Stenting Strategy Research Articles

Clinical outcomes of double stent strategy for unprotected left main distal bifurcation lesions using current generation drug eluting stent comparing to early generation drug eluting stent; The Milan and New Tokyo (MITO) registry.

There are only little data available on the comparison of clinical outcomes between a early generation drug eluting stent (eDES) and a current generation drug eluting stent (cDES) for percutaneous coronary intervention (PCI) with double stent strategy (DSS) for unprotected distal left main disease (ULMD). Between April 2005 and December 2015, we recruited 452 consecutive ULMD patients treated with DSS (eDES, 236 patients; cDES, 216 patients). In this study, eDES included Cipher, Taxus, and Endeavor and cDES included Ultimaster, Resolute family, Xience family, Promus family, Synergy, and Nobori. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI) during the median follow-up period of 1,809(IQR: 1,190-2,510) days. In entire population, the rate of overall TLR was significantly lower in cDES group than that in eDES group (adjusted HR 0.62, 95% CI 0.40-0.96, p = .032). The rate of TLR for the ostium of LCX was significantly lower in cDES group than that in eDES group (adjusted HR 0.63, 95% CI 0.39-0.99, p = .047). Cardiac mortality, the rate of TLR for LM-LAD, MI and definite/probable ST did not significantly differ between both groups. The results were preserved in the propensity adjusted population. cDES significantly improved the clinical outcomes in population treated with DSS mainly driven by the reduction of TLR for the ostium of LCX.

Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial

ObjectivesThe aim of this study was to determine whether an active side branch protection (SB-P) strategy is superior to the conventional strategy in reducing side branch (SB) occlusion in high-risk bifurcation treatment. BackgroundAccurate prediction of SB occlusion after main vessel stenting followed by the use of specific strategies to prevent occlusion would be beneficial during bifurcation intervention. MethodsEligible patients who had a bifurcation lesions with high risk for occlusion as determined using the validated V-RESOLVE (Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention) score were randomized to an active SB-P strategy group (elective 2-stent strategy for large SBs and jailed balloon technique for small SBs) or a conventional strategy group (provisional stenting for large SBs and jailed wire technique for small SBs) in a 1:1 ratio stratified by SB vessel size. The primary endpoint of SB occlusion was defined as an angiography core laboratory–assessed decrease in TIMI (Thrombolysis In Myocardial Infarction) flow grade or absence of flow in the SB immediately after full apposition of the main vessel stent to the vessel wall. ResultsA total of 335 subjects at 16 sites were randomized to the SB-P group (n = 168) and conventional group (n = 167). Patients in the SB-P versus conventional strategy group had a significantly lower rate of SB occlusion (7.7% [13 of 168] vs. 18.0% [30 of 167]; risk difference: –9.1%; 95% confidence interval: −13.1% to −1.8%; p = 0.006), driven mainly by the difference in the small SB subgroup (jailed balloon technique vs. jailed wire technique: 8.1% vs. 18.5%; p = 0.01). ConclusionsAn active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions. (Conventional Versus Intentional Strategy in Patients With High Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [CIT-RESOLVE]; NCT02644434)

Treatment of Persistent Leaks After Laparoscopic Sleeve Gastrectomy with the Simultaneous Over-the-Scope Clip (OTSC) and Mega Stent Strategy.

Persistent staple-line leak is a challenging complication after laparoscopic sleeve gastrectomy (LSG). The over-the-scope clip (OTSC) (Ovesco®, Tübingen, Germany) and the Mega stent (Taewoong medical, Seoul, South Korea) recently gained encouraging results in the management of early leaks. This is a retrospective series (n = 8) focused on the management of persistent leaks after LSG with the simultaneous OTSC/Mega stent strategy. Seven patients underwent primary LSG. The median time from LSG to OTSC/Mega stent treatment was 48.5days (range 28-63), and the median defect size was 9.5mm (range 7-12). The median time to clear liquid diet, hospital length of stay, and overall treatment time were 4days (range 2-5), 31days (range 26-57), and 47days (range 34-107), respectively. Overall success rate was 87.5%. Postoperative morbidity was 25%. The mean follow-up time was 18months (range 3-24) with no fistula recurrence.

Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.

