Very Long-Term (15 to 20 Years) Clinical and Angiographic Outcome After Coronary Bare Metal Stent Implantation

Yamaji, Kyohei; Kimura, Takeshi; Morimoto, Takeshi; Nakagawa, Yoshihisa; Inoue, Katsumi; Soga, Yoshimitsu; Arita, Tomohiro; Shirai, Shinichi; Ando, Koji; Kondo, Kei; Sakai, Koyu; Goya, Masahiko; Iwabuchi, Masashi; Yokoi, Hiroyoshi; Nosaka, Hideyuki; Nobuyoshi, Masakiyo

doi:10.1161/circinterventions.110.958249

Cited by 88 publications

(68 citation statements)

References 26 publications

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“…1,2 However, the permanence of metallic DES may result in expansive remodeling, late strut fractures, abnormal vasomotion, and neoatherosclerosis, which collectively contribute to a 2% to 3% annual risk of stent-associated events beyond the first year after implantation, potentially for the life of the patient. [3][4][5] Drug-eluting bioresorbable vascular scaffolds (BVS) were designed to mitigate these very late risks of metallic stents by providing mechanical support only during the required period of stent-induced vascular remodeling, with complete bioresorption within several years thereafter. The temporary nature of BVS may also confer other advantages compared with permanent stents such as treatment of bifurcation lesions, long diffuse disease, and in-stent restenosis.…”

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confidence: 99%

Three-Year Outcomes With the Absorb Bioresorbable Scaffold

et al. 2018

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Background: The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. Methods: We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. Results: BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10–1.73; P =0.006), driven by greater target vessel myocardial infarction (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26–2.35; P =0.0006) and ischemia-driven target lesion revascularization (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05–1.98; P =0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47–1.88; P =0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70–8.11; P =0.001). Between 1 and 3 years, target lesion failure rates (6.1% versus 3.9%; P =0.02) and device thrombosis rates (1.1% versus 0.0%; P <0.0001) were higher with BVS than cobalt-chromium everolimus-eluting stents. Conclusions: In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

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Three-Year Outcomes With the Absorb Bioresorbable Scaffold

et al. 2018

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“…[3][4][5][6] First-generation drugeluting stents (DES) succeeded in further reducing the rate of early TLR, 7,8 but were associated with continued occurrence of late TLR and very late stent thrombosis (ST), which might have been attenuated with newer-generation DES using biocompatible or biodegradable polymer. [9][10][11] Currently, a fully bioresorbable drug-eluting vascular scaffold (BVS) is under clinical evaluation with expectations for better healing responses of the vessel wall and reduction of late adverse events related to the treatment site by eliminating permanent metallic implants.…”

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Influence of Sex on Long-Term Outcomes After Implantation of Bare-Metal Stent

et al. 2015

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Background-Female sex was reported to be associated with lower risk for midterm restenosis and repeat revascularization after bare-metal stent implantation. However, the influence of sex on very long-term outcomes after bare-metal stent implantation has not been yet reported. Methods and Results-Among the 9877 patients in the multicenter Coronary Revascularization Demonstrating Outcome study in Kyoto (CREDO-Kyoto) registry cohort-1, bare-metal stent implantation was performed in 5313 patients (men, n=3742 and women, n=1571). Follow-up was completed in 4515 patients (85.0%) at 10 years (duration, 10.3±3.1 [0.0-14.1] years). The cumulative incidence of target-lesion revascularization (TLR) was 27% at 1 year and 34% at 10 years (0.8%/y beyond 1 year). Non-target-lesion revascularization (non-TLR) was the dominant coronary revascularization beyond 1 year (13% at 1 year and 31% at 10 years [2.0%/y beyond 1 year]). Cumulative incidence of stent thrombosis was low (1.2% at 1 year and 1.9% at 10 years). Women were older and had greater prevalence of cardiovascular risk factors than men. The cumulative 10-year incidences of and adjusted risk for TLR were significantly higher in men than in women (36% versus 30%, P<0.001; adjusted hazard ratio, 1.29; 95% confidence interval, 1.15-1.46; P<0.001). The higher risk of men relative to women for TLR was consistent regardless of age (<75 years and ≥75 years). Men in comparison with women were also associated with significantly higher adjusted risks for all-cause death, myocardial infarction, stroke, coronary artery bypass grafting, TLR, and non-TLR. Conclusions-TLR and stent thrombosis continued to occur without attenuation up to 10 years after bare-metal stent implantation. Men in comparison with women were associated with higher adjusted 10-year risks for all-cause death, myocardial infarction, stroke, coronary artery bypass grafting, TLR, and non-TLR.

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“…1, 2 The major causes of death in these patients are cardiac death and vascular (excluding cardiac) death. 3 Patients with CAD with one or more atherosclerotic lesions have a poor prognosis 4,5 that is not improved by revascularization in patients with stable angina. 1 Little is known, however, about the long-term outcomes of CAD in patients with one or more atherosclerotic lesions after revascularization.…”

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confidence: 99%