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BYPASS & STENTS over sold

In 1967 at the request of my father, I reviewed the literature on bypass surgery.  The average life expectancy was 7 years, for those without the operation, 6 years—because those who didn’t have the operation were older.  The recommendation was that the operation was recommended to manage severe angina pain.  Things haven’t changed much--jk. 

 

New England Journal of Medicine http://content.nejm.org/cgi/content/short/359/7/677

Volume 359:677-687 August 14, 2008 Number 7

 

Effect of PCI on Quality of Life in Patients with Stable Coronary Disease

William S. Weintraub, M.D., John A. Spertus, M.D., M.P.H., Paul Kolm, Ph.D., David J. Maron, M.D., Zefeng Zhang, M.D., Ph.D., Claudine Jurkovitz, M.D., M.P.H., Wei Zhang, M.S., Pamela M. Hartigan, Ph.D., Cheryl Lewis, R.N., Emir Veledar, Ph.D., Jim Bowen, B.S., Sandra B. Dunbar, D.S.N., Christi Deaton, Ph.D., Stanley Kaufman, M.D., Robert A. O'Rourke, M.D., Ron Goeree, M.S., Paul G. Barnett, Ph.D., Koon K. Teo, M.D., William E. Boden, M.D., for the COURAGE Trial Research Group

 

ABSTRACT

Background It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease.

Methods We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]).

Results At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (±SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66±25 for physical limitations, 54±32 for angina stability, 69±26 for angina frequency, 87±16 for treatment satisfaction, and 51±25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76±24 versus 72±23 for physical limitation (P=0.004), 77±28 versus 73±27 for angina stability (P=0.002), 85±22 versus 80±23 for angina frequency (P<0.001), 92±12 versus 90±14 for treatment satisfaction (P<0.001), and 73±22 versus 68±23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups.

Conclusions Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov] .)

Drugs as good as stents for many heart patients.

 

By MARILYNN MARCHIONE

The Associated Press—story from WashingtonPost.com
Wednesday, August 13, 2008; 7:42 PM

-- People with chronic chest pain who are not in big danger of a heart attack now may have even less reason to rush into an artery-opening angioplasty: There's more evidence drugs should be tried first and often are just as effective.

The slim early advantage for angioplasty at relieving pain in these non-emergency cases starts to fade within six months and vanishes after three years, according to a new report from a landmark heart study.

That is sooner than the five years doctors estimated last year after their first analysis of the study. The new information comes from patients' own reports of how they fared after treatment. Results are in Thursday's New England Journal of Medicine.

“This study should be enlightening and practice-changing for doctors and patients alike," and should lead more to try drugs before resorting to the $40,000 heart procedure, said Duke University's Dr. Eric Peterson, who co-authored an editorial in the medical journal.

The number of angioplasties has been falling since the first results from this big study came out in 2007, according to new figures requested by The Associated Press from an American College of Cardiology database.

Angioplasty remains the top treatment for people having a heart attack or hospitalized with worsening symptoms. It involves using a tiny balloon to flatten a clog and propping the artery open with a mesh tube called a stent.

However, at least a third of angioplasties are done on people not in imminent danger, to relieve chest pain. These patients are no more likely to die or suffer a heart attack if initially treated with drugs alone, the big 2,287-patient study revealed.

Still, angioplasty's fans tout it as a quick fix that improves quality of life. That benefit is fairly small and short-lived, compared to good medication use alone, the new report found.

Researchers did follow-up health surveys of about 70 percent of the study's participants. At the start, 78 percent had chest pain.

Three months after treatment, 53 percent of patients who had angioplasties plus drug treatment and 42 percent of the drugs-alone patients were free of chest pain. Both groups continued to improve, and the gap started to narrow within six months. After three years, their scores on chest pain, quality-of-life and treatment satisfaction did not significantly differ.

"Patients get better," regardless of which initial treatment they have, said study leader Dr. William Weintraub of Christiana Care Health System in Newark, Del.

One exception: Those who started out with more severe chest pain fared better with angioplasty. And not everyone did well on drugs alone _ about one-third ultimately needed an angioplasty or heart bypass surgery.

The study was funded by the U.S. Department of Veterans Affairs, the Medical Research Council of Canada and a host of drug companies. Many of the researchers have consulted for drug makers, and many of the study's critics have consulted for stent makers.*

People in the study were properly tested to ensure they were medically stable, said Dr. Spencer King, a cardiologist at St. Joseph's Heart and Vascular Institute in Atlanta and past president of the cardiology college.

"My greatest fear" is that some patients now may be given medications without adequate testing to show angioplasty can safely be delayed, he said.

The study patients also received an ideal mix of medicines, potentially including aspirin, cholesterol-lowering statins, nitrates, ACE inhibitors, beta-blockers and calcium channel blockers.

