Long-term Clinical Outcomes After Sirolimus-Eluting Stent Implantation in Dialysis Patients

Ichimoto, Eiji; Kobayashi, Yoshio; Iijima, Yoshihiro; Kuroda, Nakabumi; Kohno, Yukinori; Komuro, Issei

doi:10.1536/ihj.51.92

Cited by 25 publications

(19 citation statements)

References 27 publications

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“…To our knowledge this is the first prospective report of TVF and in-stent late loss following DES implantation in HD patients. In previous reports, TVF 1 year following SES implantation in normal renal function was 9.8% in SIRIUS, 15 11.5% in ENDEAVOR III, 16 10.9% in ASCOT/TOSCA-4, 17 and 9.3% in J-PMS studies, 18 indicating that TVF following SES implantation was in the 10% range. Accordingly, the figure of 24.9% for TVF in the OUCH Study clearly shows that HD patients had greater risk than that of patients with normal renal function.…”

Section: Discussionmentioning

confidence: 78%

“…4-7 However, several reports showed completely opposite results, with SES failing to reduce rates of any events such as TLR, mortality, or major adverse cardiac events compared with BMS. 8- 11 Furthermore, to our knowledge, no quantitative coronary angiography (QCA) analysis has been reported for DES in HD patients. In view of the uncertain value of DES in HD patients to date, we conducted this prospective non-randomized multicenter trial of SES implantation using QCA carried out in an independent core laboratory.…”

Section: Ouch: Ses For Hd Patientsmentioning

confidence: 99%

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Sirolimus Eluting Coronary Stent Implantation in Patients on Maintenance Hemodialysis

Ikari

Tanabe

Kōyama

et al. 2012

Circ J

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Section: Discussionmentioning

confidence: 78%

Section: Ouch: Ses For Hd Patientsmentioning

confidence: 99%

Sirolimus Eluting Coronary Stent Implantation in Patients on Maintenance Hemodialysis

Ikari

Tanabe

Kōyama

et al. 2012

Circ J

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“…Thus, as described in the Methods, the outcomes of SES were compared with those of BMS through a historical comparison. The percentage of patients undergoing hemodialysis, a consistent powerful predictor of cardiac events and binary restenosis of SES (20), was low in the present cohort compared to the Japanese large-scale registry (4). In addition, since the baselines were very different between BMS and SES groups (Table 1), we did not apply the propensity matching score in this retrospective study.…”

Section: Discussionmentioning

confidence: 58%

Retrospective Comparison of the Clinical and Angiographic Outcomes of the Sirolimus-eluting Stent and the Bare-metal Stent in 2031 Nonrandomized Consecutive De Novo Native Coronary Lesions

2011

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Objective To evaluate the mid-term outcomes of sirolimus-eluting stents (SES; Cypher Bx Velocity) for de novo coronary stenosis in a Japanese clinical setting, and to compare these with the outcomes using baremetal stents (BMS). Methods This study was a nonrandomized, lesion-based, and single-center study, retrospectively investigated in October 2010. We enrolled 2031 consecutive cases with de novo coronary lesions treated with BMS (n=587) or SES (n=1,444) from January 2003 to May 2007. SES use ratio during the available interval was 95.5%. The primary endpoint was the incidence of target vessel failure (TVF: comprising cardiac death, nonfatal recurrent MI, definite stent thrombosis (ST), and severe restenosis [% diameter stenosis (%DS) at secondary angiography !70%]. The secondary endpoint was the incidence of binary in-stent restenosis (%DS > 50%). Results The TVF ratio after SES placement (6.6%) was significantly lower than that after BMS placement (11.8%, p<0.001), despite many disadvantageous variables in the SES group. SES related to the risk of TVF (mean follow-up for SES, 1,411 ± 539 days; BMS, 1,818 ± 825 days) (hazard ratio of 0.428 at 95% CI, 0.292-0.627, p<0.001). The ratio of binary in-stent restenosis after SES placement (13.4%) was significantly lower than that after BMS placement (25.1%; p<0.001). SES was significantly related to binary in-stent restenosis (odds ratio of 0.267 at 95% CI, p<0.001). Conclusion SES has a more favorable mid-term clinical and angiographic outcome than BMS for de novo coronary stenosis in clinical settings in Japan.

