Mode of death after contemporary percutaneous
coronary intervention: A report from the Evaluation
of Drug Eluting Stents and Ischemic Events registry
Joshua M. Stolker, MD,
a
David J. Cohen, MD, MSc,
b
Jason B. Lindsey, MD,
b
Kevin F. Kennedy, MS,
b
Neal S. Kleiman, MD,
c
and Steven P. Marso, MD
b
St Louis, and Kansas City, MO; and Houston, TX
Background
When selecting clinical trial end points, some investigators prefer cardiovascular death (CVD) while others
believe that all-cause mortality is more relevant. However, the relative contribution of CVD to 1-year mortality after
contemporary percutaneous coronary intervention (PCI) is not known.
Methods
We evaluated the mode of death (MOD) in EVENT, a prospective PCI registry at 55 US hospitals. Vital status was
assessed at 6 and 12 months as part of the study protocol, and MOD was independently reviewed in blinded fashion.
Results
Between 2004 and 2007, EVENT enrolled 10,144 patients of whom 295 (2.9%) died within the first year:
51 (17%) ≤30 days; and 244 (83%) between 31 and 365 days after index PCI. Overall, CVD accounted for 42% of deaths,
and no clear cause could be identified in a substantial subgroup (25% of deaths). Among patients who died ≤30 days, the
MOD was more likely to be CVD (odds ratio 3.96, 95% CI 2.08-7.55), whereas the incidence of CVD and non-CVD was
similar after 30 days. Findings were similar after a series of sensitivity analyses including reassignment of unknown MOD to the
CVD category, using multiple imputation modeling, or when evaluating MOD in prespecified subgroups of patients with
diabetes, acute coronary syndromes, or left ventricular dysfunction.
Conclusions
Among unselected PCI patients, 1-year mortality is approximately 3%, and CVD is confirmed in b50% of
all deaths. Regardless of analytic approach, CVD is the primary contributor to overall mortality during the first 30 days after
PCI, whereas rates of CVD and non-CVD are remarkably similar after the first month after PCI. (Am Heart J 2011;162:914-21.)
Historically, patients undergoing coronary angioplasty
were at high risk of experiencing cardiovascular death
(CVD), often related to periprocedural mechanical
complications and suboptimal adjunctive medical thera-
py.
1,2
Advances in interventional techniques, equipment,
and pharmacologic treatment strategies have contributed
to a marked decline in mortality after contemporary
percutaneous coronary intervention (PCI), with recent
studies demonstrating N95% angiographic success and
b1% early mortality in the coronary stent era.
3
These
improvements, coupled with significant advances in
secondary prevention of coronary artery disease (CAD)
and changes in upstream decision making before selecting
patients for PCI, have contributed to a significant
reduction in CVD.
4,5
Because of these temporal changes, the relative
contribution of CVD to overall mortality is likely to
have changed over time, and the timing of mortality in
these patients may have shifted from the index PCI
hospitalization to later time points. These findings may
also affect clinical trial design, as some investigators
prefer to use CVD as an end point (or a component of a
composite end point), whereas others believe that all-
cause mortality is more relevant.
6
However, factors
related to death after PCI are not well described in the
current era of drug-eluting stents (DES) and prolonged
dual antiplatelet therapy.
We therefore used data from the EVENT registry to
evaluate the frequency, timing, and mode of death (MOD)
during the first year after PCI among unselected patients
treated for a wide variety of clinical indications. We then
analyzed post-PCI mortality among subgroups of patients
experiencing CVD, non-CVD, and unknown MOD.
From the
a
Saint Louis University, St Louis, MO,
b
Saint Luke's Mid America Heart and
Vascular Institute, Kansas City, MO, and
c
Methodist DeBakey Heart Center, Houston, TX.
Submitted February 7, 2011; accepted August 19, 2011.
Reprint requests: Joshua M. Stolker, MD, Saint Louis University, 3635 Vista Avenue, St
Louis, MO 63110.
E-mail: jstolker@yahoo.com
0002-8703/$ - see front matter
© 2011, Mosby, Inc. All rights reserved.
doi:10.1016/j.ahj.2011.08.014