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Philip Urban

Publications and source records attributed to Philip Urban.

At least 19 recordsLinked to original sources
PubMed2006

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 > or =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.

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PubMed2005

Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology.

In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients' preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a 'heart attack centre' observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients' outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly--independent of 'maximal' medical therapy.

Angioplasty, Balloon, Coronary↗
PubMed2005

Differential outcome after intracoronary radiation therapy is related to a simple classification based on lesion length and reference diameter.

OBJECTIVE: We sought to develop a prognostic lesion classification based on simple angiographic parameters, lesion length and reference diameter that predicts differential outcome in patients undergoing intracoronary radiation. METHODS AND RESULTS: Three types of lesions were identified: Type A characterized by lesion length less than or equal to 30 mm, reference diameter > 2.5 mm to less than or equal to 4.0 mm (short lesion: normal diameter), Type B by lesion length less than or equal to 30 mm, reference diameter less than or equal to 2.5 mm or > 4 mm (short lesion: extreme diameter), and Type C by lesion length > 30 mm (long lesion). A total of 1,151 lesions (77.7% in-stent restenosis) in 1,098 consecutive patients undergoing brachytherapy were classified into these 3 lesion types. Overall, 79.9%, 10.3% and 9.8% patients met the criteria for Type A, B and C lesions. While the in-hospital major adverse cardiac event (MACE) rate was 1.4%, 3.6% and 3.8% (p = 0.026), the 6-month MACE rate was 16.1%, 22.5% and 32.1% (p < 0.001), the angiographic restenosis rate was 21.3%, 32.4% and 42.4% (p < 0.001), and the late thrombosis rate was 4.1%, 9.0% and 11.3%, (p < 0.001) in Type A, B and C lesions, respectively. Consequently, with increasing lesion severity, 3 risk groups with low, medium and high risk were defined. Multivariate analysis showed that Type B and C lesions were independent predictors of 6-month MACE (OR, 1.5 and 1.9, respectively). CONCLUSION: The proposed novel and easily applicable lesion classification effectively predicts early and medium term outcome, and may be used for appropriate therapeutic decision making in patients undergoing brachytherapy.

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PubMed2004

Comparison of neointimal formation in polymer-free paclitaxel stents versus stainless stents (from the ASPECT and ELUTES randomized clinical trials).

The investigators examined 326 pairs of angiograms from 2 randomized dose-finding (0.2 to 3.1 microg paclitaxel/mm(2) of stent surface area) clinical trials of polymer-free paclitaxel-eluting stents in de novo lesions (the ASian Paclitaxel-Eluting stent Clinical Trial [ASPECT] and the European evaLUation of Taxol Eluting Stent [ELUTES]). A dose-dependent effect was observed: the largest dose of paclitaxel in the 2 trials resulted in a significantly larger proportion of lesions at follow-up with <10% diameter stenosis (54% vs 16%, p = 0.00012 in ASPECT; 53% vs 21%, p = 0.013 in ELUTES) and with minimal luminal diameter located outside the stent compared with control stents (62% vs 20% in ASPECT, 48% vs 18% in ELUTES; p <0.05). Also, significantly shorter lesion lengths at 6-month follow-up were observed for the doses of 0.7 to 3.1 microg/mm(2) (p <0.03) relative to their respective lengths before the procedure compared with control stents.

Angiogenesis Inhibitors↗
PubMed2004

Successful reduction of in-stent restenosis in long lesions using beta-radiation--subanalysis from the RENO registry.

