Predictors Of Target Lesion Revascularization Research Articles

TCT-500 Long-term Outcomes and Predictor of Target Lesion Revascularization in Patients After Treatment With Paclitaxel Coated Balloon for Drug-Eluted Stent Restenosis

TCT-500 Long-term Outcomes and Predictor of Target Lesion Revascularization in Patients After Treatment With Paclitaxel Coated Balloon for Drug-Eluted Stent Restenosis

Clinical Impact of In-Stent Calcification in Coronary Arteries: Optical Coherence Tomography Study

In-stent restenosis with neoatherosclerosis has been known as the predictor of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). However, impact of in-stent calcification (ISC) alone on clinical outcomes remains unknown since neoatherosclerosis by optical coherence tomography (OCT) includes both in-stent lipid and calcification. We aimed to assess an effect of ISC on clinical outcomes and clinical differences among different types of ISC. We included 126 lesions that underwent OCT-guided PCI and divided those into the ISC group (n=38) and the non-ISC group (n=88) according to the presence of ISC. The cumulative incidence of clinically-driven TLR (CD-TLR) was compared between the ISC and non-ISC groups. Impact of in-stent calcified nodule and nodular calcification on CD-TLR was evaluated in the Cox hazard model. The incidence of CD-TLR was significantly higher in the ISC group than in the non-ISC group (p=0.004). In the multivariate Cox hazard model, ISC was significantly associated with CD-TLR [hazard ratio (HR): 3.58; 95% confidence interval (CI): 1.33-9.65; p=0.01]. In-stent calcified nodule/nodular calcification and in-stent nodular calcification alone were also the factors significantly associated with CD-TLR (HR: 3.34; 95%CI: 1.15-9.65; p=0.03 and HR: 5.21; 95%CI: 1.82-14.91; p=0.002, respectively). ISC without in-stent calcified nodule/nodular calcification, which was defined as in-stent smooth calcification, was not associated with CD-TLR. In conclusion, ISC was associated with the higher rate of CD-TLR. Types of calcifications that led to the high rate of CD-TLR were in-stent calcified nodule/nodular calcification and in-stent nodular calcification alone but not in-stent smooth calcification. In-stent calcified nodule and nodular calcification should be paid more attention.

Long-term clinical outcomes of drug-coated balloon for the management of chronic total occlusions.

This study aims to compare the clinical outcomes of patients with de novo chronic total occlusion (CTO) lesions treated by hybrid strategy and drug-coated balloons (DCB)-only strategy. DCBs have been used as an alternative to or in combination with drug-eluting stents in CTO lesions. However, the clinical impact of DCB treatment on CTO lesion remains uncertain. We retrospectively enrolled 154 patients with de novo CTO lesions treated by DCB, including 57 cases in hybrid group and 97 cases in DCB-only group. The lesions in hybrid group were more complicated than those in DCB-only group as shown by higher J-CTO score, and therefore higher percentage of retrograde approach, more IVUS guidance, more CTO guidewires, and longer procedural time were demonstrated. Although the percentage of non-flow-limiting dissection and residual stenosis of more than 30% were lower in hybrid group, TIMI flow grade, satisfactory and acceptable recanalization rate were not significantly different between two groups. During a median follow-up was 470 days, the incidence of target lesion revascularization (TLR), myocardial infarction and cardiac death was 11.0%, 1.3% and 1.9%, respectively. The long-term TLR-free survival was comparable between hybrid and DCB-only groups. By multivariate analysis, DCB length and age were predictors of TLR. DCB treatment appears effective and safe in selected de novo CTO lesions during long-term follow up. The recanalization results and long-term outcomes are comparable between hybrid and DCB-only group despite more complicated lesions in hybrid group.

