Randomized controlled trial

Effectiveness of a text-messaging-based smoking cessation intervention (“Happy Quit”) for smoking cessation in China: A randomized controlled trial

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Abstract

Background

China has the highest global prevalence of cigarette smokers, accounting for more than 40% of the total cigarette consumption in the world. Considering the shortage of smoking cessation services in China, and the acceptability, feasibility, and efficacy of mobile-phone-based text messaging interventions for quitting smoking in other countries, we conducted a mobile-phone-based smoking cessation study in China.

Methods and findings

We conducted a randomized controlled trial in China across 30 cities and provinces from August 17, 2016, to May 27, 2017. Adult smokers aged 18 years and older with the intention to quit smoking were recruited and randomized to a 12-week high-frequency messaging (HFM) or low-frequency messaging (LFM) intervention (“Happy Quit”) or to a control group in a 5:2:3 ratio. The control group received only text messages unrelated to quitting. The primary outcome was biochemically verified continuous smoking abstinence at 24 weeks. Secondary outcomes included (1) self-reported 7-day point prevalence of abstinence (i.e., not even a puff of smoke, for the last 7 days) at 1, 4, 8, 12, 16, 20, and 24 weeks; (2) self-reported continuous abstinence at 4, 12, and 24 weeks; and (3) self-reported average number of cigarettes smoked per day. A total of 1,369 participants received 12 weeks of intervention or control text messages with continued follow-up for 12 weeks. The baseline characteristics of participants among the HFM (n = 674), LFM (n = 284), and control (n = 411) groups were similar. The study sample included 1,295 (94.6%) men; participants had a mean age of 38.1 (SD 9.79) years and smoked an average of 20.1 (SD 9.19) cigarettes per day. We included the participants in an intention-to-treat analysis. Biochemically verified continuous smoking abstinence at 24 weeks occurred in 44/674 participants in the HFM group (6.5%), 17/284 participants in the LFM group (6.0%), and 8/411 participants (1.9%) in the control group; participants in both the HFM (odds ratio [OR] = 3.51, 95% CI 1.64–7.55, p < 0.001) and the LFM (OR = 3.21, 95% CI 1.36–7.54], p = 0.002) intervention groups were more likely to quit smoking than those in the control group. However, there was no difference in quit rate between the HFM and LFM interventions. We also found that the 7-day point quit rate from week 1 to week 24 ranged from approximately 10% to more than 26% with the intervention and from less than 4% to nearly 12% without the intervention. Those who continued as smokers in the HFM group smoked 1 to 3 fewer cigarettes per day than those in the LFM group over the 24 weeks of trial. Among study limitations, the participants were able to use other smoking cessation services (although very few participants reported using them), cotinine tests can only detect smoking status for a few days, and the proportion of quitters was small.

Conclusions

Our findings demonstrate that a mobile-phone-based text messaging intervention (Happy Quit), with either high- or low-frequency messaging, led to smoking cessation in the present study, albeit in a low proportion of smokers, and can therefore be considered for use in large-scale intervention efforts in China. Mobile-phone-based interventions could be paired with other smoking cessation services for treatment-seeking smokers in China.

Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial.

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Abstract

Background Patients with severe asthma are at increased risk of exacerbations and lower respiratory tract infections (LRTI). Severe asthma is heterogeneous, encompassing eosinophilic and non-eosinophilic (mainly neutrophilic) phenotypes. Patients with neutropilic airway diseases may benefit from macrolides.

Methods We performed a randomised double-blind placebo-controlled trial in subjects with exacerbation-prone severe asthma. Subjects received low-dose azithromycin (n=55) or placebo (n=54) as add-on treatment to combination therapy of inhaled corticosteroids and long-acting β2agonists for 6 months. The primary outcome was the rate of severe exacerbations and LRTI requiring treatment with antibiotics during the 26-week treatment phase. Secondary efficacy outcomes included lung function and scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ).

Results The rate of primary endpoints (PEPs) during 6 months was not significantly different between the two treatment groups: 0.75 PEPs (95% CI 0.55 to 1.01) per subject in the azithromycin group versus 0.81 PEPs (95% CI 0.61 to 1.09) in the placebo group (p=0.682). In a predefined subgroup analysis according to the inflammatory phenotype, azithromycin was associated with a significantly lower PEP rate than placebo in subjects with non-eosinophilic severe asthma (blood eosinophilia ≤200/µl): 0.44 PEPs (95% CI 0.25 to 0.78) versus 1.03 PEPs (95% CI 0.72 to 1.48) (p=0.013). Azithromycin significantly improved the AQLQ score but there were no significant between-group differences in the ACQ score or lung function. Azithromycin was well tolerated, but was associated with increased oropharyngeal carriage of macrolide-resistant streptococci.

