j-Cypher Registry Research Articles

J-Cypher Registry.

j-Cypher Registry.

J-Cypher Registry.

j-Cypher Registry.

Safety and Efficacy of Sirolimus-Eluting Stent Implantation in Patients With Acute Coronary Syndrome in the Real World

The use of drug-eluting stents in patients with acute coronary syndrome (ACS), particularly those with acute myocardial infarction (AMI), is controversial owing to concerns about late adverse events. We evaluated the long-term safety of sirolimus-eluting stent implantation in patients with ACS. Of 10,778 patients treated exclusively with a sirolimus-eluting stent in the j-Cypher registry, the 3-year outcomes of 2,308 patients with ACS (953 patients with AMI) were compared to those of 8,470 patients without ACS. Compared to patients without ACS, the patients with ACS had a significantly greater adjusted risk of death or myocardial infarction (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12 to 1.37, p <0.0001) and definite or probable stent thrombosis (HR 1.43, 95% CI 1.11 to 1.82, p = 0.006) within the first year after sirolimus-eluting stent implantation. However, after 1 year, patients with ACS no longer had a greater risk of death or myocardial infarction (HR 1.01, 95% CI 0.90 to 1.13, p = 0.87) and stent thrombosis (HR 1.32, 95% CI 0.92 to 1.86, p = 0.13). Of the patients with ACS, those with AMI had a greater risk of death or myocardial infarction (HR 1.33, 95% CI 1.12 to 1.6, p = 0.001) and stent thrombosis (HR 1.57, 95% CI 1.05 to 2.39, p = 0.03) than those with unstable angina pectoris within the first year. However, they had a similar risk of death or myocardial infarction (HR 1.00, 95% CI 0.78 to 1.22, p = 0.83) and stent thrombosis (HR 0.83, 95% CI 0.38 to 1.6, p = 0.59) after 1 year. The risk of late adverse events >1 year after sirolimus-eluting stent implantation was similar between those with and without ACS and between those with AMI and those with unstable angina pectoris.

Lack of Effect of Oral Beta-Blocker Therapy at Discharge on Long-Term Clinical Outcomes of ST-Segment Elevation Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention

Beta-blocker therapy is recommended after ST-segment elevation acute myocardial infarction (STEMI) in current guidelines, although its efficacy in those patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. Of 12,824 consecutive patients who underwent sirolimus-eluting stent implantation in the J-Cypher registry, we identified 910 patients who underwent PCI within 24 hours from onset of STEMI. Three-year outcomes were evaluated according to use of β blockers at hospital discharge (349 patients in β-blocker group and 561 patients in no-β-blocker group). Patients in the β-blocker group more frequently had hypertension, low left ventricular ejection fraction (LVEF), a left anterior descending artery infarct, and statin use than those in the no-β-blocker group. No difference was observed between the β-blocker and no-β-blocker groups in mortality (6.6% vs 6.6%, p = 0.85; propensity score adjusted hazard ratio 1.10, 95% confidence interval 0.64 to 1.90, p = 0.70) or in incidence of major adverse cardiac events (all-cause death, recurrent myocardial infarction, and heart failure hospitalization, 13.5% vs 12.1%, p = 0.91; hazard ratio 1.13, 95% confidence interval 0.76 to 1.66, p = 0.53). Better outcomes were observed in the β-blocker group than in the no-β-blocker group in a subgroup of patients with LVEF ≤40% (n = 125, death 6.4% vs 17.4%, p = 0.04; major adverse cardiac events 14.5% vs 31.8%, p = 0.009). In conclusion, β-blocker therapy was not associated with better 3-year clinical outcomes in patients with STEMI who underwent primary PCI and had preserved LVEF.

Sirolimus-Eluting Stent Versus Balloon Angioplasty for Sirolimus-Eluting Stent Restenosis: Insights From the j-Cypher Registry

Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet. During the 3-year follow-up of 12 824 patients enrolled in the j-Cypher registry, 1456 lesions in 1298 patients underwent target-lesion revascularization (TLR). Excluding 362 lesions undergoing TLR for stent thrombosis or TLR using treatment modalities other than SES or balloon angioplasty (BA), 1094 lesions with SES-associated restenosis in 990 patients treated with either SES (537 lesions) or BA (557 lesions) constituted the study population for the analysis of recurrent TLR and stent thrombosis after the first TLR. Excluding 24 patients with both SES- and BA-treated lesions, 966 patients constituted the analysis set for the mortality outcome. Cumulative incidence of recurrent TLR in the SES-treated restenosis lesions was significantly lower than that in the BA-treated restenosis lesions (23.8% versus 37.7% at 2 years after the first TLR; P<0.0001). Among 33 baseline variables evaluated, only hemodialysis was identified to be the independent risk factor for recurrent TLR by a multivariable logistic regression analysis. After adjusting for confounders, repeated SES implantation was associated with a strong treatment effect in preventing recurrent TLR over BA (odds ratio, 0.44; 95% confidence interval, 0.32 to 0.61; P<0.0001). The 2-year mortality and stent thrombosis rates between the SES- and the BA-treated groups were 10.4% versus 10.8% (P=0.4) and 0.6% versus 0.6%, respectively. Repeated implantation of SES for SES-associated restenosis is more effective in preventing recurrent TLR than treatment with BA, without evidence of safety concerns.