Clinical outcomes of endovascular therapy with vascular stents for central venous obstruction in hemodialysis patients

BackgroundSymptomatic central venous obstruction (CVO) is sometimes observed in patients undergoing hemodialysis. Angioplasty is generally performed for salvage purposes, and stent implantation is performed as a last resort to prevent permanent venous occlusion. However, published reports about the clinical outcomes of stenting for CVO have been limited by the small number of included patients and the relatively old generation of analyzed stents. This study aimed to clarify the safety and efficacy of endovascular therapy (EVT) using stents for symptomatic CVO in contemporary practice. MethodsThis retrospective review was performed between May 2012 and August 2021. We retrospectively analyzed consecutive 31 lesions (31 patients, 64 ± 10.7 years old) treated with a vascular stent for elastic recoil after balloon angioplasty or recurrent stenosis <3 months after angioplasty. The primary outcome was primary patency, defined as freedom from target lesion revascularization. The secondary outcome was assisted primary patency, defined as freedom from permanent occlusion of the target stents. ResultsIn all cases, stents were successfully deployed on the target lesions. No EVT-related complications were observed. Self-expandable and balloon-expandable stents were used in 26 and 5 lesions, respectively. The median follow-up period was 18 months (interquartile range, 7–40). Kaplan-Meier analysis revealed that the primary patency rates were 66.1 % at 6 months, 61.7 % at 12 months, and 38.4 % at 24 months after EVT. The assisted primary patency rate was 70.3 % 24 months after EVT. In the multivariate analysis, younger age was the only independent predictor of target lesion revascularization (hazard ratio: 0.92, 95 % CI: 0.85–0.99, p = 0.04). ConclusionsStent implantation for CVO that is resistant to standard angioplasty seems safe and effective.

Evaluation of Stent Angioplasty in the Treatment of Arteriosclerotic Lesions of the Common Femoral Artery.

In many vascular segments, endovascular therapy is the treatment of choice for arteriosclerotic lesions. For the treatment of common femoral artery (CFA) lesions, surgical reconstruction is still considered the gold standard. The purpose of this study is to evaluate the safety and efficacy of stent angioplasty for the treatment of common femoral artery (CFA) lesions in a real-world population during a two-year follow up. This retrospective, single-center study includes 250 patients requiring treatment with stent angioplasty of CFA lesions. The primary end point was the target lesion revascularization (TLR) rate. Secondary end points were the overall procedural complication rate, the rate of ipsilateral CFA punctures during follow-up, changes in the Rutherford–Becker class (RBC) and ankle–brachial index (ABI), primary patency rates, amputation rate, time to and the type of TLR. A total of 236 interventions (94.4%) were successfully defined as a residual stenosis < 30%. Periinterventionally, there were 23 complications (9.1%), 3 of which had to be treated surgically. Median follow up was 21 months (average 19.2 ± 7.8). In total, 41 patients (16.4%) needed a TLR. The primary patency rate was 90.8%, 81.2% and 72% at 6, 12 and 24 months, respectively. ABI and RBC were significantly better at all time points compared to baseline. During follow up, seven amputations (three minor and four major) had to be performed. More than half of the patients (56.0%) were punctured at the stented CFA during the follow up. Multivariate logistic regression analysis showed continued nicotine use and coronary heart disease as predictors for TLR. Stent angioplasty for the treatment of CFA lesions is safe and effective. Further studies are needed to compare this endovascular option with surgical therapy.

Total thrombus-formation analysis system (T-TAS) can predict target lesion revascularization in patients undergoing endovascular therapy for critical limb ischemia

