The Bare Metal Stent

The Randomized Studies

It is important to remember that before we understood the necessity of dual antiplatelet therapy, two randomized studies had already validated the concept of coronary stenting with the Palmaz-Schatz endoprosthesis. In December 1993, the FDA would not approve the Palmaz-Schatz stent without a randomized trial, even though this had not been required for the Gianturco-Roubin 10 months earlier, nor for two different additional types of devices: laser and rotational atherectomy. The “Stent war” would finally be won by Julio Palmaz and Johnson & Johnson in August 1994 with the final FDA approval for the Palmaz-Schatz coronary balloon-expandable stent. This stent, invented by Julio Palmaz, became available in the US “to reduce restenosis of balloon angioplasty”. It was the conclusion of 12 years of litigation involving Julio Palmaz’s original 665 and 762 patents. It should be remembered that 18 months after the introduction of the Palmaz-Schatz stent, several companies commercialized their own balloon-expandable stents, all without randomized trials! A BMS was accepted if it proved “equivalent” in performance to the Palmaz-Schatz stent, benefiting from the intensive trials and investment done by Julio Palmaz and Johnson & Johnson. Let us take a closer look at these two randomized trials that...