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.

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.

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.

Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion.

BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

The impact of percutaneous coronary intervention using the novel dynamic coronary roadmap system.

The dynamic coronary roadmap (DCR) is a novel technology that creates a dynamic, motion-compensated, real-time overlay of the coronary arteries on a fluoroscopic image. Whether the DCR reduces contrast volume and enables safe and effective treatment was examined. A total of 146 patients undergoing percutaneous coronary intervention (PCI) from June 2017 to September 2017 in our hospital were retrospectively evaluated. Chronic total occlusion lesions, acute coronary syndrome, and hemodialysis patients were excluded. Patients were divided into the control group (PCI without DCR, 92 patients, 103 lesions) and the DCR group (38 patients, 43 lesions). The primary endpoint was contrast medium volume, and secondary endpoints were radiation dose, fluoroscopy time, and clinical success rate. There was no significant difference in the success rate (100% vs. 100%, P = 1.000) between the groups. Fluoroscopy time (16.3 ± 11.2 min. vs. 11.4 ± 5.5 min, P = 0.007) and contrast medium volume (152.1 ± 73.0 ml vs. 118.8 ± 49.7 ml, P = 0.006) were significantly lower in the DCR group than in the control group. DCR use during PCI was associated with a significant reduction in contrast volume and fluoroscopy time compared to a control group despite similar clinical, lesion, and procedural characteristics.

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.

Association between J-CTO score and long-term target lesion revascularization rate after successful chronic total coronary occlusion angioplasty (from the J-CTO Registry).

OBJECTIVES: The aim of this study was to evaluate the impact of the J-CTO score on long-term target lesion revascularization (TLR) after successful native chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). BACKGROUND: We previously reported that the J-CTO score could be used to stratify the lesion complexity and procedural success rate in CTO lesions. METHODS: We evaluated the prognostic significance of a high J-CTO score for long-term TLR rate in the J-CTO Registry. RESULTS: In the 425 lesions of 408 patients who underwent successful CTO-PCI during a median follow-up of 63.0 (interquartile range: 21.2-72.9) months in the J-CTO Registry, the cumulative incidence of TLR of lesions with a J-CTO score ≥ 2 (n = 216) was significantly higher than in those with a J-CTO score ≤ 1 (n = 209) (27.0 versus 19.4% at 5 years, respectively, P = 0.04). Among 323 lesions of 309 patients with a complete 5-year follow-up, the rate of TLR was 28% (n = 91). A J-CTO score ≥ 2 was independently associated with a higher risk of TLR (odds ratio, 1.73; 95% confidence interval, 1.01-2.99, P = 0.048) even after adjustment for clinically relevant baseline factors. CONCLUSIONS: Patients with high J-CTO score lesions had a higher 5-year risk of TLR.

Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　- Pooled Analysis From the RESET and NEXT Trials.

BACKGROUND: The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results:We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55). CONCLUSIONS: The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.

Sex Differences in Long-Term Clinical Outcomes in Patients With Atrial Fibrillation Undergoing Coronary Stent Implantation.

BACKGROUND: Patients with concomitant atrial fibrillation (AF) and coronary stenting are at high risk for both cardiovascular and bleeding events. We aimed to evaluate the influence of sex on long-term clinical outcomes in this patient subset.Methods and Results:We identified 1,450 patients with AF and coronary stenting in a patient-level pooled database from 3 Japanese studies, and compared 3-year clinical outcomes between men and women (n=1,075, and n=375, respectively). The cumulative 3-year incidence of all-cause death was significantly higher in women than in men (26.5% vs. 17.2%, log-rank P<0.001), although after adjusting for confounders, the excess mortality risk of women relative to men was no longer significant (hazard ratio (HR): 1.12, 95% confidence interval (CI): 0.85-1.46, P=0.42). There were no significant differences in the adjusted 3-year risks for myocardial infarction or stroke between men and women (HR: 1.25, 95% CI: 0.62-2.40, P=0.52, and HR: 1.15, 95% CI: 0.75-1.74, P=0.52, respectively). However, both the cumulative 3-year incidence of and adjusted risk for major bleeding were significantly higher in women than in men (17.0% vs. 11.3%, log-rank P=0.002, and HR: 1.47, 95% CI: 1.03-2.07, P=0.03). CONCLUSIONS: Among patients with concomitant AF and coronary stenting, there were no significant differences in the adjusted 3-year risks for all-cause death, myocardial infarction, and stroke between men and women. However, women as compared with men were associated with excess adjusted risk for major bleeding.

