FDA OKs first drug-eluting stents for use in MI

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Drug-eluting stents (DES) have been used in diabetics and/or acute MI as off-label use up till now. With the FDA approving specific stents in these conditions, its legal implications are many.

Drug-eluting stents are preferred to bare-metal stents because they reduce the incidence of restenosis and target vessel revascularization. Similar outcomes have also been shown in patients with acute ST elevation myocardial infarction (STEMI) undergoing primary PCI.

Since patients with an acute MI (within 48 to 72 hours) were excluded from the pivotal SIRIUS and TAXUS IV trials, primary PCI is considered an “off-label” use in the United States for all DES.

In the HORIZONS AMI trial, 3006 patients with STEMI patients were randomly assigned to either paclitaxel-eluting Taxus stents (PES) or BMS in a 3:1 ratio. The 12 month rates of ischemia-driven target vessel revascularization were significantly lower after treatment with PES a difference that was entirely due to a lower rate of target lesion revascularization.

Based on the results HORIZONS-AMI trial, two drug-eluting stents from Boston Scientific have become the FIRST to be approved by the US FDA for treating patients with acute myocardial infarction.

  • Ion: Paclitaxel-eluting platinum chromium
  • Taxus Liberté  - Paclitaxel-eluting

The Ion stent, which employs polymer and drug elution similar to that of the Taxus, differs with respect to its platinum chromium metal alloy structure and design, which allow for thinner struts and more flexibility within the coronary arteries.

Diabetic stent FDA approved

US FDA has also approved Medtronic Resolute Integrity drug-eluting stent, which is the first stent the agency has approved to treat coronary artery diseases in diabetics.

Diabetics suffering from coronary artery disease represent 30% of the nearly 1 million PCI procedures performed yearly in the U.S and 1.2 lakhs in India. Such procedures are inherently more difficult in patients with diabetes because their coronary arteries are narrower than those not afflicted by the condition.

The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it is exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment.

Is it time to stop using sulfonylureas

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Is it time to stop using sulfonylureas?

The American College of Physicians has detailed a guideline regarding use of oral agents in type 2 diabetes entitled “Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline From the American College of Physicians.”

Earlier guidelines

  • AACE/ACE guideline: metformin is probably best, but you can start with whatever you want,
  • for sulfonylurea.
  • ADA: start with metformin and then add either SU, TZD or insulin.

ACP’s three recommendations

  • Recommendation 1: use medications in patients diagnosed with type 2 diabetes when lifestyle modifications are not working.
  • Recommendation 2: Start with metformin in most patients with type 2 diabetes
  • Recommendation 3: Add a second agent when metformin alone is not enough.

Physicians, after starting on metformin, can choose a second agent based on properties of those specific agents that may be beneficial to a particular patient (i.e. GLP-1 analogues for overweight patients), avoid agents with unwanted side effects (i.e. not using TZDs in patients with fluid overload) as well as other factors such as cost and patient preference.

  1. The evidence shows that most diabetes medications reduced HbA1c levels to a similar degree.
  2. Metformin was more effective than other medications as monotherapy as well as when used in combination therapy.
  3. The risk for hypoglycemia with sulfonylureas exceeds the risk with metformin or thiazolidinediones.
  4. Physicians should start with metformin, then add something else (TZD, DPP4, GLP-1, SGLT-2 -when available), but probably not sulfonylurea, since it clearly causes more hypoglycemia then anything else.
  5. SUs are effective, but not good medications.  They cause significant hypoglycemia. They cause weight gain. The “burn out” the pancreas.  All of the others do not cause hypoglycemia.
  6. All except for TZD’s are weight neutral or cause weight loss.
  7. All the other appear to preserve beta cell function.
  8. The only reason to use SU’s in 2012 is due to cost.
  9. Sulfonylureas should today be used only as 3rd or 4th line agent.

India starts TAVI Programme (transcatheter aortic valve implantation)

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India was ultimately granted permission to start the TAVI program informed CSI president Dr Ashok Seth during India Live 2012. He said that Escorts Heart Institute has done three successful cases this week.

India is the last country to have been granted permission by its government. Commenting on this Dr Kirti Punamiya said that it was unfortunate that India was denied permission for this for so long as India will miss the opportunity to compete with the World in expertise with this procedure as the learning period in this technology is long.

Dr Seth also said that permission given by the government is conditional and from case to case on compassion basis.

Dr Kirti said because of this delay the center of excellence in India on TAVI may never come.

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