The Doctor's Channel

Longer follow-up confirms advantage of sirolimus-eluting vs bare metal stents

2010-03-10T16:43:41+00:00

NEW YORK (Reuters Health) – Three years after ST-segment elevation myocardial infarction (STEMI), sirolimus-eluting stents still provide better protection against major adverse cardiovascular events compared to bare metal stents, new research shows.

The findings are based on 3 years of data from the randomized SESAMI trial. The 1-year results from SESAMI indicated superior outcomes with sirolimus-eluting stents.

Until now, however, long-term safety and efficacy data for sirolimus-eluting stents in STEMI patients came only from registries, according to author Dr. Carmine Musto, from San Camillo Hospital, Rome, and colleagues.

As reported in the February 23rd Journal of the American College of Cardiology, SESAMI included 320 patients, with long-term data available for more than 97% in each group.

The primary outcome – the incidence of major adverse cardiovascular events at 3 years – was 12.7% with sirolimus-eluting stents vs 21% with bare metal stents (p = 0.034). The endpoint was a composite of cardiac and noncardiac death, Q-wave and non-Q-wave infarction, coronary artery bypass graft surgery, or target lesion revascularization.

Patients with sirolimus-eluting stents also had significantly lower rates of target lesion revascularization (7% vs. 13.5%, p = 0.048), target vessel revascularization (8% vs. 16%, p = 0.027), and target vessel failure (11.5% vs. 20.5%, p = 0.028) compared to patients with bare metal stents.

In addition, significantly more sirolimus-treated patients were alive and free from these adverse outcomes (87% to 93%, depending on the event) compared to patients with bare metal stents (79% to 86.5%; p < 0.05). Prevention of target lesion revascularization drove the benefit of the drug-eluting stents, and this was first apparent in the first year of follow-up.

After clopidogrel was discontinued, the two groups had similar cumulative rates of death and recurrent myocardial infarction, the report indicates.

The study had two principal limitations, the authors note. First, it examined only clinical endpoints. Second, it was not powered to detect differences in cardiac event rates between 12 and 36 months.

Reference:
J Am Coll Cardiol 2010;55:810-814.

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Continuous intraperitoneal insulin linked with better quality of life

2010-03-10T16:36:00+00:00

NEW YORK (Reuters Health) - Patients report higher quality of life with continuous intraperitoneal versus subcutaneous insulin, Dutch investigators have found.

The researchers had previously reported that continuous intraperitoneal insulin allows better glycemic control compared to intensified subcutaneous insulin therapy (see Reuters Health story, August 11, 2009).

Their new paper reports on health-related quality of life outcomes and treatment satisfaction in 23 adults with type 1 diabetes who enrolled in a randomized cross-over trial of the two approaches. Patients had 6 months of intensive subcutaneous insulin followed by 6 months of peritoneal infusion, or vice versa. The subcutaneous insulin was given either continuously or via injection - whatever the patient was doing before enrollment.

In their article, published online February 25th in Diabetes Care, lead author Dr. Susan J. Logtenberg, from Isala Clinics, Zwolle, and colleagues write that scores on six subscales of the 36-item Short-Form Health Survey were significantly higher with peritoneal infusion. The only exceptions were in the social functioning and bodily pain domains.

On the World Health Organization-Five Well-Being Index, significantly fewer patients had a score below 50 -- an indication of poor emotional well-being - after peritoneal treatment (6 vs 13, p = 0.02).

Moreover, patients perceived significantly fewer hypoglycemic and hyperglycemic events during their peritoneal infusion phase, leading to greater treatment satisfaction.

As the authors point out, patients preferred the peritoneal approach despite the fact that it requires hospital admission and surgery to insert the pump. It also costs more than twice as much as continuous subcutaneous insulin infusion.

"Continuous intraperitoneal insulin infusion should be (re)considered as a treatment option, at least when satisfactory results of treatment are not reached with subcutaneous intensive insulin treatment regimens," Dr. Logtenberg's team concludes.

Medtronic Europe, which sells insulin pumps, provided an unrestricted grant to the authors.

Reference:
Diabetes Care 2010.

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Melamine-related kidney stones can be managed conservatively

2010-03-10T16:32:38+00:00

NEW YORK (Reuters Health) - Kidney stones linked to melamine-tainted infant milk formula can usually be managed conservatively, Chinese authors report. For infants with renal failure, hemodialysis without surgery was usually adequate.

In August 2008, Chinese officials reported that melamine had been illegally added to some milk-based formulas to increase the protein content. Since then, several young children who drank the tainted milk have died and thousands have developed kidney stones. (See Reuters Health reports September 12 and December 2, 2008.)

In a paper scheduled for publication in the April Journal of Urology, Dr. Jian Guo Wen and colleagues at the First Affiliated Hospital of Zhengzhou University report that in their region, more than 3,000 children came for free medical evaluations after ingesting melamine-tainted formula. In 165, the researchers diagnosed melamine related urinary stones. Fifty children (mean age 23.4 months) had bilateral stones.

