Retrograde Coronary Chronic Total Occlusion Intervention (JR-CTO) Score: From the Japanese CTO-PCI Expert Registry.

BACKGROUND: Despite the effectiveness of the retrograde approach for chronic total occlusion (CTO) lesions, there are no standardized tools to predict the success of retrograde percutaneous coronary intervention (PCI). OBJECTIVES: The objective of this study was to develop a prediction tool to identify CTO lesions that will achieve successful retrograde PCI. METHODS: This study evaluated data from 2,374 patients who underwent primary retrograde CTO-PCI and were enrolled in the Japanese CTO-PCI Expert Registry between January 2016 and December 2022 (NCT01889459). All observations were randomly assigned to the derivation and validation cohorts at a 2:1 ratio. The prediction score for guidewire failure in retrograde CTO-PCI was determined by assigning 1 point for each factor and summing all accrued points. RESULTS: The JR-CTO score (moderate-severe calcification, tortuosity, Werner collateral connection grade ≤1, and nonseptal collateral channel) demonstrated a C-statistic for guidewire failure of 0.72 (95% CI: 0.67-0.76) and 0.71 (95% CI: 0.64-0.77) in the derivation and validation cohorts, respectively. Patients with lower scores had higher guidewire and technical success rates and decreased guidewire crossing time and procedural time (P < 0.01). CONCLUSIONS: The JR-CTO (Japanese Retrograde Chronic Total Occlusion) score, a simple 4-item score that predicts successful guidewire crossing in patients undergoing retrograde CTO-PCI, has the potential to support clinical decision-making for the retrograde approach.

The Characteristics of Primary Retrograde Approach Selection for Native Coronary Chronic Occlusion With Short Occlusion Length from the Japanese CTO-PCI Expert Registry.

Although the coronary chronic total occlusion (CTO) crossing algorithm has been published, the characteristics associated with the first strategy selection for short-length lesions <20 mm is still debatable. This study aimed to determine the characteristics associated with primary retrograde approach (PRA) for native CTO with short occlusion length in percutaneous coronary intervention (PCI). Between January 2014 and December 2021, we examined data on 4,088 lesions in the Japanese CTO-PCI Expert Registry with occlusion lengths <20 mm. Then, the characteristics for short-length CTO, which was performed by way of the PRA, were assessed. PRA was performed in 785 patients (19.2%). The guidewire success rate was 93.6%, and the technical success rate was 91.3%. Previous coronary artery bypass grafting, chronic kidney disease, and 6 lesion/anatomic characteristics (i.e., blunt stump, distal runoff <1 mm, CTO lesion tortuosity, reattempt procedures, ostial location, and the presence of collateral channel grade 2) were associated with PRA (p <0.05). Moreover, hemodialysis was an independent factor of unsuccessful anterograde guidewire crossing, along with distal runoff <1 mm, the existence of calcification, and CTO lesion tortuosity (all p <0.05). In clinical settings, these independent factors for PRA in short-length CTO can help in selecting the CTO-PCI strategy.

New Angiographic Difficulty Score for First-Attempt Chronic Total Occlusion in the 3 Major Coronary Arteries.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is still challenging due to complex lesion morphology. Success rates may vary among the 3 major coronary arteries, influenced by clinical and angiographic characteristics. OBJECTIVES: This study sought to evaluate the differences in the predictors of unsuccessful PCI in first-attempt CTO lesions of the 3 major coronary arteries compared with the J-CTO (Japanese CTO) score. METHODS: This study assessed 6,408 first-attempt CTO patients from the Japanese CTO-PCI expert registry between January 2014 and December 2021, randomly assigned to derivation and validation sets. Difficulty scores for each artery were determined by assigning points to predictive unsuccessful factors. RESULTS: The CTO lesions were distributed as follows: left anterior descending coronary artery: 2,245 (35%), left circumflex coronary artery: 1,131 (18%), and right coronary artery (RCA): 3,032 (47%). Regarding success rates, left circumflex coronary artery CTO had the lowest procedural success rate (90%) followed by RCA CTO (92%) and left anterior descending coronary artery CTO (94%). RCA CTO was significantly longer and more severely angulated, requiring more often the retrograde approach. A multivariate logistic analysis revealed that predictors of failed PCI were different in CTO lesions among the 3 major coronary arteries, respectively. Moreover, our difficulty score for RCA CTO was superior to the J-CTO score in predicting unsuccessful PCI. CONCLUSIONS: Clinical and angiographic differences might explain the discrepancies of success rates in CTO lesions among the 3 major coronary arteries. Our novel difficulty score was comparable to the J-CTO score in predicting unsuccessful CTO-PCI with a superior discriminatory capacity.

