Tryton Stent Research Articles

Morphological studies of stented coronary artery bifurcations on anatomical preparations of the heart

Introduction. One of the most difficult and completely unsolved problems of modern interventional cardiology is bifurcation stenting of the coronary arteries. This problem requires a comprehensive study, including using the possibility of morphological analysis.Material and methods. Stenting of the bifurcation lesions of the coronary arteries on 46 cadaveric hearts was performed using the bifurcation and conventional stents with subsequent plating and study of the preparations obtained.Results. From the point of view of the safety of the lateral branch, T-stenting is optimal, especially when implanting a BIOSS stent. When using the Tryton stent with the culotte stenting technique, there was never a stenosis of the side branch, due to the stent in the lumen, but there was always an excessive metal saturation in the main branch before the bifurcation. When using conventional stent with a provisional T-stenting technique residual, stenosis of the mouth of the lateral branch was also observed. In addition, in all cases there was a deformation of the stent beams near the mouth of the lateral branch.Conclusions. Morphological studies of stented coronary arteries on anatomical preparations of the heart, plastized with epoxy resin, make it possible to obtain new results that cannot be obtained with traditional morphological and clinical research methods (histological, corrosive, radiological, etc.).

Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.

We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Biomechanical Impact of Wrong Positioning of a Dedicated Stent for Coronary Bifurcations: A Virtual Bench Testing Study.

The treatment of coronary bifurcations is challenging for interventional cardiologists. The Tryton stent (Tryton Medical, Inc., USA) is one of the few devices specifically designed for coronary bifurcations that underwent large clinical trials. Although the manufacturer provides specific recommendations to position the stent in the bifurcation side branch (SB) according to four radio-opaque markers under angiographic guidance, wrong device positioning may accidentally occur. In this study, the virtual bench testing approach was used to investigate the impact of wrong positioning of the Tryton stent in coronary bifurcations in terms of geometrical and biomechanical criteria. A finite element model of the left anterior descending/first diagonal coronary bifurcation was created with a 45° distal angle and realistic lumen diameters. A validated model of the Tryton stent mounted on stepped delivery balloon was used. All steps of the Tryton deployment sequence were simulated. Three Tryton positions, namely 'proximal', 'recommended', and 'distal' positions, obtained by progressively implanting the stent more distally in the SB, were compared. The 'recommended' case exhibited the lowest ostial area stenosis (44.8 vs. 74.3% ('proximal') and 51.5% ('distal')), the highest diameter at the SB ostium (2.81 vs. 2.70mm ('proximal') and 2.54mm ('distal')), low stent malapposition (9.9 vs. 16.3% ('proximal') and 8.5% ('distal')), and the lowest peak wall stress (0.37 vs. 2.20MPa ('proximal') and 0.71MPa ('distal')). In conclusion, the study shows that a 'recommended' Tryton stent positioning may be required for optimal clinical results.

Differences in rotational positioning and subsequent distal main branch rewiring of the Tryton stent: An optical coherence tomography and computational study.

To evaluate the occurrence of rewiring through one of the panels of the Tryton stent (instead of the assumed re-wiring in-between the panels) and the influence on stent geometry and mechanics. Tryton is a side branch stent used in combination with a main branch device. It is placed without the need of rotational orientation. However, it is unknown whether main branch re-wiring accidentally may occur through a panel, instead of in-between the panels. We used three-dimensional optical coherence tomography to evaluate the location of distal main branch re-wiring through Tryton. Furthermore, we used computer simulations to evaluate the influence on stent geometry and mechanics. Rewiring through a panel (instead of in-between two panels) occurred in 45% of the cases. By using virtual stent deployment, we found minimal differences in ostial side branch stenoses (44.8% in-between the panels and 39.0% through a panel). There were no differences in minimum stent areas of the distal main branch (6.38 mm2 vs. 6.39 mm2 ). In both scenarios, the re-wired Tryton cell was large enough for main branch stenting (expressed as the diameter of the largest possible circle that fits within the cells): 3.40 mm (in-between the panels) vs. 3.02 mm (through a panel). In 45% of the Tryton implantations, distal main branch rewiring (and subsequent main branch stenting) was performed through one Tryton panel, instead of the assumed rewiring in-between the panels. However, this did not result in unfavorable stent geometries or mechanics, as evaluated with computer simulations.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study

To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.

