Estudio primario

No clasificado

Año 1995
Revista Journal of the American College of Cardiology
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<b>

OBJECTIVES:

</b>Our purpose was to evaluate the relation between smoking and the outcomes of patients receiving thrombolysis for acute myocardial infarction.<b>

BACKGROUND:

</b>A paradoxic beneficial effect has been observed in smokers with a myocardial infarction. We analyzed outcomes and baseline characteristics of 11,975 nonsmokers, 11,117 ex-smokers and 17,507 current smokers in a multinational trial of thrombolysis for acute myocardial infarction.<b>

METHODS:

</b>Patients were randomized to one of four thrombolytic protocols. An angiographic substudy in 2,431 patients evaluated reperfusion, reocclusion and ventricular function. Effects of smoking were evaluated by logistic regression analysis after adjustment for age and gender. A mortality model evaluated the simultaneous effect of baseline characteristics on the prognostic importance of smoking. These processes were performed with data from both the main trial and the angiographic substudy; then angiographic factors (coronary anatomy, patency and ejection fraction) were added to the model.<b>

RESULTS:

</b>Smokers were significantly younger by a mean of 11 years) and had less comorbidity or severe coronary artery disease than nonsmokers. Nonsmokers had significantly higher hospital and 30-day mortality rates (9.9% and 10.3%, respectively) than smokers (3.7% vs. 4%, respectively, both p < 0.001) and more in-hospital complications. The unadjusted odds ratio for 30-day mortality in nonsmokers was 3.36 (95% confidence interval [CI] 2.08 to 5.41), 1.21 (95% CI 0.71 to 2.08) after adjustment for age and gender and 1.08 (95% CI 0.59 to 1.96) after adjustment for all clinical baseline characteristics.<b>

CONCLUSIONS:

</b>Smokers receiving thrombolysis for acute myocardial infarction presented 11 years earlier than nonsmokers, which generally accounted for their better outcome. When other differences in clinical and angiographic baseline factors and therapeutic responses were evaluated, no significant difference in mortality was seen between smokers and nonsmokers.

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Estudio primario

No clasificado

Año 2012
Revista The Lancet. Neurology
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BACKGROUND:

Only 2-5% of patients who have a stroke receive thrombolytic treatment, mainly because of delay in reaching the hospital. We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy.

METHODS:

We did a randomised single-centre controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit (MSU) and hospital intervention. For inclusion in our study patients needed to be aged 18-80 years and have one or more stroke symptoms that started within the previous 2·5 h. In accordance with our week-wise randomisation plan, patients received either prehospital stroke treatment in a specialised ambulance (equipped with a CT scanner, point-of-care laboratory, and telemedicine connection) or optimised conventional hospital-based stroke treatment (control group) with a 7 day follow-up. Allocation was not masked from patients and investigators. Our primary endpoint was time from alarm to therapy decision, which was analysed with the Mann-Whitney U test. Our secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. We also assessed safety endpoints. This study is registered with ClinicalTrials.gov, number NCT00153036.

FINDINGS:

We stopped the trial after our planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because we had met our prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 min (IQR 31-39) versus 76 min (63-94), p<0·0001; median difference 41 min (95% CI 36-48 min). We also detected similar gains regarding times from alarm to end of CT, and alarm to end of laboratory analysis, and to intravenous thrombolysis for eligible ischaemic stroke patients, although there was no substantial difference in number of patients who received intravenous thrombolysis or in neurological outcome. Safety endpoints seemed similar across the groups.

INTERPRETATION:

For patients with suspected stroke, treatment by the MSU substantially reduced median time from alarm to therapy decision. The MSU strategy offers a potential solution to the medical problem of the arrival of most stroke patients at the hospital too late for treatment.

FUNDING:

Ministry of Health of the Saarland, Germany, the Werner-Jackstädt Foundation, the Else-Kröner-Fresenius Foundation, and the Rettungsstiftung Saar.

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Resumen estructurado de revisiones sistemáticas

No clasificado

Año 2013
Revista Database of Abstracts of Reviews of Effects (DARE)
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CRD SUMMARY:

This review concluded that use of pre-hospital stroke code was an important intervention to improve the accessibility of the benefits of thrombolysis, especially when combined with educational campaigns to raise awareness. The conclusion seems overly strong given the limitations of the review and available evidence.

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Revisión sistemática

No clasificado

Año 2015
Revista Stroke; a journal of cerebral circulation
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BACKGROUND AND PURPOSE:

Cerebral venous thrombosis is generally treated with anticoagulation. However, some patients do not respond to medical therapy and these might benefit from mechanical thrombectomy. The aim of this study was to gain a better understanding of the efficacy and safety of mechanical thrombectomy in patients with cerebral venous thrombosis, by performing a systematic review of the literature.

METHODS:

We identified studies published between January 1995 and February 2014 from PubMed and Ovid. We included all cases of cerebral venous thrombosis in whom mechanical thrombectomy was performed with or without intrasinus thrombolysis. Good outcome was defined as normal or mild neurological deficits at discharge (modified Rankin Scale, 0-2). Secondary outcome variables included periprocedural complications and recanalization rates.

