to 1-year period post-procedure. Valve deterioration did not seem to be associated with an excess
of cardiovascular events, based on cumulative
incidence of the composite measure that included
death, stroke, MI, and aortic valve re-intervention.
Patient factors linked to valve deterioration included AF or atrial flutter, age, severe lung disease,
and high body mass index (BMI).
Said Dr. Vemulapalli: “Our finding—including
the low incidence of valve deterioration and apparent lack of association with major cardiovascular
events up to 18 months after the procedure—may
help to inform TAVR care. The information on
patient risk factors may aid in patient selection, surveillance and preventive strategies.”
time trends in anticoagulant use in PCI for acute
MI, had another study at ACC.16, this time examining the comparative effectiveness of bivalirudin
versus UFH in the same setting.
In the largest, real-world population examined to
date, bivalirudin data came from 550,396 patients
and UFH data from another 515,988 patients. After
instrumental variable analysis, bivalirudin was associated with a 2.59% absolute reduction in bleeding
(p < 0.01) but with no difference in mortality (p =
0.35) and a 0.23% increase in repeat PCI for stent
thrombosis (p < 0.01). Bleeding reductions were
greatest in STEMI patients but negligible for those
undergoing PCI via trans-radial access (remember
this for another study reported below).
Yes, Interventionalists Respond to Data
PCI Operator Volume: It Varies (a lot)
Given the vast amount of new data and so little
time to absorb it all, there is always a question as
to whether news makes its way to clinical practice.
A report from the ACC’s CathPCI Registry® shows
how well PCI operators are paying attention.
Bivalirudin for PCI in the United States increased until 2013 in patients with acute MI,
followed by a rapid early decline in early 2014,
corresponding to the release of HEAT-PPCI (How
Effective are Antithrombotic Therapies in PPCI?)
involved a “real-world” population of patients to
evaluate bivalirudin + ‘bailout’ glycoprotein IIb/IIIa
inhibitors (GPI) (n = 905) versus heparin + ‘bailout’ GPI (n = 907), per guideline-directed recommendations for such use.
For the primary outcome of major acute
coronary events (MACE) at 28 days (a combined
endpoint including death, stroke, reinfarction, and
target lesion revascularization [TLR]), bivalirudin
was associated with significantly more events (8.7%
vs. 5.7%, RR 1.52; p = 0.01), mostly due to an
increase in MI/stent thrombosis. Moreover, while
decreased bleeding is often touted as the predominant reason to use bivalirudin, HEAT PPCI showed
no major bleeding reduction with bivalirudin.
The authors concluded that their results suggest
substantial savings in drug costs with heparin plus
selective (‘bailout’) glycoprotein inhibition.
The new NCDR® analysis was based on an analysis of 1,066,384 PCIs (49% STEMI) performed
from July 2009, through Dec. 2014. Bivalirudin
monotherapy use increased linearly from 2009
through 2013 (increasing from 26.3% to 50.4%)
followed by a decline in 2014 (42.4% by the 4th
quarter of the year). Conversely, there was a sharp
increase in unfractionated heparin (UFH) monotherapy starting in 2014, jumping from 18.7% early
in the year to 27.5% in the 4th quarter. Operators
were more likely to use bivalirudin during PCI for
NSTEMI and GPIs during PCI for STEMI.
Having said that, clearly there remains significant
variation in bivalirudin and GPI use during PCI for
acute MI that persists in the U.S.
What about the bleeding issue? Does bivalirudin really have no impact on bleeding? One of the
problems with the data has been the unbalanced
use of GPI with UFH in comparator arms. Eric
Secemsky, MD, of Harvard and associated centers,
and colleagues, who reported the data above on
Due to increasing procedural success and sa fety, the
2013 ACC/AHA/SCAI clinical competence statement
for PCI reduced the recommended annual minimum
number of PCI procedures performed by each operator
to 50. Again, using NCDR® CathPCI Registry® data,
a team of DCRI investigators analyzed about 99% of
operators (the National Provider Identifier number was
missing for fewer than 1% of the registry participants).
The overall number of PCIs has stabilized since
2010 in the West and South and since 2011 in the
Northeast and Midwest. Median annual operator
volume was 60, with 44% of operators performing
fewer than the recommended 50 procedures per
year. Other findings:
ACC.org/CSWNInterventions
• Patient characteristics were similar for low(< 50 procedures), medium- (50 to 100), and
high-volume (> 100) centers.
• Low-volume operators practiced at smaller hospitals with lower average annual PCI volumes.
• Low-volume operators attempted more
emergent PCIs.
• High-volume operators more often used drugeluting stents, radial access, and UFH; they less
often used GPIs.
Of course, operators may perform PCIs at nonCathPCI hospitals (such as Veterans Administration
hospitals), which means the data for these procedures are not included in this study.
Operator volume varied substantially across the
U.S., with significant differences in procedure type
and interventional practice patterns. The authors
concluded that further research on procedure appropriateness and outcomes are needed before the
guideline-based volume standards are enforced.
Which Strategies Impact 30-day
Readmission After PCI?
Operator volume varied
substantially across the
U.S. , with significant
differences in procedures
and interventional
practice patterns.
Estimated rates vary, but it seems safe to say that
more than one in 10 PCI patients are readmitted
to the hospital within 30 days of discharge. These
patients are at increased risk of adverse events and
poorer short-term outcomes.
We do know that risk-standardized readmission rates (RSRR) post-PCI vary substantially across
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