j-Cypher Registry Research Articles

Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies.

It is unknown whether there is a threshold of creatine kinase (CK) or CK-MB affecting the subsequent mortality for post-discharge myocardial infarction (PDMI) after percutaneous coronary intervention. Current study sought to evaluate the impact of PDMI. The study population included 30,051 patients with successful coronary stenting and discharged alive in the pooled patient-level database of 4 Japanese studies (j-Cypher registry, CREDO-Kyoto PCI/CABG registry cohort-2, RESET, and NEXT). During 4.4 ± 1.4year follow-up, 915 patients experienced PDMI (cumulative 5-year incidence of 3.6%). Among 466 patients with available peak CK ratio (peak CK/upper limit of normal), peak CK ratio (< 3) was present in 21% of patients, while peak CK ratios (≥ 3 and < 5), (≥ 5 and < 10), (≥ 10 and < 30), and (≥ 30) were present in 17, 25, 30, and 7.3% of patients, respectively. The excess mortality risk of patients with relative to those without PDMI for subsequent mortality was significant (adjusted HR 5.12, 95% CI 4.52-5.80, P < 0.001) by the Cox model with PDMI incorporated as the time-updated covariate. However, the mortality risk of patients in the smallest peak CK ratio category (< 3) was insignificant (HR 0.85, 95% CI 0.43-1.71, P = 0.65). In conclusion, despite significant overall mortality risk of PDMI, the mortality risk of small PDMI was similar to that of no PDMI, suggesting the presence of some threshold about infarct size influencing mortality.Trial registrations The Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET); NCT01035450 and NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT); NCT01303640. J-Cypher and CREDO-Kyoto PCI/CABG registry cohort 2 were not registered into clinical trial database.

Differences in coronary risk factors, procedural characteristics, mortality and stent thrombosis between two all-comers percutaneous coronary intervention registries from Europe and Japan: a patient-level data analysis of the Bern-Rotterdam and j-Cypher registries.

The reported rate of stent thrombosis (ST) after drug-eluting stent (DES) implantation varies among registries. To investigate differences in baseline characteristics and clinical outcome in European and Japanese all-comers registries, we performed a pooled analysis of patient-level data. The j-Cypher registry (JC) is a multicentre observational study conducted in Japan, including 12,824 patients undergoing SES implantation. From the Bern-Rotterdam registry (BR) enrolled at two academic hospitals in Switzerland and the Netherlands, 3,823 patients with SES were included in the current analysis. Patients in BR were younger, more frequently smokers and presented more frequently with ST-elevation myocardial infarction (MI). Conversely, JC patients more frequently had diabetes and hypertension. At five years, the definite ST rate was significantly lower in JC than BR (JC 1.6% vs. BR 3.3%, p<0.001), while the unadjusted mortality tended to be lower in BR than in JC (BR 13.2% vs. JC 14.4%, log-rank p=0.052). After adjustment, the j-Cypher registry was associated with a significantly lower risk of all-cause mortality (HR 0.56, 95% CI: 0.49-0.64) as well as definite stent thrombosis (HR 0.46, 95% CI: 0.35-0.61). The baseline characteristics of the two large registries were different. After statistical adjustment, JC was associated with lower mortality and ST.

Antiplatelet therapy discontinuation and stent thrombosis after sirolimus-eluting stent implantation: Five-year outcome of the j-Cypher Registry

BackgroundThe influence of antiplatelet therapy discontinuation on the incidence of stent thrombosis, especially very late stent thrombosis, after drug-eluting stent implantation has not been yet fully addressed. MethodsRelationship between antiplatelet therapy discontinuation and stent thrombosis up to 5years was evaluated in 12,812 consecutive patients undergoing sirolimus-eluting stents (SES) implantation in the j-Cypher registry. Data on status of antiplatelet therapy during follow-up were collected prospectively. ResultsMedian follow-up interval was 1699days (interquartile range, 1184–1928days). Incidences of definite stent thrombosis were 0.34% at 30days, 0.55% at 1year, and 1.6% at 5years. Dual antiplatelet therapy was maintained in 97.4%, 63%, and 43.9% of patients at 30days, 1year, and 5years, respectively. The rates of stent thrombosis in patients who discontinued both thienopyridine and aspirin were significantly higher in the time intervals of 31–365days, 2–3years and 3–4years, and tended to be higher in the time intervals of 1–2years and 4–5years than those in patients who continued both (31–365days: 1.26% versus 0.2%, P<0.001; 1–2years: 0.59% versus 0.15%, P=0.06; 2–3years: 1.35% versus 0.2%, P=0.004; 3–4years: 1.09% versus 0.25%, P=0.0496; 4–5years: 1.35% versus 0.43%, P=0.17). Patients who discontinued either thienopyridine or aspirin only did not have an excess of stent thrombosis in any time intervals. ConclusionsIn conclusion, discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine or aspirin only, was associated with an increased incidence of late and very late stent thrombosis up to 5years after SES implantation.