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“…The large late luminal loss and the high BR ratio of SES with RA for calcified lesions can be attributed to the 3 reasons described above. In addition, the relatively high percentages of hemodialysis, the consistent predictor of both endpoints after SES placement, 2,3,35) included in the present cohort (Tables I, III, V) are related to the ineffectiveness of SES for the angiographic outcome. Accordingly, SES with RA for calcified lesions did not exert a beneficial effect at reducing the incidence of BR in the widespread indication in our daily practice.…”

Section: Discussionmentioning

confidence: 76%

Retrospective Comparison of Clinical and Angiographic Outcomes After Sirolimus-Eluting and Bare-Metal Stent Implantation in 312 Consecutive, Nonrandomized Severely Calcified Lesions Using a Rotablator

et al. 2011

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SummaryIn order to compare the long-term clinical and angiographic outcomes after sirolimus-eluting stent (SES) and baremetal stent (BMS) placement in severely calcified lesions using a rotablator under the widespread indication of SES, a nonrandomized examination of 312 consecutive lesions after successful implantation of a BMS (99 lesions in 84 patients; from January 2003) or SES (213 in 167; from September 2004) using a rotablator was conducted. The lesionbased primary endpoints (cardiac death and nonfatal recurrent myocardial infarction) and the secondary endpoint [binary restenosis (BR) (diameter stenosis > 50%) at follow-up angiography] were retrospectively determined in August 2010. The incidence of primary endpoint in the SES group (2.3%; mean follow-up period of 1289 ± 526 days) was significantly lower than that in the BMS group (7.1%; P = 0.043; 1803 ± 887 days), although the several variables related to the endpoints were present in the SES group. Cox proportional hazard model analysis revealed that SES was not significantly related to a primary endpoint [hazard ratio of 0.42 (95% CI, 0.073-2.42; P = 0.33)]. The incidence of BR in the SES group (21.3%) was not significantly different from that in the BMS group (27.1%) (P = 0.33). Multivariate logistic regression analysis revealed that SES was not a significant predictor of BR [Odds ratio of 0.78 (95% CI, 0.41-1.51; P = 0.47)]. Thus, although the results of the present retrospective nonrandomized study demonstrate the long-term safety of SES for calcified lesions using a rotablator in daily practice, SES did not show a benefit for the angiographic outcomes and is one of the complex and challenging targets of percutaneous coronary intervention (PCI). Since calcified coronary lesions are associated with the risk of suboptimal stent expansion, calcification of coronary arteries relates to in-stent restenosis (ISR) and target lesion revascularization (TLR) 2-4) and subsequent stent thrombosis (ST) 5) after sirolimuseluting stent (SES; Cypher Bx Velocity, Cordis, Johnson & Johnson, NJ, USA) implantation. Therefore, it is necessary to evaluate whether SES is consistently beneficial for the treatment of calcified lesions in daily clinical practice with a widespread indication in the field of percutaneous coronary intervention (PCI). However, the impacts of severely calcified lesions on the long-term clinical and angiographic outcomes after successful SES placement in daily clinical practice are still not fully understood.Rotational atherectomy (RA) using a rotablator (Boston Scientific, Natick, MA, USA) is useful for treating calcified lesions. The rotablator facilitates optimal stent implantation by debulking the hard calcified matrix and modifies vessel compliance.6) However, SES implantation with RA for a calcified coronary artery has yielded inconsistent outcomes, 7-9) despite the consistent efficacy revealed in the overall field of PCI using SES. 2,10,11) In the present study, we retrospectively examined whether SES implantation with RA improved clinical...

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Long-term Clinical Outcomes After Sirolimus-Eluting Stent Implantation in Dialysis Patients

Cited by 25 publications

References 27 publications

Sirolimus Eluting Coronary Stent Implantation in Patients on Maintenance Hemodialysis

Sirolimus Eluting Coronary Stent Implantation in Patients on Maintenance Hemodialysis

Retrospective Comparison of the Clinical and Angiographic Outcomes of the Sirolimus-eluting Stent and the Bare-metal Stent in 2031 Nonrandomized Consecutive De Novo Native Coronary Lesions

Retrospective Comparison of Clinical and Angiographic Outcomes After Sirolimus-Eluting and Bare-Metal Stent Implantation in 312 Consecutive, Nonrandomized Severely Calcified Lesions Using a Rotablator

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