Impact of minimum contrast media volumes during percutaneous coronary intervention for chronic total occlusion lesion.

Contrast media exposure is associated with contrast-induced nephropathy (CIN) following percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). Aim of this study is to assess the utility of minimum contrast media volume (CMV ≤ 50 mL) during CTO-PCI for CIN prevention in patients with chronic kidney disease (CKD). We extracted data from the Japanese CTO-PCI expert registry; 2863 patients with CKD who underwent CTO-PCI performed from 2014 to 2020 were divided into two groups: minimum CMV (n = 191) and non-minimum CMV groups (n = 2672). CIN was defined as an increased serum creatinine level of ≥ 25% and/or ≥ 0.5 mg/dL compared with baseline levels within 72 h of the procedure. In the minimum CMV group, the CIN incidence was lower than that in the non-minimum CMV group (1.0% vs. 4.1%; p = 0.03). Patient success rate was higher and complication rate was lower in the minimum CMV group than in the non-minimum CMV group (96.8% vs. 90.3%; p = 0.02 and 3.1% vs. 7.1%; p = 0.03). In the minimum CMV group, the primary retrograde approach was more frequent in the case of J-CTO = 1,2 and 3-5 groups compared to that in non-minimum CMV-PCI group (J-CTO = 0; 11% vs. 17.7%, p = 0.06; J-CTO = 1; 22% vs. 35.8%, p = 0.01; J-CTO = 2; 32.4% vs. 46.5%, p = 0.01; and J-CTO = 3-5; 44.7% vs. 80.0%, p = 0.02). Minimum CMV-PCI for CTO in CKD patients could reduce the incidence of CIN. The primary retrograde approach was observed to a greater extent in the minimum CMV group, especially in cases of difficult CTO.

Machine Learning for Prediction of Technical Results of Percutaneous Coronary Intervention for Chronic Total Occlusion.

(1) Background: The probability of technical success in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) represents essential information for specifying the priority of PCI for treatment selection in patients with CTO. However, the predictabilities of existing scores based on conventional regression analysis remain modest, leaving room for improvements in model discrimination. Recently, machine learning (ML) techniques have emerged as highly effective methods for prediction and decision-making in various disciplines. We therefore investigated the predictability of ML models for technical results of CTO-PCI and compared their performances to the results from existing scores, including J-CTO, CL, and CASTLE scores. (2) Methods: This analysis used data from the Japanese CTO-PCI expert registry, which enrolled 8760 consecutive patients undergoing CTO-PCI. The performance of prediction models was assessed using the area under the receiver operating curve (ROC-AUC). (3) Results: Technical success was achieved in 7990 procedures, accounting for an overall success rate of 91.2%. The best ML model, extreme gradient boosting (XGBoost), outperformed the conventional prediction scores with ROC-AUC (XGBoost 0.760 [95% confidence interval {CI}: 0.740-0.780] vs. J-CTO 0.697 [95%CI: 0.675-0.719], CL 0.662 [95%CI: 0.639-0.684], CASTLE 0.659 [95%CI: 0.636-0.681]; p < 0.005 for all). The XGBoost model demonstrated acceptable concordance between the observed and predicted probabilities of CTO-PCI failure. Calcification was the leading predictor. (4) Conclusions: ML techniques provide accurate, specific information regarding the likelihood of success in CTO-PCI, which would help select the best treatment for individual patients with CTO.

Procedural results and in-hospital outcomes of percutaneous coronary intervention for chronic total occlusion in patients with reduced left ventricular ejection fraction: Sub-analysis of the Japanese CTO-PCI Expert Registry.