Impact of angiographic peri-stent contrast staining (PSS) on late adverse events after sirolimus-eluting stent implantation: an observation from the multicenter j-Cypher registry PSS substudy

This study sought to assess clinical significance of angiographic peri-stent contrast staining (PSS) after sirolimus-eluting stent (SES) implantation in a large multicenter study with 5-year follow-up. The j-Cypher PSS substudy is a multicenter study including 5712 patients (7838 lesions) who underwent follow-up angiographic study within 12months after SES implantation. Late acquired PSS was observed in 184 patients (3.2%) or 194 lesions (2.5%). Independent risk factors of PSS were chronic total occlusion and left anterior descending artery lesion, while negative risk factors were in-stent restenosis, diabetes mellitus, ≥70years of age, and left circumflex coronary artery lesion. Cumulative incidence of definite very late stent thrombosis (VLST) at 4years after the index follow-up angiography in lesions with PSS was significantly higher than that in lesions without PSS (5.3 versus 0.7%, P<0.0001). Late target-lesion revascularization (TLR) was also more frequently observed in the PSS group (13 versus 6.9%, P=0.01), while late TLR for restenosis excluding those TLR procedures for VLST tended to be higher in the PSS group (9.9 versus 6.3%; P=0.15). PSS found in 2.5% of lesions within 12months after SES implantation was associated with higher risk for subsequent VLST.

Sirolimus-eluting stent implantation for ostial right coronary artery lesions: five-year outcomes from the j-Cypher registry

Ostial right coronary artery (RCA) lesions are associated with a high restenosis rate after bare-metal stent implantation. However, long-term outcomes after drug-eluting stent (DES) implantation for ostial RCA lesions have not been adequately evaluated. Among 12824 patients enrolled in the j-Cypher registry, 5-year outcomes were compared between 397 patients with ostial RCA lesions, and 3716 patients with non-ostial RCA lesions treated with sirolimus-eluting stents (SES). Through 5-year follow-up, patients with ostial RCA lesions had a significantly higher cumulative incidence of target lesion revascularization (TLR) (28.2 versus 13.7%, P<0.0001) than those with non-ostial RCA lesions. After adjusting for confounders, excess TLR risk of the ostial group relative to the non-ostial group was significant for both early TLR within 1-year and late TLR beyond 1-year (HR 2.14 [95% CI 1.59-2.84], P<0.0001, and HR 1.58 [95% CI 1.06-2.26], P=0.02, respectively). Although the cumulative incidence of death was also significantly higher in the ostial group than in the non-ostial group (25.7 versus 14.4%, P<0.0001), the excess risk of the ostial group relative to the non-ostial group was no longer significant after adjusting for confounders (HR 1.25 [95% CI 0.99-1.57], P=0.07). SES implantation for ostial RCA lesions was associated with higher risk for TLR as compared with that for non-ostial RCA lesions. Restenosis, both early and late, remains an issue in coronary DES implantation for ostial RCA lesions.

