July 2009 Archives

AFFIRM. NEJM 2002; 347(23): 1825.

Randomization: 7401 eligible, 4060 enrolled. 2027 in rate-control group, 2033 in rhythm-control group.

Baseline: Mean age 69.7y, 40% women, 11% ethnic minorities, 71% HTN, 38% CAD, 5% valvular disease, 23% CHF, 35% had first episode of afib, 90% had afib in last 6wks, 69% had afib > 2d.

Therapy:

Rate-control: Initial treatment was 49% digoxin, 47% beta-blockers, 30% diltiazem, 10% verapamil. 70% had used digoxin at least once. At five years 35% in sinus rhythm, 80% in afib had rate control, and 15% had crossover to rhythm-control. Continuous anticoagulation with goal INR 2-3.

Rhythm-control: Initial treatment was 33% digoxin, 22% beta-blockers, 38% amiodarone, & 31% sotalol. 63% had used amiodarone at least once. At five years, 63% were in sinus rhythm and 37.5% had crossover to rate-control. Anticoagulation could be stopped if NSR > 4 wks, preferably > 12 wks. Goal INR 2-3.

Primary Outcome: rate vs rhythm

Overall mortality: 25.9% vs 26.7%, ARR 0.8%, NNT 125, p = 0.08

Secondary Outcomes: rate vs rhythm

Composite death, disabling stroke, encephalopathy, bleed, arrest: 32.7 vs 32.0%, p = 0.33

Cardiac arrest: no difference

Encephalopathy: no difference

Ischemic stroke: 5.5 vs 7.1%, p = 0.79

Myocardial infarction: 4.9 vs 6.1%, p = 0.60

Pulmonary embolism: no difference

Adverse Events:

Hemorrhage not involving CNS: 7.7 vs 6.9%, p = 0.44

Sort P. NEJM 1999; 341(6): 403-9.

RESULTS

Randomization: 199 consecutive patients with cirrhosis who had spontaneous bacterial peritonitis, 73 excluded, 126 randomized.   

Baseline: Average age 62y, 30% had alcoholic cirrhosis, 11% had hepatocellular carcinoma, average Child-Pugh score was 10.2, 44% had renal failure, 65% on diuretic therapy, 57% had isolated organism, most being E. coli.

Outcomes:  

Resolution of infection: 98 vs 94%, p = 0.36
Renal impairment: 10 vs 33%, ARR 23%, NNT 4.3, p = 0.002
Death, in hospital: 10 vs 29%, ARR 19%, NNT 5.3, p = 0.01
Death, at three months: 22 vs 41%, ARR 19%, NNT 5.3, p = 0.03

Adverse Events: no reported adverse events

Discussion: Cost of albumin is between $5 and $25 per gram in the US. For the average 70kg man, this would cost between $875 to $4,375 per patient, and $4,375 to  $23,200 to save one life. Mortality rates from SBP have been steadily decreasing over the last 15 years, this serves as another tool for prevention of hepatorenal syndrome and death.  

Duckworth W. NEJM 8 Jan 2009; 360(2): 129-39.  Supplement

Randomization: 20,027 patients screened, 17,788 (88.8%) excluded by chart review, 2239 (11.2%) provided consent, 448 (20.0%) excluded, 1791 (80%) underwent randomization. 899 received standard treatment, 892 received intensive treatment.

Baseline: Mean age 60.4y, diabbetes diagnosed for a mean of 11.5y, mean BMI 31.3, mean HBA1c was 9.4%, HTN in 72%, at least one cardiovascular event in 40%, 52% receiving insulin, 62% had microvascular complications.

Follow-up: SBP 125 vs 127, DBP 69 vs 68, LDL 80 vs 80, HDL 41 vs 40, quit smoking 77% vs 86%. 

Primary Outcome:

HBA1c: 6.9% vs 8.4%
Time to first occurence of a cardiovascular event: no significant difference
MI: ARR 1.5%, NNT 66, p = 0.24
Stroke: ARR 0.8%, NNT 115, p = 0.32
Amputation: ARR 0.6%, NNT 152, p = 0.26
CV Death: ARR -1.0%, NNH 97, p = 0.26

Secondary Outcomes:

All Cause Mortality: ARR (-)0.8%, NNH 115, p = 0.62
Sudden Death: ARR (-)0.8%, NNH 115, p = 0.07
Otherwise, there were no significant differences between the groups

Microvascular Events: no significant differences 

Adverse Events:

Hypoglycemia: Absolute Risk Increase 5.4%, NNH 18.5%, p = 0.000 

Stein PD. NEJM 1 June 2006; 354(22): 2317-27.

RESULTS

Randomization: 7284 screened, 3262 eligible, 1090 enrolled. 238 did not receive reference diagnosis, 824 underwent subsequent analysis (11% of those screened, 25% of those eligible).  

Baseline: mean age 51.7y, majority had low or moderate probability of pulmonary embolism (Wells score).  

Reference Diagnosis: 192/824 diagnosed with PE (23%), of the 632 ruled out, 592 had interpretable CTA, 590 did not receive anticoagulatants, 2/590 had initially unrecognized PE.

Wells Score | Table 4 | Table 5 

Results of CTA:

Sensitivity 83% (76-92%)
Specificity 96% (93-97%)
Likelihood ratio for a positive test was 19.6 (13.3 - 29.0)
Likelihood ratio for a negative test was 0.18 (0.13 - 0.24)
PPV 86% (79-90%)
NPV 95% (92-96%)

PPV for PE in main or lobar artery 97%
PPV for PE in segmental vessel 68%
PPV for PE in subsegmental vessel 25%

Results of CTA-CTV:

Sensitivity 90% (84-93%)
Specificity 95% (92-96%)
Likelihood ratio for a positive test was 16.5 (11.6 - 23.5)
Likelihood ratio for a negative test was 0.11 (0.07 - 0.16)
PPV 85% (78-94%)
NPV 97% (94-97%)

Results using the Wells score:

High Clinical Probabiltiy: PPV 96%, NPV 60%
with CTV, PPV 96%, NPV 82%

Discussion: In high clinical probability patients, a positive CTA provides sufficient evidence to start treatment. Venous phase imaging increased the sensitivity by 7%. In high clinical probability patients who have a negative CT, the false negative rate was 40% which poses a dilemna regarding treatment.