OBJECTIVES: To evaluate the procedural results and in-hospital outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in patients with reduced left ventricular ejection fraction (LVEF). BACKGROUND: While the technical success of general CTO-PCI has improved, CTO-PCI patients with reduced LVEF remain at high-risk for adverse events. METHODS: The data of 820 patients with LVEF ≤ 35% (Group 1), 1816 patients with LVEF = 35%-50% (Group 2), and 5503 patients with LVEF ≥ 50% (Group 3), registered in the Japanese CTO-PCI Expert Registry from January 2014 to December 2019, were retrospectively analyzed. The primary endpoint was in-hospital major adverse cardiac or cerebrovascular events (MACCEs), including death, myocardial infarction, stent thrombosis, stroke, and emergent revascularization. Secondary endpoints included procedural details, guidewire success, and technical success. RESULTS: There were no differences in guidewire and technical success rates between the groups. In-hospital MACCEs was significantly higher in Group 1 (Group 1 vs. Group 2 vs. Group 3: 3.4% vs. 1.7% vs. 1.5%, p = 0.001) and was especially driven by death (1.3% vs. 0.3% vs. 0.1%, p < 0.001) and stroke (0.7% vs. 0.2% vs. 0.2%, p = 0.007). Multivariate analysis showed that LVEF ≤ 35% (odds ratio [OR]; 1.58, 95% confidence interval [CI]; 1.04-2.41, p = 0.03) and New York Heart Association (NYHA) class ≥ 3 (OR; 2.01, 95% CI; 1.03-3.93, p = 0.04) were predictors of in-hospital MACCEs. CONCLUSIONS: In-hospital MACCEs were significantly higher in patients with LVEF ≤ 35%. LVEF ≤;35% and NYHA class ≥ 3 were predictors of in-hospital MACCEs after CTO-PCI.

Impact of Timing and Treatment Strategy on Coronary Perforation During Percutaneous Coronary Intervention for Chronic Total Occlusion.

Coronary perforations during chronic total occlusion percutaneous coronary intervention (CTO-PCI) are potential complications and reportedly associated with adverse events. This study aimed to describe the clinical characteristics and timing of perforations during CTO-PCI. Data from the Japanese CTO-PCI expert registry included 8,760 patients who underwent CTO-PCI between January 2014 and January 2019. The major adverse cardiac and cerebrovascular events were defined as death, tamponade, myocardial infarction, stent thrombosis, stroke, and revascularization. The guidewire manipulation time was defined as the time required to cross the CTO without perforation. Among these patients, 333 (3.8%) developed perforation during the CTO crossing attempt. Of the 333 patients, 29 developed cardiac tamponades (8.7%). Perforations more frequently occurred in a retrograde wiring than in an anterograde wiring (6.6% vs 1.7%, p <0.0001). A longer guidewire manipulation time was associated with the occurrence of perforation (median 101 minutes [interquartile range 59 to 150 minutes] in the perforation group vs 54.9 minutes [interquartile range 21.1 to 112.7 minutes] in the nonperforation group, p <0.0001). Risk factors for perforation were age, history of coronary bypass graft, right coronary artery lesion, de novo lesion, use of a stiff guidewire, and guidewire manipulation time of >60 minutes during anterograde wiring and age, non-left anterior descending artery lesion, use of a polymer-jacketed guidewire, and use of epicardial channel during retrograde wiring. In conclusion, risk factors for perforation were different between anterograde and retrograde wirings. A prolonged guidewire manipulation time was associated with the occurrence of perforation, especially during anterograde wiring.

Predictors of prolonged guidewire manipulation time for native coronary chronic total occlusion percutaneous coronary intervention via primary antegrade approach.

OBJECTIVES: This study aimed to identify the predictive factors for the guidewire manipulation time (GWMT) of ≥20 and 30 min for chronic total occlusion-percutaneous coronary intervention (CTO-PCI) via the primary antegrade approach (PAA). BACKGROUND: Selection of primary retrograde approach (PRA) and the optimal timing to switch from antegrade to retrograde approach for coronary CTO-PCI is still debatable. METHODS: Using the Japanese CTO-PCI expert registry data, we selected and analyzed 4461 patients who underwent CTO-PCI via PAA alone. The considerable lesion/anatomical factors for GWMT ≥20 and 30 min were analyzed. The risks of prolonged GWMT ≥20 and 30 min were stratified as easy, intermediate, difficult, and very difficult according to the multivariate analysis. RESULTS: Nine lesion/anatomical characteristics (blunt stump, side branch at proximal cap, bifurcation at the exit point, calcification, tortuosity, occlusion length ≥ 20 mm, reattempt, nonleft anterior descending artery (nonleft anterior descending artery [LAD]), and tandem CTO) were independent predictors of GWMT ≥20 min (all p < 0.05). Excluding the nonLAD and tandem CTO, the same factors of GWMT ≥20 min correlated with GWMT ≥30 min (all p < 0.05). The distributions were increased in easy, intermediate, difficult, and very difficult subsets of GWMT ≥20 min (58.3%, 77.2%, 89.1%, and 100%) and GWMT ≥30 min (47.5%, 69.2%, 83.9%, and 100%). CONCLUSIONS: These predictive factors of prolonged GWMT should be assessed before CTO-PCI via PAA and when considering an adequate timing to switch the retrograde or PRA if clinically available.