Abstract Background Despite of the development of endovascular therapy (EVT), the frequency of target lesion revascularization (TLR) after EVT in patients with critical limb ischemia (CLI) is still high. Recent histrogical study suggested the possibility of thromboembolic phenomenon in the development of CLI; however, there is few monitoring system of total thrombogenicity in perioperative period of EVT in CLI patients. The total thrombus-formation analysis system (T-TAS), a novel system for quantitatively analyzing thrombus formation using microchips with thrombogenic surfaces (collagen plus tissue factor, atheroma [AR]-chip), is validated and can evaluate the total thrombogenicity. Purpose To investigate the utility of T-TAS parameters in predicting TLR after EVT in CLI patients. Methods We analyzed 27 CLI patients (45 lesions; aortoiliac 20%, femoropopliteal 40%, infrapopliteal 40%) who underwent EVT at our institution between January 2018 and December 2020. Patients undergoing hemodialysis were excluded. Blood sample was collected on the day of EVT and was used in T-TAS to compute the thrombus formation area under the curve (AUC; AUC for the first 30 minutes for AR tested at flow rate of 10 lL/min [AR10-AUC30]). We investigated the relationship between the AR10-AUC30 level and the occurrence of clinically-driven TLR, and the predictors of TLR among CLI patients. Results Study population had a mean age of 77 years, and 56% were male. During the follow-up period (mean 1.0±0.7 years), 11 lesions (24%) required clinically-driven TLR. The AR10-AUC30 level was significantly higher in patients requiring TLR than those without TLR (1783±121 vs. 1587±205; p&amp;lt;0.01). The frequency of TLR significantly increased in association with a tertile of the AR10-AUC30 level (Figure 1, p for trend=0.003). As shown in Figure 2, univariate logistic regression analysis demonstrated male sex and the third tertile of the AR10-AUC30 level compared to its first or second tertiles were significantly associated with TLR in patients with CLI, whereas platelet count, PT-INR, APTT, and atherosclerotic risk factors including glycated hemoglobin, low-density lipoprotein cholesterol, and renal function were not. Multivariate logistic regression analysis also revealed that the AR10-AUC30 level ≥1707 (=its third tertile) as an independent predictor for TLR, even after adjusted by age and sex (OR=6.28, 95% CI=1.18–33.3, p=0.03). Conclusions In patients with CLI, the AR10-AUC30 level measured by the T-TAS may be a potential predictor to identify the high-risk patients requiring TLR after EVT. This finding suggests the hypercoagulability in CLI patients and that an anticoagulant agent following EVT may be useful in preventing a restenosis in CLI patients. Further study with a larger sample size is warranted to validate this finding. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

A neural system dynamics modeling platform and its applications in randomized controlled trial data analysis

Conventional statistical methods used in clinical trials lack the ability to predict patient specific risk and very often do not consider the effects of time varying interventions. The aim of this study is to test a novel artificial neural network based model for clinical trial analysis to represent the continuous time evolution of risk. The novel methodology tested utilizes system dynamics and artificial neural networks. This methodology was applied to analyze data from 2,221 patients with acute myocardial infarction enrolled in a well characterized randomized study, the HORIZONS-AMI trial. Outcomes analyzed included: (1) target lesion revascularization (TLR) and (2) stent thrombosis. The proposed neural system dynamics (NSD) model was compared against traditional Cox Proportional Hazards (Cox PH) and Cox neural network (NN) models. Model performance was evaluated using C-statistic at 1, 2 -and 3- years follow-up and model-based simulation studies were performed to examine the effect of different variables on the predicted risk of TLR and stent thrombosis. The NSD model achieved comparable performance to Cox models for TLR. For stent thrombosis, the NSD model outperformed Cox models (1-year C-statistic: Stent thrombosis – Cox PH: 0.60, Cox NN: 0.66, neural SD model: 0.69). The neural SD model identified clinically relevant variables such as stent count, stent type and multiple lesions treated as significant predictors for TLR; and stent count and peak platelet count for stent thrombosis. Simulations illustrated change in predicted TLR risk maximal for the neural SD model, compared to other models. For stent thrombosis, simulation scenario illustrated predicted event rate doubling when clopidogrel is discontinued at 6 months compared to extended use. We have demonstrated an alternative analytical methodology that combines system dynamics and artificial neural networks to analyze results from a randomized trial. This novel approach can incorporate patient-specific longitudinal data and provide personalized risk prediction. • Incorporation of non-linear interactions and time-varying data improves personalized risk prediction. • Neural System Dynamics (NSD) model combines neural networks with system dynamics. • NSD model represents continuous time evolution of risk. • NSD model captures clinically relevant risk predictors of Target Lesion Revascularization and Stent Thrombosis. • NSD model based simulations provide more personalized risk trajectories with actionable insights using follow-up intervention information.

Outcomes of endovascular treatment for infrapopliteal peripheral artery disease based on the updated TASC II classification.

