FDA OKs first drug-eluting stents for use in MI

Health Care Comments Off

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.