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Objective: This study aimed to compare the clinical outcomes of double kissing mini-culotte (DKMC) stenting with those of mini-culotte (MC) stenting in treating patients with true coronary bifurcation lesions (CBLs) in the clinical real world. Methods: This retrospective observational cohort study included 180 consecutive patients with true CBLs (Medina type 1,1,1; 1,0,1; 0,1,1). All eligible patients underwent coronary angiography and percutaneous coronary intervention with two-stent techniques in our hospital; among them, 97 received DKMC treatment and 83 MC treatment. The primary clinical endpoints were the major adverse cardiovascular events (MACE), which included cardiac death, myocardial infarction, and target vessel/lesion revascularization (TVR/TLR). The secondary endpoints were stent thrombosis, in-stent restenosis, and individual components of MACE. Results: Quantitative coronary angiography analysis (at 5 years) revealed that late lumen loss (0.25 ± 0.41â mm vs. 0.14 ± 0.32â mm, P = 0.032) and segmental diameter restenosis of the side branch (27.84 ± 12.34% vs. 19.23 ± 9.76%, P = 0.016) were lower in the DKMC treatment group than that in the MC treatment group. Notably, compared to that in the MC treatment group, the cumulative event rate of MACE at 5 years (22.8% vs. 8.3%, P = 0.007) and TVR/TLR (17.7% vs. 6.3%, P = 0.018) was higher in the DKMC treatment group, driven mainly by TVR/TLR. Especially, the DKMC group was related to a significant reduction in the primary and secondary endpoints in high-risk patients. Conclusion: DKMC treatment was associated with less late lumen loss and restenosis in the side branch and a lower rate of cumulative MACE and TVR/TLR. DKMC treatment is more effective for treating true CBLs than MC treatment; however, these findings warrant further confirmation through a randomized clinical trial.
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Abstract Introduction: The current standard treatment for bifurcation lesions is the provisional stent technique, by implanting only one stent in the main branch; however, in certain cases, the use of more complex techniques that require double stenting should be considered. Objective: To perform a clinical and angiographic assessment of patients with true bifurcation lesions treated with the two-stent culotte technique. Materials and methods: A prospective study was done, which included patients diagnosed with significant obstructive coronary artery disease in bifurcation areas, who were candidates for angioplasty with culotte technique. The study included 44 patients with proved diagnosis of coronary bifurcation lesions; 66% of the treated bifurcation lesions compromised the anterior descending artery and the diagonal branch and 27%, the circumflex artery with the marginal branch. It was found that 68% of the cases had Medina 1,1,1 lesions and 23% had Medina 0,1,1 lesions. Six months later, it was found that 12.5% of the patients followed up by angiography had in-stent restenosis (ISR) > 50% that involved at least one of the bifurcation areas. In 9% of these patients, the ISR was at the origin of the side branch only, and in 3%, the ISR was confined to the distal segment of the main branch stent. Conclusion: The use of the culotte technique with two new-generation stents to treat complex coronary bifurcation lesions is an effective option and does not increase the risk of complications during the procedure nor the risk of the appearance of ISR.
Resumen Introducción: El tratamiento estándar actual para las lesiones en bifurcaciones es la técnica de stent provisional, implantando solo un stent en la rama principal, sin embargo, en ciertos casos, se debería considerar el uso de técnicas más complejas que requieren de doble stent. Objetivo: Realizar una evaluación clínica y angiográfica de pacientes con verdaderas lesiones en bifurcaciones tratados con la técnica culotte de doble stent. Material y métodos: Se realizó un estudio prospectivo que incluyó pacientes diagnosticados con enfermedad obstructiva significativa de arterias coronarias en bifurcaciones, quienes eran candidatos a angioplastia con la técnica culotte. El estudio incluyó 44 pacientes con un diagnóstico comprobado de lesiones coronarias en bifurcaciones; el 66% de las lesiones en bifurcaciones tratadas comprometían la arteria descendente anterior y la rama diagonal, y el 27% la arteria circunfleja con la rama marginal. Se encontró que el 68% de los casos tenían lesiones Medina 1,1,1 y el 23% tenían lesiones Medina 0,1,1. A los seis meses, se encontró que el 12,5% de los pacientes en seguimiento con angiografía presentaban reestenosis intrastent (RIS) mayor al 50%, que comprometía al menos una de las áreas de bifurcación. En el 9% de estos pacientes, la RIS se ubicaba únicamente en el origen de la rama lateral, y en el 3%, la RIS se restringió al segmento distal del stent de la rama principal. Conclusiones: El uso de la técnica culotte empleando dos stents de nueva generación es una opción efectiva para tratar las lesiones complejas en bifurcaciones coronarias, y no aumenta el riesgo de complicaciones durante el procedimiento ni el riesgo de la aparición de reestenosis intrastent.
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This case demonstrates that the high radial strength of a dedicated nitinol venous stent is able to achieve good acute angiographic results and clinical efficacy.