PROCEDURAL SUCCESS AND CLINICAL OUTCOME OF TRYTON,A DEDICATED BIFURCATION STENT USE IN COMPLEX BIFURCATION LESIONS IN UNSELECTED PATIENTS: A SINGLE CENTRE REGISTRY DATA

Coronary Bifurcation Lesions (CBL) account for approximately of 15% of all lesions treated with Percutaneous Intervention (PCI). While main branch (MB) stent with provisional side branch (SB) stenting is the preferred approach in the treatment of coronary bifurcations, not uncommonly a 2-stent strategy with SB stenting is required to maintain patency of the MB and SB. There remains no consensus on the optimal 2 stent strategy because of paucity in data.Consequently, dedicated bifurcation stents have been designed to treat both the MB and SB without compromising the carina of CBL`s. The Tryton Side-Branch Stent (Tryton Medical, Inc., MA, and USA) is one of the dedicated bifurcations which have shown promising long term outcome in FIM trial and other selective registries. We prospectively evaluated the safety and efficacy of the Tryton Side-Branch Stent in an unselected group of patients who were treated with PCI for CBL within our centre. Data from the in hospital Cardiac Catheter Laboratory Registry between 2009 -2013 identified 38 successive patients who were treated with Tryton Side-Branch Stent. Procedural information was obtained from British Cardiac Intervention Society database. Follow up data was collected by reviewing follow up clinic letters via in hospital database over a mean period of 18 months. Mortality data was verified with Welsh Demographic Service data base. The Tryton stent was successfully deployed in 97% cases with 74% of patients being males, mean age of 71yrs. 92% of cases were done via radial access using 6F sheaths. The indications for PCI were: Stable angina 17(45%), NSTEMI 18(47%) STEMI 3(8%). Of all the CBL, 68% were true bifurcation lesion as per Medina classification. The median angle between the MB and SB was at 60 degrees. Most lesions (75%) were crossed with BMW wires with IVUS used in 7(18%) cases. Final kissing balloon inflation was carried out in 30(79%) of cases. Mean MB and SB stent diameter was 3.5mm and 2.75 respectively. Procedural success was 97% with 1 in-hospital mortality. Both TVR and TLR were at 0% with no cases of stent thrombosis. Most CBL can be safely and efficiently treated with the Tryton dedicated Side Branch stent and is not associated with any significant short or long term major adverse cardiac events. This study demonstrates that dedicated stents can be used in a wide spectrum of clinical presentations and can be safely delivered in default transradial PCI centres.

Serial intravascular ultrasound analysis of complex bifurcation coronary lesions treated with the Tryton Bifurcation Stent in conjunction with an everolimus-eluting stent: IUVANT (Intravascular Ultrasound Evaluation of Tryton Stent) study.

To characterize the treatment of complex bifurcation lesions (BL) with the Tryton Bifurcation Stent (TBS) paired with an everolimus-eluting stent (EES). Complex BL are associated with higher procedural complications and poorer long-term outcomes. The TBS is a dedicated side-branch (SB) stent designed to be used in conjunction with a standard drug-eluting stent. Prospectively identified, consecutive patients underwent TBS+EES stenting of BL using a protocol which included TBS postdilation and simultaneous final kissing balloon inflations (FKBI). All lesions were systematically evaluated with coronary angiography and IVUS, obtained at procedure completion and at 9 months, and were assessed by independent core laboratories. Thirty-three BL were treated in 32 patients presenting primarily (87.5%) with stable angina and complex BL with angiographic apparent disease in the main vessel (MV) and SB in 87.9% and 75% by site and core evaluation, respectively. Procedural success was 100% and high postprocedure percent stent expansion (MV 96 [93, 109]%, SB 88 [77, 100]%, carina MV 135 [99, 166]%, carina SB 116 [91, 130]%) was demonstrated by IVUS. At 9-month angiographic follow-up (n = 28 patients), one MV in-segment restenosis and one SB in-stent restenosis were observed. SB in-stent late lumen loss was 0.41 ± 0.27 mm. IVUS assessment revealed the absence of stent recoil; percent carinal neointimal hyperplasia (NIH) was 1.8 [0.0,11.2]% in MV and 15.0 [6.7,23.5]% in SB, with NIH volume obstruction of 2.0 [0.7,4.3]% in MV and 14.2 [7.5,29.6]% in SB. Stenting of complex BL with the TBS+EES provides high acute success with sustained clinical, angiographic, and IVUS results at 9 months. These excellent results are likely due to the extent of stent expansion at the carina.

