Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS).

PURPOSE: Stents coated with hypothrombogenic silicon carbide (a-SiC:H) exhibited low restenosis rates in the rabbit and in an observational study in humans. Thus, the clinical and angiographic outcome was assessed in a large multicenter study. MATERIAL AND METHODS: Four hundred and ninety-seven patients (63.4 +/- 9.8 years) were randomized to either receive the a-SiC:H-coated Tenax stent or the stainless steel Nir stent. Lesions (diameter > or = 2.8 mm, length < 20 mm) were covered with one single stent. RESULTS: Fifty-one of 497 (10.3%) patients were excluded for protocol violation. Three hundred and forty-two of 446 (76.7%) patients presented for scheduled angiographic follow-up after 4.7 +/- 1.2 months and 29 of 446 (6.5%) prematurely. In-hospital complications comprised two deaths (0.8%) (P > 0.99) and one (0.4%) (P > 0.99) CK-elevation in each group, target lesion revascularization in 5 of 250 (2%) of the Tenax and 4 of 244 (1.6%) of the Nir sample (P > 0.99), and subacute thrombosis in 2 of 250 (0.8%) of the Tenax patients (P = 0.5). In the Tenax/Nir patients mean percent diameter stenosis decreased from 82.3 +/- 9.1%/80.7 +/- 8.4% (P = 0.49) to 17.6 +/- 5.5%/17.6 +/- 5.5% (P = 0.99) postprocedure and increased to 34.5 +/- 21.5%/34.2 +/- 23.1% (P = 0.90) at follow-up. CONCLUSIONS: Thus, there appears to be no advantage of the silicon carbide coated stent over a stainless steel stent after 4.7 +/- 1.2 months with regard to clinical and angiographic restenosis rates.

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

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 > or =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 > or =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.