Incidence, nature, and temporal trends of adverse events associated with noncardiac procedures among veterans with drug-eluting coronary artery stents

Abstract

Background: The incidence of adverse events with noncardiac procedures (NCP) after the use of drug eluting stents (DES) is not well studied. We sought to determine the incidence and temporal trends of adverse events in patients undergoing NCP after coronary DES.

Methods: We performed a retrospective review of patients receiving DES during percutaneous coronary intervention (PCI) in the Lexington VAMC between January 1, 2004 and December 31, 2010 to determine the circumstances and the results of their NCP.

Results: We identified 1,092 patients who underwent at least one PCI with DES who were followed for at least 3 years. Of those, 452 patients (41%) had a NCP at a median of 534 days after PCI with 1,081 procedures (894 low-, 160 Intermediate-, and 27 high-risk) performed. Clinically relevant NCP-related complications were defined as significant bleeding or stent thrombosis and occurred in 13 individuals (nine perioperative bleeding and four probable/possible stent thrombosis including two mortalities). Five adverse events occurred within the first year at a rate of 0.014 event/patient-year. During the remainder of follow-up (up to 9 years), eight events were documented at a rate of 0.0004 event/patient-years. During the first year of follow-up, there was no significant increase in risk of recurrent myocardial infarction (MI) or target vessel revascularization (TVR) in patients undergoing NCP but higher risk of all-cause mortality in those who did not undergo NCP. However, in patients who underwent NCP, there was a statistically significant increase in myocardial infarction (MI), target vessel revascularization (TVR), and rehospitalization for cardiac reasons compared with those without NCP during long term follow-up (median of 5.6 years).

Conclusion: NCP after DES requiring management of DAT are relatively common among veterans following PCI using DES. The risk of bleeding and stent thrombosis is concentrated in the first year but remains very low.

Keywords: adverse events; drug eluting stents; dual antiplatelet therapy; noncardiac procedures; percutaneous coronary intervention.

Figure 1. The distribution of patients among the various risk non-cardiac procedures

Pie graph demonstrating the distribution of patients among the various risk procedures. Most of the patients underwent low risk procedures (see methods for details).

Figure 2

Flow chart summarizing the incidence of complications in the study sample.

Figure 3

Bar graphs demonstrating the rates of clinically important adverse events in patients who underwent non-cardiac procedures vs. those who did not The rate of all cause mortality (Panel A) did not differ significantly among the study groups. However, the rates of repeat revascularization (Panel B), recurrent myocardial infarction (Panel C), rehospitalizations (Panel D) and target vessel revascularization (Panel E) were higher in patients who underwent non-cardiac procedures.

Figure 3

Bar graphs demonstrating the rates of clinically important adverse events in patients who underwent non-cardiac procedures vs. those who did not The rate of all cause mortality (Panel A) did not differ significantly among the study groups. However, the rates of repeat revascularization (Panel B), recurrent myocardial infarction (Panel C), rehospitalizations (Panel D) and target vessel revascularization (Panel E) were higher in patients who underwent non-cardiac procedures.

Figure 4. Kaplan-Meier curves demonstrating the event free survival from all cause mortality throughout the follow up duration

The rates of all cause mortality were higher in patients who did not undergo non-cardiac procedures for the first 4 years following their index PCI. However, the curves overlapped after the fourth year and there was no statistically significant difference in the overall analysis. The numbers in the table represent the numbers still at risk for the endpoint at the indicated time points.

Figure 5. Kaplan-Meier curves demonstrating the event free survival from recurrent myocardial infarction throughout the follow up duration

The overall rates of recurrent myocardial infarction were higher in patients who underwent non-cardiac procedures at the end of study follow-up. However, the curves did not start separating until after the first year after the index percutaneous coronary intervention. The numbers in the table represent the numbers still at risk for the endpoint at the indicated time points.

Figure 6. Kaplan-Meier curves demonstrating the event free survival from target vessel revascularization throughout the follow up duration

The overall rates of target vessel revascularization were higher in patients who underwent non-cardiac procedures at the end of study follow-up. However, the curves did not start separating until after the first year after the index percutaneous coronary intervention. The numbers in the table represent the numbers still at risk for the endpoint at the indicated time points.

Figure 7

Forest plot demonstrating the adjusted hazard ratio of all cause mortality in the study population. Chronic kidney disease was statistically associated with higher risk for all cause mortality. Diabetes showed a trend towards higher risk of all cause mortality. On the other hand, second generation drug eluting stents were protective.

Figure 8

Forest plot demonstrating the adjusted hazard ratio of recurrent myocardial infarction in the study population. Diabetes was statistically associated with higher risk for recurrent myocardial infarction. Hypertension and chronic kidney disease showed trends towards higher risk of recurrent myocardial infarction. On the other hand, second generation drug eluting stents showed trends for being protective.

Figure 9

Forest plot demonstrating the adjusted hazard ratio of target vessel revascularization in the study population. Diabetes, hypertension and tobacco use showed trends towards higher risk of target vessel revascularization. On the other hand, second generation drug eluting stents showed trends for being protective.