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions (n = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses (n = 214) and 95% for occlusions (n = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, p = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, p = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, p < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall p = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; p = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; p = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome.

Blood adipocytokine concentration in patients with peripheral artery disease.

Inflammatory responses mediated by adipocytokines may affect both atherosclerosis development and progression, as well as the risk of in-stent restenosis. The aim of this study was to determine the relationships between blood leptin, adiponectin and tumor necrosis factor-α (TNF-α) concentrations and the 1-year outcome of superficial femoral artery (SFA) stenting. Blood concentrations of leptin, adiponectin and TNF-α were determined in 70 patients undergoing SFA stenting due to intermittent claudication and in 40 patients undergoing carotid artery stenting (CAS). All subjects were followed up for at least 1 year in relation to the occurrence of clinically driven target lesion revascularization (TLR) or a major adverse cardiovascular event (MACE). Patients undergoing SFA stenting and CAS had similar blood adipocytokine concentrations. Patients with diabetes mellitus presented a higher leptin concentration, lower adiponectin-to-leptin ratio, and lower blood adiponectin concentration indexed to fat mass (FM) and to visceral adiposity score (VAS). In Kaplan-Meier analysis, blood concentration of TNF-α indexed to FM and to VAS was higher in patients who underwent TLR and MACE. However, in multifactorial analysis, the severity of atherosclerosis lesions in the femoropopliteal vascular region, estimated in relation to TASC-II classification, was the only predictor of TLR. Circulating adipocytokines did not distinguish patients with different clinical manifestations of atherosclerosis. Higher ratios of TNF-α -to-FM and to VAS before SFA stenting were related to TLR and MACE occurrence. Dysregulation in adipocytokine secretion may be a potential mediator of a proatherogenic action of diabetes mellitus in patients with peripheral artery disease.

P2690Safety and effectiveness of thin-strut DES for bifurcated coronary lesions not involving left main: a RAIN (veRy thin stents for patients with left mAIn or bifurcatioN in real life) sub-analysis

Abstract Background Thinner stent struts of new DES (drug eluting stent) are associated with shorter time of reendothelialization, a reduction of shear stress and inflammation of coronary walls. Despite this great innovations their clinical safety and efficacy in challenging scenarios as non left main bifurcation coronary lesions has not been tested. Methods RAIN is a multicenter registry enrolling patients treated on bifurcated coronary lesions and left main with thin-strut DES. Baseline characteristics and procedural data were recorded. Target lesion revascularization (TLR) was the primary endpoint, whereas major adverse clinical events (MACE; composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), TLR and stent thrombosis (ST)) along with its single components were the secondary endpoints. A multivariate analysis to identify predictors of TLR and sub-analysis according to stenting strategy (provisional vs 2-stent technique), use of final kissing balloon (FKB) and IVUS/OCT optimization were performed. Results Data from 1803 patients (59% ACS, 61% stable CAD) treated on bifurcations were retrospectively evaluated. Follow up was available for 1685 (94%) patients for a median of 12 months (IQR 7–18). TLR occurred globally in 2.5% of cases (2.2% in provisional stenting, 3.5% in 2-stent technique). The rate of MACE was 9.4%, whereas all-cause death and MI, occurred in 4.1% and 3.2% of cases respectively. TVR and definite ST incidence were 3.7% and 1.1%. At multivariate analysis, chronic kidney disease (CKD) negatively influenced the main endpoint (HR 1.95, 95% CI 1.06–3.6, p=0.03), whereas post-dilatation (HR 0.56, 95% CI 0.3–0.93, p=0.04) and provisional stenting resulted being protective factors. FKB reduced TLR occurrence at FU only in 2-stent technique (p=0.03), whereas intracoronary imaging (performed in 29% of patients) were uninfluential. Conclusion Very thin-strut DES represents a highly effective solution in bifurcation lesions. The risk of TLR is reduced by post-dilatation and provisional stenting. FKB is recommended in 2-stent technique, whereas further studies are required to address the impact of intracoronary imaging in this setting.

