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

Abstract

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 ≥2.8 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 217 (14.3%) of the Nir recipients ( P = .50). Acute myocardial infarctions were less frequent in the Tenax recipients after ≥60 weeks. Premature target lesion revascularization was performed in 16 of 233 (6.9%) patients in the Tenax group and 11 of 217 (5.1%) ( P = .54) patients in the Nir group. Coronary bypass operations were similar after Tenax 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. (Am Heart J 2003;145:e17.)