TCT-353 Long-term Clinical Outcomes in Patients with Renal Insufficiency After Sirolimus-eluting Stent Implantation: Five-year Follow-up Results of the J-Cypher Registry

TCT-353 Long-term Clinical Outcomes in Patients with Renal Insufficiency After Sirolimus-eluting Stent Implantation: Five-year Follow-up Results of the J-Cypher Registry

Sirolimus-eluting stent implantation for ostial right coronary artery lesions: five-year outcomes from the j-Cypher registry

Sirolimus-eluting stent implantation for ostial right coronary artery lesions: five-year outcomes from the j-Cypher registry

Percutaneous Coronary Intervention in Patients With Previous Coronary Artery Bypass Grafting (from the j-Cypher Registry)

A paucity of data is available from large-scale studies evaluating the long-term outcomes of percutaneous coronary intervention in patients who had previously undergone coronary artery bypass grafting (CABG) in the drug-eluting stent era. Of 12,812 patients who had undergone sirolimus-eluting stent implantation in the j-Cypher registry, 919 (7.2%) had a history of CABG and had significantly higher crude 5-year mortality (19.9% vs 14.0%, p<0.001). After adjusting for confounders, the excess risk of death was no longer significant (hazard ratio 0.99, 95% confidence interval 0.83 to 1.18, p= 0.90), and the adjusted risk of target lesion revascularization was significantly higher in patients with previous CABG than in those without (hazard ratio 1.25, 95% confidence interval 1.06 to 1.47, p= 0.01). Of the patients with previous CABG, those who had undergone ≥1 saphenous vein graft intervention had significantly higher adjusted risks of cardiac death (hazard ratio 2.21, 95% confidence interval 1.26 to 3.76, p= 0.01), myocardial infarction (hazard ratio 2.56, 95% confidence interval 1.10 to 5.60, p= 0.03), target lesion revascularization (hazard ratio 2.65, 95% confidence interval 1.82 to 3.81, p <0.001), and definite stent thrombosis (hazard ratio 7.70, 95% confidence interval 1.99 to 29.1, p= 0.004) compared with those who underwent percutaneous coronary intervention only for the native coronary artery. In conclusion, the adjusted mortality was similar between patients with and without previous CABG, despite a significantly different risk of target lesion revascularization. Among the patients with previous CABG, those with saphenous vein graft intervention using a first-generation drug-eluting stent had worse clinical outcomes than those with a native coronary artery target only.

Comparison of 5-Year Outcomes in Patients With and Without Unprotected Left Main Coronary Artery Disease After Treatment With Sirolimus-Eluting Stents: Insights From the j-Cypher Registry

This study assessed 5-year outcomes after implantation of sirolimus-eluting stents (SES) for unprotected left main coronary artery (ULMCA) disease in comparison with that for non-left main disease. More information on long-term outcomes after ULMCA stenting is needed. The j-Cypher is a multicenter prospective registry of consecutive patients undergoing SES implantation in Japan. Among 12,812 patients enrolled in the j-Cypher registry, the unadjusted mortality rate at 5 years was significantly higher in patients with ULMCA stenting than in patients without ULMCA stenting (22.8% vs. 14.1%; p < 0.0001); however, the risk for death with ULMCA stenting was no longer significant after adjusting for confounders (hazard ratio: 1.18, 95% confidence interval: 0.95 to 1.46; p = 0.14). In the lesion-level comparison, the nonbifurcation ULMCA lesions treated exclusively with SES had a significantly lower rate of target lesion revascularization (TLR) than those in non-ULMCA nonbifurcation lesions (2.4% vs. 12.7%; p = 0.04). Among bifurcation lesions, those treated with a provisional 2-stent approach had similar rates of TLR (12.1% vs. 11.4%; p = 0.79) between the ULMCA and non-ULMCA groups. Lesions treated with an elective 2-stent approach had higher TLR rates in the ULMCA group as compared with the non-ULMCA group (33.5% vs. 19.7%; p = 0.002). The safety of ULMCA stenting relative to non-LMCA stenting was maintained through 5 years follow-up. In terms of efficacy, SES implantation in nonbifurcation ULMCA lesions was associated with an extremely low cumulative incidence of TLR, whereas the elective 2-stent approach for ULMCA bifurcation lesions was associated with a markedly higher cumulative incidence of TLR as compared with that for non-ULMCA bifurcation lesions.