Ischemic/bleeding event after short dual-antiplatelet therapy in patients with high bleeding risk: Sub-analysis of the MODEL U-SES study.

BACKGROUND: This analysis aimed to evaluate the clinical impact of high bleeding risk (HBR) on adverse events after percutaneous coronary intervention (PCI). METHODS: We retrospectively analyzed 1695 patients in the MODEL U-SES study, which was a multicenter, open-label, prospective observational study evaluating safety of 3-month dual antiplatelet therapy (DAPT) after Ultimaster stent (Terumo Corporation, Tokyo, Japan) implantation at 65 sites in Japan. Patients were divided into 2 groups (HBR/Non-HBR) according to modified Academic Research Consortium-HBR criteria. Ischemic/thrombotic event (cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis) and bleeding event (Bleeding Academic Research Consortium 3 or 5) at 1 year were evaluated. RESULTS: Of 1695 patients, 840 patients were categorized as HBR and 855 patients were Non-HBR. One-year follow-up was completed in 95.3%. During 1-year follow-up, ischemic/thrombotic events were observed in 31 cases (1.8%) and bleeding events occurred in 21 cases (1.2%). Presence of HBR was significantly associated with higher incidence of ischemic/thrombotic events as compared to Non-HBR (adjusted hazard ratio, 0.16; 95% confidence interval, 0.05 to 0.50), whereas the incidence of bleeding events did not reach statistical significance between HBR and Non-HBR. In comparison of monotherapy after DAPT, P2Y12 inhibitor monotherapy after DAPT had comparable ischemic/thrombotic and bleeding events with aspirin monotherapy after DAPT in both HBR and Non-HBR. CONCLUSION: In contemporary PCI practice, nearly half of patients had HBR and presence of HBR significantly increased risk of ischemic/thrombotic events. Both aspirin and P2Y12 inhibitor monotherapy following short DAPT had low and comparable ischemic/bleeding events.

Occlusion patterns, strategies and procedural outcomes of percutaneous coronary intervention for in-stent chronic total occlusion.

BACKGROUND: In-stent chronic total occlusion (CTO) presents various occlusion patterns, which complicate percutaneous coronary intervention (PCI). AIMS: The aim of the study was to investigate the initial outcome and strategy of PCI for in-stent CTO according to the angiographic occlusion patterns. METHODS: This study assessed 791 in-stent CTOs from the Japanese CTO-PCI Expert Registry from 2015 to 2018. They were divided into four patterns: pattern A (n=419), CTO within the stent segment; pattern B (n=196), CTO beyond the distal edge; pattern C (n=85), CTO beyond the proximal edge; and pattern D (n=69) CTO beyond both the proximal and distal edges. RESULTS: There were significant differences in the technical success rates (96.2%, 86.2%, 92.9%, and 75.4% for patterns A-D, respectively; p<0.001), guidewire crossing times (22 [interquartile range: 10-46], 52 [24-102], 40 [20-78], and 86 [45-127] min, respectively; p<0.001), and the rates of antegrade approach alone (90.9%, 61.2%, 67.1%, and 31.9%, respectively; p<0.001). CONCLUSIONS: PCI for CTO within the stent segment was associated with excellent initial outcomes with the antegrade approach. However, PCI for CTO beyond both the proximal and distal edges was associated with the poorest outcomes, even with the bidirectional approach.

Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment.

Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm2 versus 0.68 ± 1.07 mm2, p = 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28-26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454.

One-year clinical outcomes of patients with versus without acute coronary syndrome with 3-month duration of dual antiplatelet therapy after everolimus-eluting stent implantation.

