Provisional T-stenting Technique 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.).

Branch ostial optimization treatment and optimized provisional t-stenting with polymeric bioresorbable scaffolds: Ex-vivo morphologic and hemodynamic examination.

The optimal side-branch (SB) ostium treatment after provisional side-branch scaffolding remains a subject of debate in bioresorbable vascular scaffold (BVS) era. In this study, we evaluated a novel optimized provisional T-stenting technique (OPT) and assessed its feasibility by comparison with T and small protrusion technique (TAP).Two provisional SB scaffolding techniques (OPT, n = 5; TAP, n = 5) were performed using polymeric BVS in a bifurcated phantom. The sequential intermediate snuggling balloon dilation, also called ostial optimal technique, was added to OPT but not TAP to dilate the side-branch ostium while the final snuggling balloon dilation applied for both procedures. Microcomputed tomography (microCT) and optical coherence tomography (OCT) were performed to assess morphology, and computational fluid dynamics (CFD) was performed to assess hemodynamics in the scaffolded bifurcations. Compared with TAP in microCT analysis, OPT created shorter neo-carina length than TAP (0.34 ± 0.10 mm vs 1.02 ± 0.26 mm, P < .01), longer valgus struts length (2.49 ± 0.27 mm vs 1.78 ± 0.33 mm, P < .01) with larger MB ostial area (9.46 ± 0.04 mm vs 8.34 ± 0.09 mm, P < .01). OCT found that OPT significantly decreased the struts mal-apposition (13.20 ± 0.16% vs 1.94 ± 0.54%, P < .01). CFD revealed that OPT generated more favorable flow pattern than TAP, as indicated by less percent (4.68 ± 1.40% vs 8.88 ± 1.21%, P < .01) of low wall shear stress (<0.4 Pa) along the lateral walls.By using BVSs for bifurcation intervention, the sequential intermediate snuggling balloon dilation is feasible for optimizing ostial SB and facilitating subsequent SB scaffolding. Results show OPT is better than TAP for bifurcated morphology and hemodynamics in this ex-vivo study.

Safety and efficacy of lesion preparation with the AngioSculpt Scoring Balloon in left main interventions: the ALSTER Left Main registry.

Left main interventions require optimal initial results for good clinical outcome. Lesion preparation with the AngioSculpt Scoring Balloon (ASB) combined with the provisional T-stenting technique, if proven safe, might lead to better lumen gain and better clinical outcome. The aim of this registry was to investigate the safety and efficacy of the ASB as an option for lesion preparation in unprotected left main interventions (ULMI). Out of the all-comers unprotected left main registry (ULMI ALSTER), 47 patients with elective ULMI fulfilled the inclusion criteria for this study. The endpoints were acute lumen gain and 12-month MACCE. The drop-out rate was 4%. The provisional T-stenting technique was used in 97% of distal ULMI. The interventions were grouped according to use of ASB with an in-house, historical no-ASB patient control group. Lumen gain was 1.63±0.12 mm in the ASB group (n=34) and 1.35±0.12 mm in the no-ASB group (n=8, p=0.26), respectively. The use of the ASB was safe. Intravascular ultrasound (IVUS) data for 21 patients showed numerically greater lumen area gain of 3.14±0.33 mm2 in the ASB group compared to 2.33±0.88 mm2 with the conventional technique. TLR/TVR was 6.6% overall. Twelve-month MACCE was 12.5% (4/32) for ASB and 15.4% (2/13) in the historical control group. Adding ASB lesion preparation to the standard provisional T-stenting technique for ULMI is feasible and safe. Low TLR and TVR rates were observed. Lesion preparation led to a numerically larger lumen gain; the data allow valid power statistics to show this approach as leading to improved outcome in a possible randomised trial.

A multicenter randomized comparison of drug‐eluting balloon plus bare‐metal stent versus bare‐metal stent versus drug‐eluting stent in bifurcation lesions treated with a single‐stenting technique: Six‐month angiographic and 12‐month clinical results of the drug‐eluting balloon in bifurcations trial

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 (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES. In this randomized, international, multicenter, single-blinded 3-arm study, 117 patients with coronary bifurcation lesions underwent treatment with: (A) DEB in both main branch (MB) and SB and BMS in MB; (B) BMS in MB and regular balloon angioplasty in SB; or (C) paclitaxel DES in MB and regular balloon in SB. All patients underwent provisional T-stenting with an identical stent platform in the MB. Paclitaxel was the drug for elution in groups A and C. The primary endpoint was 6-month angiographic late luminal loss. Secondary end points were 6-month binary restenosis and 12-month major adverse cardiac events (MACE: death, myocardial infarction, target vessel revascularization). The procedure was successful in all cases. Late luminal loss, measured respectively in the proximal MB, distal MB and SB was 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm in group A; 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm in group B; and 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm in group C (P = 0.001). Binary restenosis rates per bifurcation and MACE rates were 24.2%, 28.6%, and 15% (P = 0.45) and 20%, 29.7%, and 17.5% (P = 0.40) in groups A, B, and C, respectively. Pretreatment of both MB and SB with DEB failed to show angiographic and clinical superiority over conventional BMS, using a provisional T-stenting technique. Moreover DES showed superior angiographic results than DEB and BMS.

Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study

Coronary bifurcation lesions, which account for 15-20% of all lesions treated percutaneously, remain hampered by procedural difficulties, post-procedural complications and suboptimal long-term results, even with the introduction of the drug-eluting stent (DES). Side branch (SB) restenosis rates remain a drawback even in the provisional T-stenting technique with final kissing balloons. The introduction of drug-eluting balloons (DEB) creates a new hope for this technique by maintaining the relatively easy provisional T-technique but promising better long term outcomes for the SB treated with DEB. The DEB delivers locally a high concentration of an anti-restenotic drug, paclitaxel, thereby potentially reducing restenosis rates as compared to a regular balloon. However little is still known on the optimal use and long-term outcomes of DEB in bifurcations. First results of the DEBIUT study will help to understand future directions in development of this new and promising device.

Long‐Term Outcomes of Sirolimus‐Eluting Stents vs Paclitaxel‐Eluting Stents in Unprotected Left Main Coronary Artery Bifurcation Lesions

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging. We hypothesized that the type of drug-eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions. One hundred fifteen patients who underwent stent implantation using a provisional T-stenting technique with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization. Ninety-four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow-up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow-up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs. 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug-eluting stent used (SES vs. PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29-11.67, P = 0.016). According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials.

Use of Drug-Eluting Stent with Provisional T-Stenting Technique in the Treatment of Renal Artery Bifurcation Stenosis; Long-term Angiographic Follow-up

Atherosclerotic renal artery stenosis (RAS) usually involves the ostium and the proximal one-third of the renal artery main branch. Percutaneous renal artery angioplasty with stent placement is a well recognized treatment for atherosclerotic RAS. Occasionally, atherosclerotic RAS involves renal artery bifurcations. However, stent implantation in atherosclerotic RAS involving bifurcation is not only troublesome, but also challenging because of side branch occlusion and in-stent restenosis (ISR). In the present report, we describe the use of drug-eluting stents (DES) with provisional T-stenting technique for the treatment of renal artery bifurcation lesion. Follow-up angiogram showed no significant ISR 18 months after the procedure. In the treatment of renal bifurcation lesions, a two-stent strategy using DES could be a viable option in selected patients.

One-year clinical outcome after provisional T-stenting for bifurcation lesions with the endothelial progenitor cell capturing stent compared with the bare-metal stent

Objective Currently no data exists regarding the outcomes after the novel endothelial progenitor cell capturing stent (EPCcS) placement in bifurcation lesions using a provisional T-stenting. This study evaluates the 1-year clinical outcome in patients treated with the EPCcS for a bifurcation lesion using a provisional T-stenting technique and compared these to a historical control group treated with an identical bare-metal stent (BMS). Methods In single-center study, 178 consecutive patients with a de novo bifurcation lesion treated with an EPCcS and 465 consecutive patients treated with an equivalent BMS were included. Multivariate and propensity-score analyses were performed to adjust for differences in clinical and angiographic characteristics between the EPCcS group and the BMS group. Results At 1-year, the cumulative rate of the primary end point (cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)) was 12.4% in the EPCcS group and 17.2% in the BMS group (hazard ratio [HR] 0.70; 95% confidence interval CI, 0.44–1.12; P = 0.13). The 1-year cumulative rate of TLR was lower among patients treated with EPCcS compared with the control stent as a result of fewer coronary artery bypass grafting, 10.7% vs. 12% respectively (HR 0.88; 95% CI, 0.53–1.49; P = 0.64). The cumulative rate of definite ST was 0.6% in the EPCcS as compared with 0.4% in the BMS group. Conclusions Although, the EPC stent shows favorable outcomes in the treatment of bifurcation lesions, the reduction in the cumulative rate of cardiac death, MI, or TLR as compared with the BMS was statistically non-significant.

In‐Hospital and 12‐Month Postprocedural Clinical Outcome of Coronary Bifurcational Lesion Treatment with the Endeavor Stent

The zotarolimus-eluting stent (ZES) has been documented as significantly reducing restenosis and target lesion revascularization (TLR) requirement compared to bare metal stents (BMS). In this single-centered, prospective study we sought to evaluate the short- and medium-term outcomes of ZES placement in bifurcated coronary artery lesions. Between August 2006 and December 2007, 107 consecutive patients (110 bifurcations) were recruited to have ZES placement in the lesion. The provisional T stenting (PTS) technique was used in 96.3%. Angiographic success was 100% in main vessel (MV) cases and 97.2% in that of side branch (SB). With a mean follow-up of 12.4 +/- 1.77 (mean +/- SD) months there were four deaths, three from cardiac cause (2.85%). There were 18 patients (19 bifurcations) requiring TLR (17.59%) for clinical reasons. The only predictor of TLR was the use diameter of ZES <or=3 mm. ZES can be used for bifurcation lesions using the PTS technique with a high rate of intraprocedural success; however, frequency of TLR is high, especially for stents with a diameter <or=3 mm.

Evaluation of the dedicated Frontier™ coronary bifurcation stent: A matched pair analysis with drug-eluting and bare metal stents

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.