Comparative effectiveness of drug-eluting stents on long-term outcomes in elderly patients treated for in-stent restenosis: a report from the National Cardiovascular Data Registry.

OBJECTIVE: We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies. BACKGROUND: Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI). METHODS: We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims. RESULTS: Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS. CONCLUSIONS: There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

Effect of race and ethnicity on outcomes with drug-eluting and bare metal stents: results in 423 965 patients in the linked National Cardiovascular Data Registry and centers for Medicare & Medicaid services payer databases.

BACKGROUND: Black, Hispanic, and Asian patients have been underrepresented in percutaneous coronary intervention clinical trials; therefore, there are limited data available on outcomes for these race/ethnicity groups. METHODS AND RESULTS: We examined outcomes in 423 965 patients in the National Cardiovascular Data Registry CathPCI Registry database linked to Medicare claims for follow-up. Within each race/ethnicity group, we examined trends in drug-eluting stent (DES) use, 30-month outcomes, and relative outcomes of DES versus bare metal stents. Overall, 390 351 white, 20 191 black, 9342 Hispanic, and 4171 Asian patients > 65 years of age underwent stent implantation from 2004 through 2008 at 940 National Cardiovascular Data Registry participating sites. Trends in adoption of DES were similar across all groups. Relative to whites, black and Hispanic patients undergoing percutaneous coronary intervention had higher long-term risks of death and myocardial infarction (blacks: hazard ratio, 1.28; 95% confidence interval, 1.24-1.32; Hispanics: hazard ratio, 1.15; 95% confidence interval, 1.10-1.21). Long-term outcomes were similar in Asians and whites (hazard ratio, 0.99; 95% confidence interval, 0.92-1.08). Use of DES was associated with better 30-month survival and lower myocardial infarction rates compared with the use of bare metal stents among all race/ethnicity groups except Hispanics, who had similar outcomes with DES or bare metal stents. CONCLUSIONS: Black and Hispanic patients undergoing percutaneous coronary intervention had worse long-term outcomes relative to white and Asian patients. Compared with bare metal stent use, DES use was generally associated with superior long-term outcomes in all racial and ethnic groups, although these differences were not statistically significant in Hispanic patients.

Long-term safety and effectiveness of mechanical versus biologic aortic valve prostheses in older patients: results from the Society of Thoracic Surgeons Adult Cardiac Surgery National Database.

BACKGROUND: There is a paucity of long-term data comparing biological versus mechanical aortic valve prostheses in older individuals. METHODS AND RESULTS: We performed follow-up of patients aged 65 to 80 years undergoing aortic valve replacement with a biological (n=24 410) or mechanical (n=14 789) prosthesis from 1991 to 1999 at 605 centers within the Society of Thoracic Surgeons Adult Cardiac Surgery Database using Medicare inpatient claims (mean, 12.6 years; maximum, 17 years; minimum, 8 years), and outcomes were compared by propensity methods. Among Medicare-linked patients undergoing aortic valve replacement (mean age, 73 years), both reoperation (4.0%) and endocarditis (1.9%) were uncommon to 12 years; however, the risk for other adverse outcomes was high, including death (66.5%), stroke (14.1%), and bleeding (17.9%). Compared with those receiving a mechanical valve, patients given a bioprosthesis had a similar adjusted risk for death (hazard ratio, 1.04; 95% confidence interval, 1.01-1.07), higher risks for reoperation (hazard ratio, 2.55; 95% confidence interval, 2.14-3.03) and endocarditis (hazard ratio, 1.60; 95% confidence interval, 1.31-1.94), and lower risks for stroke (hazard ratio, 0.87; 95% confidence interval, 0.82-0.93) and bleeding (hazard ratio, 0.66; 95% confidence interval, 0.62-0.70). Although these results were generally consistent among patient subgroups, bioprosthesis patients aged 65 to 69 years had a substantially elevated 12-year absolute risk of reoperation (10.5%). CONCLUSIONS: Among patients undergoing aortic valve replacement, long-term mortality rates were similar for those who received bioprosthetic versus mechanical valves. Bioprostheses were associated with a higher long-term risk of reoperation and endocarditis but a lower risk of stroke and hemorrhage. These risks varied as a function of a patient's age and comorbidities.