Subject(s)
Angioplasty, Balloon/methods , Catheters, Indwelling/adverse effects , Endovascular Procedures/methods , Graft Occlusion, Vascular/surgery , Stents/adverse effects , Subclavian Vein/surgery , Vena Cava, Superior/surgery , Female , Graft Occlusion, Vascular/diagnosis , Graft Occlusion, Vascular/etiology , Humans , Kidney Failure, Chronic/therapy , Middle Aged , Phlebography , Renal Dialysis/adverse effects , Reoperation , Subclavian Vein/diagnostic imaging , Vena Cava, Superior/diagnostic imagingABSTRACT
Objective: The aim of this study was to investigate whether intermediate kissing balloon dilation (IKBD) is necessary during mini-culotte stenting (MCS) and how it can be properly conducted. Methods: MCS was emulated in a bifurcation model with a branch diameter difference (BDD) in three-step sizes of 0.50, 0.75 and 1.00 mm, and with intermediate balloon dilation (IBD) in three treatments of routine intermediate solo balloon dilation (rISBD), concurrent IKBD (cIKBD) or sequential IKBD. Microcomputed tomography was performed to assess stent under-expansion (SUE) around the polygon of confluence (POC), residual ostial stenosis (ROS) at the ostial side-branch (SB) and main-branch (MB) and stent cell distortion (SCD) in the bifurcation segments. Results: There were both main and interactive effects of IBD and BDD on ROS at the ostial SB and SCD in the ostial SB, but there were only main effects of IBD or BDD on SUE around the POC, ROS at the ostial MB and SCD in the ostial MB. Analysis of the main effects showed that SUE around the POC or ROS at the ostial SB was significantly different between sIKBD and rISBD and between cIKBD and rISBD. There was also a significant difference in SCD in the ostial SB between sIKBD and rISBD and between sIKBD and cIKBD. Analysis of the interactive effects showed that ROS at the ostial SB or SCD in the ostial SB was affected by all IBD treatments in all BDD step-sizes. Moreover, increasing the BDD step-sizes significantly increased ROS at the ostial SB as treated by rISBD and SCD in the ostial SB as treated by rISBD or cIKBD. Conclusions: SIKBD was shown to be essential and superior to rISBD or cIKBD, resulting in better bifurcated stent expansion and coverage when using MCS.
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BACKGROUND: Coronary bifurcated lesions (CBL) represent a hot topic of interventional cardiology. Provisional stenting, i.e. implantation of a drug-eluting (DES) in the main branch followed by side-branch (SB) intervention in case of suboptimal SB result, represents the gold standard to treat the vast majority of CBL undergoing percutaneous coronary interventions (PCI). The best technique for bail-out SB stenting has not been established. Prospective randomized trials comparing different stenting techniques may help provide important insights regarding the best way to conduct PCI in patients with CBL. METHODS: The recently published Bifurcations Bad Krozingen (BBK) II trial is the last important randomized study in the field of bifurcation PCI and is focused on the search for the best management of those patients with suboptimal SB result during provisional stenting. Two different SB implantation strategies after provisional stenting have been compared. In the present manuscript, we employed BBK II results in the context of available literature highlighting important specific features of the study with main emphasis on patient selection process and techniques applied.
Subject(s)
Coronary Artery Disease/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/methods , Humans , Prosthesis DesignABSTRACT
AIMS: In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. METHODS AND RESULTS: This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. CONCLUSIONS: Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis.
Subject(s)
Drug-Eluting Stents , Coronary Angiography , Coronary Artery Disease , Coronary Restenosis , Humans , Sirolimus , Treatment OutcomeABSTRACT
BACKGROUND: Despite various culotte-based stenting techniques available clinically, the optimal one remains undetermined. The study aimed to test whether ex vivo mono-ring culotte stenting (MRC) was technically feasible and superior to mini culotte stenting (MCS) in treatment of coronary bifurcation lesions. METHODS: Mono-ring culotte stenting was characterized by ex vivo wiring of the most proximal cell of the side branch (SB) stent to ensure a mono-ring result of the culotte stenting. Comparison of MRC vs. MCS in treatment of true bifurcation lesions was performed in vitro (n = 15 for each group) and in clinical case-controlled study with propensity matching at a ratio of 1:2 (n = 21 for MRC group; n = 42 for MCS group). RESULTS: Compared to MCS, MRC had lower incidence of stent under-expansion band (0% vs. 53.3%, p = 0.002) and less residual ostial area stenosis of SB (9.2 ± 9.0% vs. 20.0 ± 14.8%, p = 0.023), as assessed in vitro by micro-computed tomography. In a case-controlled study, no adverse cardiac events were observed in the MRC group. The procedural success was similar between MRC and MCS (100% vs. 95.2%, p = 0.548), but MRC had less residual ostial stenosis of the SB (8.7% ± 11.0% vs. 16.8% ± 11.2%, p = 0.008), lower procedural (33.3 ± 9.5 min vs. 46.7 ± 15.6 min, p = 0.001) and fluoroscopic (19.7 ± 4.9 min vs. 26.2 ± 7.1 min, p < 0.001) time, and less contrast use (114.3 ± 28.9 mL vs. 156.5 ± 56.4 mL, p = 0.002). CONCLUSIONS: Mono-ring culotte stenting as compared to MCS is associated with better bifurcation stent morphology, less procedural complexity and residual ostial SB stenosis.