There has been no previous prospective study evaluating 3-month dual antiplatelet therapy (DAPT) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in patients with acute coronary syndrome (ACS). The STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration in all-comer population after CoCr-EES implantation. Among 1525 study patients enrolled from 58 Japanese centers, the present study compared the 1-year clinical outcomes between ACS patients (N = 487) and stable coronary artery disease (CAD) patients (N = 1038). In the ACS group, 228 patients (47%) had unstable angina and 259 patients (53%) had myocardial infarction. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding. Thienopyridine was discontinued within 4-month in 455 patients (94.0%) in the ACS group and 977 patients (94.3%) in the stable CAD group. Cumulative 1-year incidence of and the adjusted risk for the primary endpoint were not significantly different between the ACS and stable CAD groups (2.3% vs. 3.0%, P = 0.42, and HR 0.94, 95%CI 0.44-1.87, P = 0.87). In the 3-month landmark analysis, cumulative incidence of the primary endpoint was also not significantly different between the ACS and stable CAD groups (1.3% vs. 2.4%, P = 0.16). There was no definite/probable ST through 1-year in both groups. In the propensity matched analysis, the cumulative 1-year incidence of the primary endpoint were similar between the ACS and stable CAD groups (2.3% versus 2.1%, P = 0.82). In conclusion, stopping DAPT at 3 months after CoCr-EES implantation in patients with ACS including 47% of unstable angina was as safe as that in patients with stable CAD.

Effect of Aggressive Lipid-Lowering Therapy in Single-Vessel vs. Multivessel Coronary Artery Disease Patients With Acute Coronary Syndrome　- Heart Institute of Japan-Proper Level of Lipid Lowering With Pitavastatin and Ezetimibe in Acute Coronary Syndrome (HIJ-PROPER) Substudy.

Background: The effects of aggressive lipid-lowering therapy according to the number of diseased coronary arteries in acute coronary syndrome (ACS) are still controversial. This study investigated the efficacy of this therapy in ACS patients with multivessel disease (MVD) and single-vessel disease (SVD). Methods and Results: The subjects were derived from the HIJ-PROPER study, in which ACS patients with dyslipidemia were randomized to receive either pitavastatin+ezetimibe (targeting low-density lipoprotein cholesterol [LDL-C] <70 mg/dL) or pitavastatin monotherapy (targeting LDL-C <90 mg/dL). In this study, treatment efficacy was compared between patients with MVD and SVD. The primary endpoint was a composite of major advanced cardiovascular events (MACE; all-cause death, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven revascularization). We identified 1,702 eligible patients (MVD, n=869; SVD, n=833; mean age, 65.6 years; male, 75.6%; acute revascularization, 96.2%). MACE incidence was significantly higher in the MVD group than in the SVD group (43.7% vs. 25.9%, HR, 1.95; 95% CI: 1.65-2.31, P<0.001). In the SVD group, pitavastatin+ezetimibe had significantly fewer MACE than pitavastatin monotherapy (34.6% vs. 47.4%, HR, 0.72; 95% CI: 0.55-0.94, P=0.02). Conclusions: The benefits of aggressive lipid-lowering therapy, with the addition of ezetimibe to statins, were enhanced in ACS patients with SVD, but not with MVD, in the early invasive strategy era.

Successful guidewire crossing via collateral channel at retrograde percutaneous coronary intervention for chronic total occlusion: the J-Channel score.

AIMS: Guidewire (GW) tracking in a collateral channel (CC) is an important step during retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The aim of this study was to create a prediction score model for CC GW crossing success. METHODS AND RESULTS: We analysed data on 886 CCs included in the Japanese CTO PCI Expert Registry during 2016. CCs were categorised as septal (n=610) and non-septal (n=276). CCs were randomly assigned to derivation and validation sets in a 2:1 ratio. The score was developed by multivariate analysis with angiographic findings. Small vessel, reverse bend, and continuous bends were independent predictors in the septal CC subset. Small vessel, reverse bend, and corkscrew were independent predictors in the non-septal CC subset. The extent of intervention was easy, intermediate, and difficult in 92.9%, 57.4%, and 16.7% in the septal CC subset and 91.7%, 54.3%, and 19.0% in the non-septal CC subset, respectively, in the validation set. The area under the receiver operating characteristic curve was >0.7 in the derivation and validation sets of both CC subsets. CONCLUSIONS: The prediction score model can suggest grading of the difficulty of CC GW crossing based on angiographic findings for each type of CC.

