Effectiveness of a Sirolimus-Eluting Stent (Cypher ) for Diffuse In-Stent Restenosis Inside a Bare Metal Stent

Abstract

SUMMARYWe estimated the benefit of a sirolimus-eluting stent (SES, Cypher ® ) for diffuse ( > 10 mm) in-stent restenosis (ISR) inside bare metal stents (BMS) because the feasibility of the SES was not confirmed after its recent approval in Japan. Clinical and angiographic outcomes after SES implantation to 93 diffuse ISR were compared with those of 3 groups treated by plain old balloon angioplasty (POBA, (n = 54)), cutting balloon angioplasty (CB, (n = 24)), and BMS (n = 41) in a series of 153 patients whose follow-up quantitative coronary angiography (QCA) evaluated 3-9 months after the treatments was obtained from January 2003 through December 2005. For 33 lesions in the SES group, 12-month follow-up QCA results were obtained and compared with those at 6 months. Ticlopidine (200 mg/day) was prescribed for at least 12 weeks after SES implantation and for 2 weeks after BMS in addition to aspirin (81-100 mg/day). Patient characteristics and the characteristics of previous implanted BMS in the SES group were not significantly different from those in the other groups. Death from cardiac causes and nonfatal myocardial infarction did not occur in any group. Stent thrombosis was not observed in the BMS and SES groups. The incidence of repeat target lesion revascularization (re-TLR) in the SES group (3.23%) was significantly lower compared with that of the POBA (37.0%), CB (25.0%), and BMS (29.3%) groups (P < 0.001, respectively). Late loss in the SES group (0.44 ± 0.41 mm) was significantly smaller than that in the BMS group (1.34 ± 0.74 mm) (P < 0.05). The rate of recurrent ISR (re-ISR) in SES (5.38%) was significantly lower than that in POBA (46.3%), CB (41.7%), and BMS (46.3%) (P < 0.001, respectively). The QCA variables at 6 months in the SES group were not significantly different from those at 12 months. Thus, SES implantation for diffuse ISR was far superior since it markedly reduced the incidence of re-TLR with re-ISR at up to 6-months follow-up. In addition, this angiographic patency after SES implantation continued until 12 months. (Int Heart J 2006; 47: 651-661)

Comparison of Long-Term Clinical Outcome After Sirolimus-Eluting Stent Implantation in Patients With and Without Hemodialysis

“…Drug-eluting stents have been reported to be superior to conventional treatment for in-stent restenosis, such as balloon angioplasty and vascular brachytherapy. [19][20][21] In the present study, there was a significantly higher incidence of target lesion revascularization in the instent restenosis lesions (15.4%) than in de novo lesions (4.2%) (P = 0.022). Although SESs are superior to conventional treatment for in-stent restenosis, instent restenosis lesions themselves may be inferior to de novo lesions even in the SES era.…”

Predictors of Target Lesion Revascularization and Documented Stent Thrombosis Beyond 30 Days After Sirolimus-Eluting Stent Implantation Retrospective Analysis in Consecutive 1,070 Angiographic Follow-up Lesions

“…t is necessary in Japan to further confirm both benefits (reduction of target lesion revascularization (TLR) with in-stent restenosis (ISR)) and the risk (stent thrombosis) of sirolimus-eluting coronary stent (SES, Cypher ® ) by meeting the following 5 conditions compared with the previous Japanese original reports; [1][2][3][4] (1) studies among larger angiographically follow-up lesions; (2) studies during longer interval after SES implantation because more than 2 years has passed after the approval; (3) studies including large number of variables to conclude the predictor of TLR with ISR of SES (SES-ISR) because SES-ISR implicated in suboptimal treatment; 5 (4) studies including larger percentages of acute coronary syndrome (ACS), acute myocardial infarction and unstable angina, because there has been the tendency to refrain from using emergently SES in Japan; and (5) estimating the incidence of documented late (30 day -1 year) and very late (>1 year) stent thrombosis (LST and VLST) because recently the committee of United States Food and Drug Administration (FDA) 6 was made aware about these risks of SES. Thus, in the present study, (1) the predictor of TLR with SES-ISR at chronic phase was retrospectively estimated in 1,070 consecutive angiographic follow-up lesions after unrestricted SES implantation including 50 variables related to percutaneous coronary intervention (PCI).…”

Initial and Long-Term Outcomes of Sirolimus-Eluting Stents for Calcified Lesions Compared With Bare-Metal Stents

“…Subsequent reports have described the beneficial effects of SES on ostial lesions, 4) chronic total occlusion lesions, 5) bifurcated lesions, 6) small vessel lesions, 7) and stent restenosis. 8) However, few studies have examined the effects of using DES for calcified lesions. [9][10][11] In severely calcified lesions, where stent crossing or stent expansion is limited, the lesions are first debulked by means of rotational atherectomy (RA) using a rotablator TM .…”