyzed utilizing HPLC. In the biological response evaluation, self-expandable stents were implanted followed by post dilation with either mcPCB (n 5 10) or POBA (n 5 5). After 28 days, angiography was performed, animals were sacrificed and stented segments harvested for histopathological evaluation. Results: The 1-hr, 3 and 7 days vessel paclitaxel concentrations were 152.9 6 154.5, 36.5 6 49.5, and 0.9 6 0.7 ng/mg respectively. In the biological response study, stents in the mcPCB group presented lower angiographic measures of neointimal hyperplasia as expressed by late loss when compared to POBA (20.43 6 0.9 vs. 0.23 6 1.2; P 5 0.24) at 28 days. In the histopathological evaluation, percent area of stenosis (%AS) was reduced by 42% in the mcPCB group (P < 0.05). The healing process in mcPCB group was comparable to POBA with regard to fibrin deposition (0.7 vs. 0.7; P 5 ns), neointimal maturity (1.97 vs. 1.93; P 5 ns), inflammation score (0.92 vs. 1; P 5 ns) and endothelialization score (1.77 vs. 1.73; P 5 ns). The mcPCB group did however display a greater tendency of medial cell loss and mineralization (60% vs. 0; P 5 0.08). Conclusions: Delivery of paclitaxel via a novel mcPCB resulted in low long-term tissue retention of paclitaxel.

IntroductionDespite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents.AimThe aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population.Material and methodsA prospective multi-center registry was conducted in five clinical sites of American Heart of Poland. Three hundred and eighty-three patients who underwent percutaneous coronary intervention (PCI) with NexGen stent implantation were included. Clinical follow-up was performed at 1, 6 and 12 months. Additionally, a group of 42 randomly selected patients underwent control angiography at 6 months (10.96% of study population). The primary endpoint was occurrence of target vessel revascularization (TVR) at 6-month follow-up. Angiographic endpoints included rates of binary restenosis and late lumen loss at 6-month follow-up based on QCA analysis. Multivessel disease was present in more than 70% of patients, and 52.4% of lesions were complex. The main indications for angiography were non-ST elevation acute coronary syndromes (54.8%) and ST elevation myocardial infarction (34.99%).ResultsAt 6-month follow-up 47 (12.7%) patients reached the primary endpoint of TVR. The composite of major acute cardiac event rates at 30-day and 6- and 12-month follow-up was 6.01% (n = 23), 18.5% (n = 69) and 25.21% (n = 92) respectively. Control angiography performed after 6 months showed in-stent late loss of 0.66 ±0.71 mm and a binary restenosis rate of 16.7%.ConclusionsOur study showed that PCI with the NexGen stent is safe and effective at 6- and 12-month follow-up. Angiographic results showed a satisfactory restenosis rate and low late lumen loss.

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Background:The role of percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. More liberal use of drug-eluting stents (DES) increased proportion of those patients undergoing PCI procedure, raising a need for more clinical evidence. The recent reported COMPARE II trial showed similar results of Biolimus-eluting Nobori stent (BES) and Everolimus-eluting Xience/Promus stent (EES) at 1-year in an all comers population. We aim to compare safety and efficacy outcomes in patients with multivessel CAD (a pre-specified study subset) treated with BES and EES in COMPARE II trial. Methods: COMPARE II trial is a large randomized, multicentre, non-inferiority trial with total of 2707 patients enrolled at 12 sites across Europe, randomized in 1:2 ratio to the treatment with BES and EES with similar 12 months dual antiplatelet therapy. Primary endpoint was the composite of cardiac death (CD), non-fatal myocardial infarction (MI) and target vessel revascularization (TVR). Results: Total of 683 patients with multivessel CAD have been enrolled in COMPARE II trial, 453 of which in BES and 230 in EES arm. There were no significant differences in baseline characteristics such as age (64.3 vs. 63.7; pϭ0.4), male gender (78.2% vs. 78.7%; pϭ0.9), or presence of diabetes mellitus (23.0% vs. 25.7%; pϭ0.4) in BES and EES arms respectively. The lesion length and reference diameters were also similar. At 12 months, rate of CD (1.1% vs 1.3%; pϭ1.0), MI (4.4% vs 5.7%; pϭ0.5), target lesion revascularization (4.2% vs 2.6%; pϭ0.4), TVR (5.7% vs 3.9; pϭ0.4), target lesion failure (6.8% vs 7.4%; pϭ0.9) and composite of CD, non-fatal MI and TVR (8.6% vs 9.1%; pϭ0.9) were similar in BES and EES arms, Definite and propable stent thrombosis rate up to 12-months was also not different (1.1% in BES vs 1.3% in EES arm; pϭ1.0). Conclusions: Although this substudy was not powered to detect differences between the two stents, the BES with biodegradable polymer, was found as safe and effective as the EES even in this challenging patients population. This adds valuable evidence about clinical outcomes with contemporary DES.Background: With the introduction of drug eluting stents (DES) in this decade, treatment of patients with STEMI with these devices has emerged as a rational PCI alternative. In spite of the unquestionable benefits of DES in terms of reduction of restenosis and TVR, specific concerns have arisen with regard to their short-and long-term safety. We aim to assess short-and long-term outcomes in STEMI patients treated with Nobori, DES with biodegradable polymer. Methods: NOBORI 2 and eNOBORI are two large, prospective, single-arm, multicenter, registries that enrolled 3067 and 7750 patients respectively, out of which 248 and 703 were STEMI patients. All adverse events were adjudicated by an independent clinical event committee in NOBORI 2, while adjudication in eNOBORI (including stent thrombosis) is ongoing. The primary endpoint was Target Lesion Failure...