4.5 Article

Comparison of a silicon carbide-coated stent versus a noncoated stent in human beings: The Tenax versus Nir Stent Study's longterm outcome

Journal

AMERICAN HEART JOURNAL
Volume 145, Issue 4, Pages -

Publisher

MOSBY-ELSEVIER
DOI: 10.1067/mhj.2003.90

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Background Stents coated with amorphous hypothrombogenic silicon carbide (a-SiC:H) have low restenosis rates in humans. Recurrence in a-SiC:H at mid-term follow-up has been shown to be similar to a stainless steel device. The long-term outcome, however, may be different. Methods Four hundred ninety-seven patients (63.4 +/- 9.8 years of age) received either the a-SiC:H-coated Tenax stent (Biotronik, Berlin Germany). or the 316L Nir stent (Boston Scientific, Maple Grove, Minn). Lesions had to be covered with one stent only (diameter greater than or equal to2.8 mm, length <20 mm). Exclusion criteria comprised acute myocardial infarction and angiographic thrombus within the target vessel. Twenty-five of 497 (5%) patients were excluded for protocol violation. Clinical follow-up was completed in 450 of 472 (95.3%) and angiographic follow-up was completed in 365 of 472 (77.3%); 22 of 472 (4.7%) patients were lost to follow-up. Results Major adverse coronary events occurred in 28 of 233 (12%) of the Tenax recipients and in 31 of 2 17 (14.3%) of the Nir recipients, (P = .50). Acute myocardial infarctions were less frequent in the Tenax recipients after greater than or equal to60 weeks. Premature target lesion revascularization was performed in 16 of 233 (6.9%) patients in the Tenox group and I I of 2 17 (5.1%) (P = .54) patients in the Nir group. Coronary bypass operations were similar after Tenox or Nir stent deployment (3/233 [1.3%] vs 6/217 [2.8%], P = .43), as were deaths in 7 of 233 (3%) versus 8 of 217 (3.7%) (P = .88), respectively. Conclusions Both stents had, a low rate of major adverse coronary events at 81 +/- 12 weeks of follow-up, with no definite superiority of any of the devices.

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