Early anticoagulation of bioprosthetic aortic valves in older patients: results from the Society of Thoracic Surgeons Adult Cardiac Surgery National Database.

OBJECTIVES: The aim of this study was to evaluate the risks and benefits of short-term anticoagulation in patients receiving aortic valve bioprostheses. BACKGROUND: Patients receiving aortic valve bioprostheses have an elevated early risk of thromboembolic events; however, the risks and benefits of short-term anticoagulation have been debated with limited evidence. METHODS: Our cohort consisted of 25,656 patients ≥65 years of age receiving aortic valve bioprostheses at 797 hospitals within the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2004 to 2006). The associated 3-month incidences of death or readmission for embolic (cerebrovascular accident, transient ischemic attack, and noncerebral arterial thromboembolism) or bleeding events were compared across discharge anticoagulation strategies with propensity methods. RESULTS: In this cohort (median age, 77 years), the 3 most common discharge anticoagulation strategies included: aspirin-only (49%), warfarin-only (12%), and warfarin plus aspirin (23%). Among those receiving aspirin-only, 3-month adverse events were low (death, 3.0%; embolic events, 1.0%; bleeding events, 1.0%). Relative to aspirin-only, those treated with warfarin plus aspirin had a lower adjusted risk of death (relative risk [RR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.96) and embolic event (RR: 0.52, 95% CI: 0.35 to 0.76) but a higher risk of bleeding (RR: 2.80, 95% CI: 2.18 to 3.60). Relative to aspirin-only, warfarin-only patients had a similar risk of death (RR: 1.01, 95% CI: 0.80 to 1.27), embolic events (RR: 0.95, 95% CI: 0.61 to 1.47), and bleeding (RR: 1.23, 95% CI: 0.85 to 1.79). These results were generally consistent across patient subgroups. CONCLUSIONS: Death and embolic events were relatively rare in the first 3 months after bioprosthetic aortic valve replacement. Compared with aspirin-only, aspirin plus warfarin was associated with a reduced risk of death and embolic events, but at the cost of an increased bleeding risk.

Linking the National Cardiovascular Data Registry CathPCI Registry with Medicare claims data: validation of a longitudinal cohort of elderly patients undergoing cardiac catheterization.

BACKGROUND: The National Cardiovascular Data Registry CathPCI Registry was recently linked with longitudinal Centers for Medicare & Medicaid (CMS) claims data. The degree to which this linked cohort is representative of the overall CathPCI Registry and CMS PCI populations is unknown. METHODS AND RESULTS: CathPCI Registry records were linked to CMS inpatient claims using indirect identifiers. We examined the degree to which hospitals and patients in the linked cohort are representative of the elderly (≥65 years) CathPCI Registry and CMS populations. From 2004 to 2006, 1492 hospitals filed CMS PCI claims and 663 contributed CathPCI Registry data. Of these hospitals, 643 (97%) were linked across data sources. Compared with all CMS PCI hospitals, the linked data set contained fewer governmental, northeastern, southern, and low-volume (<200 beds) sites. Among CMS beneficiaries, 993,351 PCI procedures were performed, including 398,508 (40.1%) at centers in the linked database. Of these, 341,916 (86%) were linked to CathPCI Registry records. Linked and unlinked CMS patients had similar demographic and clinical features. In the CathPCI Registry database, 477,456 elderly patients underwent PCI, with 359,077 (75%) linked to CMS claims. Linked and unlinked National Cardiovascular Data Registry patients were similar, except for less commercial or health maintenance organization insurance in the linked cohort. CONCLUSIONS: By using deterministic matching strategies, a large and representative cohort with detailed clinical data from the CathPCI Registry and longitudinal follow-up from CMS claims has been created.