Independent predictors of retrograde failure in CTO-PCI after successful collateral channel crossing.

OBJECTIVES: To evaluate factors for predicting retrograde CTO-PCI failure after successful collateral channel crossing. BACKGROUND: Successful guidewire/catheter collateral channel crossing is important for the retrograde approach in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). METHODS: A total of 5984 CTO-PCI procedures performed in 45 centers in Japan from 2009 to 2012 were studied. The retrograde approach was used in 1656 CTO-PCIs (27.7%). We investigated these retrograde procedures to evaluate factors for predicting retrograde CTO-PCI failure even after successful collateral channel crossing. RESULTS: Successful guidewire/catheter collateral crossing was achieved in 77.1% (n = 1,276) of 1656 retrograde CTO-PCI procedures. Retrograde procedural success after successful collateral crossing was achieved in 89.4% (n = 1,141). Univariate analysis showed that the predictors for retrograde CTO-PCI failure were in-stent occlusion (OR = 1.9829, 95%CI = 1.1783 - 3.3370 P = 0.0088), calcified lesions (OR = 1.9233, 95%CI = 1.2463 - 2.9679, P = 0.0027), and lesion tortuosity (OR = 1.5244, 95%CI = 1.0618 - 2.1883, P = 0.0216). On multivariate analysis, lesion calcification was an independent predictor of retrograde CTO-PCI failure after successful collateral channel crossing (OR = 1.3472, 95%CI = 1.0614 - 1.7169, P = 0.0141). CONCLUSIONS: The success rate of retrograde CTO-PCI following successful guidewire/catheter collateral channel crossing was high in this registry. Lesion calcification was an independent predictor of retrograde CTO-PCI failure after successful collateral channel crossing. Devices and techniques to overcome complex CTO lesion morphology, such as lesion calcification, are required to further improve the retrograde CTO-PCI success rate. © 2016 Wiley Periodicals, Inc.

Randomized comparison between provisional and routine kissing-balloon technique after main vessel crossover stenting for coronary bifurcation lesions.

We compared the myocardial ischemic burden of provisional and routine final kissing-balloon inflation (FKI) with the 1-stent strategy using a second-generation drug-eluting stent for coronary bifurcation lesions (CBL). There are no established guidelines for side branch (SB) intervention after main vessel stenting. In total, 113 CBL patients were randomized to receive different SB intervention strategies: provisional-FKI group (n = 57; FKI only when SB flow was TIMI <3) and routine-FKI group (n = 56; mandatory FKI with aggressive treatment until SB-residual stenosis <50%). Dipyridamole-stress myocardial perfusion scintigraphy with 99mTc was performed after 8 months. The regional summed-difference score (r-SDS) was calculated according to the coronary territory. The primary endpoint included target vessel ischemia (TVI; r-SDS ≥ 2) at 8 months, whereas the clinical primary endpoint was major adverse cardiovascular events (MACE) at 3 years. The percent (%) myocardial ischemia (100 × SDS/68) was also calculated. At 8 months, TVI was identified in 11 and 4% in the provisional-FKI and routine-FKI groups, respectively (p = 0.226). SB-binary restenosis (48 vs. 4%, p < 0.001) and myocardial ischemia at the SB territory (11 vs. 0%, p = 0.030) were more common in the provisional-FKI group; however, in TVI patients, % myocardial ischemia (4.12 ± 1.23% vs. 3.68 ± 1.04%; p = 0.677) did not significantly differ. Moderate/severe ischemia (>10% myocardial ischemia) was not observed in the target vessel in either group. Long-term cumulative MACE were similar between the groups (9 vs. 14%; p = 0.358). Provisional-FKI according to TIMI-SB flow grade led to similar and acceptable myocardial ischemia, in comparison with routine-FKI, which may contribute to the identical long-term follow-up.

Complications during retrograde approach for chronic coronary total occlusion: Sub-analysis of Japanese multicenter registry.