P2689Irregular protrusion area is associated with incidence of cardiac events after implantation of new generation drug-eluting stents - optical coherence tomography study

Abstract Background Several studies using optical coherence tomography (OCT) have shown that the prevalence of irregular protrusion was associated with the incidence of adverse cardiac events. However, the correlation between cardiac events and protrusion area is not well investigated. Method One hundred twenty-nine consecutive patients with 138 clesions with 2nd and 3rd generation drug-eluting stents (DES) which had pre-stenting and post-stenting OCT imaging between April 2016 and April 2018 were evaluated. We compared baseline characteristics, procedure findings and OCT findings including minimum stent area, protrusion type and maximum protrusion area between target lesion revascularization (TLR) group and non-TLR group. Results TLR occurred in 12 (9.3%) in 129 patients. The baseline characteristics and procedure findings were similar between TLR group and non-TLR group. Univariate analysis revealed that maximum irregular protrusion area was significantly larger (0.51 [0.00–0.63] vs 0.00 [0.00–0.27], p=0.036) in TLR group than non-TLR group. Receiver operating characteristic curve analysis revealed that the suitable cutoff value of maximum irregular protrusion area were 0.43mm2 for TLR. In multivariate analysis using the parameters with p value&lt;0.10 determined by univariate analysis, maximum irregular protrusion (≥0.43mm2) and minimum stent area (MSA) were independently correlated with TLR (table). Odd's ratio (95% CI) P value Major irregular protrusion (≥0.43mm2) 17.3 (3.63–82.6) &lt;0.001 MSA 2.13 (1.15–3.93) 0.002 Conclusion Major irregular protrusion (&gt;0.43mm2) in post-stenting OCT findings may be a powerful predictor of TLR in the patients with new generation DES.

Post-intervention minimal stent area as a predictor of target lesion revascularization after everolimus-eluting stent implantation for in-stent restenosis: a single-center observational study.

Everolimus-eluting stent (EES) is effective for treating in-stent restenosis (ISR). However, the long-term incidence of target lesion revascularization (TLR) is unknown. Further, the role of post-intervention minimal stent area (MSA) measured by intravascular ultrasound (IVUS) in TLR is unknown in this setting. Overall, 223 ISR lesions (192 patients) that were treated with EES between 2010 and 2016 were analyzed retrospectively. Lesions were divided into two groups according to the post-intervention MSA [ ≤ 5.3 mm: 72 lesions (67 patients), and > 5.3 mm: 151 lesions (138 patients)]. The cut-off point was determined on the basis of receiver operating characteristic curve analysis. The cumulative 5-year incidence of TLR was significantly higher in the group with MSA of 5.3 mm or less than in the group with MSA more than 5.3 mm (15.8 and 7.2%, P = 0.01). After adjusting for confounders, the excess risk of the group with MSA of 5.3 mm or less relative to the group with MSA more than 5.3 mm for TLR remained significant [hazard ratio: 3.07, 95% confidence interval (CI): 1.17-8.51, P = 0.02]. Using multivariate logistic regression analysis, we identified female sex (odds ratio: 2.39, 95% CI: 1.06-5.49, P = 0.04) and stent size of 3.0 mm or less (odds ratio: 13.43, 95% CI: 6.23-32.38, P < 0.0001) as independent predictors of MSA of 5.3 mm or less. EES implantation for ISR was associated with an acceptable rate of TLR through long-term follow-up. Postintervention MSA of 5.3 mm or less was associated independently with a higher risk for TLR.

The Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent Era.

Objectives The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29–5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03–5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05–1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801–138-918).

Treatment for in-stent restenosis requiring rotational atherectomy.

