[Position paper on the indication for and implementation of interventional treatment of extracranial carotid stenosis].
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Angioplasty, Balloon↗
Biomedical subjects
H Sievert
Publications and source records attributed to H Sievert.
[Interventional treatment of extracranial carotid stenoses: current status, requirements and indications].
Interventional treatment of extracranial carotid stenoses: current status, requirements and indications Around 30000 strokes per year in Germany are caused by extracranial obstructions of the carotid arteries. Besides the well established surgical endatherectomy, which has been proven to be superior to medical treatment alone in randomized multicenter trials, percutaneous treatment by balloon angioplasty and stent placement is increasingly performed. This consensus paper summarizes the present status of scientific studies and controlled treatment registries of carotid angioplasty and stenting and yields to recommendations regarding its performance and indication. A Medline search was done until August 2005 including all randomized comparative studies with clinical endpoints and all controlled registries with more than 500 patients included. Both completed randomized trials comparing angioplasty and stenting with surgery (CAVATAS and SAPPHIRE) did not show a significant difference with respect to stroke and death within 30 days. The incidence of this combined endpoint was between 3.3 and 6.9% in large multicenter registries. Thus, the current endovascular treatment results in a perlinterventional complication rate comparable to that which is commonly accepted for vascular surgery. A systematic preferably external quality monitoring as well as interdisciplinary cooperation most importantly with neurologists is recomendedfor all interventionalists. Based on available clinical data, this consensus paper defines recommendation classes I or II with a level of evidence B or C depending on symptoms, operative risk status of the patient and severity of the underlying stenosis.
Angioplasty, Balloon↗
Carotid artery stenting: where are we now?
Carotid artery disease is a frequent risk factor for ischemic stroke. Carotid endarterectomy was considered to be the standard treatment for high graded stenosis until carotid artery stenting (CAS) developed with promising results in early series and randomized trials. At present, stenting is supported in patients at high risk for surgery. Randomized trials analyzing low risk patient groups and studying the long-term results of CAS are necessary and partly underway. Although randomized trials are not yet available, current evidence suggests that cerebral protection devices reduce the number of neurological events. This review discusses the results of randomized trials and clinical series.
Carotid Artery Diseases↗
[Percutaneous endovascular aneurysm repair without arteriotomy (Perclose system)].
BACKGROUND AND OBJECTIVE: It is common clinical practice to perform an arteriotomy for the endovascular treatment of infrarenal and thoracic aortic aneurysms. Instead we used the percutaneous endovascular Perclose device to perform the aneurysm repair without arterial cut-down. PATIENTS AND METHODS: The Perclose device contains four needles with two suture loops for closing the femoral artery access site. The sutures were deployed after the arterial puncture, before introduction of sheaths (diameter 12 - 27 F = 4 - 9 mm). After the procedure the sutures were used to close the puncture site. We attempted to achieve hemostasis with the Perclose system in 104 femoral arteries in 60 patients (7 females, mean age 69 +/- 12 years). The mean vessel diameter was 10 +/- 2 mm. RESULTS: The percutaneous graft implantation was successfully achieved in 58 of 60 patients. The graft could not be forwarded into the aorta in two cases because of calcified iliac arteries. The Perclose suture technique was successfully used in 97 femoral arteries. In one case a false aneurysm developed and in another case a secondary hemorrhage occurred. Seven patients needed additional manual compression to achieve complete hemostasis. A surgical repair was not necessary. The time to hospital discharge ranged from 4.5 hours to 32 days (median: 18 hours). 20 patients stayed longer than 24 h in the hospital, only 2 of them for reasons related to the puncture site. CONCLUSION: Closing the access site with the Perclose system is technically feasible and effective, even with large sheaths up to 27 F = 9 mm. This technique reduces the invasiveness of the endovascular repair of aortic aneurysms and decreases the length of hospital stay, i. e. it allows treatment in outpatients.
Adult↗
Does carotid artery stenting work on the long run: 5-year results in high-volume centers (ELOCAS Registry).
