Two-year follow-up data from the STEPP-AMI
study: A prospective, observational, multicenter
study comparing tenecteplase-facilitated PCI versus
primary PCI in Indian patients with STEMI
i n d i a n h e a r t j o u r n a l 6 8 ( 2 0 1 6 ) 1 6 9 – 1 7 3
DR MALLESWARA RAO
• patients who do reach the hospital early still have to deal with other issues, such
asarranging for finances, as most Indian patients pay out-of
• introduction of fibrin-specific lytic agents like tenecteplase (TNK) has improved
the IRA patency rates significantly.
• Rapid fibrinolytic treatment improved the outcomes in patients treated within
an hour of symptom onset, with tapering benefits after 3 hrs
• fibrinolysis -high rates of reocclusion of IRA
• initial bolus lysis followed by early CAG within 3–24 h
of fibrinolysis, with an appropriate PCI ='pharmacoinvasive strategy-good
alternative especially in a developing country such as India.
• STK vs immediate transport for PCI where the distance between
primary hospitals and tertiary PCI centres does not exceed 120 km.
• STEMI presenting within 12 h of symptom
• thrombolysis administered at the initial receiving hospital
(thrombolysis group, n=421) or immediate transport (within 30
min of randomisation) for primary PCI (PCI group, n=429)
Comparison of primary angioplasty and pre-
hospital fibrinolysis in acute myocardial
infarction (CAPTIM) trial: a 5-year follow-up
• primary angioplasty (n = 421)VS pre-hospital fibrinolysis (rt-PA) with
immediate transfer to a centre with interventional facilities (n = 419)
all-cause mortality at 5 years
• 9.7% in the pre-hospital fibrinolysis group
• 12.6% in PPCI [ P = 0.18].
patients included within 2 h, 5 year mortality
• 5.8% in the pre-hospital fibrinolysis group
• 11.1% in PPCI [HR 0.50 ( P = 0.04],
Patients included after 2 h, 5 year mortality
• 14.5 vs 14.4% [ P = 0.92].
• prospective, observational, multicenter pilot study,
• between August 2011 and May 2013
• Study sites, which were capable of performing 24/7 primary
PCI, were selected from Tamilnadu ,Karnataka , and
• 200 patients
• observational study, the treatment options were chosen entirely by
the patient and the attendants
• some patients who presented outside the recommended timelines
for thrombolysis have received lytic therapy .
• assess the safety, efficacy, and
feasibility of a pharmacoinvasive strategy in comparison to
primary PCI in STEMI
• primary endpoint
• set at 30 days
• composite of death, cardiogenic shock, reinfarction, repeat
revascularization, and congestive heart failure, and extended to 2
• Safety end points are bleeding assessed using the
TIMI classification at 30 day
• Baseline characteristics were no different between both groups,
except more patients in arm B were in killip's class I.
• 6.7% (n = 3) patients in arm A had insignificant disease; hence no
intervention was performed for them
• 100% of patients in arm B required angioplasty and stent
(arm 'A') -
PPCI arm (arm 'B') 155 patients
• Patients in arm A also had better TIMI flow at CAG (TIMI 3 flow in
27.9%), higher radial procedures (76.7%), more IRA patency
(82.2%), and less thrombus burden.
• In arm 'A', 12.1% -failed thrombolysis.
• 2.2% vs. 2.6%, 'p' not significant).
• efficacy end points are studied at 30 days, 3 months, 6 months, 1 year, and 2
• There is trend of benefit for arm B in the initial few months
• Primary endpoint -trend toward benefit in the primary PCI group (11.1% vs.3.9%,
p = 0.07, RR = 2.8).
• At the end of 2-year follow-up, the initial benefit from PPCI seems to be
narrowed as more events have occurred in PPCI group (A-17.8% vs. B-13.6%, p =
0.47, RR = 1.31;).
• The additions of events in the primary endpoint of PPCI group are mainly due to
death and repeat revascularization
• This may be partly due to the fact that 6.7%of patients in arm A did
not require a stent placement due to insignificant disease at the
angiogram, which means they are at no risk of stent thrombosis or
• non-urgent basis on which the angioplasty was performed in arm A
may also have influenced the primary endpoint over a period of
time, but this fact needs further large studies to provide
• fibrinolysis followed by an early coronary angiogram within 3–24 h
with PCI, if appropriate, resulted in similar outcomes when
compared to primary PCI in patients with STEMI at 2-year
• pharmacoinvasive strategy where patient and system related delays