This study aimed to evaluate the outcomes of patients with in-stent restenosis (ISR) who underwent rotablation (RA) followed by balloon angioplasty (BA), drug-eluting stent (DES) implantation, or drug-coated balloon (DCB) angioplasty. Interventional treatment of ISR is occasionally challenging. Despite the availability of various percutaneous treatments, the optimal solution remains unclear. A total of 200 patients with ISR who underwent RA were retrospectively identified from our institutional database. Clinical outcomes at 12 months and independent predictors of target lesion revascularization (TLR) were assessed. Of patients, 90, 55, and 55 underwent BA, DES implantation, and DCB angioplasty, respectively. The incidence of all-cause death, cardiac death, and hospitalization due to heart failure was low in all groups. Moreover, no definite stent thrombosis was observed in the three groups. The TLR rate of BA, DES implantation, and DCB angioplasty following RA for ISR were 40.7%, 35.0%, and 27.3%, respectively. The adjusted outcomes for TLR using the inverse probability of treatment weighting method based on propensity scores indicated that DCB angioplasty following RA was superior to BA after RA. Intraprocedural complications, which could be successfully managed with interventional treatment, were identified in only three cases. TLR at 12 months is dismal. RA is not effective for ISR requiring RA. In unfavorable settings, DCB angioplasty following RA is the most effective treatment option in patients with ISR requiring debulking strategy.

TCT-166 Predictors of Target Lesion Revascularization After Implantation of Second-Generation Drug-Eluting Stents in Randomized Trials and the “Real-World”: Analysis From Two Large Datasets

Despite progress made in stent technologies, target lesion revascularization (TLR) still occurs after PCI with DES. Identification of predisposing factors is important not only for prognostication, but also to test strategies that mitigate this risk. We performed an individual patient pooled

Optimizing Percutaneous Coronary Intervention in Calcified Lesions: Insights From Optical Coherence Tomography of Atherectomy.

Optimal coronary stent implantation is among the few successful strategies in preventing stent failures, notably in-stent restenosis and stent thrombosis.1 Understanding the intravascular milieu is a prerequisite for optimization of percutaneous coronary intervention (PCI). Calcified lesions limit stent expansion, the most robust predictor of target lesion revascularization, and are thus associated with worst outcomes.2 Coronary angiography is a poor discriminator of calcium distribution and thickness. Reliance on angiography to guide PCI and define procedural success in severe coronary calcification is associated with poor outcomes.3 Both intravascular ultrasound and optical coherence tomography (OCT) enable detailed evaluation of cross-sectional calcium distribution (angle of calcium), and OCT provides additional information on calcium thickness. The combination of large calcium angle (>270°) and thickness (>670 μm) predicts nondilatable lesions.4 OCT is the ideal method to capture these parameters and indicate or defer the use of atherectomy before stent implantation and guide optimization of PCI. Preintervention OCT imaging delineates plaque constituents and provides accurate measurements of the minimal lumen area, lesion length, and reference vessel diameters, as well as visualization of the projected stent landing zones. These parameters can be used for procedural planning, including proper lesion preparation and stent sizing. Knowledge of plaque characteristics can be used to select a plaque modification strategy prior to stent implantation and to minimize stent edge dissection at the stent landing zone.5 Calcified lesions pose a bigger challenge, with difficult device delivery, suboptimal stent expansion, and increased procedural time and complications. Although atherectomy facilitates stent delivery and improves procedural success and acute lumen gain, long-term outcomes in severely calcified lesions are not improved with the routine use of angiographically guided ablative techniques in the drug eluting stent era.6 Indiscriminate use of atherectomy can also increase procedural complications. Intravascular frequency domain OCT is the …

Two-Year Outcomes and Predictors of Target Lesion Revascularization for Non-Left Main Coronary Bifurcation Lesions Following Two-Stent Strategy With 2nd-Generation Drug-Eluting Stents.