RESULTS:

Our study included 42 studies (185 patients). Sixty percent of patient had a pretreatment intracerebral hemorrhage and 47% were stuporous or comatose. AngioJet was the most commonly used device (40%). Intrasinus thrombolysis was used in 131 patients (71%). Overall, 156 (84%) patients had a good outcome and 22 (12%) died. Nine (5%) patients had no recanalization, 38 (21%) had partial, and 137 (74%) had near to complete recanalization. The major periprocedural complication was new or increased intracerebral hemorrhage (10%). The use of AngioJet was associated with lower rate of complete recanalization (odds ratio, 0.2; 95% confidence interval, 0.09-0.4) and lower chance of good outcome (odds ratio, 0.5; 95% confidence interval, 0.2-1.0).

CONCLUSIONS:

Our systematic review suggests that mechanical thrombectomy is reasonably safe but controlled studies are required to provide a definitive answer on its efficacy and safety in patients with cerebral venous thrombosis.

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Estudio primario

No clasificado

Año 2012
Revista Stroke; a journal of cerebral circulation
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BACKGROUND AND PURPOSE:

The American Stroke Association guidelines emphasized the need for further high-quality studies that assess agreement by radiologists and nonradiologists engaged in emergency telestroke assessments and decision-making. Therefore, the objective of this study was to determine the level of agreement of baseline brain CT scan interpretations of patients with acute stroke presenting to telestroke spoke hospitals between central reading committee neuroradiologists and each of 2 groups, spoke hospital radiologists and hub hospital vascular neurologists (telestrokologists).

METHODS:

The Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona trial was a prospective, urban single-hub, rural 2-spoke, randomized, blinded, controlled trial of a 2-way, site-independent, audiovisual telemedicine and teleradiology system designed for remote evaluation of adult patients with acute stroke versus telephone consultation to assess eligibility for treatment with intravenous thrombolysis. In the telemedicine arm, the subjects' CT scans were interpreted by the hub telestrokologist and in the telephone arm by the spoke radiologist. All subjects' CT scans were subsequently interpreted centrally, independently, and blindly by 2 hub neuroradiologists. The primary CT outcome was determination of a CT-based contraindication to thrombolytic treatment. Kappa statistics and exact agreement rates were used to analyze interobserver agreement.

RESULTS:

Fifty-four subjects underwent random assignment. The overall agreement for the presence of radiological contraindications to thrombolysis was excellent (0.91) and did not differ substantially between the hub telestrokologist to neuroradiologist and spoke radiologist to neuroradiologist (0.92 and 0.89, respectively).

CONCLUSIONS:

In the context of a telestroke network designed to assess patients with acute stroke syndromes, agreement over the presence or absence of radiological contraindications to thrombolysis was excellent whether the comparisons were between a telestrokologist and neuroradiologist or between spoke radiologist and neuroradiologist. Clinical Trial Registration- URL.: http://www.clinicaltrials.gov. Unique identifier: NCT00623350.

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Estudio primario

No clasificado

Año 1998
Revista Lancet
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<b>

BACKGROUND:

</b>Thrombolysis for acute ischaemic stroke has been investigated in several clinical trials, with variable results. We have assessed the safety and efficacy of intravenous thrombolysis with alteplase (0.9 mg/kg bodyweight) within 6 h of stroke onset.<b>

METHODS:

</b>This non-angiographic, randomised, double-blind, trial enrolled 800 patients in Europe, Australia, and New Zealand. Computed tomography was used to exclude patients with signs of major infarction. Alteplase (n=409) and placebo (n=391) were randomly assigned with stratification for time since symptom onset (0-3 h or 3-6 h). The primary endpoint was the modified Rankin scale (mRS) at 90 days, dichotomised for favourable (score 0-1) and unfavourable (score 2-6) outcome. Analyses were by intention to treat.<b>

FINDINGS:

</b>165 (40.3%) alteplase-group patients and 143 (36.6%) placebo-group patients had favourable mRS outcomes (absolute difference 3.7%, p=0.277). In a posthoc analysis of mRS scores dichotomised for death or dependency, 222 (54.3%) alteplase-group and 180 (46.0%) placebo-group patients had favourable outcomes (score 0-2; absolute difference 8.3%, p=0.024). Treatment differences were similar whether patients were treated within 3 h or 3-6 h. 85 (10.6%) patients died, with no difference between treatment groups at day 90+/-14 days (43 alteplase, 42 placebo). Symptomatic intracranial haemorrhage occurred in 36 (8.8%) alteplase-group patients and 13 (3.4%) placebo-group patients.<b>

INTERPRETATION:

</b>The results do not confirm a statistical benefit for alteplase. However, we believe the trend towards efficacy should be interpreted in the light of evidence from previous trials. Despite the increased risk of intracranial haemorrhage, thrombolysis with alteplase at a dose of 0.9 mg/kg in selected patients may lead to a clinically relevant improvement in outcome.