The children in this subgroup drank the formula for an average of roughly one year, the authors said. Thirty-one had symptoms, including altered frequency of urination, crying at urination or unexplained crying, and oliguria or anuria. Twenty-eight had mildly acidic urine (pH 6 or less), and 11 had renal failure.

Thirty-three patients had stones ranging from 4-10 mm in diameter (based on ultrasound findings); the other youngsters had smaller calculi. The stones - mainly uric acid and melamine -- were radiolucent on plain x-ray but clearly visible on CT.

Management consisted of hydration, IV sodium bicarbonate 5% to raise urine pH, and an antispasmodic drug (anisodamine 0.1-0.3 mg/kg or atropine 0.1-0.2 mg/kg) to help the stones pass.

Eight of the 11 children with renal failure received up to four sessions of hemodialysis. One patient required ureteral catheterization for a week to drain the renal pelvis.

Children remained in the hospital for an average of 8 days; by discharge, all clinical symptoms resolved. No patient died. Within a month, 33 children passed their stones; in the other 17 youngsters, the stones became smaller.

Despite the good outcomes, the authors advise that "these children need to be monitored for long-term effects of melamine-tainted mild formula consumption."

In a short editorial comment, Dr. John C. Pop at Vanderbilt Children's Hospital, Nashville, Tennessee, disagrees with using hemodialysis to treat renal failure in these children. Instead, he advocates "stenting to relieve the obstruction, followed by conservative treatment" until the stones resolve. He would reserve hemodialysis for patients whose renal insufficiency persists.

Dr. Wen's team defends its management decisions, noting that not all the hemodialysis patients had significant ureteral obstruction. "Hemodialysis was performed according to the regimen issued by the Ministry of Health," and parents of the patients opted for this treatment instead of stenting.

Reference:
J Urol 2010;183:1533-1538.

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Alternative Medicine

2010-03-09T20:01:31+00:00

A new survey finds that most medical students think conventional medicine could benefit to some extent by integrating complementary and alternative medicine, also known as CAM. Supporters of CAM considered it to be a more holistic and highly individualized approach to patient care than conventional medicine.

For more information on Modern Physician, visit:
Modern Physician

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Information Technology Adoption

2010-03-09T19:59:09+00:00

If you’re looking for a word to describe the adoption of information technology by physician practices, “drip” would be more appropriate than “gush.” According to a new government study, the percentage of office-based physicians using electronic health record systems has increased, but the pace of adoption has slowed.

For more information on Modern Physician, visit:
Modern Physician

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The Reality of Electronic Medical Records

2010-03-09T19:52:54+00:00

When it comes to the power of electronic medical records to coordinate patient care, perception and reality are two totally different things. At least according to a new study published in the Journal of General Internal Medicine. The study suggests that the federal government should do more to ensure that the information technology it’s pushing through financial incentives gives physicians the tools they need to coordinate care for their patients.

For more information on Modern Physician, visit:
Modern Physician

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Museum of Anthropology - Vancouver, British Columbia

2010-03-09T17:02:18+00:00

The First Nations Collection at the Museum of Anthropology is a sight to see while you're in Vancouver. Join Dr. David Best for a first-hand look at beautifully carved totem poles and perfect reconstructions of Haida villages. One of the highlights of the collection is the work of Bill Reid, a celebrated Haida artist.

For more information about the Museum of Anthropology, check out their website at
Museum of Anthropology.

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Fertility-conserving surgery safe for early cervical cancer

2010-03-09T16:57:54+00:00

NEW YORK (Reuters Health) – In young women with stage IA1 cervical cancer, a fertility-preserving conization does not reduce survival compared to hysterectomy, researchers report in the March Obstetrics and Gynecology.

With either procedure, 5-year survival is excellent, approaching 100%, the findings indicate.

Small series and case control studies have suggested that conization is safe, but large studies comparing conization and hysterectomy for stage IA1 cervical cancer have been lacking until now, according to lead author Dr. Jason D. Wright, from Columbia University College of Physician and Surgeons, New York, and colleagues.

For the current analysis, the researchers used data from the Surveillance, Epidemiology, and End Results database from 1988 to 2005. They identified 1409 women, age 40 or younger, with stage IA1 cervical cancer; 841 had hysterectomy and 568 underwent conization.

On logistic regression analysis, predictors of conization included Asian ethnicity, single status, diagnosis later in the study period, and residence in the eastern United States. In addition, women younger than 30 had a 78% higher likelihood of conization compared to women above 35.

At 5 years, 98% of those treated with conization and 99% treated with hysterectomy were alive.

“Our study suggests that fertility-conserving surgery is safe for young women with stage IA1 squamous cell carcinoma of the cervix,” the authors conclude. “Young women with microinvasive cervical tumors should weigh the risks and benefits of conization in the context of individual preferences and tumor characteristics.”