There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P=0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P=0.030) and target lesion revascularization (7.3% versus 15.2%; P=0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P=0.034), while long overlap was not (6.8% versus 5.4%; P=0.567). In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

CRT-100.81 Three-Year Clinical Outcomes Following Ostial Stenting for Left Main Coronary Artery Disease Without Ostial Lesion Using Second-Generation DES

Advances in stenting technology and procedural technique are changing the role of percutaneous coronary intervention (PCI) in the treatment of left main coronary artery (LMCA) disease. The location of the lesion in LMCA has a great influence on the stenting strategy. In many cases, the length of the

A new intravascular ultrasound-guided stenting strategy compared with angiography on stent expansion and procedural outcomes in patients with positive lesion remodeling.

We investigated the role of a new intravascular ultrasound (IVUS)-guided stenting strategy versus angiography on optimal stent expansion (OSE) and procedural outcomes in patients with positive lesion remodeling. There are no IVUS criteria on how to achieve OSE. A total of 100 patients were assigned to a new IVUS-guided stenting strategy (IVUS group) versus angiography-guided stenting (Angio group). In the IVUS group, among patients with positive lesion remodeling, defined as a remodeling ratio (RR; lesion external elastic membrane (EEM) area/distal reference EEM area) >1.05, the stent was expanded with a balloon sized to the distal reference EEM diameter. In the Angio group, the stent was expanded by visual estimation. In both groups, IVUS was performed after postdilation. Minimum stent area (MSA) and stent volume index were significantly larger in the IVUS versus Angio group (7.1 ± 1.9 vs. 5.9 ± 1.5 mm2 , and 8.7 ± 2.1 vs. 7.5 ± 1.8 mm3 /mm, respectively; p < .01). The percentages of OSE, defined as an MSA ≥5.4 mm2 , MSA ≥90% of distal reference lumen area (DRLA), or MSA > DRLA, were significantly higher in the IVUS versus Angio group (80 vs. 56%, 78 vs. 54%, and 71 vs. 38%, respectively; p < .01). Stent underexpansion, malapposition, and residual reference segment stenosis were significantly higher in the Angio versus IVUS group (44 vs. 12%, 16 vs. 4%, and 12 vs. 0%, respectively; p < .05). In the IVUS group, owing to positive remodeling, there was no incidence of dissection or perforation. This new strategy of IVUS-guided stenting in patients with positive lesion remodeling, compared with angiography, significantly increased stent expansion and decreased stent underexpansion, malapposition, and residual reference segment stenosis with no complications.

What Is the Optimal Stent Strategy for Malignant Hilar Biliary Obstruction

Patients with biliary obstruction at the level of the ductal hilum are often difficult to treat via endoscopic retrograde cholangiopancreatography

Engineering &lt;i&gt;In Situ&lt;/i&gt; Weldable Vascular Devices

Endovascular Aneurysm Repair (EVAR) procedures are based on the implantation of a stent graft consisting of a metallic stent and a polymeric fabric attached to it. A leading trend fueling much research activity in this field is the minimization of the insertion profiles of the stent grafts used. Aiming at solving the key problems marring current stent grafts, a stenting strategy whereby the metal stent and the graft are deployed sequentially and welded together at the aneurysmal site is presented. Decoupling the stent and the graft greatly reduces the stent graft profile, which largely eases insertion and increases maneuverability through hostile anatomies. To render the metallic stent in vivo weldable, its struts were coated with an in vivo weldable polymer. Polyurethane thermoplastic elastomers were used to generate the graft - called in this study the sleeve - and to coat the stent struts, and their composition was fine-tuned, to optimize their welding properties. The device was successfully implanted in pigs through an 8F introducer, remarkably smaller than the 14-18F introducers currently used in the clinic. In situ welded devices implanted in pigs for 3 months were navigated to the site and deployed straightforwardly and demonstrated that the strength of the welded connection was retained, with no de-welding being observed. To our knowledge, this is the first time that the welding phenomenon is performed inside the body.