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Estudio primario

No clasificado

Año 2001
Revista Journal of vascular and interventional radiology : JVIR
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The strong fibrin affinity of recombinant tissue plasminogen activator (rt-PA) theoretically obviates continuous infusion or replacement of t-PA after direct intrathrombic injection. This hypothesis led the authors to evaluate single daily catheter-directed injection of rt-PA as a thrombolytic treatment for acute deep vein thrombosis of the lower extremity. Once-daily injection of rt-PA was performed in large thrombosed veins (popliteal or larger) with use of pulse-spray catheters and in small thrombosed veins in patients' calves with use of 3-4-F coaxial catheters. Patients received only full systemic anticoagulation on his/her patient care unit. This dosing regimen has been tested in 10 patients (12 legs) with a maximum dose of 50 mg per leg per day. Extensive thrombolysis was achieved in nine patients and partial thrombolysis was achieved in one patient, at an average total dose of 106 mg of rt-PA per leg. Minor bleeding was seen in three patients and no transfusions were needed. Our technique and the rationale for this pilot study is the focus of this article.

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Estudio primario

No clasificado

Año 1993
Revista Radiology
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PURPOSE:

To evaluate the long-term results of recanalization of occluded iliac arteries with local low-dose thrombolysis, angioplasty, and, if necessary, stent implantation.

MATERIALS AND METHODS:

Forty-seven patients with acute or chronic occlusions of the common or external iliac artery, or both, underwent local low-dose thrombolysis (n = 47), percutaneous transluminal angioplasty (PTA) (with balloon dilation [n = 43] and rotational angioplasty [n = 30] in the patients in whom a retrograde recanalization was performed), and, if needed, intravascular stent placement (n = 18). Follow-up lasted 3-53 (mean, 21) months.

RESULTS:

The primary recanalization rate was 98% (46 of 47). The mean ankle-brachial index increased from 0.33 to 0.81 within 14 days after treatment and was 0.76 at the most recent follow-up. Two early (< 14 days) and two late reocclusions (after 24 and 30 months) occurred; one restenosis detected with duplex sonography and angiography was observed after 19 months.

CONCLUSION:

This therapy represents a true alternative to vascular surgery and a first-line treatment for acute or chronically occluded iliac arteries.

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Estudio primario

No clasificado

Año 1991
Revista Radiology
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The effects of two urokinase (UK) dose regimens on lysis time, lytic success, primary clinical success, and frequency of complications of peripheral thrombolysis were compared. Seventy-two intraarterial UK infusions were performed by means of standard catheter-directed infusion techniques in 63 patients with symptomatic peripheral arterial or bypass graft occlusions. Patients were prospectively randomized to high-dose (250,000 U/h for 4 hours and then 125,000 U/h) or low-dose (50,000 U/h) regimens. The mean time to complete lysis was 20.8, 26.0, 16.5, and 18.2 hours for the high-dose artery, low-dose artery, high-dose graft, and low-dose graft groups, respectively (P was not significant). Respective mean infusion durations were 27.1, 35.4, 22.2, and 25.3 hours. Clinical success was achieved in 65%-85% of cases. The frequency of complications was equivalent between groups, except for a higher frequency of minor bleeding complications in the high-dose group. The two urokinase dose regimens studied were equally effective in enabling peripheral thrombolysis.

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Revisión sistemática

No clasificado

Año 1991
Autores Topol EJ , Holmes DR , Rogers WJ
Revista Annals of internal medicine

Sin referencias

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PURPOSE:

To review the status of emergency, urgent, routine, and selective angiography after intravenous thrombolytic therapy.

DATA SOURCES:

Relevant English-language articles published from January 1985 to July 1990 were identified through MEDLINE.

STUDY SELECTION:

For emergency angiography, four major randomized studies were reviewed and data from nine studies that incorporated rescue coronary angioplasty were pooled for meta-analysis. For urgent angiography, two controlled trials were reviewed. Comparisons of routine and selective angiography were done using data from two dedicated, large-scale, controlled trials and the ancillary findings of four other studies of reperfusion that incorporated angiography.

DATA EXTRACTION:

The review emphasizes the findings from multicenter, randomized, controlled trials.

DATA SYNTHESIS:

Emergency coronary angiography is done primarily in preparation for primary or rescue angioplasty; the value of rescue angioplasty has yet to be assessed in a randomized trial, but technical success and reocclusion improve significantly after therapy with nonspecific plasminogen activators compared with relatively specific agents (success rate, 86% compared with 75%, respectively; P = 0.03; reocclusion rate, 10.9% compared with 26.8%, respectively; P less than 0.001). Urgent coronary angiography has value for treating recurrent ischemia, but patients who develop this complication after thrombolysis are likely to have a suboptimal outcome despite aggressive care. Studies support the use of either selective or routine angiography in uncomplicated patients after thrombolytic therapy; either approach is acceptable, but the former is more practical and may prove to be cost effective.

CONCLUSIONS:

Optimal follow-up for patients with evolving myocardial infarction who receive thrombolysis may incorporate coronary angiography at various stages. Although our ability to noninvasively detect reperfusion, reocclusion, or viable but ischemic myocardium is limited at present, available data may assist in selecting a catheterization strategy.

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