Conclusions Azithromycin did not reduce the rate of severe exacerbations and LRTI in patients with severe asthma. However, the significant reduction in the PEP rate in azithromycin-treated patients with non-eosinophilic severe asthma warrants further study.

 

Source: Thorax

Nutritional interventions for reducing morbidity and mortality in people with HIV.

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HIV/AIDS has long been synonymous with wasting and weight loss. For example, in South Africa, it was known as “slims” disease. Coupled with this, it’s known that adequate nutrition is important for optimal immune and metabolic function and, so, one might expect that dietary support would improve clinical outcomes in HIV-infected individuals by reducing HIV-related complications and attenuating progression of HIV disease. This should lead to better quality of life and, ultimately, less disease-related mortality. Therefore, this Cochrane Review from February 2013 examines the experimental evidence for the effects of nutritional interventions given orally on important clinical outcomes for adults and children with HIV infection and finds that there is relatively little research to help decision makers.

The authors searched many databases, trawled through references and contacted people working in the area. However, only 14 relatively small, randomized trials came to light, which met their inclusion criteria. Just three of these reported on mortality, two that had recruited adults and the other, from South Africa, had recruited children.

A wide range of macronutrient supplements were studied with just two of the trials (one in adults and one in children) studying the same one, a food supplement called Spirulina. There was also wide variation in other aspects of the trials, including the outcomes that were measured and reported and the types of people who took part, in relation to stage of HIV, HIV treatment status and general nutrient status. When the authors assessed the quality of the trials, none of the trials were graded as providing strong evidence. This was mostly because the trials were small and had a high risk of bias due to a lack of blinding and the large proportion of people who left the trials early.

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The latest version of the review is an update of the earlier review from 2007, which had included 8 trials from high-income countries, with fewer than 500 HIV+ adults in total. Patients with confirmed secondary infections or other signs and symptoms of infection, such as fever, chills, or persistent diarrhea, were not eligible for any of those trials. This made it difficult to determine the applicability of the findings to the types of people who are most likely to need effective macronutrient supplementation. Six new studies have been added in the update, bringing the number of participants to more than 1700 adults and nearly 300 children. Four of the new trials are from Africa, and there is one from Brazil and one from India. The new trials also include two trials that had recruited participants with opportunistic infections (tuberculosis and persistent diarrhea).

Bringing the evidence together and, where possible, combining the findings of similar trials in meta-analyses identified no significant benefits for supplementary food, daily supplement of Spirulina or a nutritional supplement enhanced with protein with respect to death in HIV+ adults and children. In HIV+ adults with weight loss, nutritionally balanced macronutrient supplements aimed at improving energy intake by 600-960 kcal/day increased intakes of energy and protein compared with no supplement or nutrition counselling alone, but had no effect on other anthropometric or immunologic parameters. From the meta-analyses, supplementation with macronutrient formulas given to provide protein, energy or both and fortified with micronutrients, in conjunction with nutrition counselling, significantly improved energy intake (3 trials; n=131; MD 394 kcal/day; 95% CI: 225 to 562; p<0.00001) and protein intake (2 trials; n=81; MD 23.5 g/day; 95% CI: 12.7 to 34.0; p<0.00001) compared with no nutritional supplementation or nutrition counselling alone.

The authors conclude that supplementation with specific macronutrients such as amino acids, whey protein concentrate or Spirulina did not significantly alter clinical, anthropometric or immunological outcomes in HIV-infected adults and children. They call for future research that takes better account of the needs and resources of the HIV+ individual, the clinician treating them and the people caring for them. They highlight areas of ongoing uncertainty, including the choice between using resources for antiretroviral treatment for HIV+ people or nutritional interventions, the populations that might benefit most (e.g. malnourished HIV+ people, HIV+ people with uncontrolled weight loss, HIV+ people with opportunistic infections or HIV+ lactating mothers), the role of nutritional counseling compared to nutritional interventions in well-resourced settings, and how the use of anti-retroviral therapy might make it difficult to detect the effects of nutritional interventions.