AIM: Although the first long-term results of Carotid Artery Stenting (CAS) became available only recently, CAS has become an accepted treatment for carotid artery disease. We report CAS data up to 5 years, both late stroke rate and patency rates as observed in 4 high-volume European centers. METHODS: Between February 1, 1993 and December 31, 2004, 2 172 patients were selected over the 4 participating centres, with intention to treat endovascularly. Conscientious follow-up was done according to the in-hospital stipulations of each centre and was entered into a database both retrospectively and prospectively. Long-term restenosis and stroke-death rates were investigated and statistically analysed and stratified using the Kaplan-Meier method. RESULTS: Of the 2 172 patients with intention to treat 2 165 (99.7%) were technically successful. Of these 306 (14.1%) were performed without and 1 859 (85.9%) with embolic protection device (EPD); 96 patients (4.4%) received balloon dilation only and stenting was performed in 2 069 (95.6%) cases. Kaplan-Meier analysis of major stroke/all death and of significant restenosis (>50%) for the total population showed stroke/death rates of 4.1% (nar=1 356), 10.1% (nar=476) and 15.5% (nar=138); and restenosis rates of 1% (nar=1 363), 2% (nar=480) and 3.4% (nar=139), after 1, 3 and 5 years respectively. CONCLUSIONS: The patency and stroke/death rates resulting from our database analysis are pleasing and indicate that CAS also on longer term is a valuable treatment method for carotid artery disease. Due to the fact that our dataset contains prospective as well as retrospective data, it may have its limitations. Until this moment, data indicating that certain patient subgroups are at increased risk for neurological complications and in-stent restenosis during and after CAS are sparse. Further multivariant analysis on this unique dataset is mandatory in order to identify any potential links in between plaque morphology, preprocedural neurological complications, risk factor distribution, procedural steps and clinical outcome.
Adult↗
First clinical experiences with an endovascular clamping system for neuroprotection during carotid stenting.
OBJECTIVES: This report evaluates the feasibility and efficacy of an endovascular blood flow blockage technique to prevent intracerebral embolization of plaque debris during carotid artery stenting. METHODS: Forty-two patients were enrolled in five clinical sites in Germany and Italy with either an asymptomatic internal carotid artery stenosis > or =75% (mean 87%) or a symptomatic stenosis > or =60% (mean 85%). Cerebral protection during the stenting procedure was achieved using an endovascular clamping technique, obtained by occlusion of the external and common carotid artery via two independently inflatable balloons integrated in the Mo.Ma system. Blood with particulate plaque debris was aspirated before flow was restored. The patient's clinical and the neurological status were assessed during intervention, at discharge, and at 3 months follow-up. RESULTS: Stenting was performed in all but one patient. The mean flow occlusion time was 10.6+/-6.5 min. Transient clamping intolerance was observed in five patients (12%). In two patients, neurological deficits persisted for 2 and 12 h, respectively. Two minor strokes (4,7%) occurred at 5 and 72 h after the procedure. No major strokes or deaths were observed at 3 months follow-up. CONCLUSIONS: This first clinical experience with the Mo.Ma device substantiates the feasibility of endovascular clamping in preventing cerebral embolization during carotid artery stenting.
Carotid Artery, Internal↗
A review on the results of carotid stenting.
In the past several years, carotid angioplasty as an alternative to carotid endarterectomy has developed as an evolving technology performed routinely in many centres worldwide. In this article we review the current status of the results of carotid artery stenting based on observational series and randomised trials. We highlight the acute outcome, the long-term results and the occurrence of restenosis of the endovascular therapy and present a brief description of the latest stenting studies compared to randomized surgery trials.
Angioplasty↗
Balloon-protected carotid artery stenting: relationship of periprocedural neurological complications with the size of particulate debris.
BACKGROUND: Carotid artery stenting (CAS) has been advocated as an alternative to endarterectomy. To prevent cerebral atheroembolism during CAS, distal balloon occlusion of the target artery increasingly is employed during the procedure. A correlation of the size of captured particles with the incidence of periprocedural neurological complications (PNCs) has not been attempted. METHODS AND RESULTS: In a 4-center, phase-1 trial, 54 patients (46 men; age, 69+/-8 years) underwent 58 CAS procedures using the PercuSurge GuardWire system for distal protection. Aspirated debris was sent for histological/cytological analysis. Stent placement was successful in all cases. Mean balloon occlusion time was 10.4+/-4.0 minutes (range, 3.0 to 22.0 minutes). Three patients (5.2%) experienced PNCs: 1 prolonged reversible ischemic neurological deficit that resolved in </=48 hours, 1 stroke, and 1 transient ischemic attack. Relevant particles (those with an area >/=10 000 micrometer(2)) were found in 48 aspirates (83%). The median number of particles, their maximum diameter, and their maximum area were all significantly higher in the aspirates obtained during procedures associated with PNCs than in aspirates obtained during procedures not associated with PNCs. However, pronounced overlap in the distributions (PNCs versus no PNCs) of the number and maximum diameter of particles precluded any predictive inferences. In contrast, a maximum particle area >800 000 micrometer(2) (>0.8 mm(2)) was associated with a 60% chance of having a PNC. CONCLUSIONS: Despite balloon protection, PNCs occurred in 5.2% of patients who underwent CAS procedures. The maximum area of aspirated particles seems to be an indicator of increased risk for PNCs.