OBJECTIVES: This study was performed to determine the complications occurring during retrograde percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on analysis of the multicenter, prospective, nonrandomized Retrograde Summit registry. BACKGROUND: Retrograde PCI for CTO has improved treatment success rates, but several complications related to the retrograde approach have been reported, including collateral channel injury and donor artery injury due to their use as retrograde roots. METHODS: This registry included data from 1,166 patients who underwent retrograde PCI for CTO in 28 Japanese centers between January 2009 and December 2011. RESULTS: Overall procedure success and retrograde procedure success were achieved in 985 (84.5%) and 838 (71.9%) of the 1,166 patients, respectively. In-hospital major adverse cardiac and cerebrovascular events (MACCE) occurred in 18 (1.5%) of the 1,166 patients. With regard to complications related to the retrograde approach, channel injury occurred in 111 (9.5%) of the 1,166 patients, but treatment was required in only 24 (2.1%) patients and subsequent cardiac tamponade occurred in only 4 (0.3%) patients. Donor artery problems occurred in only 10 (0.9%) of the 1,166 patients. In sub-analysis regarding the types of collateral channels, the septal channel was significantly safer than epicardial channel because of the lower frequency of non-Q-wave myocardial infarction (non-QMI) and channel injury requiring treatment. CONCLUSIONS: The MACCE rate during retrograde PCI for CTO determined from the Retrograde Summit registry was low and the frequency of complications related to the retrograde approach was acceptable. © 2015 Wiley Periodicals, Inc.

Comparison of percutaneous coronary intervention for chronic total occlusion outcome according to operator experience from the Japanese retrograde summit registry.

OBJECTIVES: This study was performed to evaluate the acute outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on operator experience. BACKGROUND: Despite developments in both technology and techniques, PCI procedures for CTO's remain challenging. METHODS: A total of 3,229 eligible subjects who underwent CTO-PCI were enrolled from 56 centers by a retrograde summit using a web registry system. To compare the acute outcomes of the CTO data, 18 centers were classified as higher volume centers (HC) and 38 centers as lower volume centers (LC) depending on the CTO-PCI experience of the operator. RESULTS: The mean procedural success rate of all centers was 88.4%. The overall procedural success rate was significantly higher in HC than LC (90.6% vs. 85.6%, respectively; P < 0.0001). In addition, overall antegrade success rate was also higher in HC than LC (91.0% vs. 83.9%, respectively; P < 0.0001). Although the overall retrograde approach success rate was significantly higher in HC than LC (85.0% vs. 77.6%, respectively; P < 0.0001), there was no significant difference in that of the retrograde alone (89.0% vs. 93.7%, respectively; P = 0.051). Major in-hospital adverse events were observed in 0.53% of cases, and the rates were similar between the two groups (0.45% vs. 0.62%, respectively; P = 0.25). CONCLUSIONS: Although CTO-PCI was safe in both groups, the procedural success rate was significantly higher in HC than LC, even in this new era of CTO-PCI. This difference was attributed to the difference in the antegrade procedural success rate. © 2015 Wiley Periodicals, Inc.

Impact of ultra-long second-generation drug-eluting stent implantation.

OBJECTIVES: This study investigated the safety and prognosis of ultra-long second DES (UL-2nd DES) implantation in real-world practice. BACKGROUND: Long stenting is a widely known predictor of stent thrombosis (ST) or target lesion revascularization (TLR) in first-generation drug-eluting stents (DES). METHODS: Participants were 1,669 patients (2,763 lesions) who had undergone successful second DES implantation; they were assigned to one of three groups: ultra-long 2nd DES (UL-DES; >50 mm, 166 patients, 259 lesions), long second DES (L-DES; 20-50 mm, 758 patients, 1,212 lesions), or short second DES (S-DES; <20 mm, 745 patients, 1,292 lesions). The primary endpoint was TLR, and secondary endpoints were ST, cardiac death, and major adverse cardiac events (MACE; composite of TLR, ST and cardiac death). A Cox proportional hazards model was used to identify independent predictors of TLR. RESULTS: Patient characteristics including dual antiplatelet therapy duration were similar across groups. Follow-up data were obtained from hospital charts, by contacting patients. Target lesion characteristics in the UL-DES group showed higher right coronary artery and chronic total occlusion lesion rates. TLR rates (23.1 ± 13.2 months) were significantly higher in the UL-DES group relative to other groups during follow up (P < 0.001). TLR rate was similar between S-DES and L-DES (P = 0.30). The incidence of ST was similar across groups (P = 0.40). MACE was significantly higher in the UL-DES group relative to other groups due to higher TLR rates (P = 0.01). In a Cox proportional hazard model, hemodialysis (RR: 2.53, 95% CI: 1.69-3.67, P < 0.001) and total stent length of >50 mm (RR: 1.67, 95% CI: 1.07-2.55, P = 0.02) were independent predictors of TLR. CONCLUSIONS: Ultra-long DES implantation was associated with higher TLR rates but did not increase ST, while long DES implantation up to 50 mm was safe and acceptable.