PURPOSE: Long lesions remain a challenging task in interventional cardiology, with a high propensity of restenosis, especially within the stented segment. Although intracoronary gamma-radiation has been proved to reduce diffuse in-stent restenosis in long lesions, such an effect remains to be determined using beta-radiation. METHODS AND MATERIALS: Of 1098 consecutive patients at 46 European centers treated with localized beta-radiation ((90)Sr, Novoste Beta-Cath System), 139 patients (mean age 61.5 +/- 10.7 years, 84% male, 22% with diabetes mellitus) with lesions treated using a >40-mm source length underwent radiation using a single 60-mm source train (34%) or a stepping/pullback procedure with a 30-mm (12%) or 40-mm (87%) source length after conventional interventional procedures. The mean lesion length was 35.3 +/- 17.9 mm. RESULTS: Technical success was achieved in 96% of cases. Geographic miss was noted in 9 patients (6.5%). The reference (placebo) group was obtained from the Washington Hospital Center for In-Stent Restenosis Trial (WRIST) and the WRIST Trial for long lesions (LONG WRIST) studies by selecting the cases (94 patients) that required a dummy source length >/=13 seeds (or >51 mm in length). Statistically significant improvement was noted in late angiographic restenosis (34.7% vs. 76.5%, p <0.0001), target vessel revascularization (14.9% vs. 60.6), and major adverse cardiac events (i.e., death, myocardial infarction, or total vessel revascularization) (17.9% vs. 64.9%, p <0.0001) at 6 months in reference to the nonradiation group. CONCLUSION: This subanalysis from the Radiation in Europe with Novoste study confirms the safety and efficacy of beta-radiation combined with conventional interventional procedures in patients with diffuse, long, in-stent restenosis

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PubMed2004

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 microg/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-microg/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 (> or =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 microg/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.

Coronary Angiography↗
PubMed2004

Use of sirolimus-eluting coronary stents in routine clinical practice.

Restenosis has long remained the major limitation of intracoronary stenting, but several randomized trials have recently shown that the use of drug-eluting stents appear to reduce markedly the risk of recurrence following treatment of de novo lesions. To evaluate whether the results of randomized trials can be generalized to routine clinical practice, all patients receiving at least one sirolimus-eluting stent (SES) in two Swiss hospitals were entered into a prospective registry. Only target vessels with a reference diameter > 3.5 mm were excluded. Clinical follow-up was obtained after 6 months. A total of 183 patients were included. The procedural success was 97.8% and the incidence of in-hospital MACE was 2.2%. At 7 +/- 2 months, 95.6% of the patients were event-free, and target lesion revascularization was required in only three patients (1.6%). The excellent medium-term results obtained with the SES in randomized trials can be replicated in routine clinical practice.

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PubMed2004

Intracoronary brachytherapy, a promising treatment option for diabetic patients: Results from a European multicenter registry (RENO).

Despite advances in the interventional treatment of coronary disease, diabetics still have double the case fatality rate as nondiabetics. The purpose of this analysis from the Radiation in Europe With Novoste (RENO) registry was to assess the clinical and angiographic 6-month outcome of diabetic patients in comparison to nondiabetic patients after localized beta-radiation. A total of 1,098 patients (83.8% with in-stent restenosis) treated with the Novoste Beta-Cath system in Europe were enrolled in the RENO registry. Diabetes was, irrespective of the type of lesion treated, no significant risk factor for major adverse cardiac events or target vessel revascularization. Individuals with diabetes (n = 256) and without diabetes (n = 833) displayed no significant differences concerning clinical or angiographic endpoints. Vascular brachytherapy appears to be the first technique to even out the increased risk of diabetic patients undergoing percutaneous coronary interventions in the routine clinical setting. Thus, intracoronary brachytherapy represents a promising treatment option for diabetic patients.

Brachytherapy↗
PubMed2004

Results of intracoronary beta-brachytherapy administered by 60 mm transfer device/radiation source train: a subgroup analysis from the RENO registry.