Aged↗
Carotid artery stenosis: who should undergo surgery and who should undergo stenting?
Carotid angioplasty and stent implantation is a rapidly evolving treatment option currently under evaluation in several randomized trials. Although this technique needs some special technical skills and knowledge, it is technically simpler than many other interventional procedures. Current data indicate that the results regarding success rate and complication rate may be similar to surgery. It will take years to get the results of the randomized trials that are currently planed or have already started. Unfortunately, the results of these studies will not reflect the state-of-the-art because new stents and new protection devices will become available during these studies. Therefore, in clinical practice the decision has to be made depending on individual patient and lesion characteristics. Patients with concomitant diseases considered to be a risk factor for surgical procedures and patients with contralateral occlusion may be better candidates for angioplasty and stenting. However, patients with diffuse disease of the common carotid artery and patients with difficult vascular access may be better candidates for surgery.
Blood Vessel Prosthesis Implantation↗
Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices.
BACKGROUND: Atrial septal aneurysm is frequently associated with patent foramen ovale (PFO) and atrial septal defects (ASD). Moreover, a relationship between atrial septal aneurysm and embolic cerebrovascular events has been suggested. The aims of this study were to analyze morphological and functional characteristics of atrial septal aneurysm in PFO and ASD patients and to assess the feasibility and efficacy of different devices for transcatheter closure and the influence of atrial septal aneurysm. METHODS: Between March 1997 and May 2000 transcatheter ASD or PFO closure was attempted in 63 patients (mean age 47 +/- 13 years) with an atrial septal aneurysm using one of the following devices: Angelwings (n = 3), Cardioseal (n = 5), Cardioseal-Starflex (n = 7), Amplatzer (n = 11), Amplatzer-PFO (n = 5), PFO-Star (n = 25), or Helex (n = 7). RESULTS: Implantation was primarily successful (after the first or second attempt) in all patients. One PFO-Star device embolized 12 hours after the procedure. During follow-up (0.6-37 months, mean 10.4 +/- 9.2) a residual shunt could be detected by transesophageal echocardiography after 2 weeks in four patients and after 6 months in one patient. Three PFO patients had cerebrovascular events after implantation. Two patients had a transient ischemic attack (TIA) and one patient a stroke. A thrombus formation on the device detected in three patients disappeared after antithrombotic therapy. CONCLUSION: We conclude that ASDs and PFOs with an associated atrial septal aneurysm can be closed with different available devices. There seem to be no additional risks compared with patients without atrial septal aneurysm.
Adult↗
Patent foramen ovale closure in patients with transient ischemia attack/stroke.
Paradoxical embolism through a patent foramen ovale (PFO) has been recognized as a potential cause of transient ischemia attack (TIA) and stroke especially in younger patients. The therapeutic options are medical treatment (antiaggregation or anticoagulation) with an annual recurrence rate of 3% to 4% for stroke or TIA, surgical PFO closure, or catheter closure. Randomized studies are ongoing; however, the results will not be available soon. Since August 1994, we have attempted catheter closure of a PFO in 281 patients (age 17 to 79 years, mean 46.8 +/- 13.2) with paradoxical embolism. Of these, 184 patients had at least one embolic stroke, 112 patients at least one TIA, and 15 patients at least one peripheral embolism. The diameter of the PFO, measured with a balloon catheter, ranged from 3 mm to 24 mm with a mean of 10 +/- 3.5 mm. Implantation of the occluder was technically successful in all patients (two attempts in four patients). Seven different devices were used: 26 Sideris buttoned, 11 ASDOS, 19 Angel Wings, 98 PFO-Star, 37 Cardioseal-Starflex, 57 Amplatzer and, 33 Helex devices. One patient suffered from septicemia and subsequently died. In 2 patients, device embolization occurred during or after the procedure (1 Sideris, 1 PFO-Star; catheter retrieval successful). Thirty-seven patients had other minor complications without long-term sequelae: atrial fibrillation within the first weeks after implantation in five patients, asymptomatic thrombus on the device at routine transesophageal echocardiogram (TEE) in 7 patients (1 Angel Wings, 1 ASDOS, 1 CardioSeal, 4 PFO-Star), and device frame fracture in 25 patients (2 Sideris, 4 ASDOS, 1 Angel Wings, 1 CardioSeal, 17 PFO-Star). No complications