No effect of highly dosed XXXX donor @entity17728 on the angiographic restenosis rate after percutaneous coronary angioplasty: a randomized, placebo controlled, double-blind trial.

@entity1 @entity1423 @entity256 @entity842 @entity299 @entity583 @entity850 @entity17728
BACKGROUND: @entity842 (NO) counteracts several mechanisms involved in the restenotic process after coronary angioplasty. NO mediates an antiproliferative effect on smooth muscle cells, inhibition of leukocyte-vessel wall interactions, and @entity1423 and adhesion. Because these effects are mainly dose dependent, NO-releasing drugs have to be applied at a high dose to have an effect on restenotic mechanisms. OBJECTIVES: To study the effect of the NO donor @entity17728 at a high dose of 8 mg tid on angiographic restenosis rate in a randomized, placebo controlled, double-blind trial. @entity1 AND METHODS: One hundred and sixty-six @entity1 with de novo @entity850 were randomly assigned to @entity17728 or placebo treatment for six months (83 @entity1 each). The primary end point was the angiographic restenosis rate at six months. The secondary end points were major adverse @entity299 (MACE) including death, @entity583 and revascularization. Analyses were performed by intention to treat. RESULTS: There were no differences in clinical, procedural and angiographic data, including minimum lumen diameter and reference diameter. Provisional stenting was performed in 28% of @entity1 receiving @entity17728 and 25% of @entity1 treated with placebo. All other @entity1 were treated with standard balloon angioplasty. Reangiography rate was 89.3% ( @entity17728 90 lesions, placebo 97 lesions). @entity256 rate (greater than 50% diameter @entity850 ) was not significantly different ( @entity17728 25.6% and placebo 29.9%). @entity1 receiving @entity17728 improved significantly more in their anginal class than @entity1 receiving placebo (P<0.026). Occurrence of MACE did not significantly differ between both groups ( @entity17728 26.8% and placebo 34.9%, P=0.26). CONCLUSION: Treatment with the NO donor @entity17728 at a high dose of 8 mg tid for six months after coronary angioplasty has no effect on the angiographic restenosis rate. Due to the vasodilating effect of NO, the anginal status improves slightly more in @entity1 receiving @entity17728 .