Comparison of Outcomes Using the Sirolimus-Eluting Stent in Calcified Versus Non-Calcified Native Coronary Lesions in Patients On- Versus Not On-Chronic Hemodialysis (from the j-Cypher Registry)

The impact of lesion calcium on long-term outcomes after drug-eluting stent implantation has not been adequately addressed. In 10,595 patients (16,803 lesions) who were exclusively treated with sirolimus-eluting stents in the j-Cypher registry, 5-year outcomes were compared between patients with ≥1 lesion with moderate or severe calcification (the calcium group) and those with noncalcified lesions only (the noncalcium group). Analyses were stratified by hemodialysis (HD) status (non-HD stratum [calcium n = 3,191, noncalcium n = 6,824] and HD stratum [calcium n = 415, noncalcium n = 165]). Adjusted risk in the calcium group for death and target lesion revascularization was significant in the non-HD stratum (hazard ratio [HR] 1.34, 95% confidence interval [CI] 1.18 to 1.52, p <0.0001, and HR 1.2, 95% CI 1.07 to 1.36, p = 0.003) and the HD stratum (HR 1.4, 95% CI 1.06 to 1.86, p = 0.02, and HR 2.25, 95% CI 1.51 to 3.36, p <0.0001). Risk for definite stent thrombosis tended to be higher in the calcium group in the HD stratum (HR 5.05, 95% CI 0.66 to 38.9, p = 0.12) but not in then non-HD stratum (HR 1.16, 95% CI 0.81 to 1.67, p = 0.41). The use of rotational atherectomy in patients with severe calcification did not have a significant impact on the cumulative incidence of target lesion revascularization in the non-HD stratum (17.7% [n = 268] with vs 18.2% [n = 588] without rotational atherectomy, p = 0.68) and the HD stratum (54.7% [n = 115] with vs 51.9% [n = 118] without rotational atherectomy, p = 0.19). In conclusion, regardless of HD status, patients with calcified lesions have increased long-term risk for death and target lesion revascularization after sirolimus-eluting stent implantation.

Abstract 9000: Long-term Outcomes After Sirolimus-Eluting Stent Implantation for Calcified Coronary Lesions: Insights From the j-Cypher Registry

Background: The long-term clinical outcomes of drug-eluting stents for calcified coronary lesions in patients with and without dialysis have not yet been adequately addressed. Methods: Among 10,717 patients (16,947 lesions) who were exclusively treated with sirolimus-eluting stents (SES) in the j-Cypher registry, 5-year clinical outcome was compared between patients with at least 1 lesion with moderate to severe calcification (Calc group), and patients with non-calcified (no to mild calcification) lesions only (Non-calc group). Analyses were made separately according to dialysis status (non-dialysis stratum [Calc group: 3208 patients, and Non-calc group: 6919 patients], and dialysis stratum [Calc group: 419 patients, and Non-calc group: 171 patients]. Results: Cumulative incidence of adjusted risk for 5-year mortality was significantly higher in the Calc group than in the Non-calc group in both non-dialysis stratum (13.5% versus 8.3%: P&lt;0.0001, and hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.07-1.41, P=0.004) and dialysis stratum (49.4% versus 38.6%: P=0.016, and HR 1.53, CI 1.12-2.09, P=0.008). Regardless of dialysis status, the Calc group as compared with the Non-calc group had a significantly higher cumulative incidence of target lesion revascularization (TLR) (non-dialysis, 14.0% versus 11.2%, P&lt;0.0001; dialysis, 33.4% versus 18.7%, P&lt;0.0001) and major adverse cardiac events (MACE) (non-dialysis, 30.4% versus 22.9%, P&lt;0.0001; dialysis, 69.2% versus 53.8%, P&lt;0.0001). In non-dialysis stratum, the cumulative incidence of late TLR beyond 1 year was similar between the Calc and Non-calc groups (7.2% versus 7.0%, P=0.84). However, dialysis patients with calcified lesions had a significantly higher late TLR rate (17.2% versus 8.1%, P=0.014). Stent thrombosis was unrelated to both dialysis and calcification (non-dialysis, 1.5% versus 1.2%, P=0.23; dialysis, 2.6% versus 0.6%, P=0.076). Conclusion: Regardless of dialysis status, patients with calcified coronary artery lesions have an increased long-term risk for adverse events, such as mortality, TLR, and MACE, after SES implantation. Lesion calcification in dialysis patients was associated with higher risk for late TLR through 5 years.

