Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009).

OBJECTIVES: To evaluate the safety of drug-eluting stents (DES) when treating patients with failing saphenous vein grafts (SVG). BACKGROUND: DES reduce target vessel revascularization in patients with failing SVGs; however, compared with bare metal stents (BMS), DES have been variably associated with increased mortality. METHODS: Clinical records from National Cardiovascular Data Registry(®) CathPCI Registry(®) (49,325 older individuals [≥65 years] who underwent SVG stenting 2005-2009) were linked to Medicare claims to create a longitudinal record. Death, myocardial infarction (MI), and urgent revascularization with DES versus BMS were evaluated to 3 years using propensity matching (PM). Results were stratified by clinical presentation (acute coronary syndrome [ACS], non-ACS), previous lesion treatment (in-stent, de novo), and graft segment (aortic, body, distal anastomosis). RESULTS: In this older cohort (median age, 75 years), acute presentations were prevalent (ACS, 69%; TIMI flow <3, 45%), and adverse clinical outcomes were common by 3 years (death, 24.5%; MI, 14.6%; urgent revascularization, 29.5%). Among DES patients (n = 31,403), 3-year mortality was lower (vs. BMS) (22.7% vs. 28.0%, P < 0.001; PM hazard ratio [HR] 0.87, 95% confidence interval 0.83-0.91), and no difference was observed in the adjusted risk for MI (PM HR 0.97, 0.91 to 1.03) or urgent revascularization (PM HR 1.04, 0.99-1.08). These findings were independent of clinical presentation, previous lesion treatment, and graft segment (P interaction, ns). CONCLUSIONS: In this large SVG PCI cohort, all-cause mortality was lower among those receiving DES, and no difference in MI or urgent revascularization was observed to 3 years. © 2015 Wiley Periodicals, Inc.

Three-year outcomes associated with embolic protection in saphenous vein graft intervention: results in 49 325 senior patients in the Medicare-linked National Cardiovascular Data Registry CathPCI Registry.

BACKGROUND: Information is limited on contemporary use and outcomes of embolic protection devices (EPDs) in saphenous vein graft interventions. METHODS AND RESULTS: We formed a longitudinal cohort (2005-2009; n=49 325) by linking National Cardiovascular Data Registry CathPCI Registry to Medicare claims to examine the association between EPD use and both procedural and long-term outcomes among seniors (65+ years), adjusting for clinical factors using propensity and instrumental variable methodologies. Prespecified high-risk subgroups included acute coronary syndrome and de novo or graft body lesions. EPDs were used in 21.2% of saphenous vein grafts (median age, 75; 23% women) and were more common in acute coronary syndrome (versus non-acute coronary syndrome; 22% versus 19%), de novo (versus restenotic; 22% versus 14%), and graft body lesions (versus aortic and distal anastomosis; 24% versus 20% versus 8%, respectively). EPDs were associated with a slightly higher incidence of procedural complications, including no reflow (3.9% versus 2.8%; P<0.001), vessel dissection (1.3% versus 1.1%; P=0.05), perforation (0.7% versus 0.4%; P=0.001), and periprocedural myocardial infarction (2.8% versus 1.8%; P<0.001). By 3 years, death, myocardial infarction, and repeat revascularization occurred in 25%, 15%, and 30% of cases, respectively. EPD use was associated with a similar adjusted risk of death (propensity score-matched hazard ratio, 0.96; 95% confidence interval, 0.91-1.02), myocardial infarction (propensity score-matched hazard ratio, 1.00; 95% confidence interval, 0.93-1.09), and repeat revascularization (propensity score-matched hazard ratio, 1.02; 95% confidence interval, 0.96-1.08) in the overall cohort and high-risk subgroups. CONCLUSIONS: In this contemporary cohort, EPDs were used more commonly among patients with high-risk clinical indications, yet there was no evidence of improved acute- or long-term outcomes. Further prospective studies are needed to support routine EPD use.