occurred with the newer devices (Amplatzer and Helex). A residual shunt after 6 months was found in 5.5% of the patients who had completed their 6-month TEE follow-up. In two patients, a second occluder was implanted because of a residual shunt. During a follow-up period of 1 month to 71 months (mean 12 +/- 16 months, 268 patient years), a recurrence of an embolic event (seven TIA, two stroke) occurred in eight patients. None of these occurred with the newer devices (Amplatzer, Helex). Freedom from recurrence of the combined end point of TIA, ischemic stroke, and peripheral embolism was 95.7% (95% CI: 89.0%-98.4%) at 1 year and 94.1% (95% CI: 80.1-98.4%) at 3 years. Catheter PFO closure is a technically simple procedure. With the newer devices and increasing experience, the success rate has improved and the complication rate has decreased. The advantage of the procedure is that closing the defect means a causal treatment. However, catheter closure of PFO despite a very low morbidity has inherent potential risks like any other interventional procedure. Furthermore, selection of patients who definitely have PFO as the cause of their cerebral event has not been defined. For these reasons, further studies are warranted.
Adolescent↗
[The treatment of iatrogenic spurious aneurysm of the femoral artery by direct thrombin injection].
BACKGROUND AND OBJECTIVE: After percutaneous catheter introduction a false aneurysm occasionally develops at the site of puncture. This has been treated either surgically or, more recently, by ultrasound-guided compression. A new method has been tried in which the false aneurysm is thrombosed by injecting thrombin into it. PATIENTS AND METHODS: In 29 patients thrombin was injected directly into the false aneurysm of the femoral artery, caused by catheter introduction into the vessel. Puncture of the aneurysm and injection of the thrombin solution was performed with continuous duplex-sonographic monitoring. The patients' age ranged from 42 to 88 years (mean 71 +/- 12 years). The false aneurysm had occurred after diagnostic catheterization (n = 5), balloon dilatation of peripheral vessels (n = 5) or balloon catheter dilatation of the coronary arteries (n = 19) with catheters size 5 F (n = 4), 6 F (n = 6), 8 F (n = 16) or 9-13 F (n = 3). The catheterization had been done 1-30 days previously (mean 5.3 +/- 6.9 days). The diameter of the aneurysm ranged from 2.1 to 5 cm (mean 3.5 +/- 0.9 cm). RESULTS: The aneurysms thrombosed within seconds after injection of 0.075 to 1.5 ml (mean 0.4 +/- 0.4 ml). All interventions were successful and without complications. Any resulting haematoma regressed within a few days to a few weeks and none recurred. In two patients a persisting haematoma had later to be removed surgically, and in another patient a second aneurysm was removed surgically without prior thrombin injection. CONCLUSION: A false aneurysm of the femoral artery caused by percutaneous catheterization can be successfully thrombosed by direct thrombin injection.
Adult↗
Global experience in cervical carotid artery stent placement.
The purpose of this article is to review and update the current status of carotid artery stent placement in the world. Surveys to major interventional centers in Europe, North and South America, and Asia were initially completed in June 1997. Subsequent information from these 24 centers in addition to 12 new centers has been obtained to update the information. The survey asked the various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 5,210 procedures involving 4,757 patients. There was a technical success of 98.4% with 5,129 carotid arteries treated. Complications that occurred during the carotid stent placement or within a 30-day period following placement were recorded. Overall, there were 134 transient ischemic attacks (TIAs) for a rate of 2.82%. Based on the total patient population, there were 129 minor strokes with a rate of occurrence of 2.72%. The total number of major strokes was 71 for a rate of 1.49%. There were 41 deaths within a 30-day postprocedure period resulting in a mortality rate of 0.86%. The combined minor and major strokes and procedure-related death rate was 5.07%. Restenosis rates of carotid stenting have been 1.99% and 3.46% at 6 and 12 months, respectively. The rate of neurologic events after stent placement has been 1.42% at 6-12-month follow-up. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative for vascular surgery, especially for patients that are high risk for standard carotid endarterectomy. The periprocedure risks for major and minor strokes and death are generally acceptable at this early stage of development and have not changed significantly since the first survey results. Cathet. Cardiovasc. Intervent. 50:160-167, 2000.