Subject(s)
Coronary Artery Disease/surgery , Coronary Vessels/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Coronary Angiography , Coronary Artery Disease/diagnosis , Coronary Vessels/diagnostic imaging , Equipment Design , Humans , X-Ray MicrotomographyABSTRACT
Objective To report our first clinical experience with a novel modified culotte technique for the treatment of true coronary bifurcation lesions. Methods The novel modified culotte technique (the mono-ring culotte) stenting was done in which the side branch (SB) stent was deployed firstly followed by ex vivo wiring of a most proximal cell of SB stent with the hard end of main branch (MB) wire. Secondly, the MB stent was deployed through the most proximal cell of SB stent. The procedure was ended with kissing balloon dilation. From June 2014 to March 2015, 15 patients with true coronary bifurcation lesion were treated with mono-ring culotte stenting in our center. Results The procedures were successful in all cases without procedural complication and in-hospital major adverse cardiovascular events. The procedural time was (34. 3 ± 9. 6) min, fluoroscopic time was (18. 1 ± 3. 8) min, and contrast volume was (112. 0 ± 24. 5) ml, respectively. Post-procedurally, the residual stenosis of the main and the side branch were (10. 0 ± 2. 5)% and (10. 2 ± 5. 3)% , respectively. Conclusions The mono-ring culotte stenting is safe and feasible for treatment of true coronary bifurcation lesions, and may be superior to the conventional culotte stenting.
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OBJECTIVES: The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 3 years after double-kissing (DK) crush versus culotte stenting for unprotected left main distal bifurcation lesions (LMDBLs). BACKGROUND: The multicenter and randomized DKCRUSH-III (Comparison of double kissing crush versus culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective study) showed that DK crush stenting was associated with fewer MACE at 1-year follow-up in patients with LMDBLs compared with culotte stenting. Here, we report the 3-year clinical outcome of the DKCRUSH-III study. METHODS: A total of 419 patients with LMDBLs who were randomly assigned to either the DK crush or culotte group in the DKCRUSH-III study were followed for 3 year. The primary endpoint was the occurrence of a MACE at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by simple and complex LMDBLs according to the DEFINITION (Definition and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) study criteria. RESULTS: At 3 years, MACE occurred in 49 patients the culotte group and in 17 patients in the DK crush group (cumulative event rates of 23.7% and 8.2%, respectively; p < 0.001), mainly driven by increased myocardial infarction (8.2% vs. 3.4%, respectively; p = 0.037) and target-vessel revascularization (18.8% vs. 5.8%, respectively; p < 0.001) between groups. Definite ST rate was 3.4% in the culotte group and 0% in the DK crush group (p = 0.007). Complex LMDBLs were associated with a higher rate of MACE (35.3%) at 3 years compared with a rate of 8.1% in patients with simple LMDBLs (p < 0.001), with an extremely higher rate in the culotte group (51.5% vs. 15.1%, p < 0.001). CONCLUSIONS: Culotte stenting for LMDBLs was associated with significantly increased rates of MACE and ST. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-11001877).
Subject(s)
Coronary Artery Disease/therapy , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Stents , Aged , Asia , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prospective Studies , Risk Factors , Thrombosis/etiology , Thrombosis/mortality , Time Factors , Treatment OutcomeABSTRACT
Objective To investigate the differences of various two-stent techniques in vitro and virtual bench testing. Methods Stent implantation with classic crush, double kissing ( DK) crush and culotte stenting techniques were performed in the silicone simulation model of bifurcation vessels with various distal bifurcation angles. The whole processes were recorded by a micro-focus camera. Results Distal side branch (SB) re-crossing in classical crush technique left a significant gap without stent coverage near the carina in T type bifurcation model after final kissing balloon inflation (FKBI) . The gap was also noted in either classic crush with proximal SB re-crossing or DK crush with two times proximal SB re-crossing in T type bifurcation model. The size of the gap in DK crush technique was smaller than that of classic crush. In Y type bifurcation model, both DK crush and culotte stenting left no gap compared to T type bifurcation model. Two times proximal SB re-crossing in culotte stenting resulted in a new stent carina formation after FKBI. Conclusions Distal bifurcation angle was an anatomatic predictor of gap formation in two-stent technique. In T type bifurcation model, the size of gap in DK crush technique was smaller than that of classic crush. It was suggested to perform two times proximal SB re-crossing for DK crush technique and distal SB re-crossing for culotte stenting.