Dedicated Tryton Side Branch Stents used in the treatment of coronary bifurcation lesions

IntroductionCoronary bifurcation lesions account for 15–20% of all percutaneous coronary interventions.Dedicated bifurcation stents have recently been introduced with the aim to simplify treatment and improve early and late outcomes following stenting of bifurcation lesions.The purpose of our study was to assess the safety and effectiveness of the Tryton dedicated side branch stent at a 6-month clinical and angiography follow-up. MethodsForty-two patients with bifurcation lesions were included in our study. The primary endpoint was a 6-month MACE and angiographic stent patency was also evaluated by MS-CT coronarography. ResultsTwenty-two patients (52.38%) were treated for acute coronary syndromes, 39 (92.85%) lesions were “true bifurcations”. The 6-month clinical follow-up was performed in all patients. The 6-month MACE rate (cardiac death, myocardial infarction and target lesion revascularization) was 9.52% (95% CI: 2.66–22.62%); of these one patient (2.38%; 95% CI: 0.06–12.57%) died due to cardiogenic shock caused by early stent thrombosis and three patients (7.14%; 95% CI: 1.50–19.48%) required repeated revascularization (TVR) due to in-stent restenosis, all of them in bare metal stents. Tryton stent implantation was successful in 100% lesions.6-Month MS-CT coronarography was performed in 39 (92.85%) patients. The implanted bifurcation Tryton stents were satisfactorily visualized in 97.43% of them and a satisfactory 6-month angiographic patency was demonstrated in 37 patients (88.1%). ConclusionThe usage of a dedicated bifurcation Tryton Side Branch Stent for PCI of the bifurcation lesions is technically feasible with satisfactory long-term results.

The Tryton Side Branch Stent™ for the treatment of coronary bifurcation lesions

Coronary bifurcation lesions account for approximately 15% of all percutaneous coronary interventions (PCI) performed. Although clinical outcomes after PCI have been improved considerably, PCI of bifurcation lesions remains to be associated with adverse clinical events, when compared with non-bifurcation PCI. Therefore, several dedicated bifurcation devices have been developed to improve clinical outcomes. The Tryton Side Branch Stent™ is such device and is used in combination with a regular tubular balloon expandable stent in the main branch. Multiple single and multicenter registries and a patient pooled analysis including 900 patients have shown promising results regarding clinical outcomes after bifurcation PCI with Tryton. The pivotal Tryton IDE randomized trial is currently underway comparing the Tryton stent with side branch balloon angioplasty as side branch treatment in bifurcation lesions challenging the current dogma of provisional single stent strategy as treatment for coronary bifurcation lesions.

Additional side branch stent placement in patients with long side branch lesions treated with the Tryton dedicated bifurcation side branch stent

Treatment of bifurcation lesions account for approximately 20% of all percutaneous coronary interventions (PCI) and is associated with increased risk of adverse cardiac events when compared with percutaneous treatment of non-bifurcation lesions [1,2]. Therefore, several dedicated bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA), have been developed to improve clinical outcomes after PCI of bifurcation lesions. The Tryton stent is a balloon-expandable cobalt–chromium bare-metal stent conceived specifically to treat bifurcation lesions.

Placement of tryton side branch stent only; A new treatment strategy for Medina 0,0,1 coronary bifurcation lesions

We propose a new treatment strategy of Medina 0,0,1 bifurcation lesions using a dedicated side branch stent alone (Tryton Side Branch Stent™) without additional main branch stenting, with the advantage of an optimal ostial side branch coverage without the disadvantage of an excessive amount of metal in the main branch. Medina 0,0,1 lesions are relatively rare and there is no consensus on treatment strategy. Several previous techniques have been described, all with considerable disadvantages. Between October 2009 and November 2011, 12 patients with Medina 0,0,1 lesions treated with Tryton alone were included. Clinical outcomes were reported as all-cause mortality, recurrent myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), and target vessel failure (TVF; defined as the composite of all-cause mortality, MI, and TVR). Procedural success was defined as successful stent placement with residual stenosis <30%, postprocedural TIMI 3 flow, and no in-hospital TVF. Mean age was 64 years. Median side branch reference vessel diameter was 2.6 [2.5-3.0] mm (median stenosis 75%). Procedural success was 100%. Median clinical follow-up duration was 868 [470-906] days with just one of the patients suffering from a late adverse clinical outcome: TLR at 427 days, resulting in TVF, TVR, and TLR rates of 8.3%. Treatment of Medina 0,0,1 lesions with the Tryton stent alone was associated with a 100% procedural success and only one late clinical adverse event (median follow-up of 868 days). These first positive results need to be confirmed in larger prospective randomized studies.

