Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry

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.

[1]  M. Chiariello,et al.  Different vascular response to concurrent implantation of sirolimus- and zotarolimus-eluting stents in the same vessel , 2009, Heart and Vessels.

[2]  Joseph P Ornato,et al.  ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). , 2006, Journal of the American College of Cardiology.

[3]  Winfried März,et al.  Prevalence, predictors, and consequences of unrecognized diabetes mellitus in 3266 patients scheduled for coronary angiography. , 2003, American heart journal.

[4]  E. Topol,et al.  Use of bivalirudin during percutaneous coronary intervention in patients with diabetes mellitus: an analysis from the randomized evaluation in percutaneous coronary intervention linking angiomax to reduced clinical events (REPLACE)-2 trial. , 2005, Journal of the American College of Cardiology.

[5]  Johan Lindbäck,et al.  Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. , 2007, The New England journal of medicine.

[6]  J. Brophy,et al.  A hierarchical Bayesian meta-analysis of randomized clinical trials of drug-eluting stents , 2004 .

[7]  M. Niemelä,et al.  Titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction: a 12-months follow-up report from the TITAX AMI trial. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[8]  Jeffrey W Moses,et al.  Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. , 2003, The New England journal of medicine.

[9]  E. DeLong,et al.  Acute and long-term cost implications of coronary stenting. , 1999, Journal of the American College of Cardiology.

[10]  William Wijns,et al.  Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. , 2007, Circulation.

[11]  W. Laskey,et al.  Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry. , 2008, JACC. Cardiovascular interventions.

[12]  B. Gersh,et al.  Prevalence, Predictors, and Outcomes of Premature Discontinuation of Thienopyridine Therapy After Drug-Eluting Stent Placement: Results From the PREMIER Registry , 2007 .

[13]  M. Niemelä,et al.  Two-year follow-up after percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus paclitaxel-eluting stents in acute myocardial infarction , 2009, Annals of medicine.

[14]  H. Yeh,et al.  Comparison of endothelial cells grown on different stent materials. , 2006, Journal of biomedical materials research. Part A.

[15]  F. Eberli,et al.  Randomized Comparison of a Titanium-Nitride-Oxide–Coated Stent With a Stainless Steel Stent for Coronary Revascularization: The TiNOX Trial , 2005, Circulation.

[16]  Lawrence Joseph,et al.  A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents , 2004, The Lancet.

[17]  Patrick W. Serruys,et al.  A randomized comparison of a sirolimus eluting stent with a standard stent for coronary revascularization , 2002 .

[18]  P. Raskin,et al.  Report of the expert committee on the diagnosis and classification of diabetes mellitus. , 1999, Diabetes care.

[19]  S. Blair,et al.  Cardiorespiratory fitness and body mass index as predictors of cardiovascular disease mortality among men with diabetes. , 2005, Archives of internal medicine.

[20]  W Rutsch,et al.  A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. , 1994, The New England journal of medicine.

[21]  Yannick Giraud-Sauveur.  TITAN 2 Bio-Active Stent (BAS) with titanium-NO. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[22]  G. Vanzetto,et al.  Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry. , 2007, Journal of the American College of Cardiology.

[23]  S. Steinemann.  Metal implants and surface reactions. , 1996, Injury.

[24]  P. Teirstein,et al.  A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. , 1994, The New England journal of medicine.

[25]  P. Karjalainen,et al.  Real world experience with the TITAN(R) stent: a 9-month follow-up report from The Titan PORI Registry. , 2006, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[26]  H. Herrmann.  Guidelines for Percutaneous Coronary Intervention , 2001 .

[27]  I. Tamari,et al.  Short- and long-term outcomes of the titanium-NO stent registry. , 2005, Cardiovascular revascularization medicine : including molecular interventions.

[28]  W. Weintraub,et al.  Influence of diabetes mellitus on early and late outcome after percutaneous transluminal coronary angioplasty. , 1995, Circulation.

[29]  Gregg W. Stone,et al.  A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease , 2004 .

[30]  M. Briel,et al.  Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. , 2006, European heart journal.

[31]  William Wijns,et al.  A Cause for Concern , 2007 .

[32]  B. Gersh.  Incidence, Predictors, and Outcome of Thrombosis After Successful Implantation of Drug-Eluting Stents , 2006 .

[33]  D. Holmes,et al.  Coronary artery stents. , 2000, JAMA.

[34]  Joseph P Ornato,et al.  ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention--summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to update the 2001 Guidelines for Percutaneous Coronary Intervention , 2006, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[35]  T. Vahlberg,et al.  Long-term clinical outcome with titanium-nitride-oxide-coated stents and paclitaxel-eluting stents for coronary revascularization in an unselected population. , 2010, International journal of cardiology.

[36]  W. O’Neill,et al.  Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients: A SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) Substudy , 2004, Circulation.

[37]  M. Leon,et al.  The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. , 1998, Journal of the American College of Cardiology.

[38]  J. Airaksinen,et al.  Titanium and nitride oxide-coated stents and paclitaxel-eluting stents for coronary revascularization in an unselected population. , 2006, The Journal of invasive cardiology.

[39]  E. Erdoğan,et al.  A novel predictor of restenosis and adverse cardiac events: asymmetric dimethylarginine , 2010, Heart and Vessels.

[40]  Christoph Kaiser,et al.  Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET) , 2005, The Lancet.

[41]  I. Tamari,et al.  The Titanium-NO Stent:results of a multicenter registry. , 2006, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[42]  Leiv Sandvik,et al.  Silent coronary atheromatosis in type 1 diabetic patients and its relation to long-term glycemic control. , 2002, Diabetes.

[43]  P. Buser,et al.  Incremental Cost-Effectiveness of Drug-Eluting Stents Compared With a Third-Generation Bare-Metal Stent in a Real-World Setting: Randomised Basel Stent Kosten Effektivitats Trial (BASKET) , 2005 .