Effect of combination of non-slip element balloon and drug-coating balloon for in-stent restenosis lesions (ELEGANT study).

BACKGROUND: In-stent restenosis (ISR) remains a problematic issue of coronary intervention. The non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal nylon elements which are attached proximally and distally to the balloon component. The expectation is that this design of balloon is able to achieve a larger lumen area due to the elements, as well as reducing balloon slippage. We investigated whether NSE pre-dilatation improves angiographic outcomes compared to a high pressure non-compliant balloon pre-dilatation, followed by a drug-coating balloon (DCB) for treatment of ISR lesions with optical coherence tomographic imaging (OCT). METHODS: Patients were eligible for the study if one or more in-stent restenosis lesions were treated with a paclitaxel-coating balloon. Patients were randomized to NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group) in a 1:1 fashion in 17 hospitals. The primary endpoint was in-segment late loss [post minimal lumen diameter (MLD)-follow-up MLD] at 8 months. RESULTS: One hundred and five patients were allocated to each group. Balloon slippage (7.9% versus 22.9%, p=0.002) and geographical miss (6.9% versus 21.9%, p=0.002) were observed less in the NSE group compared to the POBA group. Acute gain was significantly larger in the NSE group (1.17±0.42mm versus 1.06±0.35mm, p=0.04), but post minimum stent lumen area analyzed by OCT was similar between the two groups (3.85±1.67mm2 versus 3.81±1.93mm2, p=0.64). At 8 months, average lesion length was significantly shorter than the POBA group (5.78±3.26mm versus 6.97±4.59mm, p=0.04), but average in-segment late loss was similar between the two groups (0.28±0.45mm versus 0.27±0.38mm, p=0.75). CONCLUSION: Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions. However, NSE pre-dilatation has advantages such as reduction of balloon slippage and geographical miss during the procedure.

Assessment of reattempted percutaneous coronary intervention strategy for chronic total occlusion after prior failed procedures: Analysis of the Japanese CTO-PCI Expert Registry.

OBJECTIVES: We aimed to investigate strategies for reattempted percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs) by highly skilled operators after a failed attempt. BACKGROUND: Development of complex techniques and algorithms has been standardized for CTO-PCI. However, there is no appropriate strategy for CTO-PCI after a failed procedure. METHOD: From 2014 to 2016, the Japanese CTO-PCI Expert Registry included 4,053 consecutive CTO-PCIs (mean age: 66.8 ± 10.9 years; male: 85.6%; Japanese CTO [J-CTO] score: 1.92 ± 1.15). Initial outcomes and strategies for reattempted CTO-PCIs were evaluated and compared with first-attempt CTO-PCIs. RESULTS: Reattempt CTO-PCIs were performed in 820 (20.2%) lesions. The mean J-CTO score of reattempt CTO-PCIs was higher than that of first-attempt CTO-PCIs (2.86 ± 1.03 vs. 1.68 ± 1.05, p < .001). The technical success rate of reattempt CTO-PCIs was lower than that of first-attempt CTO-PCIs (86.7% vs. 90.8%, p < .001). Regarding successful CTO-PCIs, the strategies comprised antegrade alone (reattempt: 36.1%, first attempt: 63.8%), bidirectional approach (reattempt: 54.4%, first attempt: 30.3%), and antegrade approach following a failed bidirectional approach (reattempt: 9.4%, first attempt: 5.4%). Parallel wire technique, intravascular ultrasound guide crossing, and bidirectional approach technique were frequently performed in reattempt CTO-PCIs. Reattempt CTO-PCIs showed higher rates of myocardial infarction (2.1% vs. 0.9%, p < .001) and coronary perforation (6.9% vs. 4.2%, p = .002) than first-attempt CTO-PCIs. CONCLUSIONS: The technical success rate of reattempt CTO-PCIs is lower than that of first-attempt CTO-PCIs. However, using more complex strategies, the success rate of reattempt CTO-PCI can be improved by highly skilled operators.

Vascular response to biolimus A-9 eluting stent in patients with shorter and prolonged dual antiplatelet therapy: optical coherence tomography sub-study of the NIPPON trial.

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.