Outcomes Of Sirolimus-eluting Stent Implantation Research Articles

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.

Impact of Calcification on the Long-Term Outcomes of Sirolimus-Eluting Stent Implantation - Subanalysis of the Cypher Post-Marketing Surveillance Registry -

The aim of the present study was to investigate the long-term outcome of sirolimus-eluting stent (SES) implantation in lesions with severe calcification that may disturb adequate stent expansion and increase the risk of restenosis and target lesion revascularization (TLR). The Cypher Post-Marketing Surveillance Registry study has been conducted since August 2004 in Japan to evaluate the efficacy and safety of SES in a real-world setting. Data on 2,458 lesions in 2,050 patients were reviewed, and the angiographical outcomes at 240 days and clinical outcomes at 1,080 days after implantation compared between calcified lesions and non-calcified lesions in dialysis patients and non-dialysis patients. In non-dialysis patients, the rates of major adverse cardiac events (MACE; 16.0% vs. 12.8%; P=0.144) including TLR (4.9% vs. 6.0%; P=0.457), and restenosis (10.1% vs. 7.8%; P=0.207) were similar in calcified lesions and non-calcified lesions. In dialysis patients, the rate of MACE was similar in calcified lesions and non-calcified lesions (51.1% vs. 43.1%; P=0.544), but the rates of TLR (29.8% vs. 9.8%; P=0.020), and restenosis (39.5% vs. 17.0%; P=0.029) were significantly higher in calcified lesions than in non-calcified lesions. There is a differential impact of calcification on the long-term outcome of SES implantation in dialysis and non-dialysis patients.

TCT-272: Impact of Stent Length on Long-Term Clinical Outcomes of Sirolimus-Eluting Stent Implantation for Chronic Total Occlusion

TCT-272: Impact of Stent Length on Long-Term Clinical Outcomes of Sirolimus-Eluting Stent Implantation for Chronic Total Occlusion

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.

Long-Term Outcome of Sirolimus-Eluting Stent Implantation for Left Main Coronary Artery Stenosis in Infancy

Drug-eluting stents (DES) have markedly reduced the incidence of coronary in-stent restenosis. However, DES may be still vulnerable to coronary thrombus, and the long-term outcome remains unknown, especially in infancy. Here, we present a 9-month-old infant, who developed severe stenosis of the left main coronary artery after surgery for Brand-White-Garland syndrome, and was successfully treated with DES. He was healthy and his cardiac function had improved to the normal level at 6 years old. An angiographic examination and computed tomography showed the complete persistence of DES and no evidence of intimal thickening.

Primary and mid-term outcome of sirolimus-eluting stent implantation with angiographic guidance alone

Usefulness and efficacy of intravascular ultrasound (IVUS) for the implantation of sirolimus-eluting stent (SES) is controversial. We investigated the primary and mid-term results of SES deployment with angiographic guidance comparing with IVUS guidance, retrospectively. SESs were deployed in 480 de novo lesions of 459 patients (341 lesions treated without IVUS and 139 lesions treated using IVUS); 368 lesions underwent follow-up coronary angiography. Late luminal loss, in-stent restenosis (ISR) rate and target lesion revascularization (TLR) rate were not significantly different between the non-IVUS group and the IVUS group. There was no acute thrombosis or other major adverse cardiac events except for TLR in both groups. Multivariate logistic regression analysis showed that SES implantation without IVUS was not an independent risk factor for restenosis. On the other hand, in one case, target-vessel revascularization was difficult because of the mal-apposition of the SES previously implanted without IVUS. For lesions for which stent size and endpoint are decided from angiographic information alone, angio-guided SES implantation is safe and provides a good mid-term outcome that is comparable to the IVUS-guided SES stent deployment., while IVUS may be helpful to decide stent size for complex lesions and reduce possible complications.

Angiographic and Clinical Outcome Following Sirolimus-Eluting Stent (Cypher) Implantation A Single Center Experience

To investigate the late outcomes of sirolimus-eluting stent implantation in patients with coronary artery disease. Drug-eluting stents reduce intimal hyperplasia, which is the main cause of in-stent restenosis. Sirolimus-eluting stents significantly reduce clinical and angiographic restenosis and improve event-free survival. The study population consisted of 207 patients (273 stents) who had undergone coronary Cypher stent implantation. Patients were eligible for enrollment if there was symptomatic coronary artery disease or positive exercise testing, and angiographic evidence of single or multivessel disease with a target lesion stenosis of > or = 70% in a > or = 2.25 mm vessel. Follow-up coronary angiography was performed 18 months after stent deployment. Patients were followed-up for a mean of 24.7 +/- 7.4 months. All patients survived after stent implantation, but 5 (2.4%) patients experienced acute ST elevation myocardial infarction and 4 (1.9%) patients developed non-Q wave myocardial infarction following angioplasty. Recurrent angina pectoris was observed in 16 (7.7%) patients (11 stable angina pectoris and 5 unstable angina pectoris). Angiographic evidence of restenosis was observed in these 20 (9.66%) patients. The 5 other patients had noncritical angiographic restenosis. Eleven (5.3%) patients underwent angioplasty because of restenosis, and coronary artery bypass grafting was conducted in the other 9 (4.3%) patients. The results of the present study indicate that Cypher stents could be implanted with a very high success rate and have encouraging long-term angiographic and clinical results.

Immediate and Mid-term Outcomes of Sirolimus-Eluting Stent Implantation for Chronic Total Occlusions

Immediate and Mid-term Outcomes of Sirolimus-Eluting Stent Implantation for Chronic Total Occlusions

Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions

To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO). We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up. Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.

Comparison of clinical and angiographic outcome of sirolimus-eluting stent implantation versus cutting balloon angioplasty for coronary in-stent restenosis

Sixty in-stent restenotic lesions were treated with sirolimus-eluting stent implantation and retrospectively compared with a group of matched lesions treated with cutting balloon angioplasty. The results indicate a good safety profile of the procedure and a 57% reduction in the incidence of recurrent restenosis in comparison with cutting balloon angioplasty.