Soure: Cochrane Library

Specialized Care Didn’t Affect Healthcare Use Among Confused Hospitalized EldersBut patients were happier, and their families were satisfied with their care..

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Some hospitals have specialized units to care for older, cognitively impaired patients, but whether such units improve outcomes is unclear. In this randomized trial, investigators compared care in a specialized unit versus standard care (geriatric or general medical wards) in 600 patients (median age, 85) identified as “confused” on admission to a large U.K. hospital. Specialized unit staff were skilled in managing patients with delirium and dementia, and specialized care included regular psychiatrist visits, organized activities, a physical environment tailored to patients with cognitive impairment, and proactive involvement of family caregivers.

After adjusting for multiple variables, investigators found no significant differences between patients randomized to specialized care and those randomized to standard care in days spent at home during 90 days after randomization (51 and 45 days) or in median length of hospital stay (11 days in both groups). Rates of return home from the hospital, in-hospital mortality, 90-day survival, hospital readmission, and nursing home placement also were similar. However, specialized-unit patients were significantly more likely than standard-care patients to be in a positive mood (79% vs. 68%), and their family caregivers were significantly more likely to be satisfied with their care (91% vs. 83%).

COMMENT

In this trial, confused elders admitted to a specialized unit did not have superior healthcare-use outcomes or longer survival than those admitted to geriatric or general medical wards. Although patient mood and family caregivers’ satisfaction favored specialized care over standard care, the absolute differences were small. Based on these findings, justifying the costs associated with such specialized units would be difficult.

Source: NEJM

 

Global eradication rates for Helicobacter pylori infection: systematic review and meta-analysis of sequential therapy.

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Abstract

Objective To do a systematic review and meta-analysis of studies comparing sequential therapy for eradication of Helicobacter pylori with pre-existing and new therapies, thus providing a glimpse of eradication success worldwide.

Design Systematic review and meta-analysis.

Data sources Medline, Embase, and Cochrane Central Register of Controlled Trials up to May 2013; abstract books of major European, American, and Asian gastroenterological meetings.

Study selection Randomised controlled trials in previously untreated adults, in which sequential therapy was compared with a pre-existing or new therapy.

Results 46 randomised controlled trials were reviewed and analysed. 5666 patients were randomised to sequential therapy and 7866 to other (established and new) treatments. The overall eradication rate of sequential therapy was 84.3% (95% confidence interval 82.1% to 86.4%). Sequential therapy was superior to seven day triple therapy (relative risk 1.21, 95% confidence interval 1.17 to 1.25; I2=29.3%; number needed to treat 6 , 95% confidence interval 5% to 7%), marginally superior to 10 day triple therapy (1.11, 1.04 to 1.19; I2= 67.2%; NNT 10, 7 to 15), but not superior to 14 day triple therapy (1.00, 0.94 to 1.06; I2=54.3%), bismuth based therapy (1.01, 0.95 to 1.06; I2=21.1%), and non-bismuth based therapy (0.99, 0.94 to 1.05; I2=52.3%). Data on eradication according to pre-treatment antimicrobial susceptibility testing were available in eight studies, and sequential therapy was able to eradicate 72.8% (61.6% to 82.8%) of the strains resistant to clarithromycin.

Conclusions Eradication rates with pre-existing and new therapies for H pylori are suboptimal. Regional monitoring of resistance rates should help to guide treatment, and new agents for treatment need to be developed.

 

Source: BMJ

 

 

Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).

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Abstract

Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.

Design Multicentre observer blinded randomised controlled trial.

Participants Patients undergoing laparotomy at 21 UK hospitals.

Interventions Standard care or the use of a wound edge protection device during surgery.

Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.

Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.

Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.

Source: BMJ

 

A Randomized, Double-Blind, Controlled Trial Comparing Rifaximin Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy. .

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Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of HE are primarily directed at the reduction of the blood ammonia levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the efficacy and safety of rifaximin plus lactulose vs. lactulose alone for treatment of overt HE.

