Stents, contd


Big deal, will enroll a total of  1500 women and non-white people in a 12 month study.  It's sponsored by big pharma, one has to be suspect of any optimistic conclusions.


Harm Outweighs Good in Asymptomatic ECG Screening : Cardiology News
July 30, 2012
Here are some quotes from the article:

"The incremental information offered by resting or exercise ECG (beyond that obtained with conventional CHD risk factors) is highly unlikely to result in changes in risks stratification that would prompt interventions and ultimately reduce CHD-related events."
However, the harms may be very real, noted Dr. Moyer of the Baylor College of Medicine, Houston, and her coauthors.
"An ECG abnormality, as a result of a true- or false-positive test, can lead to invasive confirmatory testing and treatments that have the potential for serious harm, including unnecessary radiation exposure and the associated risk for cancer," the panel members noted (Ann. Intern. Med.; 2012 July 31 [online first]).
Invasive testing – angiography and revascularization – could confer an additional set of problems, including bleeding, contrast-induced nephropathy, and allergic reactions to contrast agents.  
and another quote
The recommendation also addresses ECG screening in adults who are at intermediate or high risk of heart disease, because these people would potentially reap the greatest benefit from early detection and intervention.
"Reclassification into a higher risk category might lead to more intensive medical management that could lower the risk for CHD events, but it might also result in harms, including medication adverse events such as gastrointestinal bleeding and hepatic injury," the panel noted. "The risk-benefit tradeoff would be most favorable if persons can be accurately reclassified from intermediate to high risk."  
**************end of quote
My comment:
If you are sent to a cardiologist you risk the possibility that their specialty biases them to find you at high risk.

Hazards of PTCA

The following is a quote from this Medtronic link

Potential Adverse Events

The following complications may be associated with the use of coronary stenting devices or PTCA:
  • Acute myocardial infarction
  • Allergic reaction to contrast medium/stent material/ medications
  • Arrhythmias (including ventricular fibrillation and ventricular tachycardia)
  • Arteriovenous fistula
  • Bleeding complications
  • Cardiac tamponade
  • Cerebrovascular accident/stroke
  • Death
  • Dissection of coronary artery
  • Drug reactions
  • Embolization (air, stent, tissue or thrombotic)
  • Emergency coronary artery bypass graft surgery (CABG)
  • Endocarditis
  • Failure to deliver the stent
  • Stent deformation, collapse or fracture
  • Hematoma
  • Hemorrhage requiring transfusion
  • Injury of the coronary artery
  • Myocardial ischemia/infarction
  • Pain and tenderness at the insertion site
  • Perforation
  • Peripheral Ischemia
  • Peripheral nerve injury
  • Pseudoaneurysm (coronary/ femoral/radial)
  • Pyrogenic reaction
  • Restenosis of the dilated artery or stented segment
  • Sepsis/infection
  • Short-term hemodynamic deterioration (hypotension/ hypertension)
  • Stent thrombosis or occlusion
  • Total occlusion of coronary artery
  • Unstable angina
  • Vascular thrombosis
  • Vessel dissection/perforation/spasm
This study was of 54 patients.  It is a beginning toward understanding the risk of MI associated with PTCA
Microvascular function before PCI predictive of periprocedural MI
quote: Conclusion Microvascular function prior to PCI is an important determinant of PPMI. Measuring IMR pre-PCI and rPIMR may allow prospective identification of patients at risk of periprocedural myocardial infarction. Future studies in a larger cohort are required to establish the predictive ability of IMR in PPMI. 

This study indicates that DES stents do not increase rates of stent thrombosis, three years out.  It does not answer the question about whether patients can ever discontinue dual anti-platelet therapy.
The  PROTECT study - August 27, 2012 presentation
The first paragraph of the story in ptca.org is
Three year results from the largest randomized clinical trial of drug-eluting stents ever conducted, and the only trial sufficiently powered to measure stent thrombosis, show low rates of blood clots occurring inside drug-eluting stents implanted in "real-world" patients. 

FDA: Mortality Increased With Dronedarone and Permanent AF By: ELIZABETH MECHCATIE, Cardiology News Digital Network
 
Dronedarone increases the risk of death and serious cardiovascular events in people with permanent atrial fibrillation, and its use should be limited to the approved indication: the treatment of nonpermanent AF, the Food and Drug Administration has concluded.
In a statement issued Dec. 19, the FDA announced that its safety review of dronedarone (Multaq), an antiarrhythmic drug approved in July 2009, has been completed. "The FDA believes that Multaq provides a benefit for patients with nonpermanent AF and recommends that healthcare professionals who prescribe Multaq follow the recommendations in the revised Multaq drug label," the FDA statement said.
Dronedarone, marketed as Multaq by Sanofi-Aventis, is indicated to "reduce hospitalizations for AF in patients in sinus rhythm with a history of nonpermanent AF."

In late November 2012 this occurred.
Ranbaxy recalls generic lipitor doses
Possible contamination with glass particles


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