Data on outcomes of non-left main coronary bifurcation lesions treated with the 2-stent strategy using 2nd-generation drug-eluting stents (DES) are insufficient.Methods and Results:The 2-year outcomes and predictors of target lesion revascularization (TLR) in 356 patients with 364 non-left main coronary bifurcation lesions treated with the 2-stent strategy using 2nd-generation DES were retrospectively evaluated. The primary outcome measure was defined as TLR. The median follow-up duration was 3.6 years (interquartile range, 2.7-4.9 years). A 2-year clinical follow-up was achieved in 99.2%. The 2-year cumulative incidence of TLR was 9.2%. Multiple stents implanted in either the main branch (adjusted odds ratio [OR] 3.01; 95% confidence interval [CI]: 1.37-6.62; P=0.006) or the side branch (adjusted OR 4.55; 95% CI: 1.99-10.4; P<0.001) and the culprit in the left anterior descending artery and its diagonal branch (adjusted OR 0.33; 95% CI: 0.15-0.75: P=0.008) were independent predictors of TLR within 2 years. The 2-year outcomes for the 2-stent strategy using 2nd-generation DES in non-left main coronary bifurcation lesions were acceptable. Coronary bifurcation location in the left anterior descending artery and its diagonal branch is protective against TLR, whereas multiple stents implanted in either the main branch or the side branch was associated with TLR.

Intracoronary Brachytherapy in the Era of Drug-Eluting Stents

Intracoronary brachytherapy (ICBT) is an effective percutaneous trans-luminal solution for in-stent restenosis (ISR). Our objective is to assess the feasibility, safety, and efficacy of ICBT as a treatment option for ISR. We retrospectively identified adult patients who underwent ICBT for ISR in our institution, between March 2015 and January 2017 in an IRB approved database. All lesions were treated with Y-90 source, with an activity of 1.66 gigabecquerel to a prescription depth of 2mm. Lesions were prescribed 18.4 Gy (n=35), for reference vessel diameter (RVD) of < 3.35 mm or 23 Gy (n=36) for RVD of ≥ 3.35mm. Demographic variables, rates of peri-procedural complications and incidence of target lesion revascularization (TLR) were collected. Predictors of TLR were determined using Cox proportional hazards modelling. We identified 60 patients treated to a total of 71 lesions with 11 patients undergoing a second ICBT procedure. The median age of patients was 66 years with a median follow-up of 5 months. All patients had hyperlipidemia, 63% were male, 98.3% were hypertensive, and 58.3% had diabetes. Never smokers, former smokers, and current smokers represented 49.3%, 39.4%, and 11.3% respectively. The number of previous ISR at the site of ICBT was known for 47 treatments with < 4 prior ISR in 56.8% and ≥4 in 43.2%. Number of stent layers at the site of ICBT was known for 58 lesions and was < 2 layers in 65.5% and ≥3 in 34.5%. Left anterior descending artery (LAD) was the most commonly treated vessel (32.4% of ICBT). The median true vessel diameter (TVD) was 3.4 mm (range, 2.5-4.5), median injury length was 32 mm (range, 5-120mm) and median number of dwell positions was 1 (range, 1-4). Fifteen lesions (21.1%) required TLR resulting in 6 and 12-month actuarial rates of ISR of 9% and 30.3% respectively. No peri-procedural myocardial infarctions, arrhythmias, vessel perforations or dissections were observed. Univariate analysis revealed an association between TLR and history of prior ICBT HR = 3.24 (95% CI 0.93 - 12.7 p = 0.065), fewer stent layers HR = 3.13 (95% CI 0.70 – 14.0 p = 0.14) and a higher number of previous ISR at the ICBT site HR = 2.25 (95% CI 0.71 to 7.14 p = 0.17). There was no statistically significant association between TLR and age (p = 0.36), sex (p = 0.57), DM (p = 0.46), smoking (p = 0.97), TVD (p = 0.76), radiation dose (p = 0.77) or number of dwell positions (p = 0.71). One patient has died resulting in an actuarial overall survival rate of 83.3% at 24 months. ICBT in the era of drug-eluting stents is a feasible and safe treatment option for patients with ISR with low rates of severe peri-procedural complications. This preliminary report suggests a history of prior ICBT may be associated with a higher rate of TLR after ICBT. For patients with in-stent restenosis in the era of drug-eluting stents, ICBT should be considered to minimize the risk of ISR.

5708Incidence and predictors of target lesion revascularization in lesions with moderate to severe calcification which underwent percutaneous coronary intervention guided by optical coherence tomography

5708Incidence and predictors of target lesion revascularization in lesions with moderate to severe calcification which underwent percutaneous coronary intervention guided by optical coherence tomography