Erratum to: Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry

Erratum to: Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry

Comparison of Five-Year Outcome of Sirolimus-Eluting Stent Implantation for Chronic Total Occlusions Versus for Non-Chronic Total Occlusion (from the j-Cypher Registry)

The aim of this study was to evaluate the 5-year clinical outcomes of patients who underwent sirolimus-eluting stent implantation for chronic total occlusion (CTO). Among 10,759 patients treated exclusively with sirolimus-eluting stent in the j-Cypher registry, clinical outcomes were compared between 1,210 patients with revascularization for CTO and 9,549 patients with revascularization for non-CTO only. The cumulative 5-year incidence of all-cause death (13.2% vs 14.3%, p = 0.56) and definite stent thrombosis (1.9% vs 1.6%, p = 0.76) was similar between the 2 groups. The adjusted risk for CTO relative to non-CTO for all-cause death and definite stent thrombosis was insignificant (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.81 to 1.16, and HR 0.99, 95% CI 0.6 to 1.65, respectively). The cumulative incidence of target lesion revascularization was significantly higher in the CTO group (20.7% vs 14.8%, p <0.001). The adjusted risk for target lesion revascularization was significant (HR 1.31, 95% CI 1.13 to 1.52, p <0.001). In the subgroup analysis, the risk for CTO for all-cause death tended to be lower in the subgroup of patients with left ventricular ejection fractions ≤40% (HR 0.68, 95% CI 0.45 to 1.01, p = 0.053), while the risk was significantly higher in the subgroup of patients with end-stage renal disease without hemodialysis (HR 1.66, 95% CI 1.02 to 2.70, p = 0.04). In conclusion, sirolimus-eluting stent implantation for CTO appears to be as safe as that for non-CTO for up to 5 years, except for the modestly elevated risk for target lesion revascularization and the higher risk for all-cause death in patients with end-stage renal disease without hemodialysis.

Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry

Due to serious concerns on very late stent thrombosis (VLST), extended use of dual antiplatelet therapy (DAPT) beyond 1 year after DES implantation has become a common clinical practice despite apparent lack of evidence suggesting its efficacy in reducing VLST. The study population consisted of 12812 patients in the j-Cypher registry who were treated with at least one sirolimus-eluting stent (SES). We assessed the relation between duration of thienopyridine therapy and clinical outcomes with a landmark analysis at 1 year after SES implantation. Among 11713 patients without myocardial infarction (MI), stent thrombosis and stroke at 1 year who were eligible for the landmark analysis, 7414 patients (63 %) were maintained on thienopyridine at 1-year landmark point, while 4299 patients (37 %) had discontinued thienopyridine before 1-year landmark point. Patients in the on-thienopyridine group had more complex characteristics than patients in the off-thienopyridine group. Cumulative incidence of and the risk for definite VLST in the on-thienopyridine group relative to the off-thienopyridine group favored prolonged DAPT, but were not significant [0.9 and 1.2 %, P = 0.1, and adjusted HR (95 % CI): 0.71 (0.47-1.06), P = 0.11]. Cumulative incidence of and the risk for a composite of death, MI, or stroke in the on-thienopyridine group relative to the off-thienopyridine group were also not significant [15.3 and 14.3 %, P = 0.15, and adjusted HR (95 % CI): 0.99 (0.89-1.11), P = 0.89]. Prolonged use of thienopyridine beyond 1 year after SES implantation was not associated with significant decrease in the risks for VLST or for serious cardiovascular events including death, MI or stroke.

The long-term efficacy of cilostazol in addition to dual antiplatelet therapy after sirolimus-eluting stent implantation for Japanese patients: an analysis of the 3-year follow-up outcomes from the j-Cypher registry