Mechanism of Residual Lumen Stenosis at the Side Branch Ostium After Final Kissing Balloon Inflation: A Volumetric Intracoronary Ultrasound Study of Coronary Bifurcation Lesions.

OBJECTIVES: To investigate the mechanisms of residual stenosis (RS) at side branch ostium (SBO) after final kissing balloon inflation (FKI) and clarify the impact of carina- and plaque-shifts on RS. BACKGROUND: Carina- and plaque-shift induce SBO compromise. FKI is an effective technique to treat this complication; however, RS often persist, and are associated with restenosis at SBO. METHODS: We performed serial volumetric analysis of 91 bifurcations in which crossover-stenting with FKI and pre-/post-intravascular ultrasounds (IVUS) were completed in both branches. The plaque- and carina-shifts were defined as an increase in the plaque-volume and a decrease in the vessel-volume at the SBO, respectively. RS at the SBO, defined as area stenosis >50% on IVUS, was identified in 19 lesions. RESULTS: After FKI, the plaque volume- significantly increased at the SBO, with its reduction in the proximal main vessel (MV). However, at the SBO, the volumetric lumen change correlated with vessel change (ρ = 0.690, P < 0.001), but not plaque change (P = 0.390), suggesting that RS at SBO was more likely associated with inadequate vessel stretch, not plaque increase after FKI. Carina-shift was more frequently found in cases with RS, compared to those without RS (37% vs. 11%, P = 0.013). Pre-procedure IVUS findings to predict RS at SBO after FKI were negative-remodeling at distal MV, plaque -burden at distal MV, and plaque-burden at the SBO. CONCLUSIONS: Carina-shift has a greater contribution to the formation of RS at SBO after FKI. The pre-procedure IVUS provides helpful information for predicting the RS after FKI.

Impact of catheter size on reliability of quantitative coronary angiographic measurements (comparison of 4Fr and 6Fr catheters).

To evaluate the feasibility of catheter down sizing for QCA, the reliability of a 4Fr catheter as a calibration device was evaluated. Repeated coronary angiograms of 9 lesions were obtained using 4Fr and 6Fr catheters under otherwise identical conditions. The calibration factor was measured 10 times by 4Fr and 6Fr catheters. QCA measurements including minimal lumen diameter (MLD), interpolated normal reference (Int N), percent diameter stenosis (%DS), and lesion length (LL) were performed by two technicians twice with a 3-month interval. The intraobserver and interobserver variability of each parameter was evaluated using intraclass correlation coefficients (ICCs). Mean of mean SD of calibration factor was significantly larger in 4Fr than in 6Fr in 9 lesions. The mean of mean coefficient of variance was significantly larger in 4Fr catheters vs in 6Fr catheters. A 6Fr catheter showed excellent reliability for both intraobserver and interobserver variability in MLD, Int N, %DS, and LL. In contrast, 4Fr showed that reliability in intraobserver variability depended on the analyst. Although reliability of interobserver variability in Int N measured by the 4Fr catheter was >0.80, the value was less than that by the 6Fr catheter. Taking these results into consideration, 4Fr catheters are less reliable than 6Fr catheters when measuring QCA data especially for follow-up data that need most accurate measurements of MLD and %DS. It would be better to use a 6Fr catheter to evaluate QCA measurements such as acute gain, late loss, restenosis rate, and device size.

