CORONARY DRUG STENTS

DRUG ELUTING STENTS
Jama 1.39.98
Coronary vascularization has improved vastly with drug-eluting stents. The two drug stents: strolimus and pachitaxel stents have lowered coronary restenosis to 5% from 15% with older bare metal stents .

Because companies look for device regulatory approval, they choose patients who have low risks of restenosis as a consequence.

Since approval comparison trials have suggested equal rates of restenosis with these drug stents. Trials for approval occur in all areas of medicine. They are designed to test if the drug or device is helpful under ideal conditions rather then if the drug or device is beneficial in everyday practice. After approval of the drug or device, new studies are expected to help bridge this gap and monitor safety.

WHICH STUDY DO YOU BELIEVE

The strolimus stent was the first available clinically. Early post approval testing showed it was safe and effective in reducing restenosis and also lowering heart complications. They had similar results in their regulatory approval studies.

Later the pachitaxel stent approval studies also showed it was safe and effective and had the same outcomes as its rival strolimus stent.

A study followed comparing both stents in16 randomized head to head trials, and another 38 trial studies. It was found that strolimus stents had lower restenosis rates and lower stent clots than its rival paclitaxel.
This resulted in confusion and was challenging to interpret.

A report by Galloe published in the JAMA January 2008 reported a study that included unselected patients with varied symptoms. This randomized trial study showed no difference in the two stents in all analyzed categories. It was the largest randomized study including all comers.

THE FUTURE

Soon second generation stents this year will be on the market, namely everolimus and zotarolimus=eluting stents.. The vascular surgeon will choose a stent that is based on safety, effectiveness, deliverability, and above all which insurance company will pay for the device.

Studies have become hard to interpret because of different criteria used for patient enrollment. Real world registries and studies are limited because they don’t have valid control groups and they use historical controls. Now with a large database for all procedures, we might find the safest and most effective stents that should be used.

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