Is there a need for dedicated bifurcation devices?

J123 Introduction Coronary bifurcation disease is one of the outstanding challenges of treatment with percutaneous coronary intervention (PCI), and may be present in up to 20 to 30% of patients with multivessel disease encountered in daily practice. Compared with simple lesions, bifurcations have been associated with lower procedural success rates, higher adverse event rates, and poorer angiographic and clinical outcomes. The less favourable outcomes associated with bifurcation compared with non-bifurcation lesions may in part result from the inability of current devices and techniques to scaffold adequately and preserve the side-branch (SB) ostium, which is a common site for restenosis. Complex strategies are technically demanding and may compromise the main branch (MB) when not carried out properly or when the final result is not optimal in terms of stent apposition and flow dynamic. Furthermore, compromise of the SB during stent implantation is also common as many techniques do not allow the operator to maintain a usable wire in the SB. The use of drug-eluting stents (DES) has resulted in significantly improved outcomes compared with bare metal stents (BMS), with a single digit re-intervention rate in the majority of non-randomised real world studies and also in randomised studies comparing the systematic use of two stents to the strategy of provisional SB stenting. Meta-analyses of these randomised studies, which were performed in selected cases, did not show any advantages associated with the systematic use of two stents compared to the provisional approach. Indeed, the two-stent approach was associated with a higher rate of periprocedural myocardial infraction and a trend towards a higher rate of stent thrombosis. Consequently, there is a common acceptance that provisional SB stenting should be the gold standard approach in the majority of bifurcation lesions and the main question is when we should use two stents to improve procedural safety and long-term efficacy. Although a large variety of dedicated bifurcation stents, both BMS and DES, have been studied none of them has become widely used. An unmet need In the DES era, the most significant independent predictor of clinical outcome is the angiographic success at the level of the main branch and this is a very important point to keep in mind. The acute result achieved in the SB is not a predictive factor of late outcome and this is one of the key reasons why the provisional SB stenting approach is a successful strategy compared to a more complex approach with two stents or more. Dedicated stents are every interventionalist’s dream because they simplify the procedure and make it easy for everybody, improving procedural success rate, decreasing the risk of stent thrombosis and decreasing the risk of SB restenosis. But many questions remain unanswered: How clinically important is it compared to the provisional approach? How cost-effective is it? What about the distal left main trunk?

[1]  G. Biondi-Zoccai,et al.  A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions , 2009, Acta cardiologica.

[2]  Imad Sheiban,et al.  Update on dedicated bifurcation stents. , 2009, Journal of interventional cardiology.

[3]  C. Di Mario,et al.  A new dedicated stent and delivery system for the treatment of bifurcation lesions: Preliminary experience , 2003, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[4]  M. Leon,et al.  Serial intravascular ultrasound analysis of bifurcation lesions treated using the novel self-expanding sideguard side branch stent. , 2009, The American journal of cardiology.

[5]  P. Guyon,et al.  First-in-human feasibility and safety study of a true bifurcated stent for the treatment of bifurcation coronary artery lesions (DBS stent): six month angiographic results and five year clinical follow-up. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[6]  P. Serruys,et al.  Stenting with a true bifurcated stent: acute and mid‐term follow‐up results , 1999, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[7]  A. Baumbach,et al.  Randomized Trial of Simple Versus Complex Drug-Eluting Stenting for Bifurcation Lesions: The British Bifurcation Coronary Study: Old, New, and Evolving Strategies , 2010, Circulation.

[8]  Antonio Colombo,et al.  Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions , 2004, Circulation.

[9]  M. Niemelä,et al.  Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions: The Nordic Bifurcation Study , 2006, Circulation.

[10]  F. Neumann,et al.  Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions , 2008, European heart journal.

[11]  D. Angiolillo,et al.  Strategies for drug‐eluting stent treatment of bifurcation coronary artery disease in the United States: Insights from the e‐Cypher S.T.L.L.R.Trial , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[12]  D. Hildick-Smith,et al.  Percutaneous coronary intervention for bifurcation lesions: 2008 consensus document from the fourth meeting of the European Bifurcation Club. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[13]  Antonio Colombo,et al.  Randomized Study of the Crush Technique Versus Provisional Side-Branch Stenting in True Coronary Bifurcations: The CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study , 2009, Circulation.