Several clinical studies have reported the use of cilostazol in addition to aspirin and thienopyridine (triple antiplatelet therapy, TAPT) after percutaneous coronary intervention (PCI) decreases clinical events. However, the efficacy and safety of TAPT have not been fully evaluated in Japan. The prospectively collected data from 12824 Japanese patients received PCI as part of the j-Cypher Registry were analyzed. We selected 10356 patients who exclusively received implantation of sirolimus-eluting stents (SES), and compared the data from 10128 patients who received dual antiplatelet therapy (aspirin + thienopyridine, DAPT) with 228 patients who received TAPT at the time of discharge. Patients who received TAPT had more comorbidities, such as peripheral vascular disease, renal failure with hemodialysis or insulin dependent diabetes mellitus, and more patients received stenting for the left main trunk. The cardiovascular event rates at 3 years after PCI in the TAPT group were not significantly different from DAPT group, even after adjusted risks for cardiovascular events; all-cause death (7.8 vs. 6.7 %, log-rank p = 0.44, adjusted Hazard Ratio [HR] 0.88: 95 % confidence interval [CI] 0.52-1.38, p = 0.61), myocardial infarction (1.7 vs. 2.4 %, log-rank p = 0.49 and HR 0.71: 95 % CI 0.20-1.57, p = 0.40), target legion revascularization (12.7 vs. 9.9 %, log-rank p = 0.11 and HR 1.05: 95 % CI 0.71-1.50, p = 0.91) and stroke (3.9 vs. 3.2 %, log-rank p = 0.52 and HR 1.09: 95 % CI 0.52-2.00, p = 0.80). In conclusion, TAPT after SES implantation was associated with similar long-term clinical outcomes as DAPT in Japanese real-world clinical practice, although we did not evaluate the bleeding outcome.

Very Late Stent Thrombosis and Late Target Lesion Revascularization After Sirolimus-Eluting Stent Implantation

Background— There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST). Methods and Results— Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length &gt;28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization. Conclusion— Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

Abstract 8886: Five-Year Clinical Outcomes of Patients with Sirolimus-Eluting Stent Implantation for Chronic Total Occlusion: Insihgt from the j-Cypher Registry

Introduction Little is known about long-term efficacy and safety of sirolimus-eluting stent (SES) implantation for chronic total occlusion (CTO), compared with for non-CTO. Hypothesis Successful recanalization of CTO with SES confers equally favorable clinical outcome as that of non-CTO. Methods The design of the j-Cypher registry was multicenter prospective enrollment of consecutive patients who underwent SES implantation from 41 centers in Japan. From 5 year follow-up information of the j-Cypher registry, we divided 10759 patients treated exclusively and successfully with SES into 2 groups (CTO group: 1210 patients underwent revascularization for CTO, non-CTO group: 9549 patients for non-CTO only). A CTO was defined as complete obstruction with estimated duration ≥1 month. Baseline characteristics and cumulative incidences of major adverse cardiovascular events were compared between the 2 groups. Furthermore the 2 groups were stratified according to their ejection fraction (EF&lt;40% or ≥40%) and studied on their 5 year overall mortality. Results The median follow-up duration was 1,640 days. The CTO group was younger (67±11 years vs. 69±10 years, p&lt;0.001), had less diabetes mellitus (44% vs. 48%, p=0.023), and had more multivessel disease (61% vs. 49%, p&lt;0.001). The crude event rates through 5 years such as total death (13% vs. 14%, p=0.562), myocardial infarction (4.2% vs. 3.6%, p=0.349), and definite stent thrombosis (1.9% vs.1.6%, p=0.758) did not differ significantly among the 2 groups, though target lesion revascularization was significantly higher in CTO group (21% vs. 15%, p&lt;0.001). In stratified analysis by EF&lt;40%, CTO group showed better overall survival rate (Figure A), despite no significant difference between the 2 groups with EF≥40% (Figure B). Conclusions SES implantation for CTO seems equivalently effective and safe to that for non-CTO. Stratified by EF&lt;40%, SES implantation for CTO could bring better long-term survival.

Three-year outcome of sirolimus-eluting stent implantation in coronary bifurcation lesions: the provisional side branch stenting approach versus the elective two-stent approach

To explore optimal management strategies for bifurcation lesions with sirolimus-eluting stents (SES). Among 12,824 patients enrolled in the j-Cypher Registry, we identified 2,122 patients with 2,250 non-left main bifurcation lesions (average age: 69 years; diabetes: 39%; acute coronary syndrome: 24%; lesion length ≥30 mm: 17%; true bifurcation: 53%) treated exclusively with SES. The majority of lesions (1,978 lesions, 88%) were treated by provisional side branch stenting approach with a 4.5% crossover rate, while the elective two-stent approach (stenting both main and side branches) was adopted in 272 lesions. The 3-year incidence of target-lesion revascularisation (TLR) was significantly higher in the elective two-stent group than in the provisional group (18.5% vs. 9.8%, p<0.0001). The incidence of definite stent thrombosis was not different between the two groups (1.3% vs. 0.61%, p=0.21). Among 1,871 lesions with main branch stenting alone, final kissing balloon dilatation (FKB) was performed in 938 lesions (50%). The incidence of TLR was not different between the two groups with or without FKB (9.9% vs. 9.2%, p=0.98). The provisional approach provided a good long-term outcome in the majority of lesions with low crossover rate to the two-stent approach. Lesions treated with FKB had similar TLR outcome to those without FKB after main branch stenting alone.

