The limitations of conventional anticoagulants have stimulated the development of new anticoagulants. The central position of factor Xa (FXa) at the junction of the intrinsic and extrinsic pathways in the coagulation cascade means that direct and indirect FXa inhibitors have increasingly changed antithrombotic strategies. FXa inhibitors potently and selectively inhibit thrombin formation rather than thrombin activity. Direct FXa inhibitors may directly bind to FXa, whereas indirect inhibitors are dependent on antithrombin. Direct inhibitors may bind free FXa and, in contrast to indirect inhibitors, FXa within the prothrombinase complex or within clots as well. Fondaparinux is the prototype indirect FXa inhibitor and has been extensively studied in the prevention and treatment of thromboembolic diseases, including acute coronary syndromes. Due to a favourable efficacy and safety profile and convenient once-daily dosing without the need for monitoring, fondaparinux is preferentially recommended in recent guidelines dealing with antithrombotic treatment. A number of small-molecule direct FXa inhibitors are currently at different stages of clinical development. After an extensive clinical trial programme demonstrating superior efficacy without a significant increase in major bleeds compared with enoxaparin, rivaroxaban is now available for the prevention of thromboembolic events in patients undergoing orthopaedic surgery. Rivaroxaban also offers the convenience of oral once-daily dosing without the need for monitoring. Whereas most direct FXa inhibitors are orally active, otamixaban is administered intravenously, offering rapid on-off anticoagulant activity. Other compounds under development may offer additional options for tailored antithrombotic strategies according to differing indications, clinical situations and patient variables.

We conducted a prospective, randomized trial to compare immediate and long-term effects of percutaneous transluminal coronary angioplasty (PTCA) and high-frequency rotational atherectomy (PTCR) in patients with angiographically predefined complex coronary artery lesions (AHA type B2 and C). The relation of lesion characteristics to procedural results is reported in this angiographic analysis. Patients were randomly assigned to balloon angioplasty (n = 250 patients) or rotational atherectomy (n = 252 patients). Quantitative coronary angiography could be performed in 447 patients to evaluate immediate results and in 293 patients with a 6-month angiographic follow-up. Procedural success was comparable in the PTCR and in the PTCA group (80% vs. 76%, P = 0.260). The need for stent implantation due to a residual stenosis >50% or a bail-out situation was significantly higher in the PTCA group (9.7% vs. 2.0%, P = 0.001). In both treatment groups, diameter stenosis was effectively reduced and MLD increased. The acute gain did not differ between the two groups. At 6-month control, the restenosis rate was comparable in the PTCR and in the PTCA group (37% vs. 35%, P = 0.658), whereas diameter stenosis was significantly more severe in the PTCR group than in the PTCA group (52% vs. 46%, P = 0.039) and, correspondingly, the MLD was significantly smaller in the PTCR group (1.29 mm vs. 1.44 mm, P = 0.031). Late loss was about the same in both groups, however, net gain and net gain index were significantly higher in the PTCA group (0.82 mm vs. 0.64 mm, P = 0.008; and 31% vs. 24%, P = 0.009). Analysis of procedural results for various lesion characteristics revealed no significant difference between treatment groups. In this randomized trial, complex coronary artery lesions were treated with comparable results for angiographic and procedural success and the restenosis rate by both, PTCA and PTCR. Late loss, however, was significantly higher and net gain significantly smaller after PTCR. Stents, although infrequently used, had a relevant impact on immediate PTCA results but not on late results. Cathet Cardiovasc Intervent 2001;53:359-367.

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Reproducibility and accuracy of in vitro measurements are very high using recently developed QCA systems. We analyzed the impact of lesion characteristics ad the image quality on the quality of measurements under clinical conditions. For the study we selected 57 coronary artery lesions which had a clinically relevant distribution for stenosis severity, lesion characteristics, and image quality. Every effort was made to eliminate procedural sources of error. Three investigators measured each lesion five times with each of three QCA systems (AWOS, Cardio and CMS). Only the measurements of the minimal stenosis diameter were analyzed. The precision of all the measurements was high with the AWOS (0.04 mm), the Cardio (0.05 mm), and the CMS systems (0.06 mm). Variability of measurements increased for the following criteria: Ambrose-III morphology (CMS 0.082 mm), surface irregularities (Cardio 0.069 mm, CMS 0.073 mm), TIMI I (Cardio 0.084 mm, CMS 0.0121 mm), and moderate image quality (CMS 0.07 mm). There were no differences in the precision of the measurements in the other groups of lesion characteristics. There were no relevant differences in any of the measurements between the systems (AWOS-Cardio -0.07 mm, AWOS-CMS-0.11 mm, Cardio-CMS-0.04 mm). Smaller diameters were measured with the AWOS system than with the CMS and the Cardio systems when the lesion was calcified (AWOS-Cardio-0.109 mm, AWOS-CMS-0.161 mm). This was only a trend, however, and did not reach statistical significance, which was also true for the other differences found between the systems according to various lesion characteristics. In summary, we found that the measurement quality of the QCA systems used in this study is not altered by the underlying lesion characteristics or the image quality.

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