Billiat intra-operative stents in orthotopic liver transplantation

Presenter: Mohammed Aldamry | McGill University Background: Biliary complications can affect 40% of patients after orthotopic liver transplantation (OLTx). Endoscopic management has a high success rate but involves multiple sessions and up to 21% complications. Biliary plastic stents placed manually during OLTx can splint a choledocho-choledochal anastomosis, possibly reducing biliary strictures and leaks. This study evaluates the feasibility and clinical outcomes of “prophylactic” intraoperative stenting at a single center, using a propensity-matched analysis. Methods: All consecutive OLTx patients over a 10-year period are included except for patients with hepaticojejunostomy, fulminant hepatic failure, redo grafts and combined organ transplants. The primary outcome is the incidence of biliary complications (leaks and strictures). Secondary outcomes include: stent morbidity, number of biliary interventions, cholangitis, acute renal failure, graft and patient survival. Propensity scoring was used to diminish selection bias. Outcomes were analyzed for a minimum of 5 years. Results: 265 OLTx patients were included between 2002-2011. 95 patients (36%) received intraoperative stents whereas 170 did not. Age, Gender, and medical comorbidities were similar between groups. Total biliary complications (44.2% Vs 44.7%, P=0.94) and biliary stricture rates (45.3%Vs 43.5%, P= 0.79) were similar between groups. However biliary leaks were significantly less frequent in the stented group (2%) vs. non-stented (10%), (P=0.02). Five-year rates of cholangitis, choledocholithiasis, and acute renal failure were similar between both groups. A propensity score model based on multiple covariates including surgeon, year of transplantation and Charlson comorbidity score was used to match 95 patients in each group. The rate of biliary leaks remained significantly lower in the stented group, OR= 0.19 (95%CI= 0.04; 0.86). Conclusion: Intraoperative use of biliary stents at OLTx is feasible and safe, resulting in less biliary leaks without significantly greater adverse events. 5-year biliary stricture rates appear similar. This study suggests a stenting strategy is feasible and that a randomized trial is worthwhile.

Biliary stenting for hilar malignant biliary obstruction.

Although endoscopic intervention is the mainstay for palliation of malignant biliary obstruction, a percutaneous approach has been preferred, particularly in patients with advanced high-grade hilar malignant biliary obstruction, because of the technical difficulty and risk of complications. However, recently, primary endoscopic palliation using plastic or metal stents has had higher technical and clinical success with fewer adverse events than the percutaneous approach. Endoscopic interventions are being done more and more frequently because of advances in metal stents, accessories, and techniques. However, several concerns, such as optimal stent type, number, and deployment method, remain to be resolved. Therefore, we reviewed the literature in order to identify the optimal biliary stenting strategy for patients with hilar malignant biliary obstruction, focusing on stent type (plastic vs metal), number (unilateral [single] vs bilateral [multiple]), and deployment method (stent-in-stent vs stent-by-stent).

Incidence of Adverse Events at 3 Months Versus at 12 Months After Dual Antiplatelet Therapy Cessation in Patients Treated With Thin Stents With Unprotected Left Main or Coronary Bifurcations

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (<100 microns) in unprotected left main (ULM) or coronary bifurcation remain undefined. All consecutive patients presenting with a critical lesion of an ULM or involving a main coronary bifurcation who were treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction [MI], target lesion revascularization [TLR], and stent thrombosis [ST]) was the primary endpoint, whereas target vessel revascularization (TVR) was the secondary endpoint, with particular attention to type and occurrence of ST and occurrence of ST, CV death, and MI during DAPT or after DAPT discontinuation. All analyses were performed according to length of DAPT dividing the patients in 3 groups: Short DAPT (3-months), intermediate DAPT (3 to 12 months), and long DAPT (12-months). A total of 117 patients were discharged with an indication for DAPT ≤3 months (median 1: 1 to 2.5), 200 for DAPT between 3 and 12 months (median 8: 7 to 10), and 1,958 with 12 months DAPT. After 12.8 months (8 to 20), MACE was significantly higher in the 3-month group compared with 3 to 12 and 12-month groups (9.4% vs 4.0% vs 7.2%, p ≤0.001), mainly driven by MI (4.4% vs 1.5% vs 3%, p ≤0.001) and overall ST (4.3% vs 1.5% vs 1.8%, p ≤0.001). Independent predictors of MACE were low GFR and a 2 stent strategy. Independent predictors of ST were DAPT duration <3 months and the use of a 2-stent strategy. In conclusion, even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation.

