ABSTRACT
OBJECTIVE: To clarify the impact of off-label use of drug-eluting stent (DES) on 5-year outcomes. BACKGROUND: Studies on the outcomes of on- vs. off-label use of DES have been limited by the duration of observation. METHODS: We analyzed 1937 patients from a multicenter registry that includes 95% of patients with 5-year follow-up data. We defined 10 variables as off-label indications according to the manufacturer's instructions for use, and 1665 of 1937 patients (86.0%) met the criteria for at least 1 off-label indication. RESULTS: At 5 years, there were no differences in the rates of death, myocardial infarction (MI), and stent thrombosis between off-label and on-label use. The frequency of major adverse cardiac events (MACE), target lesion revascularization (TLR), non-TL but target vessel revascularization (TVR), and target vessel failure were higher in the off-label only during the first year. Among the off-label, having 2 indications was associated with TVR hazard ratio (HR) 1.62; 95% confidence interval (95%CI), 1.09-2.36 and TLR (HR, 1.90; 95%CI, 1.30-2.85). Moreover, having ≥3 off-label indications increased the risk of MACE (HR, 1.70; 95% CI, 1.23-2.40) compared with on-label use. Thrombosis rates increased with the number of off-label indications; it was 0.32% with 1, 0.69% with 2, and 3.54% with ≥3 off-label indications (p<0.001). This trend was also seen with other outcomes, except for non-TL TVR. Patients with ≥3 off-label indications had a remarkably different clinical course. CONCLUSION: Off-label use did not increase rates of death and MI as compared with on-label use, but the number of off-label indications influenced outcomes at 5 years.
Subject(s)
Coronary Disease/therapy , Drug-Eluting Stents , Sirolimus/administration & dosage , Aged , Coronary Disease/mortality , Databases, Factual , Drug-Eluting Stents/adverse effects , Drug-Eluting Stents/standards , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Patient Selection , Product Surveillance, Postmarketing , Registries , Risk , Thrombosis/epidemiology , Thrombosis/etiology , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To investigate the risks and benefits of prolonged dual antiplatelet therapy (DAPT: thienopyridine plus aspirin) following placement of drug-eluting stents (DES). The optimal duration of DAPT is not well established. METHODS: We analyzed a prospective registry of 2,050 patients with sirolimus-eluting stents during a 5-year follow-up. We divided 1,691 patients into two groups according to DAPT duration (DAPT ≤12 months (n=749) and DAPT >12 months (n=942)) and compared the clinical outcomes using a landmark analysis. RESULTS: The frequencies of major adverse cardiac events (MACE: 15.6% vs. 18.2%), death (10.0% vs. 11.5%), myocardial infarction (2.3% vs. 2.1%), target lesion revascularization (4.5% vs. 6.3%) and stent thrombosis (0.8% vs. 0.8%) were similar between the two groups. However, the frequency of bleeding was higher in the DAPT >12 months group (1.1% vs. 2.6%, p=0.030). The adjusted 12-month landmark analysis showed no differences in the incidence of MACE (hazard ratio (HR) 0.892; 95% confidence interval (CI) 0.689-1.155; p=0.385) or a composite of target vessel revascularization, cardiac death and myocardial infarction (target vessel failure: HR 0.922; 95% CI 0.678-1.255; p=0.606). There were no differences in the frequency of stent thrombosis between the two groups during years 2 to 5 after stenting; however, with regard to bleeding, an increase in the frequency of hemorrhage events was observed after four years from the index procedures in the DAPT >12 months group. CONCLUSION: DAPT performed beyond 12 months is associated with increased an frequency of bleeding complications and does not prevent the incidence of MACE, including stent thrombosis, during five years of follow-up after sirolimus-eluting stent implantation. Conducting larger, randomized studies will therefore be needed to confirm this finding.
Subject(s)
Asian People , Aspirin/administration & dosage , Drug-Eluting Stents/trends , Platelet Aggregation Inhibitors/administration & dosage , Pyridines/administration & dosage , Sirolimus/administration & dosage , Aged , Asian People/ethnology , Aspirin/adverse effects , Drug-Eluting Stents/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/adverse effects , Population Surveillance/methods , Prospective Studies , Pyridines/adverse effects , Retrospective Studies , Sirolimus/adverse effects , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Clinical data of sirolimus-eluting stent (SES) implantation are under investigation in Japan. METHODS AND RESULTS: The CYPHER stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 +/-10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 +/-0.58 mm and 72.0 +/-16.1%. The 8-month late loss was 0.20 +/-0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR. CONCLUSIONS: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety.
