The low pressure stent observational trial on the procedural and mid-term outcome of a trapezoid-shaped coronary stent (LOPSTER).

BACKGROUND: Stent design influences the procedural and mid-term results of coronary interventions. The trapezoid-shaped struts of the low pressure stent (LP-Stent) might improve the outcome by reducing the vascular trauma at deployment. METHODS: A total of 133 patients (64.5+/-8.6 years) with significant de novo coronary lesions (reference diameter >or=2.8 mm, length <15 mm, and stenosis >or=70% and <100%) were enrolled for single stent deployment and a 6-month clinical and angiographic follow-up. RESULTS: Stents were successfully deployed to 131/133 (98.5%) lesions. In one failed procedure (0.8%), the stenosis could be crossed with another device whereas in the second alternative stents also failed. Following edge dissection after LP-Stent implantation, in 9/133 (6.8%) patients additional stents were deployed. Follow-up was performed as scheduled after 5.9+/- 0.9 months in 98/122 (80.3%) patients, prematurely for in-stent restenosis in 8/122 (6.6%), and clinically only in 8/122 (6.6%). Deaths, one of cardiac origin (0.9%), occurred in 2/114 (1.8%), and myocardial infarctions in 1/114 (0.9%). The culprit stenoses were dilated from 78.4+/-9.7% to 23.3+/-11.0% recurring to 43.1+/-24.3% at scheduled follow-up. The late loss of 0.6+/-0.8 mm and late loss index of 0.3+/-0.5 translated into a binary restenosis rate of 24/98 (24.5%) requiring reintervention in 19/98 (19.4%). CONCLUSIONS: In summary, the LP-Stent is associated with reduced intimal proliferation as reflected by the low late loss index when being compared with either non-coated or passively coated devices and higher in comparison to active coated stents. The considerable dissection rate seems to be related to higher deployment pressures and warrants design modification at the stent's distal edges.

Clinical and angiographic procedural and mid-term outcome with new versus reused balloon catheters in percutaneous coronary interventions.

BACKGROUND: To reduce procedural cost, cardiac centers increasingly use resterilized balloon catheters for percutaneous coronary interventions. Data addressing the procedural and mid-term outcome in a prospective randomized trial comparing new and resterilized balloons are not available. METHODS AND RESULTS: Percutaneous coronary interventions were performed at random in 238 consecutive patients with either new or 1-3 times reused balloon catheters. Crossing of the stenosis decreased from 96% with new balloon catheters to 93.2% (p=0.46), with 1 time reused balloon catheters to 81.8% (p=0.0056) with 2 times reused balloon catheters and to 80.8% (p=0.01) with 3 times reused balloon catheters. In all primary failures using resterilized balloon catheters, new ones of the same nominal diameter were successful. The 4.1 +/- 1.9 month angiographic follow-up rates were 96/124 (77.4%) for new balloon catheter, 35/44 (79.5%) for 1 time reused balloon catheters, 33/44 (75.0%) for 2 times reused balloon catheters, and 21/26 (80.8%) for 3 times reused balloon catheters (p for all >0.05). The late losses for new versus reused balloon catheters were 0.48 +/- 0.75 mm versus 0.73 +/- 0.79 mm (p=0.03). The percent stenosis was higher in reused versus new balloon catheters (51.9 +/- 23.2% v. 42.3 +/- 22.3%; p=0.0042) as was the restenosis rate [39/89 (43.8%] v. 31/96 (32.3%), p=0.13]. There was one death in reused balloon catheter category but no event of myocardial infarction. Rates of target lesion revascularizations were similar in stent recipients and more frequent after stand-alone balloon angioplasty with reused versus new balloon catheters [15/55 (27.3%) versus [5/59 (8.5%), p=0.01]. CONCLUSIONS: The use of two or three times resterilized balloon catheters of the type tested does not seem to be justified in stand-alone balloon angioplasty of de novo coronary stenoses and should be limited to stent procedures until data is available for other indications.

Evaluation of the Coroflex Theca-Stent for reduction of restenosis (ECORI).

BACKGROUND: Various stent coatings have been shown to significantly reduce restenosis rates in comparison to non-coated devices. Therefore, the short- and mid-term performance of the new polyphosphazene-coated Coroflex Theca-Stent was investigated. METHODS: 103 patients [63.9 +/- 11 yrs, 5/103 (4.9%) lesion type A, 52/103 (50.5%) type B1, and 46 of 103 (44.6%) type B2] were enrolled for elective single stent deployment into de-novo coronary lesions (stenoses: greater than or equal to 70%, < 100%; reference diameter greater than or equal to 2.75 mm, less than or equal to 4 mm; lesion length: < 16 mm). RESULTS: Deployment and procedural success were 100%, in 57/103 (55.3%) patients without pre-dilatation. 3/103 (2.9%) patients were lost to follow-up. During the 7.1 +/- 2.3 months clinical follow-up, 3 of 100 (3.0%) patients underwent premature target lesion revascularizations, 4 /100 (4%) had non-target lesion-related deaths, and 1 of 100 (1%) suffered myocardial infarction. Among the 77 of 100 (77.0%) patients who underwent angiographic follow-up, the initial stenosis declined from 87.3 +/- 5.7% to 14.2 +/- 8.3% after stenting, and increased to 32.8 +/- 22.7% after 6.4 +/- 1.3 months. The late loss and late loss index were 0.6 +/- 0.7 mm and 0.2 +/- 0.4, respectively; the recurrence rate was 12 of 77 (15.6%), with reintervention required in 11 of 77 (14.3%) of these patients. CONCLUSION: The Coroflex Theca-Stent provides excellent procedural results and a low restenosis rate. Further development of this polymer as the final coating and as the basis for drug-eluting stents seems justified.

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.