P968Comparison of re-proximal optimizing technique with kissing balloon technique in provisional stenting during primary percutaneous coronary intervention

Abstract Background Re-proximal optimizing technique (rePOT) (POT, side branch inflation and final POT) is a new provisional coronary bifurcation stenting technique which has better results in bench tests in comparison with kissing balloon inflation (KBI) techique. A clinical study showed that rePOT had beneficial effects in terms of strut malapposition, side branch obstruction and stent geometry. But it has not been compared with KBI technique especially in patients with ST segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (p-PCI). Purpose The aim of our study is to compare the new rePOT technique with a known and widely used provisional stenting technique in a real-world special patient population in terms of clinical and technical aspects Methods 51 patients with STEMI who underwent p-PCI and needed provisional side branch stenting were enrolled in a tertiary center. Patients who needed “two stent strategy” at the beginning of procedure were deferred. Results Results were shown in Table 1. In-hospital death, contrast induced acute kidney injury, side branch dissection, need for side branch stenting and acute stent thrombosis were lower in rePOT group but there was no statistically significance. Table 1 rePOT group (n=23) KBI group (n=28) p value Age 51.6±11.7 51.2±9.4 0.87 Male gender 18 (78.3%) 24 (85.7%) 0.16 Diabetes Mellitus 3 (13%) 6 (21.4%) 0.43 Hypertension 5 (21.7%) 5 (17.9%) 0.73 Ejection fraction 46.8±10.6 44.8±8.4 0.43 Killip class&gt;2 1 (4.3%) 4 (14.3%) 0.47 Stent type (DES) 21 (91.3%) 23 (82.1%) 0.34 Side branch dissection 3 (13%) 8 (28.6) 0.18 Side branch stenting 3 (13%) 6 (21.4%) 0.43 In-hospital death 2 (8.7%) 3 (10.7%) 0.81 CI-AKI 3 (13%) 6 (21.4%) 0.43 Acute stent thrombosis 0 2 (7.1%) 0.19 DES: Drug eluting stent; CI-AKI: contrast induced acute kidney injury. Conclusion To the best of our knowledge this is the first study which compares the new rePOT technique with KBI in patients with STEMI who underwent p-PCI and needed provisional coronary bifurcation stenting. Although results are similiar in terms of clinical and technical aspects, rePOT may be a useful and user-friendly technique in such a complex and emergent procedure. Acknowledgement/Funding None

P5751Comparison of side branch dilation techniques after resorbable magnesium scaffold implantation: a bench study

Abstract Background Resorbable magnesium scaffolds (RMS) have demonstrated good safety profile to treat de novo lesions. Nevertheless, bifurcations lesions involving a side branch&gt;2.0mm in diameter were excluded from these studies and such lesions remain technically challenging due to concerns of scaffold deformation or fracture. Purpose We sought to evaluate different side branch dilation strategies after provisional T stenting strategy with RMS. Methods Using RMS in bifurcations phantoms, three different side branch dilation strategies after provisional T stenting were compared: POT-side-rePOT (rePOT), Kissing-Balloon Inflation (KBI) and Mini Kissing-Balloon Inflation (MKBI) strategies. In vitro experiments were performed under fluoroscopy in the catheterization laboratory. Struts and connectors fractures were evaluated by micro computed-tomography and apposition by optical coherence tomography (OCT). In addition, step by step proximal over-expansion was carried out with different incremental NC balloons and scaffolds were then re-inspected on micro-CT after each over-expansion. Results Twelve RMS (n=4 in each group) were successfully implanted. There was no difference on struts and connectors fractures among the 3 techniques as no fracture was visualized. OCT demonstrated that MKBI sequence significantly decreased global malapposition following SB inflation as compared with rePOT or KBI strategies (95.3% vs 88.3% of perfectly apposed struts; p&lt;0,0001 and 93.6%; p=0.004, respectively for MKBI vs. rePOT and KBI). After step by step overexpansion, no strut or connector fracture could be visualized. Stent strut apposition between in vitro models rePOT, n (%) KBI, n (%) MKBI, n (%) P value rePOT vs KBI P value rePOT vs MKBI P value KBI vs MKBI Overall bifurcation 1702/1928 (88.3%) 2062/2211 (93.6%) 1824/1913 (95.3%) p&lt;0,0001 p&lt;0,0001 p=0.004 MB proximal 376/390 (98.3%) 407/407 (100%) 398/398 (100%) p=0.0001 p=0.0001 p=NS MB bifurcation ostial 210/286 (77.5%) 326/391 (82%) 243/269 (89.8%) p=0.002 p&lt;0,0001 p=0.01 MB bifurcation abostial 421/425 (99.3%) 421/421 (100%) 324/324 (100%) p=0.05 p=0.08 P=NS SB bifurcation ostial 147/227 (62.8%) 321/365 (88.3%) 256/306 (85%) p&lt;0,0001 p&lt;0,0001 p=NS SB bifurcation abostial 98/150 (70.3%) 128/168 (78%) 161/173 (95.5%) p=0.03 p&lt;0,0001 p=0,0005 MB distal 450/450 (100%) 459/459 (100%) 442/443 (99.8%) p=NS p=NS p=NS Comparison between rePOT, KBI and MKBI. Abbreviations: POT, proximal optimization technique; MKBI, mini kissing balloon inflation; KBI, kissing balloon inflation. Bifurcation exemples Conclusion Provisional RMS one stent technique on a bifurcation lesion is technically feasible with these 3 different strategies without scaffold fracture. MKBI strategy resulted in better apposition rates as compared to KBI or rePOT strategies.