Not all patients do, especially when doctors are paid more to do an angioplasty than for the many office visits needed to get the meds right.

"It's a tricky business and it requires a lot of close followup," said Dr. W. Douglas Weaver, a heart specialist at Henry Ford Health System in Detroit and president of the cardiology college.

About 1 million angioplasties are done in the United States each year.

The number started to decline before the study came out, because of safety worries about certain stents, and continued to fall after it, said Dr. Ralph Brindis, a California heart specialist who heads the cardiology college's cardiovascular data registry.

The proportion of angioplasties done on people with chronic but stable chest pain dropped from 18 percent in early 2005 to just over 15 percent by March 2008, the registry shows. Started 10 years ago, it now includes information on about 530,000 angioplasties per year _ roughly 60 percent of the national total.

___

On the Net:

New England Journal: http://www.nejm.org

 

*  Again it is not what they tested but what they didn’t test.  Among them would be the use of aspirin alone, or aspirin with niacin.  And of course there was no monitoring of side effects or reporting how many stents failed because they have been occluded with plaque.  The issue of side effects of course is not raised. 

 

Cognitive decline similar to that of bypass occurs with stents (below), and who knows what happens to those on the cocktail of drugs

 

 

 

Risks associated with vascular stents

Executive function has been demonstrated to decline in patients who undergo coronary artery bypass as well as individuals who receive vascular stents. The mechanism of action for cognitive decline in bypass surgery is believed to be due to the release of tiny emboli into the blood stream that subsequently travel into the brain resulting in small strokes or ischemia. While the same degree of decline in executive function or 'IQ' occurs in vascular stenting of the coronary arteries, the mechanism of action remains unknown. This decline from pre-procedure baseline has been observed soon after surgery and as far out as six years post surgery. While the decline is minimal, it is measurable, consistent and appears to be permanent. Lifestyle modifications to treat elevated cholesterol, diabetes and hypertension offer the safest course of action in treating non-life threatening coronary artery disease.—at http://en.wikipedia.org/wiki/Stent

 

For a Scientific American article on pump head go to http://healthfully.org/heart/id3.html. 

There is an issue with cognitive impairment with statins—however, that too has not been studied--jk.   Niacin and aspirin are the safest, healthful, and cheap solution.

 

Those who have a financial interest in the outcome manipulate the results, Major study finds that all 37 journal articles positive effects over stated; the average was 32%. Statins cause erectile dysfunction, cognitive imparement, and cancer.  

Lipitor (2011) lifetime sales $131 billion, tops all drugs.  Plavix at $60 billion is second.

 

STATINS CANCER Link

52% short term

 

LA Times, Health section, July 21, 2008  --  excerpts

Vytorin, the combination drug (simvastatin (better known by its commercial name Zocor) and ezetimibe--known as Zetia) prescribed to lower cholesterol, sustained another blow today, when the author of a major clinical trial announced that the medication had failed to drive down hospitalization and death due to heart failure in patients with narrowing of the aortic valve. In the process, researchers in Norway detected a significant blip in cancers in the 1,800 subjects they followed

Today's findings suggested something more ominous: the incidence of cancer -- and of dying of cancer -- was significantly higher in the patients taking Vytorin. Altogether, 67 patients on placebo developed cancer during the trial. Among subjects on Vytorin, 102 developed cancers of various kinds.*  This is the second adverse press—the first being in March 08, when the ENHANCE trial found that Vytorin fared no better than a placebo at reducing plaque buildup on the walls of patients' arteries.* *

Comments by jk

Simvastatin (Zocor) is off patent.  Thus in a scramble for profits a combination drug (on patent) was introduced.  Direct to consumer market cost $155 in 07—mainly TV ads. 

*  The pressing issue is that since the development  of Statins, the very first animal studies in the 60s it has been known that Statins increase the incidents of cancer.  However, nearly all studies done thereafter have not included cancer. 

*  Several studies have failed to find a reduction in the build of plaque, even thought the statins including Zocor, reduce LDL and cholesterol.  Few studies include the principle reason for taking a statin, namely a reduction in the death rate.  Claims for such reduction probably entail a failure to control the contravening variable, aspirin usage.  Given a pile of evidence, including the very mechanism of plaque formation, which involves inflammation process, I must conclude that the use of statins is highly suspect.  Given the harm done including cognitive impairment, weakness, and cancer, if my skepticism is born out, the harm done by statins as a course of treatment will far surpass that of VIOXX which killed over 200,000 people world wide by accelerating atherosclerosis. 

 EXTENDED RELEASE NIACIN IS A SAFER, AND A MORE EFFECTIVE WAY TO LOWER MI RISK!