Jürgen Haase

Five-year long-term clinical follow-up of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT FIRST trial.

Background: Drug‐eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long‐term follow‐up data are scarce and only available for sirolimus‐ and paclitaxel‐eluting stents. Aim: To assess the feasibility and performance of the XIENCE V everolimus‐eluting stent (EES) versus an identical bare metal stent after a 5‐year follow‐up period. Methods: SPIRIT FIRST was a First in Man, multicentre, prospective, single‐blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent. Results: At 5‐year clinical follow‐up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1‐ and 5‐year follow‐up. The 5‐year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2‐ and 5‐year follow‐up. No additional clinically driven TVR events were observed between 3‐ and 5‐year follow‐up. The 5‐year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years. Conclusion: The favorable 5‐year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow‐up.

Edge detection versus densitometry in the quantitative assessment of stenosis phantoms: An in vivo comparison in porcine coronary arteries

The aim of this study was the in vivo validation and comparison of the geometric and densitometric technique of a computer-assisted automatic quantitative angiographic system (CAAS system). In six Landrace Yorkshire pigs (45 to 55 kg), precision-drilled phantoms with a circular lumen of 0.5, 0.7, 1.0, 1.4, and 1.9 mm were percutaneously introduced into the left anterior descending or left circumflex coronary artery. Twenty-eight coronary angiograms obtained with the phantom in a wedged intracoronary position could be quantitatively analyzed. Minimal lumen diameter, minimal cross-sectional area, percent diameter stenosis, and cross-sectional area stenosis were automatically measured with both the geometric and densitometric technique and were compared with the known phantom dimensions. When minimal lumen diameter was measured using the geometric approach, a nonsignificant underestimation of the phantom size was observed, with a mean difference of -0.06 +/- 0.14 mm. The larger mean difference observed with videodensitometry (-0.11 +/- 0.20 mm) was the result of the failure of the technique to differentiate the low lumen videodensities of two phantoms of smaller size (0.5 and 0.7 mm) from a dense background. Percent cross-sectional area stenosis measured with the two techniques showed a good correlation with the corresponding phantom measurements (mean difference between percent cross-sectional area stenosis calculated from the quantitative angiographic measurements and the corresponding phantom dimensions was equal to 2 +/- 6% for both techniques, correlation coefficient = 0.93 with both techniques, SEE = 5% with the geometric technique and 6% with the densitometric approach).(ABSTRACT TRUNCATED AT 250 WORDS)

Two-year results of a durable polymer everolimus-eluting stent in de novo coronary artery stenosis (The SPIRIT FIRST Trial).

AIMS The successful use of everolimus on a durable polymer was earlier reported with 6 and 12 months data from this first-in-man study. This reports the long-term follow-up of the XIENCE V everolimus-eluting stent. METHODS AND RESULTS This prospective, single-blinded, randomised, multicentre clinical trial evaluated the safety and efficacy of the XIENCE V everolimus-eluting coronary stent system versus an identical bare metal stent in the treatment of patients with a single de novo coronary artery stenosis of >/=50% and <100% and a vessel diameter of 3.0 mm as assessed by on-line quantitative coronary angiography that could be covered by a single 18 mm stent.Sixty patients were randomised and at two-year follow-up, clinical data was available in 96% and 97% of patients in the everolimus and control arm, respectively. Four patients were excluded due to protocol violations and two patients withdrew consent.In the everolimus arm no additional death, myocardial infarction, clinically driven TLR, or TVR events were observed between one and two-year follow-up. The 2-year hierarchical MACE rate for the everolimus arm remained 15.4% (4/26). In the control group, two patients had a clinically driven target lesion revascularisation. MACE rate increased from 21.4% (6/28) to 25.0% (7/28) in the control group. CONCLUSIONS This report confirms and extends the safety and efficacy results of the durable polymer XIENCE V everolimus-eluting stent up to two years as compared to identical bare metal stents.

Quantitative angiography during coronary angioplasty with a single angiographic view: a comparison of automated edge detection and videodensitometric techniques.

Little information is available on the reliability of coronary luminal measurements obtained from quantitative analysis of a single angiographic view, an approach that is central to the practical use of on-line quantitative angiography. In the present study we investigated the contribution of two different techniques of quantitative angiography, edge detection (ED) and videodensitometry (VD), to the application of this concept during coronary angioplasty. Forty-six balloon angioplasty procedures were included in this study, all of them performed in a stenosis located in the mid right coronary segment. This coronary location was chosen to optimize data collection on luminal morphology and to minimize the number of factors that may adversely affect quantitative analysis with both techniques. In all cases two orthogonal angiographic projections were obtained before, after balloon dilatation, and at follow-up. Correlation coefficients and differences between orthogonal measurements obtained with each technique were used to evaluate the agreement between orthogonal readings at every stage of the procedure. The obtained correlation coefficients and mean differences (MD) between orthogonal measurements were as follows: before percutaneous transluminal coronary angiography (PTCA), 0.67 (MD 0.01 +/- 0.47 mm2) and 0.57 (MD 0.05 +/- 0.64 mm2) for ED and VD, respectively (Pitmans test for SD, p < 0.05); after balloon dilatation, 0.32 (MD -0.56 +/- 1.53 mm2) and 0.53 (MD -0.15 +/- 1.43 mm2) for ED and VD, respectively (paired t test for MD, p < 0.05); and at follow-up 0.79 (MD -0.15 +/- 0.97 mm2) and 0.73 (MD 0.17 +/- 1.16 mm2) for ED and VD, respectively (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background: In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods: A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results: Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions: Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent.