METHODS:In this prospective double-blind randomized controlled trial, 120 patients with overt HE were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63) and group B (lactulose (n=57) plus placebo). The primary end point was complete reversal of HE and the secondary end points were mortality and hospital stay.
RESULTS:A total of 120 patients (mean age 39.4+/-9.6 years; male/female ratio 89:31) were included in the study. 37 (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP class C. Mean CTP score was 9.7+/-2.8 and the MELD (model for end-stage liver disease) score was 24.6+/-4.2. At the time of admission, 22 patients (18.3%) had grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%) in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004). There was a significant decrease in mortality after treatment with lactulose plus rifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4, P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS). Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8+/-3.4 vs. 8.2+/-4.6 days, P=0.001).
CONCLUSION:Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE.

Source: American  Journal  Gastroenterology

 

Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial..

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BACKGROUND:

On the basis of mixed results from previous trials, we assessed whether therapeutic hypothermia for 48-72 h with slow rewarming improved mortality in children after brain injury.

METHODS:

In this phase 3, multicenter, multinational, randomised controlled trial, we included patients with severe traumatic brain injury who were younger than 18 years and could be enrolled within 6 h of injury. We used a computer-generated randomisation sequence to randomly allocate patients (1:1; stratified by site and age [<6 years, 6-15 years, 16-17 years]) to either hypothermia (rapidly cooled to 32-33°C for 48-72 h, then rewarmed by 0·5-1·0°C every 12-24 h) or normothermia (maintained at 36·5-37·5°C). The primary outcome was mortality at 3 months, assessed by intention-to-treat analysis; secondary outcomes were global function at 3 months after injury using the Glasgow outcome scale (GOS) and the GOS-extended pediatrics, and the occurrence of serious adverse events. Investigators assessing outcomes were masked to treatment. This trial is registered with ClinicalTrials.gov, number NCT00222742.

FINDINGS:

The study was terminated early for futility after an interim data analysis on data for 77 patients (enrolled between Nov 1, 2007, and Feb 28, 2011): 39 in the hypothermia group and 38 in the normothermia group. We detected no between-group difference in mortality 3 months after injury (6 [15%] of 39 patients in the hypothermia group vs two [5%] of 38 patients in the normothermia group; p=0·15). Poor outcomes did not differ between groups (in the hypothermia group, 16 [42%] patients had a poor outcome by GOS and 18 [47%] had a poor outcome by GOS-extended paediatrics; in the normothermia group, 16 [42%] patients had a poor outcome by GOS and 19 [51%] of 37 patients had a poor outcome by GOS-extended paediatrics). We recorded no between-group differences in the occurrence of adverse events or serious adverse events.

INTERPRETATION:

Hypothermia for 48 h with slow rewarming does not reduce mortality of improve global functional outcome after paediatric severe traumatic brain injury.

Source: Pubmed

Anxiolytics in patients suffering a suspected acute coronary syndrome: Multi-centre randomised controlled trial in Emergency Medical Service..

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Abstract

BACKGROUND:

The prehospital treatment of pain and discomfort among patients who suffer from acute coronary syndrome (ACS) needs a treatment strategy which combines relief of pain with relief of anxiety.

AIM:

The aim of the present study was to evaluate the impact on pain and anxiety of the combination of an anxiolytic and an analgesic as compared with an analgesic alone in the prehospital setting of suspected ACS.

METHODS:

A multi-centre randomised controlled trial compared the combination of Midazolam (Mi)+Morphine (Mo) and Mo alone. All measures took part: Prior to randomisation, 15min thereafter and on admission to a hospital. Inclusion criteria were: 1) pain raising suspicion of ACS and 2) pain score ≥4.

PRIMARY ENDPOINT:

Pain score after 15min.

RESULTS:

In all, 890 patients were randomised to Mi+Mo and 873 to Mo alone. Pain was reduced from a median of 6 to 4 and finally to 3 in both groups. The mean dose of Mo was 5.3mg in Mi+Mo and 6.0mg in Mo alone (p<0.0001). Anxiety was reported in 66% in Mi+Mo and in 64% in Mo alone at randomisation (NS); 15min thereafter in 31% and 39% (p=0.002) and finally in 12% and 26% respectively (p<0.0001). On admission to a hospital nausea or vomiting was reported in 9% in Mi+Mo and in 13% in Mo alone (p=0.003). Drowsiness differed; 15% and 14% were drowsy in Mi+Mo versus 2% and 3% in Mo alone respectively (p<0.001).

CONCLUSION:

Despite the fact that the combination of anxiolytics and analgesics as compared with analgesics alone reduced anxiety and the requirement of Morphine in the prehospital setting of acute coronary syndrome, this strategy did not reduce patients’ estimation of pain (primary endpoint). More effective pain relief among these patients is warranted.

