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Should the findings of the TASTE and TOTAL trials change
clinical practice?
The TOTAL and TASTE trials were undertaken to evaluate
whether mechanical thrombus aspiration should routinely
accompany primary percutaneous coronary intervention
(PCI) for STEMI.
Evaluating the evidence prior to the two trials, Dr David
Kettles from East London, South Africa, observed that it’s
been known for a long time that thrombus is the enemy of
good cath lab outcomes. ‘In STEMI, epicardial flow does
not equal reperfusion. Distal embolisation is often a problem
and angioplasty and stenting can contribute to this. Fifteen
per cent of patients undergoing primary PCI have visible
distal emboli, and myocardial perfusion after primary PCI
is the strongest predictor of mortality.’ He was speaking at
AfricaPCR 2016.
Aspiration is one of multiple approaches to deal with distal
embolisation of thrombus and atherosclerotic debris. Many
studies have suggested that manual thrombus aspiration
improves ST-segment resolution and various surrogate
markers.
‘It’s pathophysiologically plausible and relatively simple.
It makes PCI easier and may have short- and long-term
benefits. But what about the risk of complications? While
the literature tends to downplay these, there is very possibly
a higher stroke risk in real-world settings. It’s possible the
trials prior to TASTE and TOTAL underestimated the risks.
So we needed these randomised, controlled trials powered for
mortality.’
Reviewing the two trials, Dr Hellmuth Weich, from Cape
Town, South Africa, observed that TASTE was a multicentre,
randomised, controlled trial evaluating all-cause mortality
at 30 days in patients undergoing primary or rescue PCI for
STEMI, either with or without thrombus aspiration. Patients
were randomised after angioplasty.
There was virtually no difference in outcomes between the
two arms at 30 days (2.8 vs 3.0%), with comparable findings
at one year. ‘While it was a good trial, it may have been
underpowered. There was very low mortality overall and
there might possibly have been a selection bias, given that
patients were randomised post angioplasty.’
TOTAL was a bigger trial than TASTE, and subjects were
randomised prior to angioplasty. Its primary endpoint was
a composite of cardiovascular death, recurrent myocardial
infarction, class IV heart failure and cardiogenic shock at six
months.
Once again, there was no significant difference in outcomes
between the two arms of the trial. Of concern, however, was
an increase in stroke in the aspirated arm that continued up
to six months after the procedure.
Dr Weich noted in conclusion that there is therefore no
evidence to suggest that manual thrombus aspiration be
undertaken routinely. While the trials were interesting, it
should also be kept in mind that the patient populations were
not the same as those in Africa.
In the discussions that followed, the feeling was that the
trials don’t tell interventional cardiologists
not
to undertake
aspiration, just not to do it
routinely
. Patient selection is
therefore an important concern, as is technique, in order
to prevent stroke. ‘Pay careful attention to the guiding
catheter and start aspiration 2 cm proximal to the lesion’,
said Dr Kettles. ‘Employ multiple slow-passage techniques
– at least two or three passes. Withdraw the aspirate catheter
under aspiration and aspirate the guide thereafter.’ Another
important determinant is the size and extent of the thrombus.
Summing up the key learnings, Dr William Wijns,
chairman of PCR, made the following points:
•
There is no evidence of benefit of systematic mechanical
aspiration during PCI based on primary or secondary
efficacy measures.
•
There’s a possible safety signal in the form of increased
stroke rates; this is a hypothesis-generating finding.
•
Operators may still choose thrombus aspiration in indi-
vidual cases in order to facilitate procedural technique,
bearing in mind that it will have no benefit in respect of
endpoints such as mortality.
‘There is an open door for its selective use, for example
in cases of significant thrombus burden. Unmet needs
remain, and we require better tools to remove thrombus
efficaciously while protecting the myocardium. We also
need to bear in mind that TOTAL and TASTE are not fully
relevant to Africa, where the dominant treatment of STEMI
is pharmaco-invasive and most patients are late presenters.’
Source: AfricaPCR 2016