[14]  P. Fitzgerald,et al.  Analysis of left main coronary artery bifurcation lesions treated with biolimus‐eluting DEVAX AXXESS plus nitinol self‐expanding stent: Intravascular ultrasound results of the AXXENT trial , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[15]  Rémy Prost,et al.  Fractal geometry of arterial coronary bifurcations: a quantitative coronary angiography and intravascular ultrasound analysis. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[16]  C. Di Mario,et al.  Successful treatment of a bifurcation lesion with the Carina Bard stent: A case report , 1999, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[17]  G. Dangas,et al.  Bifurcation stenting with drug-eluting stents: a systematic review and meta-analysis of randomised trials. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[18]  S. Ramcharitar,et al.  Stentys coronary bifurcation stent. , 2007, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[19]  H. Bøtker,et al.  Comparison of sirolimus-eluting and bare metal stents in coronary bifurcation lesions: subgroup analysis of the Stenting Coronary Arteries in Non-Stress/Benestent Disease Trial (SCANDSTENT). , 2006, American heart journal.

[20]  P. Fitzgerald,et al.  9-month clinical, angiographic, and intravascular ultrasound results of a prospective evaluation of the Axxess self-expanding biolimus A9-eluting stent in coronary bifurcation lesions: the DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) study. , 2009, Journal of the American College of Cardiology.

[21]  Brett Trauthen,et al.  Six-month clinical and angiographic results of a dedicated drug-eluting stent for the treatment of coronary bifurcation narrowings. , 2007, The American journal of cardiology.

[22]  John P A Ioannidis,et al.  Double Versus Single Stenting for Coronary Bifurcation Lesions: A Meta-Analysis , 2009, Circulation. Cardiovascular interventions.

[23]  Antonio Colombo,et al.  Bifurcation disease: what do we know, what should we do? , 2008, JACC. Cardiovascular interventions.

[24]  Dick M. Goedhart,et al.  Three-year clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularisation Therapies Study, part II (ARTS II). , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[25]  J. E. Sousa,et al.  Bifurcated stents: giving to Caesar what is Caesar's. , 2007, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[26]  M. Pan,et al.  Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. , 2004, American heart journal.

[27]  F. Ye,et al.  Study comparing the double kissing (DK) crush with classical crush for the treatment of coronary bifurcation lesions: the DKCRUSH-1 Bifurcation Study with drug-eluting stents , 2008, European journal of clinical investigation.

[28]  P. Serruys,et al.  Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[29]  J. Ge,et al.  Simple versus complex stenting strategy for coronary artery bifurcation lesions in the drug-eluting stent era: a meta-analysis of randomised trials , 2009, Heart.

[30]  Antonio Colombo,et al.  The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularization Therapies Study part II (ARTS II). , 2007, European heart journal.

[31]  Ghassan S. Kassab,et al.  Design of coronary circulation: A minimum energy hypothesis , 2007 .

[32]  H. Amin,et al.  Carina modification T stenting, a new bifurcation stenting technique: Clinical and angiographic data from the first 156 consecutive patients , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[33]  C D Murray,et al.  The Physiological Principle of Minimum Work: I. The Vascular System and the Cost of Blood Volume. , 1926, Proceedings of the National Academy of Sciences of the United States of America.

[34]  R. Kornowski The need for a dedicated bifurcation stenting system , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[35]  M. Morice,et al.  Influence of technical strategies on the outcome of coronary bifurcation stenting. , 2005, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[36]  J. Ormiston,et al.  First human use of the TAXUS Petal paclitaxel-eluting bifurcation stent. , 2010 .

[37]  A. Colombo,et al.  Bifurcation stenting: current strategies and new devices , 2008, Heart.

[38]  H. Jilaihawi,et al.  The use of self-expanding stents in coronary bifurcations and beyond: a paradigm revisited. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[39]  M. Morice,et al.  2-year outcome of patients treated for bifurcation coronary disease with provisional side branch T-stenting using drug-eluting stents. , 2008, JACC. Cardiovascular interventions.

[40]  J. Ormiston,et al.  The AST petal dedicated bifurcation stent: First‐in‐human experience , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[41]  W. J. van der Giessen,et al.  The Frontier stent registry: safety and feasibility of a novel dedicated stent for the treatment of bifurcation coronary artery lesions. , 2005, Journal of the American College of Cardiology.