UNLABELLED: To investigate the safety and efficacy of a 60 mm transfer device, delivering 60 mm radiation source train, in the treatment of coronary lesions by b-brachytherapy employing the BetaCath system (Novoste, Norcross, Georgia). METHODS AND RESULTS: As part of the REgistry NOvoste (RENO), the first large-scale registry of intracoronary beta-radiation applied in routine clinical practice, 46 centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 49 patients with 56 lesions were treated with a 60 mm transfer device/radiation source train (TD/RST) in at least 1 vessel, constituting the study population. With 75.4% in-stent restenosis (ISR), 3.6% graft lesions, long lesions (30.9 +/- 14.7 mm) and 19% diabetes, the cohort had a high-risk for recurrence. The in-hospital major adverse cardiac event (MACE) rate was 4.1%. The 6-month follow-up revealed 2.0% death, 4.1% myocardial infarction, 8.2% target vessel revascularization, 12.2% MACE, 82.6% improved angina, 16.7% binary restenosis and 4.1% late thrombosis. The results were comparable to all other patients in the registry treated with standard source lengths of 30 mm and 40 mm, although much longer lesions were treated by the 60 mm device (18.4 +/- 11.3 mm versus 30.9 +/- 14.7 mm; p < 0.0001). In the ISR subgroup (mean lesion length, 32.03 +/- 14.99 mm), the 6-month MACE rate was 12.8%, while the angiographic restenosis rate was 16.0% and the late thrombosis rate was 2.6%. CONCLUSION: Beta-brachytherapy with 60 mm TD/RST was safe, feasible and effective in this broad population of high-risk patients presenting in day-to-day practice. Its efficacy in long-segment ISR, where conventional interventional strategies have poor outcome rates, is particularly noteworthy.

Angioplasty, Balloon, Coronary↗
PubMed2003

Intracoronary beta-brachytherapy in chronic total occlusions: a subgroup analysis from the RENO registry.

Conventional interventional therapy has been less rewarding in chronic total occlusion (CTO). Brachytherapy by its antiproliferative and positive remodeling effect may be more efficacious. Forty-six centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 78 patients had 82 lesions (CTO) at presentation-the study population. With 67% in-stent CTO, 8% graft CTO, 4% recurrent CTO, long lesions (27.6 +/- 20.9 mm), and 31% diabetes, the cohort had high risk for recurrence. The in-hospital event rate was 1.3%. Six-month follow-up revealed 1.3% death, 5.1% myocardial infarction, 21.8% target vessel revascularization, 77.8% improved angina, 34.5% binary restenosis, 12.7% reocclusion, and 10.3% late thrombosis. The results were comparable to all other patients in the registry, although late thrombosis rate was higher in the CTO group (10.3% vs. 5.0%; P = 0.047). In the in-stent CTO subgroup (n = 52; 66.7%), there was no in-hospital event, no follow-up death or myocardial infarction, restenosis in 35.1%, and reocclusion in 10.8% of patients. In comparison, death or myocardial infarction was significantly higher in de novo CTO subgroup (P = 0.005). Compared to all other in-stent restenosis patients in the registry, the patients with in-stent CTO had similar clinical and angiographic event rate. Thus, beta-brachytherapy was safe, feasible, and effective in this broad population of high-risk patients with CTO presenting in day-to-day practice. It was particularly effective in in-stent CTO, where conventional interventional strategies are disappointing.

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PubMed2003

Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark Registry.

AIMS: To examine differences in patient characteristics and outcomes in 19636 patients enrolled in the USA and 3027 patients enrolled in other countries undergoing intra-aortic balloon pump (IABP) counterpulsation. METHODS AND RESULTS: Indications for IABP use; a larger percentage of US patients were identified as 'early support and stabilization for angiography or angioplasty' (21.1% US vs 11.8% non-US), and 'pre-operative support for high-risk CABG' (15.9% vs 6.6%). A smaller percentage of US patients vs non-US patients were identified as 'weaning from cardiopulmonary bypass' (14.3% vs 28.2%), and 'refractory ventricular failure' (6.2% vs 9.8%). One out of five patients in both groups was listed as 'cardiogenic shock' (18.9% US vs 20.2% non-US). All cause, risk-adjusted, in-hospital mortality (20.1% vs 28.7%; P<0.001), and mortality with IABP in place (10.8% vs 18.0%; P<0.001) were lower at US vs non-US sites. In both US and non-US institutions, IABP associated complication rates, such as IABP-related mortality (0.05% vs 0.07%), major limb ischaemia (0.9% vs 0.8%), and severe bleeding (0.9% vs 0.8%), were low. CONCLUSIONS: IABP counterpulsation is deployed at an earlier clinical stage in US patients. Mortality rates are higher for non-US patients, particularly for patients with non-surgery cardiac interventions, even after adjusting for risk factors. Complication rates were low. Physicians should therefore not be reluctant to use IABP in high-risk patients undergoing cardiac procedures.

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