First-in-man (FIM) study of the Stentys™ bifurcation stent – 30 days results (original) (raw)
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First-in-man (FIM) study of the Stentys bifurcation stent-30 days results
EuroIntervention, 2009
Aims: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys™ bifurcation stent. Methods and results: The Stentys™ stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous MI and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95±3.63 mm with a bifurcation angle of 55° (range 30°-80°). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys™ stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave MI following the procedure and one ischemia-driven revascularisation six days after the procedure. Conclusions: This first-in-man (FIM) study demonstrates that the Stentys™ stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.
Present Status of Coronary Bifurcation Stenting
Clinical Cardiology, 2008
Percutaneous coronary intervention (PCI) for bifurcation lesions is technically limited by the risk of side branch occlusion. In comparison with nonbifurcation interventions, bifurcation interventions have a lower rate of procedural success, higher procedural costs and a higher rate of clinical and angiographic restenosis. The recent introduction of drug-eluting stents (DES) has resulted in reduced incidence of main vessel restenosis compared with historical controls. However, sidebranch ostial residual stenosis and long-term restenosis still remain problematic. In the era of DES, techniques employing two stents have emerged that allow stenting of the large side branch in addition to the main artery. Stenting of the main vessel with provisional side branch stenting seems to be the prevailing approach. This paper reviews outcome data with different treatment modalities for this complex lesion with particular emphasis on the use of DES as well as potential new therapeutic approaches.
Clinical Research in Cardiology, 2008
Treatment of coronary bifurcation lesions (CBL) remains challenging. This study sought to evaluate a novel dedicated stent system (Frontier™ stent) by angiographic and clinical comparison with the provisional T-stenting technique using drug-eluting (DES) and bare metal stents (BMS). The study group comprised 105 CBL in 105 patients. 35 consecutive CBL were treated with the Frontier™ system. The control group of 70 CBL (35 DES, 35 BMS) was pair matched with the former group stratified by the type of CBL (Medina classification) and the reference diameter of the main branch (MB). Clinical, procedural, and quantitative angiographic data (QCA) were obtained in all patients. A follow-up angiography 6 ± 2-month post-index intervention was performed in 84/105 (80%) patients, clinical 6-month follow-up was available in all patients (100%). All Frontier™ stent procedures were clinically and angiographically successful. Post-procedural QCA analysis of the MB and the side branches revealed comparable minimal lumen diameters (MLDs) between groups. Moreover, contrast use and radiation exposure were not different between groups. DES use, however, was associated with a significantly lower late lumen (LL) loss in the main and the side branch as compared to the Frontier™ stent and BMS group. Likewise, MACE rates were lowest in the DES group (6%, P < 0.05 vs. BMS) as compared to the Frontier™ stent (9%) and the BMS group (16%). The Frontier™ stent accomplishes treatment of CBL with excellent acute clinical, procedural, and angiographic results. Provisional T-stenting using DES provides superior clinical and angiographic long-term results as compared to BMS and Frontier™ stents. The results of next generation CBL systems combining a dedicated specific CBL design with DES surfaces are to be awaited.
Influence of technical strategies on the outcome of coronary bifurcation stenting
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2005
The purpose of this study was to analyze from a large prospective database started in 1996, the immediate and mid term results of coronary bifurcation stenting using bare metal stents. Stenting of bifurcation lesions remains a challenging subset. Various approaches have been advocated and no large prospective studies are available on this subject. Between 1996 and 2002, data were prospectively collected on all patients with bifurcation lesions treated with coronary stenting in our institution. Seven-month follow-up data were obtained in 96.7% of patients and coronary angiogram was performed in the presence of clinical or stress test ischemia. The database was analyzed to extract uni-variate and multivariate predictors of acute and 7 months adverse events. A total of 1,149 patients were included, median age 65 years, 19% diabetic patients, unstable angina in 37.3% of cases and acute MI 10.5%. The target was the LAD-diagonal bifurcation in 53.2% of cases. Angiographic success (residua...
Circulation, 2010
Background-The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques. Methods and Results-Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64Ϯ10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (Ͼ50% narrowing in both vessels). In the simple group (nϭ250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting.
Bifurcations Coronary bifurcations are encountered in about 15-20 % of percutaneous coronary interventions (PCIs). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. However, in recent years significant developments in the understanding as well as in the treatment of coronary bifurcation lesions have occurred. 1 First, the development of drug-eluting stents (DES) has considerably decreased the rates of restenosis and repeat revascularisation. Second, the acceptance of a suboptimal result in the side branch (SB) appeared since it was proved that many residual stenoses at the SB might not be physiologically significant. And, finally, numerous randomised trials focused specifically on bifurcations have been published. As a result of these changes, the provisional approach of one stent implantation only in main vessel-main branch (MV-MB) is now considered the default approach in most bifurcation lesions. 2
American Journal of Cardiology, 2006
The “crush technique” has been proposed as an alternative approach to treat bifurcation lesions because of its predictability and high procedural success rate. However, few data are available regarding its safety and long-term efficacy. We report the long-term clinical outcomes of patients with coronary bifurcation lesions treated with sirolimus-eluting stents using the crush technique. From April 2003 to May 2004, 120 patients with coronary bifurcation lesions were treated with sirolimus-eluting stents using the crush technique. Six months of clinical follow-up was completed in 95.8% of patients. Mean patient age was 64 years; 36% had diabetes mellitus, and the left anterior descending artery/diagonal was the most frequent bifurcation location (69%). Final kissing balloon inflation was performed in 87.5% of patients. Compared with the main vessel, side branch lesions were shorter, with a smaller reference diameter and final in-stent minimum lumen diameter. Procedural success was achieved in 97.5%. At 30 days of follow-up, 1 patient had died of noncardiac causes and 2 patients (1.7%) had subacute stent thrombosis. At 6 months of follow-up, target lesion revascularization was required in 13 patients (11.3%), all of whom had focal restenosis predominantly at the side branch ostium. In conclusion, the crush technique with final kissing balloon inflation can be safely used by experienced operators to treat highly complex bifurcation lesions with sirolimus-eluting stents. The safety profile of this technique is similar to that of other bifurcation stenting techniques reported thus far. Nonetheless, despite the excellent patency rates of the main vessel, the need for revascularization at the ostium of the side branch was not fully eliminated.