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November 2010
An Interview with Mahmood Razavi, MD
A discussion on current DVT therapies and how to achieve optimal outcomes for each patient.
How would you briefly describe the data landscape pertaining
to deep vein thrombosis (DVT) therapies?
Almost 20 years after the initial report by Drs. Semba
and Dake, the data landscape regarding catheter-based
interventions for clot removal is still bare. Although there
are numerous reports on the adjunctive use of thrombolysis
in patients with DVT, the level of evidence as to the best
initial therapy for these patients remains low.
Interestingly, the same is not true for anticoagulation alone, which is a very data-rich field. Many new and improved anticoagulants are on the horizon, with trials addressing both prophylactic and active treatment primary endpoints. Although these studies have and will continue to add to the quantity and quality of data for anticoagulation, the fundamental question of whether initial clot removal should be used as an adjunct to anticoagulation remains unanswered. The hope is that the ATTRACT trial will address this uncertainty.
What are the goals of the ATTRACT trial, and what is
your role in it?
The framework of this study was put together by
Principal Investigator Dr. Suresh Vedantham. ATTRACT is
funded by the National Heart, Lung, and Blood Institute
and is a phase 3, prospective, multicenter, randomized trial
of patients with proximal DVT. The primary objective of
ATTRACT is to establish whether percutaneous catheterbased
therapies for proximal DVT prevent postthrombotic
syndrome (PTS) and improve health-related quality of life
with acceptable safety and costs. PTS is a disabling complication
of proximal DVT that occurs in 25% to 50% of
patients. There are also several clinically relevant secondary
endpoints including severity of PTS, speed of symptom
relief, quality of life, and economic parameters, among others.
I am a member of the Steering Committee of this trial
and chair of its Interventional Committee. Our center at St.
Joseph Hospital Heart and Vascular Center in Orange,
California also participates in the study.
Based on the current data and experiences, how should
clinicians formulate decisions on which
treatment to offer their DVT patients?
Keeping in mind that there remains significant uncertainty
and clinical equipoise among physicians regarding the best initial treatment for proximal DVT, we strongly recommend
the first-line use of percutaneous catheter-based
therapies in appropriate patients with proximal DVT. This is
based on the favorable safety and efficacy outcomes of current
interventional therapies and the poor outcomes of
anticoagulation in preventing PTS in patients with extensive
proximal DVT.
What are some of the most important
things you have learned about preventing
PTS?
PTS is a common and often disabling
complication of proximal DVT (clot in the
iliofemoral segments). Our experience and
that of others suggest that early removal of
a clot improves venous outflow from the
limb and prevents valvular damage. This
reduces the risk of venous hypertension,
which is the main cause of PTS. We now
have to prove this to our colleagues outside
of the interventional arena.
Which DVT patients would you categorically say
are not candidates for mechanical thrombectomy
of any kind? Which treatment options would you
recommend for these patients?
Mechanical thrombectomy can be performed in almost
all patients with DVT. The problem is that the current generation
of devices is not very effective as a stand-alone therapy
in the majority of cases. Limitations on who should be
treated include patients with extensive thrombosis in the
popliteal vein and inferior vena cava (IVC). Once the clot is
removed, patency must be maintained by having good
inflow and outflow. Mechanical devices cannot physically
remove clots below the level of the sheath entry, and therefore,
these patients will require thrombolysis. These devices
are often used for debulking clots before or cleaning residual
thrombus after pharmacological thrombolysis.
Depending on the mode of action, patients with renal
insufficiency would not be good candidates for devices
causing hemolysis.
Do you view today's mechanical thrombectomy options
as complementary, interchangeable, or hierarchical in
terms of what they can do?
We should differentiate between the devices intended to
work without thrombolytic agents and those that only work with drugs. The former being the percutaneous
mechanical thrombectomy devices and latter being the
lytic-assisted devices. For the purpose of treating DVT, it is
rare for the current percutaneous mechanical thrombectomy
devices to work without lytics. These devices were
intended to compete with each other and are presumably
interchangeable. In practice, however, some work faster and
more effectively than others and hence are not really interchangeable.
Their clot debulking or cleanup functions can
be complementary to lytic-assisted devices. The efficacy of
the sequential use of these various devices has never been
rigorously studied, and therefore, their hierarchical value is
unknown.
How would you describe the use of IVC filters in your
practice? Has this changed at all during the past year or
two?
This is a very important question with potential public
health and economic implications. Although we adhere to
the classic indications for the placement of IVC filters, our
practice has grown in recent years, mostly driven by the
increasing number of oncologic or elderly patients with
DVT. The growth seen in the number of filters placed in
recent years in the United States is additionally fueled by
several other factors such as the introduction of optional
filters, more widespread adoption of prophylactic indications,
and aggressive marketing strategies on the part of
some manufacturers. I would be curious to know if the
increased use of IVC filters translates into a proportional
reduced incidence of pulmonary embolism. Interestingly,
there are data accumulating against the prophylactic use of
IVC filters, suggesting that the practice may not be as beneficial
as we think.
What are the roles of interventional therapies in patients
with pulmonary embolism (PE)?
The current indication for thrombolytic infusion is in
patients with massive PE. These patients are also good candidates
for catheter-based thrombectomy or thrombolysis.
Currently, our main percutaneous options are aspiration
thrombectomy with or without intraclot administration of
lytic drugs. In our practice, we have extended the indication
for intervention to submassive PE as well. There is an
ongoing European registry studying the efficacy of the
EkoSonic catheter system (Ekos Corporation, Bothell, WA)
for accelerated lysis of patients with PE, but the problem
(or the opportunity) here is that the PE space is a very
device-deficient arena and is badly in need of innovative
technologies.
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