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Should the findings of the DAPT trial change my practice?
One of AfricaPCR 2016’s final sessions discussed this
question and a distinguished panel concluded, albeit with
a few reservations and caveats, that the answer is ‘yes’.
DAPT was the first large trial to evaluate the benefits of
dual antiplatelet therapy prolonged beyond 12 months after
percutaneous coronary intervention (PCI).
DAPT set out to investigate, as an effectiveness
endpoint, whether prolonged dual antiplatelet therapy was
associated with a reduction in stent thrombosis and in
major cardiovascular and cerebrovascular events. The safety
endpoint was its effect on moderate or severe bleeding.
It found that prolonging therapy up to 30 months
was associated with a 71% relative risk reduction in stent
thrombosis and a 29% relative risk reduction in major events.
But there was a price to pay in that there was a 1.6–2.5%
increase in rate of bleeding.
Prior to DAPT, previous practice had been to give
therapy for much shorter periods, usually one to six months.
Reviewing what was known before the study, Dr Colin
Schamroth, from Johannesburg, noted that most previous
studies had suggested that there was no solid evidence to
support treatment beyond 12 months. TRITON-TIMI had
hinted that there might be a case for prolonging therapy, but
had still concluded that most benefit was accrued over 12
months.
The 2012 European guidelines currently recommend dual
antiplatelet therapy for a minimum of one month in patients
with bare-metal stents and six months in those with drug-
eluting stents, with three to six months for the former and six
to 12 months for the latter being the preferred strategy. Drug-
eluting stents are associated with higher rates of thrombosis.
Twelve months of therapy are recommended for unstented
STEMI patients.
Drilling down into the details of DAPT, Dr Riaz Dawood,
also from Johannesburg, noted that it was a well-designed
trial with results that were valid and not underpowered. It
included nearly 10 000 patients from 11 countries. However,
none of these was in Africa, South America or Asia. He also
underscored that it was a low-risk population, excluding
patients with a high risk of bleeding or ischaemic events.
The 29% relative risk reduction in major events was driven
mainly by a decrease in myocardial infarction (MI), with no
significant differences observed in respect of mortality and
haemorrhagic stroke. The increase in bleeding risk was driven
by moderate bleeding, with severe, life-threatening bleeding not
significant. All-cause mortality, however, showed a 36% increase,
but this was not driven by either cardiovascular death or by
bleeding, but rather by cancer. Dr Dawood felt that this was most
likely a ‘play of chance’, unrelated to dual antiplatelet therapy.
In conclusion, DAPT found that prolonging therapy up to
30 months was associated with a significant reduction in rates
of thrombosis and major events, notably MI, but at a risk of
increased rates of bleeding. The MI benefit was not limited
to stented sites. The findings were also consistent, regardless
of which thienopyridine agents were used.
So should these findings change clinical practice? Prof
Pravin Manga, from Johannesburg, offered a cautious ‘yes’.
‘The evidence suggests that longer and maybe even indefinite
therapy may be of benefit, but we need to be very careful
when it comes to patient selection.’
Dr Dawood echoed this. ‘Bleeding worries us more than
ischaemic events, and bleeding risk increases with age, so
one needs to be especially cautious in elderly patients. But
in patients without contra-indications who are at risk of
thrombosis, but with a low bleeding risk, why not continue?’
Source: AfricaPCR 2016