5/21/09
This study looked at a drug recommended before angiography in patients with myocardial infarction and found that this early use was not superior to its traditional use after angiography.
123 Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery
7/16/09
Endoscopic harvesting of the saphenous vein for use in coronary-artery bypass surgery had become popular because it eliminated the need for the long incisions associated with open harvesting, reduced wound infections, decreased postoperative pain, and shortened the length of stay in the hospital. This study, however, showed that endoscopic harvesting resulted in higher rates of vein-graft failure at 12 to 18 months and, at three years, higher rates of death, myocardial infarction, or repeat revascularization.
124 A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures
8/6/09
Studies 124 and 125 demonstrated the failure of vertebroplasty, discussed extensively in chapter 1.
125 A randomized trial of vertebroplasty for osteoporotic spinal fractures
8/6/09
See study 124.
126 Weight-lifting in women with breast cancer–related lymphedema
8/13/09
Breast cancer survivors with lymphedema (a common postsurgical complication) are commonly told to limit the use of the affected arm. This randomized trial showed that weight-lifting actually improves the symptoms of lymphedema (discussed in chapter 15).
127 Intensity of continuous renal-replacement therapy in critically ill patients
10/22/09
Prior to this study there had been a widespread increase in the use of higher-intensity continuous renal-replacement therapy among critically ill patients. This large, multicenter, randomized controlled trial of intensity of renal support showed that this practice was not justified.
128 Revascularization versus medical therapy for renal-artery stenosis
11/12/09
Renal artery stenosis is associated with hypertension and kidney disease, but it is unclear whether the relationship is causal. Despite this uncertainty, 16 percent of patients with newly diagnosed atherosclerotic narrowing of the renal artery and hypertension were treated for this narrowing. This large randomized trial found substantial risks but no evidence of benefit from this treatment.
129 A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease
11/19/09
Similar to study 80, this trial showed that the use of erythropoesis-stimulating agents among patients with anemia and chronic kidney disease did not reduce the risk of death, cardiovascular events, or renal events. It did show that the treatment was associated with an increased risk of stroke.
130 Extended-release niacin or ezetimibe and carotid intima-media thickness
11/26/09
Similar to study 106, this trial further undermined the purported benefit of ezetimibe with respect to cardiovascular risk.
131 Preoperative biliary drainage for cancer of the head of the pancreas.
1/14/10
This study addressed a procedure to relieve jaundice prior to surgery in patients with pancreatic cancer. This multicenter, randomized trial found that the procedure, preoperative biliary drainage, increases the rate of serious complications without a mortality benefit
132 Outcomes after internal versus external tocodynamometry for monitoring labor
1/28/10
Recommendations existed regarding use of internal tocodynamometry—a means of monitoring uterine contractions—during cases of induction or augmentation of labor. This multicenter, randomized trial found that internal tocodynamometry did not reduce the rate of operative deliveries, adverse neonatal outcomes, analgesia use, antibiotics use, or time to delivery.
133 Comparison of dopamine and norepinephrine in the treatment of shock
3/4/10
This study compared the use of two medications commonly used to support the blood pressure in critically ill patients and found one to be clearly superior.
134 Lenient versus strict rate control in patients with atrial fibrillation
4/15/10
A challenge in treating patients with atrial fibrillation is controlling their heart rates. Guidelines recommended strict rate control (resting heart rate fewer than 80 beats per minute and exercise heart rate fewer than 110 beats per minute). This study found that more lenient rate control was not inferior to strict rate control (and was much easier to achieve).
135 Effects of combination lipid therapy in type 2 diabetes mellitus
4/29/10
Fibrates, which are cholesterol-lowering medications, are commonly combined with statins to treat high cholesterol. This study demonstrates that a combination of a statin and a fibrate was not superior to therapy with a statin alone.
136 Effects of intensive blood-pressure control in type 2 diabetes mellitus
4/29/10
Guidelines recommended strict blood-pressure control in patients with diabetes. This study partially reversed these recommendations by showing that strict control did not differ from the standard control with respect to the study’s primary outcome of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Intensive treatment did lower the stroke risk in intensively treated patients (though the absolute benefit was small and was associated with more adverse events).
137 Aspirin plus heparin or aspirin alone in women with recurrent miscarriage
4/29/10
This study evaluated the common practice of using antiplatelet and anticoagulation therapy during pregnancy in women with unexplained, recurrent miscarriages. The large multicenter study, which randomized these women to aspirin plus heparin, aspirin alone, or placebo, failed to demonstrate a benefit in live-birth rate with aspirin plus heparin or aspirin alone.
138 Quality indicators for colonoscopy and the risk of interval cancer
5/13/10
Professional societies advocated cecal intubation as a quality-indicator for colonoscopy. This large, retrospective study failed to demonstrate that cecal intubation was a predictor of interval colon cancer.
139 Long-term outcome of open or endovascular repair of abdominal aortic aneurysm
5/20/10
Recently, endovascular repair of abdominal aortic aneurysms has become popular because this approach improves perioperative survival over conventional open repair. This randomized, controlled trial showed similar survival rates between endovascular and open repairs but higher re-intervention rates for endovascular repair.
140 A randomized trial of treatment for acute anterior cruciate ligament tears
7/22/10
This study, discussed in chapter 2, randomized young, active adults to structured rehabilitation plus early ACL reconstructive surgery or structured rehabilitation with delayed ACL reconstruction. The results suggest that more than half of all surgical reconstructions can be reasonably avoided.
141 CPR with chest compression alone or with rescue breathing
7/29/10
Studies 141 and 142 test the nearly half-century-old assumption that chest compression and rescue breathing are critical parts of CPR. These trials showed no benefit from rescue breathing when added to chest compression.
142 Compression-only CPR or standard CPR in out-of-hospital cardiac arrest
7/29/10
See study 141.
143 Suicide-related events in patients treated with antiepileptic drugs
8/5/10
This represents a complicated reversal where a practice based on inadequate data was reversed by a study providing only slightly less inadequate data. In 2008 there was an FDA warning regarding the risk of suicidality associated with antiepileptic drugs. This case-control analysis showed that treatment with antiepileptic drugs did not increase the risk of suicide-related events in patients with epilepsy but did increase the risk among patients with depression and among those without epilepsy, depression, or bipolar diso
rder.
144 A randomized, controlled trial of early versus late initiation of dialysis
8/12/10
This trial suggested that initiating dialysis early, as widely recommended, is actually no better than a later initiation.
145 Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery
9/9/10
The gentamicin-collagen sponge has been approved for use in numerous countries and used in millions of patients worldwide since 1985. Its use was based primarily on a single-center, randomized trial. This large, multicenter trial showed that the gentamicin-collagen sponge actually resulted in significantly more surgical-site infections, more visits to the emergency room or surgical office, and more hospitalizations for infection.
146 Effects of CYP2C19 genotype on outcomes of clopidogrel treatment
10/28/10
This study addressed the effectiveness of the blood-thinner clopidogrel in patients who metabolize drugs normally or more slowly. Contrary to previous understanding (and related practice), the present study showed that the safety and efficacy of clopidogrel is consistent, regardless of the rate of metabolism.
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1. WHAT IS MEDICAL REVERSAL?
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Thiele H, Zeymer U, Neumann FJ, et al. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012;367:1287–1296.
4. SCREENING TESTS
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5. SYSTEMS FAILURE
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