Incidence and Risk Factors of Late Target Lesion Revascularization After Sirolimus-Eluting Stent Implantation (3-Year Follow-Up of the j-Cypher Registry)

It yet has not been clarified whether there is a late catch-up phenomenon in target lesion revascularization (TLR) after sirolimus-eluting stent (SES) compared to bare metal stent (BMS) implantation. In 12,824 patients enrolled in the j-Cypher Registry, incidences of early (within first year) and late (1 year to 3 years) TLR were compared between 17,050 lesions treated with SESs and 1,259 lesions treated with BMSs. Incidences of TLR in SES-treated lesions were 5.7% at 1 year, 8.1% at 2 years, and 10.0% at 3 years, whereas those in BMS-treated lesions were 14.2%, 15.5%, and 15.5%, respectively (p <0.0001, log-rank test). Incidences of late TLR were significantly higher with SESs compared to BMSs (2.6% vs 1.4% at 2 years and 4.5% vs 1.4% at 3 years, p = 0.0007, log-rank test). A multivariable logistic regression model identified 7 independent risk factors for late TLR at 3 years after SES implantation: hemodialysis, low estimated glomerular filtration rate, ostial right coronary artery, lesion length >or=30 mm, 2 stents for bifurcation, American Heart Association/American College of Cardiology type B2/C, and vessel size <2.5 mm. Of these, 5 factors were common to those for early TLR. In conclusion, a late catch-up phenomenon was observed as indicated by the increasing incidence of late TLR after SES, but not after BMS, implantation. Risk factors for late TLR were generally common to those for early TLR.

Impact of Multiple and Long Sirolimus-Eluting Stent Implantation on 3-Year Clinical Outcomes in the j-Cypher Registry

Our aim was to study the relationships between total stent length (TSL) and long-term clinical outcomes after sirolimus-eluting stent (SES) implantation. SES compared with bare-metal stent use for long lesion treatment is associated with reduced restenosis rates. Three-year follow-up data were available for 10,773 patients (14,651 lesions) that had been treated with only SES (Cypher, Cordis Corp., Warren, New Jersey) in the j-Cypher registry. Patients and lesions were divided into quartile groups: TSL per patient (Q1: 8 to 23 mm, Q2: 24 to 36 mm, Q3: 37 to 54 mm, Q4: 55 to 293 mm), and TSL per lesion (QA: 8 to 18 mm, QB: 19 to 23 mm, QC: 24 to 33 mm, QD: 34 to 150 mm). In per-lesion data, longer TSL increased target lesion revascularization (TLR) rates but did not increase stent thrombosis rates (p = 0.2324). In per-patient data, the incidences of TLR remarkably increased with increasing TSL. Incidence of composite of death and myocardial infarction also increased with increasing TSL; however, after adjustment for baseline differences, there was no statistical significance. Definite stent thrombosis rate in group Q4 was significantly higher than in other groups, both unadjusted (hazard ratio: 1.770, p = 0.0081) and adjusted (hazard ratio: 1.727, p = 0.0122) for baseline differences. TSL per lesion and patient had significantly impacts on TLR rates. Longer TSL per patient was associated with increased incidence of stent thrombosis through 3 years.

Incidence and outcome of surgical procedures after sirolimus-eluting stent implantation: a report from the j-Cypher registry

The incidence of surgical procedures after sirolimus-eluting stent (SES) implantation and, more importantly, the rate of perioperative stent thrombosis (ST) and/or other adverse events have not yet been adequately addressed. The incidence and outcome of the surgical procedures after SES implantation were prospectively evaluated in a large-scale multicenter registry of patients undergoing SES implantation. Among 12,824 patients enrolled in the registry, cumulative incidences of surgical procedures were 0.7% at 60days, 5.1% at 1year and 14.7% at 3years. Surgical procedures were performed in 1,430 patients including non-coronary artery bypass graft (CABG) surgery in 1,275 patients and CABG in 189 patients. The incidences of death/myocardial infarction/ST (definite or probable) and ST (definite or probable) at 30days after surgical procedures were 2.7 and 0.35%, respectively. Surgery performed within 60days after SES implantation as compared with that performed beyond 60days was associated with significantly higher incidences of death/myocardial infarction/ST (definite or probable) and ST (definite or probable) at 30days after surgical procedures (6.4 vs. 2.5%: P=0.02 and 2.2 vs. 0.23%: P=0.002, respectively). Surgery within 60days as well as hemodialysis and small body mass index were independent risk factors of death/myocardial infarction/ST (definite or probable) identified by multivariable analysis. Surgical procedures were required fairly often after SES implantation. The incidences of adverse cardiac events including ST after surgical procedures were acceptably low. Surgery within 60days after SES implantation carried significantly higher risks as compared with those beyond 60days.

