Philip Urban

Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice One-Year Follow-Up of the e-Cypher Registry

Background— The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results— Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of ≥1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7±11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions— This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial.

Background—The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis. Methods and Results—On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 &mgr;g/mm2 stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9±26.7% in controls (n=34) and 14.2±16.6% in the 2.7-&mgr;g/mm2 group (n=31; P =0.006). Late loss decreased from 0.73±0.73 to 0.11±0.50 mm (P =0.002). Binary restenosis (≥50% at follow-up) decreased from 20.6% to 3.2% (P =0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively (P =NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only. Conclusions—Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 &mgr;g/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.

Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction ☆: The benchmark registry

OBJECTIVES We sought to examine contemporary utilization patterns and clinical outcomes in patients with acute myocardial infarction (AMI) requiring intra-aortic balloon pump (IABP) counterpulsation. BACKGROUND Despite increasing experience with and broadened indications for intra-aortic counterpulsation, the current indications, associated complications, and clinical outcomes of IABP use in AMI are unknown. METHODS Between June 1996 and August 2001, data were prospectively collected from 22,663 consecutive patients treated with aortic counterpulsation at 250 medical centers worldwide; 5,495 of these patients had AMI. RESULTS Placement of an IABP in AMI patients was most frequently indicated for cardiogenic shock (27.3%), hemodynamic support during catheterization and/or angioplasty (27.2%) or prior to high-risk surgery (11.2%), mechanical complications of AMI (11.7%), and refractory post-myocardial infarction unstable angina (10.0%). Balloon insertions were successful in 97.7% of patients. Diagnostic catheterization was performed in 96% of patients, and 83% underwent coronary revascularization before hospital discharge. The in-hospital mortality rate was 20.0% (38.7% in patients with shock) and varied markedly by indication and use of revascularization procedures. Major IABP complications occurred in only 2.7% of patients, despite median use for three days, and early IABP discontinuation was required in only 2.1% of patients. CONCLUSIONS With contemporary advances in device technology, insertion technique, and operator experience, IABP counterpulsation may be successfully employed for a wide variety of conditions in the AMI setting, providing significant hemodynamic support with rare major complications in a high-risk patient population.

Trends in intraaortic balloon counterpulsation complications and outcomes in cardiac surgery

BACKGROUND As the proportion of high-risk patients for cardiac surgery increases, use of intraaortic balloon counterpulsation (IABC) has increased, especially in preoperative therapy. Although the efficacy and cost-effectiveness of IABC have been demonstrated, historically higher complication rates have dissuaded some practitioners from using IABC. METHODS This report describes IABC use in cardiac surgery, examines trends in complications over time, and compares outcomes in preoperative versus postoperative use in a single prospective worldwide registry over the past 3 years. RESULTS The frequency of IABC use appears to be increasing with time as the complication rates have dramatically fallen. The overall IABC-related complication rate was 6.5% (460/7,101), and the rate of major complications (requiring surgery or transfusion) was 2.1% (148/7,101). Hospital mortality was significantly lower in patients treated preoperatively with IABC compared with patients treated postoperatively (8.8% vs 28.2%, p < 0.0001), although this may be due to a selection bias in the postoperative group. CONCLUSIONS Preoperative IABC therapy leads to better patient outcomes in high-risk CABG patients. Improved IABC technology and better surveillance have led to increased use with lower complication rates. Although selection bias is inherent in retrospective studies, the Benchmark Counterpulsation Outcomes Registry outcomes are in close concordance to prospective randomized studies previously reported.

Reno, a European postmarket surveillance registry, confirms effectiveness of coronary brachytherapy in routine clinical practice

PURPOSE To assess, by a European registry trial, the clinical event rate in patients with discrete stenotic lesions of coronary arteries (de novo or restenotic) in single or multiple vessels (native or bypass grafts) treated with beta-radiation. MATERIALS AND METHODS Between April 1999 and September 2000, 1098 consecutive patients treated in 46 centers in Europe and the Middle East with the Novoste Beta-Cath System were included in Registry Novoste (RENO). RESULTS Six-month follow-up data were obtained for 1085 patients. Of 1174 target lesions, 94.1% were located in native vessels and 5.9% in a bypass graft; 17.7% were de novo lesions, 4.1% were restenotic, and 77.7% were in-stent restenotic lesions. Intravascular brachytherapy was technically successful in 95.9% of lesions. Multisegmental irradiation, using a manual pullback stepping maneuver to treat longer lesions, was used in 16.3% of the procedures. The in-hospital rate of major adverse cardiac events was 1.8%. At 6 months, the rate was 18.7%. Angiographic follow-up was available for 70.4% of the patients. Nonocclusive restenosis was seen in 18.8% and total occlusion in 5.7% of patients. A combined end point for late (30-180 days) definitive or suspected target vessel closure was reached in 5.4%, but with only 2% of clinical events. Multivariate analysis was performed for major adverse cardiac events and late thrombosis. CONCLUSIONS Data obtained from the multicenter RENO registry study, derived from a large cohort of unselected consecutive patients, suggest that the good results of recent randomized controlled clinical trials can be replicated in routine clinical practice.

