Stent

President Bush’s unnecessary heart surgery.

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Vinay Prasad is chief fellow of medical oncology at the National Cancer Institute and the National Institutes of Health. Adam Cifu is a professor of medicine at the University of Chicago.

Former president George W. Bush, widely regarded as a model of physical fitness, received a coronary artery stent on Tuesday. Few facts are known about the case, but what is known suggests the procedure was unnecessary.

Before he underwent his annual physical, Mr. Bush reportedly had no symptoms. Quite the opposite: His exercise tolerance was astonishing for his age, 67. He rode more than 30 miles in the heat on a bike ride for veterans injured in the wars in Iraq and Afghanistan.

If Mr. Bush had visited a general internist practicing sound, evidence-based care, he would not have had cardiac testing. Instead, the doctor would have had conducted age-appropriate cancer screening. For the former president, this would include only colon cancer screening. It no longer would include even prostate-specific antigen testing for cancer. The doctor would have screened for cholesterol, checked for hypertension and made sure the patient was up to date on age-appropriate vaccinations, including those for pneumococcal pneumonia and shingles. Presumably Mr. Bush got these things, and he got the cardiac test as well.

What value does a stress test add for an otherwise healthy 67-year-old?No study has shown that this examination improves outcomes. The trials that have been done for so-called routine stress testing examined higher-risk patients. They found that performing stress tests on people at high risk of cardiovascular disease may detect blockages but does not improve symptoms or survival. Routine stress testing does, however, increase the use of procedures such as coronary stenting.

Unfortunately, Mr. Bush, like many VIPs, may be paying the price of these in-depth investigations. His stress test revealed an abnormality, prompting another test: a CT angiogram. This study showed a blockage, which was stented open during an invasive procedure. It is worth noting that at least two large randomized trials show that stenting these sorts of lesions does not improve survival. Because Mr. Bush had no symptoms, it is impossible that he felt better after these procedures.

Instead, George W. Bush will have to take two blood thinners, aspirin and Plavix, for at least a month and probably a year. (The amount of time a blood thinner is needed depends on the type of stent placed). While he takes these medications, he will have a higher risk of bleeding complications with no real benefit.

Although this may seem like an issue important only to the former president, consider the following: Although the price of excessive screening of so-called VIPs is usually paid for privately, follow-up tests, only “necessary” because of the initial unnecessary screening test, are usually paid for by Medicare, further stressing our health-care system. The media coverage of interventions like Mr. Bush’s also leads patients to pressure their own doctors for unwarranted and excessive care.

Source: http://www.washingtonpost.com

 

Carotid Stenting vs. Endarterectomy: Coming into.

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Findings from a large clinical trial and magnetic resonance imaging substudy strengthen the case for endarterectomy as the preferred treatment for carotid artery stenosis.

Although the use of percutaneous stenting for carotid artery stenosis is increasing, the procedure is FDA-approved only in patients at high risk for surgical complications. In direct comparisons with endarterectomy, stenting was associated with increased rates of periprocedural stroke, but questions remain about surgical complications, patient selection, timing of intervention, and operator experience. To address these issues, investigators from 50 centers in Europe, Australia, New Zealand, and Canada randomized 1713 patients with recently symptomatic carotid stenosis to undergo stenting or endarterectomy. Planned follow-up is 3 years; we now have results of an interim safety analysis.

At 120 days after randomization, the rate of disabling stroke or death was 4.0% in the stenting group and 3.2% in the endarterectomy group, a nonsignificant difference. However, the incidence of the primary endpoint — any stroke, death, or myocardial infarction (MI) — was 8.5% in the stenting group and 5.2% in the endarterectomy group (hazard ratio, 1.69; 95% confidence interval, 1.16–2.45; P=0·006). Cranial nerve palsy occurred in 1 patient in the stenting group compared with 45 in the endarterectomy group, and significantly fewer hematomas occurred in the stenting group than in the endarterectomy group.

In a substudy, 231 patients underwent preprocedural and postprocedural diffusion-weighted magnetic resonance imaging (DWI) to detect ischemic brain lesions. New postprocedural lesions were found in 50% of patients randomized to stenting and in 17% of those randomized to endarterectomy (odds ratio, 5.21; 95% CI, 2.78–9.79; P<0.001). Increasing DWI lesion volume was associated with subsequent symptomatic stroke. Moreover, DWI lesion rates were higher in centers where filter-based cerebral protection devices were used routinely during stenting than in centers where these devices were not routinely used.

COMMENT

Although longer-term follow-up results of this trial are yet to come, the evidence increasingly supports endarterectomy as the first choice for patients with symptomatic carotid stenosis who are suitable candidates for surgery. The elevated stroke risk associated with stenting is underlined by the striking increase in new ischemic lesions on DWI that appeared to be somewhat related to the use of cerebral protection devices. Whether periprocedural strokes have a greater impact on a patient’s quality of life than periprocedural MIs remains to be seen. Investigators from a U.S. trial (CREST) reported at a recent stroke meeting that stenting and endarterectomy were comparable in their trial, but we reserve judgment until their full published analysis is available.

Source: http://www.jwatch.org

 

First Drug-Eluting Stent Approved to Treat Peripheral Artery Disease.

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The FDA has approved the first drug-eluting stent to treat stenosis or occlusion of the superficial femoral artery in patients with peripheral artery disease (PAD).

In clinical trials, the Zilver PTX stent was more effective than — and at least as safe as — percutaneous transluminal angioplasty for treating symptomatic PAD. The most frequent major adverse event was restenosis necessitating additional therapy.

The paclitaxel-coated stent is contraindicated in patients with stenoses that cannot be dilated, patients with certain bleeding disorders, and women who are pregnant, breast-feeding, or planning to become pregnant within 5 years.

Source:FDA news

JACC Editorialist: Looser Control of Antiplatelet Therapy After Stenting Not Safe — Yet .

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Two studies in the Journal of the American College of Cardiology hint that loosening of dual antiplatelet therapy regimens after cardiac stenting may be possible; however, an editorialist cautions against it.

One study followed some 1600 patients who’d received drug-eluting stents. Rates of adherence to antiplatelet therapy were measured by telephone interviews every 3 months. Interruption of therapy occurred in 11% of patients; such interruptions were mostly temporary and lasted a median of 7 days. Rates of the study’s primary outcomes, cardiac death or acute coronary syndrome in the first year, did not differ between those with and without therapy interruptions.

Another study found no difference in cardiovascular event rates between patients receiving a zotarolimus-eluting stent and only 3 months’ antiplatelet therapy versus those receiving other types of drug-eluting stents and 12 months’ therapy.

An editorialist notes flaws in both studies’ designs and advises clinicians to avoid unplanned discontinuations of dual antiplatelet therapy.

Source:JACC study on interrupted antiplatelet therapy