P972A subgroup analysis from the RAIN-CARDIOGROUP VII study: incidence of adverse events after DAPT cessation in patients treated with ultrathin stents in ULM or coronary bifurcations

Abstract Introduction Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with ultrathin stents in unprotected left main (ULM) or coronary bifurcation remain undefined. Methods All consecutive patients presenting with a critical lesion of an ULM or a lesion involving a main coronary bifurcation and treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) was the primary endpoint, while target vessel revascularization (TVR) was the secondary endpoint. Moreover, type and occurrence of ST and occurrence of ST, CV death and MI during DAPT or after DAPT discontinuation were also evaluated. All analyses were performed according to length of DAPT dividing the patients in 3 groups: short DAPT (3-months), intermediate DAPT (3–12 months) and long DAPT (12-months). Results 117 patients were discharged with an indication for DAPT≤3 months (median 1:1–2.5), 200 for DAPT between 3 and 12 months (median 8:7–10) and 1958 with 12 months DAPT. After 12.8 months (8–20), MACE was significantly higher in the 3-month group compared to 3–12 and 12-month groups (9.4% vs. 4.0% vs. 7.2%, p≤0.001), mainly driven by MI (4.4% vs. 1.5% vs. 3%, p≤0.001) and overall ST (4.3% vs. 1.5% vs. 1.8%, p≤0.001). ST post DAPT cessation were comparable (1.7% vs. 0% vs. 0.7%, p=0.42) with a median time to ST post DAPT discontinuation of 1.67 months (0.48–4.7). At multivariate analysis, DAPT of 12-months compared to 3-months reduces the risk of overall ST (OR 0.103: 0.019–0.0563, 95% CI) while only a trend was noted for DAPT between 3 and 12 months (OR 0.61: 0.186–2.005, 95% CI). When analysed by stent strategy a 2-stent strategy predicted ST post DAPT cessation (OR 3.241: 1.048–10.026, 95% CI), which was reduced by use of FKB (OR 0.101:0.01–0.872, 95% CI). Conclusion Even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation. The correct identification before PCI of the more fragile patients who may receive a shorter DAPT regimen could help identify the safest PCI technique: provisional stenting and use of final kissing balloon (FKB) are the safest options.

P5753Jailed pressure wire to assess the side branch result for bifurcation lesions treated by provisional stenting strategy: iFR as a new index