Acute procedural and six-month clinical outcome in patients treated with a dedicated bifurcation stent for left main stem disease: the TRYTON LM multicentre registry

Tryton side branch (SB) reverse culotte stenting has been employed for the treatment of left main (LM) stem bifurcations in patients at high risk for bypass surgery. The aim of this study was to assess acute angiographic results and six-month clinical outcome after implantation of the Tryton stent in the LM. We studied 52 consecutive patients with LM disease treated in nine European centres. Angiographic and clinical data analysis was performed centrally. Fifty-one of 52 patients (age 68±11 yrs, 75% male, 42% unstable angina, SYNTAX score 20±8) were successfully treated with the Tryton stent. Medina class was 1,1,1 in 33 (63%), 1,0,1 in 7 (13%), 1,1,0 in 3 (6%), 0,1,1 in 8 (4%) and 0,0,1 in 1 (2%). The Tryton stent on a stepped balloon (diameter 3.5-2.5 mm) was used in 41/51 (80%) of cases. The mean main vessel stent diameter was 3.4±0.4 mm with an everolimus-eluting stent employed in 30/51 (59%) of cases. Final kissing balloon dilatation was performed in 48/51 (94%). Acute gain was 1.52±0.86 mm in the LM and 0.92±0.47 mm in the SB. The angiographic success rate was 100%; the procedural success rate reached 94%. Periprocedural MI occurred in three patients. At six-month follow-up, the TLR rate was 12%, MI 10% and cardiac death 2%. The hierarchical MACE rate at six months was 22%. No cases of definite stent thrombosis occurred. The use of the Tryton stent for treatment of LM bifurcation disease in combination with a conventional drug-eluting stent is feasible and achieves an optimal angiographic result. Safety of the procedure and six-month outcome are acceptable in this high-risk lesion PCI. Further safety and efficacy studies with long-term outcome assessment of this strategy are warranted.

Six-month and one-year clinical outcomes after placement of a dedicated coronary bifurcation stent: a patient-level pooled analysis of eight registry studies

Smaller studies have previously shown promising results after Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA) placement. However, these previous studies were limited by their small sample size and relatively short follow-up. We performed a patient-level pooled analysis to evaluate six-month and one year clinical outcomes of more than 900 patients who were enrolled in eight registries with the Tryton stent. Data from eight Tryton registries, including 905 patients with 929 bifurcation lesions, were pooled on a patient level to form one dataset. The primary outcome was six-month target vessel failure (TVF), defined as the composite of cardiac death, any myocardial infarction, and clinically indicated target vessel revascularisation. Procedural success was defined as successful stent placement and no in-hospital major adverse cardiac events. Multivariable analysis was performed to determine independent predictors for one-year TVF. Follow-up data were available in 97%. Procedural success was 95% and TVF rate was 6.5% at six months and 8.5% at one year. Stent thrombosis occurred in 0.5% of patients. Left main coronary artery bifurcation lesion (HR 6.46) and main branch reference vessel diameter <3.0 mm (HR 2.62) were independent predictors for TVF. In the real world setting of registries including more than 900 patients, the use of the Tryton stent is associated with procedural and mid-term clinical results that compare very favourably with historical studies. The primary endpoint of TVF was primarily determined by reference vessel diameter of the main branch and left main bifurcation lesion location.

Healing responses after bifurcation stenting with the dedicated TRYTON side‐branch stent™ in combination with XIENCE‐V™ stents: A clinical, angiography, fractional flow reserve, and optical coherence tomography study: The PYTON (Prospective evaluation of the TRYTON side‐branch stent™ with an additional XIENCE‐v™ everolimus‐eluting stent in coronary bifurcation lesions) study