Sirolimus-Eluting Stent Implantation for Ostial Left Anterior Descending Coronary Artery Lesions

Background— Ostial left anterior descending coronary artery (LAD) lesion has been regarded as a lesion subset unsuitable for coronary stenting. Long-term outcomes of sirolimus-eluting stent (SES) implantation for ostial LAD lesions have not been adequately evaluated. Methods and Results— Among 12 824 patients enrolled in the j-Cypher Registry, 3-year outcomes were compared between 481 patients with SES-treated ostial LAD lesions and 5369 patients with SES-treated nonostial proximal LAD lesions. Patients with ostial LAD lesions had similar incidences of target lesion revascularization (TLR) as those with nonostial proximal LAD lesions (9.4% versus 9.7%; P =0.98; adjusted hazard ratio [HR], 0.99; 95% CI, 0.7 to 1.36; P =0.94) and death/myocardial infarction (MI) (10.7% versus 11.4%; P =0.82; adjusted HR, 1.05; 95% CI, 0.76 to 1.4; P =0.77). Among the patients with ostial LAD lesions, those undergoing both main and side branch stenting (n=62) compared to main branch stenting alone (n=419) had a higher risk for TLR (adjusted HR, 4.65; 95% CI, 2.32 to 9.25; P &lt;0.0001) but similar risk for death/MI (adjusted HR, 1.15; 95% CI, 0.49 to 2.41; P =0.73). In patients with main branch stenting alone, outcomes after crossover stenting across the circumflex coronary artery (n=225) were not different from those after ostial stenting (n=194) for TLR (adjusted HR, 0.77; 95% CI, 0.33 to 1.82; P =0.55) and for death/MI (adjusted HR, 1.54; 95% CI, 0.78 to 3.2; P =0.22). Conclusions— In terms of both safety and efficacy, 3-year outcomes of percutaneous coronary intervention using SES for ostial LAD lesions were comparable to those for nonostial proximal LAD lesions. Crossover stenting with a 1-stent approach might be a reasonable option in treating ostial LAD lesions.

Comparison of Three-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation Among Insulin-Treated Diabetic, Non–Insulin-Treated Diabetic, and Non-Diabetic Patients from j-Cypher Registry

The purpose of the present study was to evaluate the 3-year clinical outcomes after percutaneous coronary intervention with sirolimus-eluting stents in patients with insulin-treated diabetes mellitus (DM-insulin) and those with non-insulin-treated DM (DM-non-insulin) compared to patients without DM. Of 10,778 consecutive patients treated exclusively with sirolimus-eluting stents in the j-Cypher registry, we identified 996 patients with DM-insulin, 3,404 with DM-non-insulin, and 6,378 without DM. Compared to the non-DM group, the adjusted risk of a serious cardiovascular event (composite of all-cause death, myocardial infarction, and stroke) was significantly greater in the DM-insulin group (hazard ratio 1.12, 95% confidence interval [CI] 1.03 to 1.23; p = 0.01), but not in the DM-non-insulin group (hazard ratio 1.02, 95% CI 0.96 to 1.09; p = 0.47). The adjusted risk of target lesion revascularization was significantly greater in both the DM-insulin group (odds ratio 1.52, 95% CI 1.19 to 1.92; p = 0.0006) and the DM-non-insulin group (odds ratio 1.24, 95% CI 1.05 to 1.45; p = 0.009). In conclusion, a diabetes-associated excess risk of target lesion revascularization was found, regardless of insulin use in this large, real-world study of Japanese patients with sirolimus-eluting stent implantation. However, regarding serious cardiovascular events, an excess risk was seen only in the DM-insulin group. The risk of serious cardiovascular events was similar between the DM-non-insulin and non-DM groups.