Source: Pubmed

 

Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis.

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Abstract

Objective To determine whether antibiotic prophylaxis at the time of removal of a urinary catheter reduces the risk of subsequent symptomatic urinary tract infection.

Design Systematic review and meta-analysis of studies published before November 2012 identified through PubMed, Embase, Scopus, and the Cochrane Library; conference abstracts for 2006-12 were also reviewed.

Inclusion criteria Studies were included if they examined antibiotic prophylaxis administered to prevent symptomatic urinary tract infection after removal of a short term (≤14 days) urinary catheter.

Results Seven controlled studies had symptomatic urinary tract infection after catheter removal as an endpoint; six were randomized controlled trials (five published; one in abstract form) and one was a non-randomized controlled intervention study. Five of these seven studies were in surgical patients. Studies were heterogeneous in the type and duration of antimicrobial prophylaxis and the period of observation. Overall, antibiotic prophylaxis was associated with benefit to the patient, with an absolute reduction in risk of urinary tract infection of 5.8% between intervention and control groups. The risk ratio was 0.45 (95% confidence interval 0.28 to 0.72). The number needed to treat to prevent one urinary tract infection was 17 (12 to 30).

Conclusions Patients admitted to hospital who undergo short term urinary catheterization might benefit from antimicrobial prophylaxis when the catheter is removed as they experience fewer subsequent urinary tract infections. Potential disadvantages of more widespread antimicrobial prophylaxis (side effects and cost of antibiotics, development of antimicrobial resistance) might be mitigated by the identification of which patients are most likely to benefit from this approach.

Discussion

In our meta-analysis of pooled data from seven studies (six of which were randomized), there were significantly fewer symptomatic urinary tract infections in patients receiving prophylaxis during removal of a urinary catheter than in those not receiving prophylaxis. Our finding in favor of antibiotic prophylaxis, however, must be tempered by possible publication bias toward positive studies, the limitations of the included studies, and practical considerations about encouraging more widespread antibiotic use.

Indwelling urinary catheters pose several risks to patients, including urethral trauma, discomfort, and urinary tract infection.31 In an era of increasingly constrained fiscal resources and evolving antibiotic resistance, evidence based antimicrobial prescribing is essential to promote antimicrobial stewardship.32 Unfortunately, there is no consensus on whether clinicians should prescribe antibiotic prophylaxis to patients when an indwelling urinary catheter is removed.

Conclusions

This meta-analysis of available data indicates an overall benefit of antibiotic prophylaxis at the time of removal of a urinary catheter to prevent subsequent urinary tract infections. The number needed to treat indicates that 17 patients would need to receive prophylaxis to prevent one symptomatic urinary tract infection. We know little, however, about the potential negative consequences of implementing antibiotic prophylaxis in this setting in a wider frame or indeed which types of patients would be most likely to benefit. Increasing antimicrobial resistance, healthcare costs for antibiotics, and the potential for side effects of antibiotic administration are disadvantages that merit careful review. From a public health standpoint, we should be careful not to encourage antibiotic use when it might not be necessary. The healthcare provider of a catheterized patient, however, might consider antibiotic prophylaxis before catheter removal, after taking individual risk factors into account. Future studies should better characterize who is at risk of developing symptomatic urinary tract infection after catheter removal (whether bacteriuric or not) and then examine antibiotic prophylaxis in those at greatest risk.

What is already known on this topic

  • Catheterization of the urinary tract is associated with an increased risk of bacteriuria and symptomatic urinary tract infection
  • Antibiotic administration at the time of removal of a urinary catheter might effectively reduce urinary tract infections, but guidelines for catheter associated infections note insufficient evidence to support this practice
  • Antibiotic prophylaxis at the time of urinary catheter removal in general surgery, prostatectomy, and medical patients effectively reduced the incidence of symptomatic urinary tract infections with a number needed to treat of 17
  • The effect size of antibiotic prophylaxis in this meta-analysis was stable to sensitivity analyses with exclusion of non-randomized trials and two studies in non-surgical patients

What this study adds.

 

Source: BMJ

 

 

e wind: �x �� �� -border-alt:none windowtext 0in; padding:0in’>12 1314 16 Although other studies have examined the links between acute kidney injury and mortality and end stage renal disease in people admitted to hospital with myocardial infarction treated with either invasive or medical management,18 33 these studies have not compared renal outcomes on the basis of treatment strategies.

