Three-Year Outcomes Associated With Embolic Protection in Saphenous Vein Graft Intervention

Abstract

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.

Outcomes of Saphenous Vein Graft Intervention With and Without Embolic Protection Device

“…These results raised questions about the safety and efficacy of EPDs in routine SVG intervention and a concern about the relevance of existing randomized data to contemporary clinical practice. Despite a Class I recommendation, we found the utilization of EPD in SVG intervention to be low (21.7%), which is consistent with previous literature, 7,11,23 with even a decreasing trend in EPD use over time. 7 There are several explanations for this lower rate of EPD use.…”

“…Except for late MI and MACE, studies were homogenous for the outcomes of all-cause mortality, periprocedural MI, and TVR. 11 NCDR CathPCI Registry study 11 has the largest sample size compared with other studies, and this may skew the results of this study. Thus, sensitivity analysis was performed excluding NCDR CathPCI Registry study showing studies were homogenous for all outcomes.…”

“…[4][5][6][7][8][9][10][11] Literature search and the selection process are shown in Figure 1. Studies overview, baseline patient characteristics, Newcastle-Ottawa quality assessment score, and outcomes are included in Table 1.…”

“…4,11,12 Moreover, in the recent era, no-reflow and periprocedural MI during SVG intervention has decreased 13,14 …”

“…Additionally, EPD use is associated with procedural complications including vessel perforation, dissection, and device entrapment. 4,11 Simpler technique such as direct stenting, 25 undersizing stents with higher stent/lesion length ratio, and periprocedural vasodilator therapy 26 has been proven beneficial in preventing noreflow phenomenon that may limit the benefits of EPD use. Studies showed that without visible thrombus, prophylactic use of intragraft abciximab and vasodilators including verapamil, adenosine, or nicardipine combined with or without direct stenting is a safe and effective strategy to prevent distal microembolization and no-reflow phenomenon in SVG intervention.…”