Abstract Purpose To analyze the feasibility and efficacy of the jailed pressure wire technique for bifurcation lesions treated by provisional stenting strategy and to assess the physiological side branch (SB) result using instantaneous wave free ratio (iFR). Methods Between June 2017 and December 2018, 50 patients who presented a bifurcation lesion considered appropriate for provisional stenting strategy were included in the study. Pressure wire was passed to side branch before treatment. Main vessel (MV) and side branch (SB) was predilated at the operator criteria. iFR determination was obtained in the SB baseline and after MV stenting (leaving the pressure wire jailed). Afterwards, the wire was removed to MV ostium to discard the possibility of drift. SB postdilation was performed if SB iFR was less than 0,89 (according to vessel thresholds established in clinical trials), evaluating the result by a new iFR determination. Results The mean age was 64±10 years. Sixteen patients (32%) had diabetes. Clinical presentation was stable angina in 26 patients (52%), non-STEMI in 19 patients (38%) and STEMI (non culprit lesion) in 5 patients (10%). The most frequent bifurcation type according to Medina classifications was 1,1,0 (21 patients, 42%). Seventeen patients (34%) had a true bifurcation lesion. The MV and SB reference diameter was 3,0±0,5 mm and 2,25±0,5 mm respectively. Most of the bifurcations were located at the left anterior descending artery/diagonal branch (27 bifurcations, 54%). Ten patients (20%) presented a distal left main bifurcation. Baseline SB iFR was 0,78±0,2. Under continuous SB iFR monitoring MV stenting was performed by trapping the pressure wire. After MV stenting, the SB iFR changed to 0,90±0,1. We confirmed the presence of drift in 5 patients (10%). In these cases, recalibration of the wire and SB rewiring was performed in 4 cases. In the remaining patient, rewiring was not possible even using specific coronary wires. According to SB IFR, postdilation was necessary in 14 patients (28%). Final SB iFR was 0,94±0,03. A second stent was not necessary in any patient because final SB iFR was higher than 0.89 in all cases. We observed discordance between angiographic and physiological result in 17 cases (34%). All the wires could be removed. Forty wires (80%) were microscopically analyzed. Some grade of microscopic damage was found in 32 wires (80%), all of them distal to the pressure sensor. However, only one of these wires (2%) presented severe damage, and no case of fracture was observed. After a mean follow up time of 10±6 months only one patient (2%) presented a major cardiac adverse event (acute coronary syndrome due to voluntary cessation of dual antiplatelet therapy). Conclusions The use of jailed pressure wire to monitor SB results for bifurcations treated by provisional stenting seems to be safe. The iFR index seems to provide new physiological information about the significance of the SB stenosis.

TCT-243 Rotablation Approach for Bifurcation Lesions

Coronary bifurcation lesion (BL) is one of the most challenging settings for percutaneous coronary interventions, because suboptimal results are commonly observed and clinical outcome could be impaired. We studied a strategy of rotational atherectomy (RA) and provisional stenting (RAPS) to improve

TCT-72 Validation of Complex Bifurcation Lesion Definition and Comparing Stenting Strategy in a Large Cohort of Patients With Left Main Bifurcation

TCT-72 Validation of Complex Bifurcation Lesion Definition and Comparing Stenting Strategy in a Large Cohort of Patients With Left Main Bifurcation

TCT-581 Jailed Pressure Wire to Assess the Side Branch Result for Bifurcation Lesions Treated by Provisional Stenting Strategy: iFR as a New Index

The aims of this study were to analyze the feasibility and efficacy of the jailed pressure wire technique for bifurcation lesions treated by provisional stenting and to assess the physiological side branch (SB) result using instantaneous wave-free ratio (iFR). Between June 2017 and December 2018,

The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

A Systematic Literature Review of Three Stenting Strategies for Bifurcation Lesions in Coronary Artery Disease.

BackgroundBifurcation lesions represent 15–20% of all patients undergoing a percutaneous coronary intervention (PCI) for coronary artery disease. The provisional 1-stent stenting strategy is the preferred strategy to treat bifurcation lesions. Other strategies used to treat bifurcation lesions include 2-stent complex stenting strategies and the Tryton Side Branch Stent® (TSB)—a dedicated side-branch stent for bifurcation lesions, which gained FDA approval in March 2017.ObjectivesTo conduct a systematic literature review of the safety and effectiveness of three stenting strategies (provisional, complex, and Tryton Side Branch Stent®) for bifurcation lesions with a side-branch diameter ≥2.25 mm, undergoing PCI.MethodsLiterature searches in Medline, Cochrane Library, Web of Science and Embase were conducted to identify prospective clinical trials from January 2007–July 2017.Results602 articles were identified. Nine articles (6275 patients) met all inclusion criteria. Seven studies (5282 patients) compared provisional to complex stenting strategies. Two studies (993 patients) compared provisional to the TSB. Outcomes of interest reported were target vessel failure in 2 studies, major adverse cardiac event (MACE) (cardiac death, all myocardial infarction, ischemic driven target legion revascularization TLR) in 5 studies. For target vessel failure, the provisional strategy ranged from 5.6% to 15.6 %; complex at 7.2% (one study); and TSB from 11.3% to 17.4%. For MACE, provisional strategy ranged from 8%–13.2%; complex from 11.9%–15.2%; and TSB from 8.2%–18.6%.ConclusionsTo our knowledge, this is the first review comparing three bifurcation lesion stenting strategies. Significant heterogeneity in the study design of the nine studies reviewed prevented a meta-analysis. A clinical trial comparing the TSB to both the provisional and complex strategies would provide better inference on the safety and effectiveness when comparing strategies.