We evaluated healing responses with optical coherence tomography (OCT), and clinical and angiographic outcome after bifurcation stenting with the TRYTON Side-Branch Stent™. Dedicated bifurcation stents have been proposed as a potential alternative for treatment of true coronary bifurcation lesions. We treated 20 consecutive patients with coronary bifurcation lesions and significant involvement of the side-branch (SB) with the TRYTON Stent and an additional XIENCE-V™ everolimus-eluting stent. At 9 months, we assessed the ratio of uncovered to total stent struts (RUTSS) with OCT, angiographic late luminal loss (LLL), and in-stent and in-segment restenosis. Clinical endpoints at 1 year included major adverse cardiac events (MACE) and their components [target lesion revascularization (TLR), myocardial infarction (MI), and cardiac death]. LLL (N = 16) was 0.34 (0.17-0.46), 0.29 (0.24-0.48) and 0.57 (0.29-0.73) mm in the proximal main vessel (MV), distal MV and SB, respectively. In-bifurcation binary in-stent restenosis occurred in four patients (25%), in-segment restenosis in five (31.25%). The RUTSS (N = 13) was 4.0 ± 5.8, 0.7 ± 1.3, 0, and 2.5 ± 3.6% in the proximal MV, distal MV, SB, and polygon of confluence, respectively. At 1 year, MACE occurred in 5 (25%) [4 TLR (20%), 3 MI (15%)]. The homogeneous stent strut coverage and the low LLL in the MV reflect proper healing characteristics of the TRYTON Stent in combination with the XIENCE-V™ stent. However, proximal MV edge and ostial SB restenoses together with overall clinical outcomes do not fulfill expectations of a dedicated bifurcation stent. © 2012 Wiley Periodicals, Inc.

Six-month clinical outcomes of the Tryton Side Branch Stent for the treatment of bifurcation lesions.

Percutaneous coronary intervention (PCI) of a bifurcation lesion (BL) is still associated with poorer clinical outcomes when compared with PCI of a non-BL. Therefore, several dedicated coronary bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA), were developed to improve clinical outcomes. We investigated 6-month clinical outcomes after placement of a Tryton stent in 91 patients treated for 93 BLs in our centre. All consecutive patients who have undergone PCI of a BL treated with the Tryton stent in our centre were included. Outcomes were defined as any death, cardiac death, myocardial infarction (MI), any revascularisation, ischaemia-driven target vessel revascularisation (TVR), ischaemia-driven target lesion revascularisation (TLR), stent thrombosis, and target vessel failure (TVF; composite of cardiac death, MI, and ischaemia-driven TVR). Event rates were estimated using the Kaplan-Meier method. Thirty-eight (42%) patients with acute coronary syndrome (ACS) were included (16% ST-segment elevation MI (STEMI)). The 6-month event rates were 5.4% (death), 4.3% (cardiac death), 2.2% (MI), 4.5% (any revascularisation), 4.5% (TVR), 4.5% (TLR) and 9.7% (TVF). In a real-world all-comers single-centre registry, the use of the Tryton Side Branch Stent was associated with acceptable procedural and promising clinical outcomes at 6months, including ACS and STEMI patients.

030 Management of bifurcation disease with a dedicated side-branch device; a single centre experience with the tryton stent

BackgroundThe optimal strategy for the treatment of bifurcation disease is not yet defined. While trial data suggests that “provisional” side-branch (SB) stenting may be superior to more complex 2-stent approaches,...

A prospective multicentre registry, evaluating real-world usage of the Tryton side branch stent: results of the E-Tryton 150/Benelux registry

The percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents. Dedicated bifurcation stents could provide an attractive alternative to improve early outcomes and reduce SB restenosis. We aimed to assess in a prospective single-arm multicentre registry, safety and effectiveness at 6-month clinical follow-up of the Tryton dedicated side branch (SB) stent. In this prospective international registry, patients with coronary bifurcation lesions underwent treatment with a dedicated stenting technique using the Tryton stent, in conjunction with a "workhorse" main branch (MB) stent (drug-eluting or bare metal). The Tryton stent is specifically designed for bifurcations, with minimal strut/vessel ratio in the proximal MB, providing full strut coverage at the SB ostium, with short stent length in the SB and with the ability to adapt to the wide spectrum of bifurcation angles and sizes. The primary endpoint was 6-month major adverse cardiac events (MACE: cardiac death, myocardial infarction and target lesion revascularisation). Secondary endpoints were technical and procedural success (respectively defined as successful implantation of Tryton at the intended lesion and successful performance of the whole procedure with Tryton without in-hospital MACE). A total of 302 patients were enrolled. Of these, 296 had 6-month data available for evaluation. Technical and procedural success occurred in 98.0% (95% confidence interval: 95.7%-99.1%) and 94.4% (91.2%-96.5%) patients, respectively. The cumulative 6-month MACE rate was 6.4% (4.2%-9.7%), including 4.7% (2.9%-7.7%) myocardial infarctions (3.7% periprocedural), and 3.4% (2.0%-6.1%) target lesion revascularisations (2.4% in the MB, 0.7% in the SB, and 0.3% in both MB and SB). One stent thrombosis (0.3% [0%-1.6%]) occurred. The treatment of bifurcation lesions with a dedicated Tryton stent is safe and feasible, with good technical and procedural success, very low revascularisation, MACE and stent thrombosis rates at 6-month clinical follow-up.