Carotid Stenosis↗
A European multicentric experience using the CardioSEal and Starflex double umbrella devices to close interatrial communications holes within the oval fossa.
In this review, we describe the experience from 13 European centres using the CardioSEAL and Starflex double umbrella devices to close interatrial communications within the oval fossa (so-called 'secundum' defects). Between October 1996 and April 1999, the procedure was attempted in 334 patients with a mean age of 12 years and a mean weight of 44kg. The mean measured stretched diameter of the defect was 15 mm. In the overall group, the defect was solitary in 245 patients (73%), multiple in 21 (6%), associated with an aneurysm of the flap valve in 15 (5 %), was represented by patency of the oval foramen in 44 (13%), and was a fenestration in a Fontan repair in 9 (3%). In all patients, the devices were inserted under general anesthesia, using fluoroscopic and transesophageal echocardiographic control. Implantation was achieved in 325 (97,3%). The device embolized within either a few minutes or a few hours in 13 patients (4%). Of these, uncomplicated surgical repair was undertaken in 10, while the device was retrieved in 3 using catheters and a second device was successfully implanted. Residual shunting was detected immediately after the procedure in 41% of the patients, with the incidence decreasing to 31% at discharge, 24% at 1 month, 21% at 6 months, and 20.5% at one year. During the period of follow-up, elective surgical repair became necessary in two patients, due to malposition of the device in one, and late embolization in the other. Fractures of arms were seen in 6.1 %, most commonly with the largest devices. All those with fractured arms of the device were asymptomatic, and no clinical complications related to the fractures were observed. There were no arrhythmias, endocarditis, valvar distortion, thromboembolic events, or other complications. After one year of follow-up, clinical success, defined as complete closure of the defect or presence of only a trivial leak, had been obtained in 92.5% of the patients. We conclude, therefore, that these devices produce excellent results when used to close defects of small to moderate size. Results are less than optimal, or else complications ensure, when attempts are made to close very large defects.
Adolescent↗
[Primary stent implantation in the internal carotid artery].
BACKGROUND AND OBJECTIVE: Advances in interventional catheter technology have made it possible to dilate stenoses also in the internal carotid artery (ICA). This may cause cerebral emboli, but primary stent implantation may fixate atherosclerotic material on the vessel wall and thus prevent embolization. PATIENTS AND METHODS: Marked stenosis in the ICA was treated by balloon dilatation in 71 consecutive patients aged between 40 and 85 years (mean 69 +/- 9 years). If possible, a stent was implanted before the first balloon dilatation. RESULTS: A stent was placed before dilatation in 53 of 76 procedures. Dilatation with a small balloon to allow stent placement was necessary in 23. Thus stent implantation before definitive dilatation was successful in all instances. The degree of stenosis was reduced from 79 +/- 11 to 9 +/- 14%. In all procedures the stenosis was reduced to less than 50%. One patient had a severe and two had a mild stroke. One patient died of a myocardial infarction 2 days after the procedure. Thus the neurological complication rate was 3.9% and the death rate 1.3%. Follow-up examination revealed an asymptomatic occlusion of the ICA after two weeks in one patient, a recurrent stenosis after 6 months in two of 46 patients. In all other patients the degree of stenosis was less than 50% at 6 months. CONCLUSION: Primary stent placement before balloon dilatation in ICA stenosis was possible in the majority of patients. This procedure would thus seem to reduce the risk of thromboembolic complications.
Adult↗
Stent or angioplasty after recanalization of chronic coronary occlusions? (The SARECCO Trial).
This study tests whether stent implantation without anticoagulation after catheter recanalization of coronary occlusions can improve outcome compared with balloon angioplasty alone. One hundred ten patients were randomly assigned to angioplasty alone (no stent group) or stent implantation (stent group) after successful recanalization and balloon angioplasty. The type of stent and angioplasty technique utilized were decided by the operator. The acute procedural success in both groups was 100%. The acute minimal lumen diameter (MLD) was 1.85 +/- 0.44 mm in the no stent group versus 2.54 +/- 0.53 mm in the stent group (p <0.01). The diameter stenosis was 21 +/- 13% versus 3 +/- 14% (p <0.01). This was achieved not only by the stent implantation itself but primarily by a larger maximum balloon diameter in the stent group after stent implantation (3.32 +/- 0.55 mm vs 2.86 +/- 0.4 mm, p <0.05). After 4 months, the MLD was 1.15 +/- 0.73 mm in the no stent group versus 1.81 +/- 0.9 mm in the stent group (p <0.01). The diameter stenosis was 56 +/- 29% versus 34 +/- 28% (p <0.01). After 2 years, event-free survival was 26% in the no stent group and 52% in the stent group (p <0.05). Thus, acute and long-term procedural and angiographic success of stent implantation without anticoagulation after recanalization of total coronary occlusions is superior to that of balloon angioplasty alone. This beneficial effect is mainly the result of the larger balloon diameters, which may be used after stent implantation.