Coronary arteriography for quantitative analysis: experimental and clinical comparison of cinefilm and video recordings.

Although use of videotape for the recording of coronary angiograms continues to grow, the validity of quantitative coronary angiographic analysis of video images remains unknown. To estimate the reliability of angiographic images recorded on videotape, experimental and clinical angiograms were recorded simultaneously on both 35 mm cinefilm and super-VHS videotape with normal images and with spatial filtering of the images (edge enhancement) on a digital cardiac imaging system. The experimental angiographic studies were performed with plexiglass blocks and stenosis phantom of 0.5 to 3.0 mm in diameter. The clinical angiograms were recorded in 20 patients undergoing percutaneous transluminal coronary angioplasty (31 frames before and 20 frames after percutaneous transluminal coronary angioplasty). The cinefilm and corresponding videotapes were analyzed off-line with the new version of the coronary angiography analysis system. For the experimental study, measurements of minimal luminal diameter obtained from cinefilm, normal-image videotape, and edge-enhanced videotape were compared with the true phantom diameter. In the clinical study the agreement between measurements obtained from cinefilm and measurements from normal-image videotape and edge-enhanced videotape was examined. In the phantom series the accuracy and precision of quantitative coronary angiography measurement for cinefilm were -0.10 +/- 0.08 mm, for normal-image videotape -0.11 +/- 0.18 mm, and for edge-enhanced videotape -0.10 +/- 0.11 mm (mean +/- SD). In the clinical series, the differences between measurements from cinefilm and normal-image videotape were 0.14 +/- 0.20 mm and from cinefilm and edge-enhanced videotape 0.04 +/- 0.13 mm.(ABSTRACT TRUNCATED AT 250 WORDS)

Increased restenosis rates 12 months after coronary implantation of the sirolimus-eluting YUKON-choice stent compared to the paclitaxel-eluting TAXUS Stent.

Previously the polymer‐free sirolimus‐eluting YUKON‐Choice stent (A) has demonstrated noninferiority compared to the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for long‐term equivalency in unselected real‐world coronary lesions of various complexities, we retrospectively compared both stents.

Percutaneous implantation of coronary stenosis phantoms in an anesthetized swine model to validate current quantitative angiography analysis systems

Computerized quantitative coronary angiography (QCA) has basically altered our approach to the assessment of interventional techniques and strategies aimed at the prevention of restenosis and progression of coronary artery disease [1, 2]. With an increasing number of QCA systems being developed, and a growing number of core laboratories for the analysis of multicenter angiographic studies, it has become crucial that the performance of QCA systems, upon which much of our scientific understanding has become integrally dependent, is evaluated in an objective and uniform manner [3].

Validation of videodensitometry in the assessment of stenosis phantoms: an in vitro and in vivo study

Computer-assisted automatic assessment of luminal contours (edge detection) is the technique normally used in quantitative angiography. The accuracy of the measurements with edge-detection, however, can be impaired by the presence of eccentric lesions or of lesions of complex lumen geometry. Under these conditions densitometry has a potential advantage because of its independence from the shape of the lesion.

Videodensitometry in percutaneous coronary interventions: a critical appraisal of its contributions and limitations

The rapid development of percutaneous coronary revascularization techniques, such as balloon angioplasty, atherectomy and stenting, has created new demands for quantitative angiography. These include the need for reducing the time dedicated to quantitative analysis during interventional procedures, as well as obtaining reliable measurements in unfavorable conditions, such as in vascular segments with complex luminal morphology resulting from percutaneous intervention [1–5]. The role that videodensitometry may play in the solution of these problems has barely been explored and is still unclear, although from a theoretical point of view it may offer at least two major potential contributions [6]. Firstly, when videodensitometry is used measurements can be performed from any angiographic projection, facilitating data collection and avoiding cumbersome and time-consuming analysis in orthogonal angiographic projections. Secondly, since luminal cross sectional area is calculated directly from the densitometric profile, no assumptions on luminal morphology are required, a fact that may contribute to a more realistic appraisal of the result of the intervention. The reliability of these appealing features in clinical practice, although supported by the theoretical background of the technique and by experimental work, is still controversial [7–15].