 

Our findings show that acute kidney injury is a relatively common complication in people with non-ST elevation acute coronary syndrome and chronic kidney disease and increases substantially with lower baseline estimated glomerular filtration rate. However, the difference in the incidence of acute kidney injury between people who receive early invasive management and similar patients treated conservatively is relatively small. Importantly, despite the modestly higher risk of acute kidney injury associated with early invasive management at all levels of estimated glomerular filtration rate, our findings suggest that this strategy is not associated with higher risks of more clinically relevant renal outcomes (including acute dialysis or progression to end stage renal disease), which occurred much less often at all levels of baseline estimated glomerular filtration rate, regardless of treatment strategy. Since early invasive management seemed to be consistently associated with a long term survival advantage at all levels of baseline estimated glomerular filtration rate, these findings (interpreted in light of their consistency with results from randomised trials showing that early invasive management improves long term survival in high risk patients3 4) suggest that restricting or delaying access to invasive coronary procedures may not avoid most cases of clinically relevant acute kidney injury and could deny high risk individuals (including those with pre-existing chronic kidney disease) important benefits.

There are several potential mechanisms for the higher risk of acute kidney injury associated with early invasive management. People who received early invasive management were more likely to receive coronary angiography, percutaneous coronary intervention, coronary artery bypass grafting surgery, and angiotensin converting enzyme inhibitors or angiotensin receptor blockers, placing them at risk of acute kidney injury from contrast exposure, perioperative ischaemia, and haemodynamic effects. Furthermore, patients who received invasive management had a longer hospital stay and more measurements of creatinine during follow-up, which may have increased the probability that acute kidney injury would be ascertained. However, the magnitude of the increased risk associated with invasive management strategies was small, suggesting that patients’ characteristics such as age, comorbidity, pre-existing chronic kidney disease, drug use (including diuretics and inhibitors of the renin angiotensin system), and haemodynamic instability are more important contributors to the risk of acute kidney injury in patients with acute coronary syndrome than whether or not they are managed invasively or medically.

The better survival associated with early invasive management of non-ST elevation acute coronary syndrome in this cohort are in keeping with the clinical benefits of angiography and revascularisation reported in clinical trials, including subgroups with pre-existing chronic kidney disease.2 3 4 Although episodes of acute kidney injury have been linked to an increased risk of end stage renal disease,18 19 34 we did not observe a higher risk of end stage renal disease in people with otherwise similar characteristics who received early angiography despite the higher risk of acute kidney injury, even among strata with lower baseline estimated glomerular filtration rate. Radiocontrast associated acute kidney injury is typically manifested by a small change in serum creatinine levels, rarely leads to acute dialysis, and is usually reversible.10 Our findings suggest that the majority of such additional episodes of acute kidney injury associated with invasive procedures may confer relatively low risks of progression to end stage renal disease, although further studies are needed to help predict those at risk of progressive chronic kidney disease after acute kidney injury.

Conclusion

In conclusion, early invasive management of non-ST elevation acute coronary syndrome is associated with a small increase in the risk of acute kidney injury compared with a conservative management approach but is not associated with higher risks of in-hospital acute kidney injury requiring dialysis or long term risk of end stage renal disease. Given the improvement in cardiovascular outcomes and long term survival observed with early invasive management, these results suggest that invasive treatments should not be withheld solely because of concern they might increase the risk of kidney injury.

What is already known on this topic

  • Acute kidney injury after invasive coronary procedures is associated with adverse outcomes, including end stage renal disease and death
  • Fear of precipitating contrast induced acute kidney injury possibly contributes to underuse of invasive treatments for acute coronary syndrome in people at high risk of kidney disease
  • Comparisons of renal outcomes between people treated with invasive versus conservative management are lacking
  • People who received early invasive management for non-ST segment elevation acute coronary syndrome were modestly more likely to develop acute kidney injury
  • After early invasive management the risks of requiring dialysis and long term risk of end stage renal disease were similar, and patients had better long term survival than those treated conservatively
  • These findings were consistent across varying levels of baseline kidney function, suggesting similar relative risks and benefits of early invasive management in people with and without pre-existing kidney disease

What this study adds

 

Source: BMJ