Angioplasty, Balloon↗
Role of smooth muscle cell death in advanced coronary primary lesions: implications for plaque instability.
OBJECTIVE: Instability of coronary atheroma leads to the onset of acute coronary syndromes including myocardial infarction and death, as well as to the progression of the arteriosclerotic disease. As yet, the underlying factors and mechanisms causing plaque rupture are not completely understood. Since a low content of smooth muscle cells (SMCs) apparently plays a key role, the question points to the events leading to the loss of intimal SMCs. METHODS: We compared coronary atherectomy specimens from 25 patients with unstable angina to those from 25 patients with stable angina. Transmission electron microscopy was used to identify intimal cell population, to detect stage and cell type of apoptosis, and to differentiate between apoptosis and necrosis. RESULTS: Plaques associated with unstable angina contained more macrophages/lymphocytes and significantly less SMCs (P = 0.01), compared with stable angina plaques. Specific cell death forms, apoptosis and necrosis, were present in all coronary atheroma. As key findings, both the proportion of SMCs undergoing apoptosis and the frequency of cytoplasmic remnants of apoptotic SMCs (matrix vesicles) were significantly increased in unstable versus stable angina lesions (P = 0.002 and P = 0.002). In addition, cellular necrosis was more frequent in the first coronary atheroma group (P = 0.02). Positive correlations were found between the frequency of apoptotic cells and necrosis (r = 0.41, P = 0.04), and that of matrix vesicles and necrosis (r = 0.63, P = 0.001) only in plaques with unstable angina, but not in those with stable angina. CONCLUSIONS: Our data demonstrate that high cell death due to apoptosis and necrosis is a basic in situ feature found in advanced coronary primary lesions associated with unstable angina, possibly explaining their low density of (viable) SMCs. Thus, antagonization of intimal cell death should be considered in order to stabilize the intimal plaque texture of coronary atheroma with the ultimate goal to prevent plaque rupture.
Adult↗
A randomized trial comparing the impact of a nonionic (Iomeprol) versus an ionic (Ioxaglate) low osmolar contrast medium on abrupt vessel closure and ischemic complications after coronary angioplasty.
OBJECTIVES: To assess the effect of nonionic versus ionic contrast media on abrupt vessel closure and major ischemic complications after coronary angioplasty. BACKGROUND: There is a continuous debate about the "thrombogenic potential" of nonionic contrast media. The results of both in vitro and in vivo investigations are incongruent. METHODS: We prospectively evaluated the outcomes of 2,000 patients undergoing percutaneous transluminal coronary angioplasty (PTCA). According to a randomized, double-blind protocol, they received either iomeprol (nonionic; n = 1,001) or ioxaglate (ionic; n = 999). Intracoronary thrombus before PTCA was found more often in the iomeprol group (4.2% vs 2.7%, p = 0.04). No other significant differences between both groups were observed with regard to pre-PTCA clinical and angiographic characteristics. RESULTS: The frequency of reocclusions necessitating repeat angioplasty occurring either in laboratory (2.9% with iomeprol and 3.0% with ioxaglate) or out of laboratory (3.1% vs 4.1%) was not significantly different. The rate of major ischemic complications was also comparable after both contrast media (emergency bypass surgery: 0.8% vs 0.7%, myocardial infarction: 1.8 vs 2.0%, cardiac death during hospital stay: 0.2% vs 0.2%). In the iomeprol group, more patients had dissections post-PTCA (30.2% vs 25.0%, p = 0.01) and more patients received intracoronary stents (31.6% vs 25.7%, p = 0.004). Allergic reactions requiring treatment occurred only in the ioxaglate group (0.0% vs 0.9%, p = 0.002). CONCLUSIONS: The nonionic contrast medium was not associated with a higher rate of abrupt vessel closure requiring repeat angioplasty, or major ischemic events. These data suggest that nonionic contrast media do not increase the risk of thrombotic complications in patients undergoing coronary interventions.
Acute Disease↗