Reference:
Obstet Gynecol 2010;115:585-590.

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Tenofovir-related renal dysfunction can't always be reversed

2010-03-09T16:55:19+00:00

NEW YORK (Reuters Health) - Tenofovir nephrotoxicity can't always be fully reversed in HIV-infected men, according to a new study.

Up to 2% of patients have adverse renal effects from the nucleotide reverse transcriptase inhibitor, and reportedly, kidney function rapidly normalizes when tenofovir is stopped. But "because of the few cases, limited follow-up and the insensitive measure used" (serum creatinine) in the previous reports, it's not known how reversible the nephrotoxicity really is, note senior author Dr. Andrew Carr, from St. Vincent's Hospital, Sydney, Australia, and colleagues.

In a paper published online February 19th in the Journal of Acquired Immune Deficiency Syndromes, Dr. Carr and his associates describe 24 men who discontinued tenofovir because their estimated glomerular filtration rate (eGFR) was less than 60 ml/minute/1.73 m2.

During a median of 30 months between start of tenofovir and drug cessation, median eGFR fell from 74 to 51 ml/min/1.73 m2 - a reduction about 10 times greater than expected with normal aging.

During the median period of 13 months after tenofovir discontinuation, eGFR rose by a median of 19 ml/min/1.73 m2. Most improvement occurred in the first month.

In only 10 (42%) patients did eGFR return to pre-tenofovir levels, and only two exceeded 90 ml/min/1.73 m2.

Twelve patients had eGFR increases above the median; this group had a more rapid monthly decline while on tenofovir compared to those with less improvement (1.9 vs 0.7 ml/min/1.73 m2, p = 0.009) and a shorter duration of tenofovir therapy (21 vs 51 months, p = 0.08), suggesting that "more acute renal damage is less likely to be permanent."

These patients were also more likely to have received protease inhibitors (100% vs 54%, p = 0.02). The authors explain that protease inhibitors can increase tenofovir levels in plasma and renal tubular epithelium. Therefore, the greater improvement was likely due to cessation of higher tenofovir exposure.

The single-center study was retrospective, relatively small and had a variable duration of follow-up, and so prospective validation in a larger, more heterogeneous population is needed, the researchers say.

Nevertheless, they conclude, earlier discontinuation of tenofovir might have led to greater improvements in renal function, "which underlines the importance of regular assessment and perhaps of earlier intervention."

Specifically, they advise, even gradual deterioration in eGFR to levels above 60 ml/min/1.73 m2 might be cause enough to discontinue tenofovir.

Reference:
J Acquir Immune Defic Syndr 2010.

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Emboli filters during PCI lead to higher risk of stent thrombosis

2010-03-09T16:49:30+00:00

NEW YORK (Reuters Health) - Using a distal filter to protect against emboli during coronary stent implantation increases long-term rates of stent thrombosis and target vessel revascularization, investigators in Denmark report.

Randomized trials have shown no benefit of distal protection in the short or intermediate term after percutaneous coronary intervention (PCI), Dr. Anne Kaltoft from Aarhus University Hospital, Skejby, and her associates note. Their article in the Journal of the American College of Cardiology for March 2 reports their 15-month follow-up of patients treated for ST-elevation myocardial infarction in the DEDICATION trial.

Patients received aspirin, clopidogrel, and unfractionated heparin in advance of the procedure. If a cardiologist believed that a wire filter could be advanced (based on pre-dilation and initial visualization of the peripheral vascular bed), the researchers then randomized the patient either to distal protection (n = 312) or conventional treatment (n = 314).

In the distal protection group, filter placement was attempted in 304 patients (97%) and was successful in 254 patients (81%).

But filter protection afforded no benefit at either 30 days, 6 months, or 15 months later, the researchers said.

Nine cases of definite stent thrombosis occurred in the protection group and one in the control group (2.9% vs 0.3%, p = 0.01).

The rate of target lesion revascularization was also significantly increased in the distal protection group (12.5% vs 7%, p = 0.05), as was the rate of target vessel revascularization (15.4% vs 8.3%, p < 0.01).

The two groups had similar rates of myocardial infarction and mortality.

Dr. Kaltoft's team suggests that vessel spasm in response to filter placement could lead "to an underestimation of the vessel diameter and to undersizing of the implanted stent, a known predictor of early stent thrombosis." Other possibilities include damage to the vessel wall at the site of filter deployment or stent apposition during filter retrieval.

Similarly, damage to the vessel wall from pre-dilation or during placement of the filter could increase restenosis rates and the need for repeat revascularization.

Whatever the cause, the authors conclude, "Routine use of a filter wire in its present form cannot be advocated and probably should be avoided with primary PCI for ST-elevation myocardial infarction."

Reference:
J Am Coll Cardiol 2010;55:867-871.

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