Three-Year Outcomes After Sirolimus-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Disease

Long-term outcomes after stenting of an unprotected left main coronary artery (ULMCA) with drug-eluting stents have not been addressed adequately despite the growing popularity of this procedure. j-Cypher is a multicenter prospective registry of consecutive patients undergoing sirolimus-eluting stent implantation in Japan. Among 12 824 patients enrolled in the j-Cypher registry, the unadjusted mortality rate at 3 years was significantly higher in patients with ULMCA stenting (n=582) than in patients without ULMCA stenting (n=12 242; 14.6% versus 9.2%, respectively; P<0.0001); however, there was no significant difference between the 2 groups in the adjusted risk of death (hazard ratio 1.23, 95% confidence interval 0.95 to 1.60, P=0.12). Among 476 patients whose ULMCA lesions were treated exclusively with a sirolimus-eluting stent, patients with ostial/shaft lesions (n=96) compared with those with bifurcation lesions (n=380) had a significantly lower rate of target-lesion revascularization for the ULMCA lesions (3.6% versus 17.1%, P=0.005), with similar cardiac death rates at 3 years (9.8% versus 7.6%, P=0.41). Among patients with bifurcation lesions, patients with stenting of both the main and side branches (n=119) had significantly higher rates of cardiac death (12.2% versus 5.5%; P=0.02) and target-lesion revascularization (30.9% versus 11.1%; P<0.0001) than those with main-branch stenting alone (n=261). The higher unadjusted mortality rate of patients undergoing ULMCA stenting with a sirolimus-eluting stent did not appear to be related to ULMCA treatment itself but rather to the patients' high-risk profile. Although long-term outcomes in patients with ostial/shaft ULMCA lesions were favorable, outcomes in patients with bifurcation lesions treated with stenting of both the main and side branches appeared unacceptable.

Abstract 3343: Incidence and Predictor of Late Stent Thrombosis After Implantation of Sirolimus-eluting Stent: From Two-year Clinical Follow-up of The j-Cypher Registry

Background: Unsolved issue about Sirolimus-eluting stent is thrombosis, especially, the potential for late stent thrombosis (ST). Methods: To clarify the incidence and predictors of ST, two-year data of the j-Cypher Registry were examined using ARC definition. Design of this registry was multi-center prospective enrollment of 15,216 consecutive patients (pts) with anti-platelet regimen of aspirin and ticlopidine in Japan. Results: Pts’ characteristics of this cohort were as follows, age 68+/−10 years, male in 75%, diabetes in 42%, emergency procedure in 6.6%, hemodialysis in 5%, CKD ( CCr&lt;60, non-Hemodialysis ) in 51% and off-label use in 77%. Bifurcation lesion was observed in 19%. The other characteristics of lesions were as follows, in-stent restenosis in 12%, CTO in 9%, STEMI culprit in 6.3%. Cumulative ST (ARC definite/probable) rates within two-year were 0.62% at six-month, 0.71% at one-year and 0.93% at two-year as shown in the table . Annual increase slope of late ST (ARC definite) was 0.25% per year. During follow-up, 439 Surgical operations excluding endovascular and CABG were needed. Within 30 days of operation, clinical event rates were death in 2.2%, MI in 0.65% and ST in 0.44%. Multivariate analysis identified 3 independent predictors of early ST (within three-month); Hemodialysis: Odds Ratio (OR) = 1.75 (95%CI 1.02–2.69) p=0.042, Male gender: OR = 2.00 (1.20–4.08) p=0.0051, and Emergency procedure: OR = 2.15 (1.36–3.22) p= 0.0017. Also, multivariate analysis identified one independent predictor of late ST (beyond three-month); Hemodialysis: OR = 2.44 (1.29–4.14) p=0.042. Conclusions : Stent thrombosis rate up to two years under Ticlopidine anti-platelet regimen in Japan seemed to be lower as compared with those reported from other registries in the real world, despite the fact that high risk pts were more prevalent in the j-Cypher registry. Hemodialysis was identified to be independent predictor of early and late stent thrombosis through two years. Cumulative stent thrombosis rates in j-Cypher registry

17. Progress in Coronary Artery Intervention: From the Results of the 5th Interim Analysis of DES Therapy Impact J-CYPHER Registry

17. Progress in Coronary Artery Intervention: From the Results of the 5th Interim Analysis of DES Therapy Impact J-CYPHER Registry

17. Progress in Coronary Artery Intervention: From the Results of the 5th Interim Analysis of DES Therapy Impact J-CYPHER Registry

17. Progress in Coronary Artery Intervention: From the Results of the 5th Interim Analysis of DES Therapy Impact J-CYPHER Registry