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Concept: Stent

171

Late rupture of external iliac artery pseudo-aneurysm is an uncommon complication in patients who undergo extensive gynecologic radical surgeries. A 28-year-old woman with stage IB cervical cancer underwent pelvic lymphadenectomy and extrafascial trachelectomy. Two months after surgery, massive bleeding from ruptured pseudo-aneurysm of the external iliac artery occurred. Endovascular management with covered stent placement was feasible and safe to stop bleeding.

Concepts: Cervical cancer, Surgery, Radiation therapy, Stent, Pelvis, Hysterectomy, External iliac artery, Internal iliac artery

168

BACKGROUND: Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery [1]. Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates [2-4]. However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery [5,6]. Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents. METHODS: This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included.The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment.The primary endpoint is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure-related parameters.Trial registrationDutch Trial Register, NTR3381.

Concepts: Atherosclerosis, Stent, Femoral artery, Arteries of the lower limb, External iliac artery, Internal iliac artery, Arteries of the abdomen, Common iliac artery

163

Although drug-eluting stents have dramatically reduced angiographic restenosis and clinical need for repeat revascularization procedures, some adverse effects, such as late stent thrombosis, have been described. We evaluated clinical performance of paclitaxel-eluting stents coated with a new bioactive polymer system (P-5) based on a copolymer of an acrylic derivative of triflusal in patients with coronary artery disease.

Concepts: Atherosclerosis, Coronary artery disease, Cardiology, Atheroma, Artery, Stent, Cardiovascular system, Drug-eluting stent

149

The GLOBAL LEADERS trial is a superiority study in patients undergoing percutaneous coronary intervention, with a uniform use of Biolimus A9-eluting stents (BES) and bivalirudin. GLOBAL LEADERS was designed to assess whether a 24-month antithrombotic regimen with ticagrelor and one month of acetylsalicylic acid (ASA), compared to conventional dual antiplatelet therapy (DAPT), improves outcomes.

Concepts: Myocardial infarction, Cardiology, Percutaneous coronary intervention, Clopidogrel, Antiplatelet drug, Stent, Aspirin

141

The pathophysiology underlying very late drug-eluting stent (DES) thrombosis is not sufficiently understood. Using optical coherence tomography, we investigated characteristics of very late stent thrombosis (VLST) according to different onset times.

Concepts: Optics, Tomographic reconstruction, Stent, Tomography, According to Jim

71

Background Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice. Methods We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events. Results The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001). Conclusions In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).

Concepts: Myocardial infarction, Cardiology, Heart, Percutaneous coronary intervention, Stroke, Cardiac arrest, Stent, Drug-eluting stent

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As bifurcation PCI can often be resource demanding due to the use of multiple guidewires, balloons and stents, different technical options are sometimes being explored, in different local settings, to meet the need of optimally treating a patient with a bifurcation lesion, while being confronted with limited material resources. Thereby, it seems important to keep a proper balance between what is recognized as the contemporary state-of-the-art, and, what is known as potentially harmful, and to be discouraged. Ultimately, the resource-tailored approach to bifurcation PCI may be characterized by the notion of minimum technical requirements for each step of a successful procedure. Hence, this paper describes the logical sequence of steps when performing bifurcation PCI with provisional SB stenting, starting with basic anatomy assessment and ending with the optimization of MB stenting and the evaluation of the potential need to stent the SB, suggesting, for each step, the minimum technical requirement of a successful intervention.

Concepts: Stent, Optimization, Potential, Requirement

29

BACKGROUND: The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients. METHODS: In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324. FINDINGS: We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p(non-inferiority)=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (p(non-inferiority)=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; p(superiority)<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups. INTERPRETATION: By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent. FUNDING: Deutsches Herzzentrum.

Concepts: Myocardial infarction, Atherosclerosis, Cardiology, Percutaneous coronary intervention, Stent, Radiology, Interventional cardiology, Restenosis

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Abstract Background: For the narrow ureter that will not accommodate a ureteroscope, it is common practice to place a ureteral stent, to allow subsequent ureteroscopy in the passively dilated ureter. Surprisingly, there are limited data on the effectiveness or safety of these maneuvers. Methods: We retrospectively analyzed patients managed with ureteral stent placement followed by another attempt at ureteroscopy after an initial attempt of flexible ureteroscopy failed because the ureteroscope would not pass up an otherwise normal ureter. Results: Of 41 patients with follow-up who underwent ureteral stenting for this reason, the ureteroscope passed with ease poststenting in 29 (71%) and there was continued resistance in 12. Of these 12 patients, the ureteroscopy was continued despite resistance in 9, while another stent was placed in the remaining 3. Of these three patients, the third attempt at ureteroscopy was successful in two, and further attempts at ureteroscopy were not made after the third attempt failed in one. With a mean overall follow-up of 32 months, two patients (5%) developed ureteral strictures. Both were among nine patients in whom repeat ureteroscopy was performed despite resistance, with a rate of obstruction of 22% in this subgroup. Overall, ureteral stenting allowed successful ureteroscopy in 98% of patients. Conclusions: Ureteral stenting with subsequent ureteroscopy is a successful and safe method of addressing a narrow ureter that initially does not allow passage of a flexible ureteroscope, as long as persistent subsequent attempts to insert the ureteroscope are made only if it passes easily.

Concepts: Stent, Restenosis, Renal pelvis, Coronary stent, Ureteric stent, PASS

28

PURPOSE: The long-term success rate of dilation and/or internal urethrotomy is low in cases of recurrent urethral stricture disease. This study investigated the Memokath™044TW stent’s ability to maintain urethral patency after dilation or internal urethrotomy of recurrent urethral stricture. MATERIALS AND METHODS: Ninety-two patients with recurrent bulbar urethral strictures (mean length 2.7 cm) were treated with dilation or internal urethrotomy and randomized to short-term urethral catheter diversion (N=29) or insertion of a Memokath™044 stent (N=63). The primary endpoint was urethral patency as assessed by the passage of a calibrated endoscope. Secondary endpoints included urinary symptoms and uroflowmetry parameters. Stents were scheduled to remain in situ 12 months. RESULTS: The rate of successful stent insertion was 93.6% (59/63). The stented patients maintained patency significantly longer than controls (292 days vs. 84 days (median), p<0.001). The patency was reflected in significantly improved uroflowmetry and symptom scores. The stent was removed in 100% of patients. The most frequently noted side-effects in the stented patients were bacteriuria, hematuria, and penile pain - all usually mild and transient. There were no differences in sexual function between the Memokath and control patients. Stent dislocation and occlusion were observed in eight and three patients, respectively. CONCLUSIONS: Patients with recurrent bulbar urethral strictures treated with dilation or urethrotomy and a Memokath™044 stent maintained urethral patency significantly longer than those treated with dilation or urethrotomy alone. The stent's side-effect profile was favorable. The stent was straightforward to insert and was removed without difficulty - even after long-term placement.

Concepts: Time, Medical terms, Urethra, Stent, Restenosis, Urethral stricture, Urethrotomy, Insertion