Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry.
ABSTRACT We sought to explore the immediate clinical and angiographic results of the Titan(®) stent implantation in diabetic patients, as well as the major adverse cardiac events (MACE) at 6-month follow-up. We enrolled 156 consecutive diabetic patients admitted to undergo percutaneous intervention for at least one significant (50%) coronary lesion. All lesions were treated with the Titan(®) stent implantation according to the contemporary interventional techniques. Patients were prospectively followed-up for at least 6 months. The primary endpoint was MACE at 6-month follow-up [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, TLR at 6-month follow-up, and stent thrombosis. The mean age was 66.7 ± 9.6 years, (68.4% males). A total of 197 Titan(®) stents were implanted in 163 lesions. Direct stenting was performed in 45.2% of the cases. The mean stent diameter was 3.1 ± 0.61 mm, and the mean length was 18.0 ± 8.9 mm. Average stent deployment pressure was 13.9 ± 4.2 bars. Angiographic procedural success was achieved in 154 (98.7%) cases, and clinical procedural success was achieved in 153 (98.1%) cases. One patient developed in-hospital non-Q-wave MI following the procedure. Clinical follow-up was completed in 155 (99.4%) patients. Three patients (1.9%) died of a cardiac or unknown cause, and two (1.3%) developed MI. TLR was performed in 11 patients (7.1%). Cumulative MACE at 6-month follow-up occurred in 16 (10.3%) patients. No patient suffered stent thrombosis. Titan(®) stent implantation in diabetic patients achieves an excellent immediate clinical and angiographic outcome, with a low incidence of MACE at mid-term follow-up.
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ABSTRACT: 5-Hydroxytryptamine type 2 antagonists are used to treat symptomatic peripheral arterial disease. However, it remains unknown as to whether the administration of sarpogrelate, a 5-hydroxytryptamine type 2 antagonist, improves the prognosis after endovascular therapy for critical limb ischemia (CLI). We performed a retrospective analysis using a database of 386 Japanese patients undergoing endovascular therapy for CLI. Sixty-seven patients were treated with sarpogrelate, and we compared their prognosis with that of an equal number of background-matched controls extracted from the population. The primary end point was the first event of either major amputation or death from any cause, and amputation-free survival was evaluated. The follow-up period was 21 ± 18 months (mean ± standard deviation), and 58 end points were observed. Patients treated with sarpogrelate had a significantly higher amputation-free survival rate than their matched controls (P = 0.036). The hazard ratio for the end point and its 95 % confidence interval was 0.57 (0.34-0.97). These results suggest that sarpogrelate treatment is associated with a favorable prognostic outcome in CLI patients undergoing endovascular therapy. Future prospective studies are required to investigate whether sarpogrelate treatment would improve the prognosis of CLI patients.Heart and Vessels 03/2013; · 2.13 Impact Factor
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ABSTRACT: Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents. We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up. Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy. Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients. In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.Archives of cardiovascular diseases 02/2012; 105(2):60-7. · 0.66 Impact Factor
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ABSTRACT: Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Full English text available from: www.revespcardiol.org/en.Revista Espa de Cardiologia 04/2014; · 3.20 Impact Factor