Duration of dual antiplatelet therapy and long-term clinical outcome after coronary drug-eluting stent implantation: landmark analyses from the CREDO-Kyoto PCI/CABG Registry Cohort-2.

BACKGROUND: Optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has not been yet fully elucidated. METHODS AND RESULTS: We assessed the influence of prolonged thienopyridine therapy on clinical outcomes with landmark analysis at 4 and 13 months after DES implantation. Among 6802 patients with at least 1 DES implantation in the CREDO-Kyoto Registry Cohort-2, 6309 patients (on thienopyridine, 5438 patients; off thienopyridine, 871 patients) and 5901 patients (on thienopyridine, 4098 patients; off thienopyridine, 1803 patients) were eligible for the 4- and 13-month landmark analyses, respectively. The majority of patients had stable coronary artery disease (73%) and received sirolimus-eluting stents (93%), and approximately 90% of thienopyridine was ticlopidine. Patients taking thienopyridine had more complex comorbidities and more complex lesion and procedural characteristics as compared with patients not taking thienopyridine. After adjusting for confounders, thienopyridine use was not associated with decreased risk for death/myocardial infarction/stroke (hazard ratio [HR], 1.13; 95% confidence interval [CI], 0.89-1.43, P=0.32 in the 4-month landmark analysis; HR, 1.14; 95% CI, 0.90-1.45, P=0.29 in the 13-month landmark analysis, respectively), whereas the risk for GUSTO moderate/severe bleeding tended to be higher in patients taking thienopyridine (HR, 1.51; 95% CI, 1.00-2.23, P=0.049 in the 4-month landmark analysis; HR, 1.44; 95% CI, 0.99-2.09, P=0.057 in the 13-month landmark analysis, respectively). CONCLUSIONS: Prolonged thienopyridine therapy beyond 4 and 13 months appeared not to be associated with reduction in ischemic events but to be associated with a trend toward increased bleeding. Optimal duration of DAPT after DES implantation might be shorter than the currently recommended 1-year interval.

Intensity of statin therapy, achieved low-density lipoprotein cholesterol levels and cardiovascular outcomes in Japanese patients after coronary revascularization. Perspectives from the CREDO-Kyoto registry cohort-2.

BACKGROUND: Association of the type of statin and the achieved level of low-density lipoprotein cholesterol (LDL-C) with cardiovascular outcome has not been fully elucidated. METHODS AND RESULTS: The study included 14,866 patients who underwent a first coronary revascularization in 2005-2007. We identified 7,299 patients with statin therapy at discharge (so-called strong statins [atorvastatin, rosuvastatin, and pitavastatin]: 4,742 patients; standard statins [pravastatin, simvastatin, and fluvastatin]: 2,557 patients). Unadjusted 3-year incidence of major adverse cardiovascular events (MACE: composite of cardiovascular death, myocardial infarction and stroke) was significantly lower (7.5% vs. 9.6%, P=0.0008) in the strong statin group, and there was a trend in adjusted risk of MACE favoring strong statins (hazard ratio [HR] 0.87, [95% confidence interval (CI) 0.73-1.04], P=0.13). Among 4,846 patients with follow-up LDL-C data available, outcomes were evaluated according to achieved LDL-C level (<80, 80-99 [reference], 100-119, ≥120 mg/dl). Compared with the reference group, the risk for MACE was significantly higher in the ≥120 mg/dl group (adjusted HR 1.74 [95%CI 1.11-2.71], P=0.01), although it was comparable in the 100-119 mg/dl group (adjusted HR 1.23 [95%CI 0.78-1.94], P=0.38) and in the <80 mg/dl group (adjusted HR 1.15 [95%CI 0.75-1.75], P=0.52). CONCLUSIONS: Strong statin therapy was associated with a trend toward lower cardiovascular risk compared with standard statin therapy. When LDL-C <120 mg/dl was achieved, risks for cardiovascular events were comparable irrespective of achieved LDL-C level.

Incidence and outcome of surgical procedures after coronary bare-metal and drug-eluting stent implantation: a report from the CREDO-Kyoto PCI/CABG registry cohort-2.

BACKGROUND: There still remain safety concerns on surgical procedures after coronary drug-eluting stents (DES) implantation, and optimal management of perioperative antiplatelet therapy (APT) has not been yet established. METHODS AND RESULTS: During 3-year follow-up of 12 207 patients (DES=6802 patients and bare-metal stent [BMS] only=5405 patients) who underwent coronary stent implantation in the CREDO-Kyoto registry cohort-2, surgical procedures were performed in 2398 patients (DES=1295 patients and BMS=1103 patients). Surgical procedures (early surgery in particular) were more frequently performed in the BMS group than in the DES group (4.4% versus 1.9% at 42-day and 23% versus 21% at 3-year, log-rank P=0.0007). Cumulative incidences of death/myocardial infarction (MI)/stent thrombosis (ST) and bleeding at 30 days after surgery were low, without differences between BMS and DES (3.5% versus 2.9%, P=0.4 and 3.2% versus 2.1%, P=0.2, respectively). The adjusted risks of DES use relative to BMS use for death/MI/ST and bleeding were not significant (hazard ratio: 1.63, 95% confidence interval: 0.93 to 2.87, P=0.09 and hazard ratio: 0.6, 95% confidence interval: 0.34 to 1.06, P=0.08, respectively). The risks of perioperative single- and no-APT relative to dual-APT for both death/MI/ST and bleeding were not significant; single-APT as compared with dual-APT tended to be associated with lower risk for death/MI/ST (hazard ratio: 0.4, 95% confidence interval: 0.13 to 1.01, P=0.053). CONCLUSIONS: Surgical procedures were commonly performed after coronary stent implantation, and the risk of ischemic and bleeding complications in surgical procedures was low. In patients selected to receive DES or BMS, there were no differences in outcomes. Perioperative administration of dual-APT was not associated with lower risk for ischemic events.