A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zotarolimus- Versus Paclitaxel-Eluting Stents in De Novo Occlusive Lesions in Coronary Arteries: The ZoMaxx I Trial

OBJECTIVES A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months. BACKGROUND The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum. METHODS Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent. RESULTS After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups). CONCLUSIONS After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Beta-Radiation for Coronary In-Stent Restenosis

To determine the feasibility and safety of an intracoronary beta‐radiation device in preventing the recurrence of in‐stent restenosis (ISR) after successful angioplasty, we studied 37 patients treated with beta‐radiation (30‐mm strontium‐90 source) after angioplasty. The mean reference diameter was 2.9 ± 0.5 mm, and 62% of lesions were diffuse, including four total occlusions. Beta‐radiation was successfully delivered in 36 of 37 (97%) cases. Over the course of 7.1 ± 4.5 mo follow‐up, there were no myocardial infarctions and three deaths: one from preexisting malignancy, one from progressive cardiac failure, and one from sudden cardiac death. Target vessel revascularization (TVR) was performed in seven of 36 (19%) patients. Thirty patients underwent angiography at 6 mo; three (10%) experienced restenosis (diameter stenosis > 50%) at the target site, four (13%) had edge stenoses, and two (7%) had late (> 1 mo) thrombotic occlusions. Beta‐radiation for ISR is associated with encouragingly low rates of target lesion restenosis and TVR. Further improvements are needed to solve the limitations of the edge effect and late occlusion. Cathet. Cardiovasc. Intervent. 51:422–429, 2000.

Repeated intracoronary beta radiation for recurrent in-stent restenosis.

More than 70% of percutaneous coronary interventions are followed by a stent implantation. In‐stent restenosis still occurs in 20‐30% of patients and remains a therapeutic challenge. At present only vascular brachytherapy has been shown to be an effective treatment option. We report here one case of recurrent in‐stent restenosis after vascular brachytherapy that was successfully treated by a second beta radiation treatment. Cathet Cardiovasc Intervent 2002;55:233–236.

Validation of a Multicenter Registry Database of Intra-Aortic Balloon Pumping in a Variety of Clinical Settings

The Benchmark Counterpulsation Outcomes Registry is a computerized database that incorporates prospectively gathered data on indications for intra-aortic balloon counterpulsation (IABP) use, patient demographics, concomitant medications and in-hospital complications and outcomes. This report summarizes the validation of the Benchmark Registry. Three audits were performed on the Registry data – the first by the sponsor and the second two by independent auditors. The data for categorical variables that could be answered by checking a box were extremely robust, with most items having at least a 95% agreement rate (except catheter size, which had an 82% agreement rate). The data were slightly less robust for quantitative variables that required a written answer (at least an 80% agreement rate). This high agreement rate supports the conclusion that the Benchmark Counterpulsation Outcomes Registry data are generalizable and suggests that the Registry is a powerful tool for tracking the evolving practice of IABP use, including indications, insertion characteristics, duration, complications and outcomes in patients undergoing IABP.

33 RENO: A European surveillance registry of coronary brachytherapy with the NovosteTM Beta-CathTM System

V. Coen, W. Sauerwein, R. Orrechia, P. Von Rottkay, P. Coucke, M. Ehnert, M. Donsbach, P. Urban, P. Levendag Radiation Oncology, University Hospital Rotterdam/Daniel den Hoed Cancer Center, Rotterdam, Netherlands, Zentrum fuer Strahlungstherapie, Universitaetsklinikum, Essen, Germany, Departement of Medicine, Centro Cuore Columbus, Milan, Italy, Mueller Hospital, Munchen, Germany, Department of Medicine, C.H.U.V., Lausanne, Switzerland, St. Georg Hospital, Hamburg, Germany, St. Johannes Hospital, Dortmund, Germany, Cardiovascular Department, La Tour Hospital Meyrin, Geneva, Switzerland