Influence of hemodialysis duration on mid-term clinical outcomes in hemodialysis patients with coronary artery disease after drug-eluting stent implantation.

Accelerated atherosclerosis in prolonged maintenance hemodialysis (HD) has been recognized; however, whether HD duration is associated with poor clinical outcome in HD patients with coronary artery disease (CAD) after drug-eluting stent (DES) implantation is unknown. We evaluated the impact of HD duration on clinical outcomes in HD patients with CAD after DES implantation. Between April 2007 and December 2012, 168 angina pectoris patients (320 de novo lesions) on HD were treated with DES. Major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) were investigated at 3 years according to the HD duration (≤ 3 years, 83 patients; >3 years, 85 patients). The incidence of MACE was significantly higher in the long HD duration group (25.3 vs. 50.6 %; P = 0.001). Especially, sudden cardiac death (SCD) was significantly higher in the long HD duration group (3.6 vs. 16.5 %; P = 0.006). On the other hand, the rates of TLR were similar between the two groups (12.0 vs. 14.1 %; P = 0.69). Cox's proportional hazard analysis revealed that HD duration (HR 1.08 per year, 95 % CI 1.03-1.13, P = 0.002), ß-blocker use (0.28, 0.17-0.46, P < 0.001), and diabetes mellitus (2.10, 1.23-3.56, P = 0.007) were independent predictors of MACE. Longer HD duration did not affect TLR; however, SCD was significantly higher in the long HD duration group.

Comparison of first- and second-generation drug-eluting stent efficacies for treating left main and/or three-vessel disease: a propensity matched study.

The efficacy of second-generation drug-eluting stent (DES) for the treatment of left main disease (LM) and/or three vessel disease (3VD) remains unclear. We compared 2-year outcomes of second- versus first -generation DES implantation among patients with LM and/or 3VD and to assess the differential of risk by complexity of coronary artery disease using synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) scores. Between April 2007 and December 2012, 341 patients with LM and/or 3VD were treated by percutaneous coronary intervention; 154 with first-generation DES and 137 with second-generation DES. After propensity matching, 101 patients remained in each group. The rate of target lesion revascularization (TLR) and major adverse cardiac event (MACE) were compared. TLR and MACE at 2 years were more common in the first- compared with second-generation DES group (TLR 19.8 vs. 8.9 %; p = 0.016, MACE 24.8 vs. 10.9 %; p = 0.008). In patients with low (0-22) and intermediate (23-32) SYNTAX scores, TLR and MACE tended to occur more often with first-generation DES group. In patients with high SYNTAX scores (≧33), TLR and MACE were significantly more common with first-generation DES group (TLR 29.0 vs. 11.1 %; p = 0.035, MACE 35.5 vs. 13.9 %; p = 0.034). Compared with first-generation DES, second-generation DES proved beneficial in reducing risk of TLR and MACE in patients with LM and/or 3VD, particularly among those with high SYNTAX scores (≧33).

Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT.

Even in the drug-eluting stent era, diabetes mellitus (DM) patients have high incidences of restenosis and repeat revascularization after percutaneous coronary intervention. The aim of this study was to compare vascular response after stent implantation between sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) by using optical coherence tomography (OCT) in DM patients as well as in non-DM patients. In the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT), the OCT sub-study enrolled 75 patients who underwent 8 months follow-up imaging after SES or PES implantation. Mean neointimal hyperplasia (NIH) thickness was significantly thinner in SES than PES in the DM group (77 ± 47 vs. 201 ± 114 µm, p < 0.001) and in the non-DM group (84 ± 37 vs. 212 ± 128 µm, p < 0.001). Unevenness of NIH thickness in longitudinal axis was significantly smaller in SES than PES in the DM group (348 ± 191 vs. 726 ± 385 µm, p < 0.001) and in the non-DM group (344 ± 174 vs. 679 ± 314 µm, p < 0.001). The percentage of uncovered struts was significantly greater in SES than PES in the DM group (24 ± 4 vs. 9 ± 14 %, p < 0.001) and in the non-DM group (16 ± 16 vs. 3 ± 4 %, p = 0.002). Compared with PES, SES showed more potent NIH inhibition in DM patients as well as in non-DM patients.