Six‐month clinical follow‐up of the tryton side branch stent for the treatment of bifurcation lesions

Treatment of bifurcation lesions with the Tryton Sidebranch stent has been shown to be feasible with an acceptable clinical outcome and low side branch late loss in the first in man trial. To report acute procedural and six month clinical follow-up after the use of the Tryton Sidebranch stent in an "all comer" registry. The first 100 coronary bifurcation lesions assigned for treatment with the Tryton stent were included in a prospective registry. Procedural and angiographic success rates were determined from patient charts and pre- and postprocedural quantitative coronary angiography. Totally, 96 patients with 100 lesions were included in the study. Seventy-two percent presented with stable angina, 25% with unstable angina/NSTEMI, and 3% STEMI. The bifurcation was located in the left main in 8%. Two lesions were chronic total occlusions. Sixty-nine percent were true bifurcation lesions. One failure of stent delivery occurred. Acute gain in SB was 0.76 ± 0.64 mm and three patients had residual stenosis of >30%. Angiographic success rate was 95%; procedural success rate reached 94%. Peri-procedural MI occurred in two and there was one cardiac death during hospitalization. At a median six months follow-up, TLR rate was 4%, MI 3%, and cardiac death 1%. The percentage MACE-free survival at six months was 94%. No cases of definite stent thrombosis occurred. In a real world the use of the Tryton Sidebranch stent is associated with good procedural safety and angiographic success rate and acceptable outcome at six months of follow-up.

Stentowanie bifurkacji tętnic wieńcowych z zastosowaniem stentu Tryton przeznaczonego do protekcji bocznicy. Obserwacja wczesna i 6-miesięczna 40 pacjentów

Background: Coronary artery bifurcation stenting using standard stents is associated with increased risk of complications and poor long-term prognosis. Bifurcation-dedicated stents raise a hope of improving the acute and late results of such procedures. Aim: To assess the early and mid-term results of bifurcation stenting with the specially designed bifurcation-dedicated Tryton side-branch stent. Methods and results: We evaluated 40 consecutive procedures of coronary artery bifurcation stenting using a Tryton stent in patients with stable angina or acute coronary syndrome without ST elevation. The stent was successfully implanted in 39 patients. The main vessel was treated with drug-eluting stents in 38 cases, whereas bare metal stents were used in the remaining two. In one case the procedure was complicated by non-Q wave myocardial infarction. During 30-day and 6-month observation no additional major adverse cardiac events were observed. Conclusion: Coronary bifurcation stenting with the Tryton side-branch stent is highly effective, with a low rate of acute and midterm complications.

Optical coherence tomography assessment of a new dedicated bifurcation stent

Dedicated bifurcation stents should facilitate deployment and improve coverage of bifurcational lesions. We used optical coherence tomography (OCT) to assess bifurcation lesions treated with a dedicated stent implanted in the side branch (SB) in conjunction with drug eluting stents in the main vessel (MV) in a culotte-like fashion. Nine patients treated with the Tryton stent underwent postprocedural OCT examination. Total percent of malapposed struts per patient was 18.1+/-8.7%. The longitudinal distribution of the percent of malapposed struts per patient showed that the prevalence of malapposed struts was significantly higher at the level of the bifurcation (33.3%), than in both the proximal segment and the distal segment (18.5% and 9.8%, respectively, p=0.011). When the bifurcation was divided into two halves (opposite SB and toward SB), the highest percent of malapposed struts was toward the SB (47.6%). Also the wall-strut distance for malapposed struts was significantly higher in the bifurcation half toward the SB than in the proximal and the distal segment. Malapposed struts are frequent in bifurcations despite the use of a dedicated stent. The highest frequency and largest vessel wall-stent strut distance are observed in the bifurcation half toward the SB.