JOURNAL CLUBTwo-year follow-up data from the STEPP-AMI

study: A prospective, observational, multicenterstudy 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

INTRODUCTION

• STEMI is a life threatening manifestation of CAD requiring timely reperfusion

• incidence of STEMI is higher in the Indian population when compared to developed countries

• Current recommendations maintain PCI as the treatment of choice , contingent upon rapid initiation of treatment at centers with a skilled PCI laboratory within suggested timelines

• unavailability of primary PCI capable hospitals across India and delays in transport -<10% of patients with STEMI-PCI in India

• patients who do reach the hospital early still have to deal with other issues, such as arranging for finances, as most Indian patients pay out-ofpocket

• 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.

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].

PRESENT STUDY• 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 Kerala • 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 .

AIM• assess the safety, efficacy, and

feasibility of a pharmacoinvasive strategy in comparison toprimary 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 years

• Safety end points are bleeding assessed using theTIMI 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 implantation.

pharmacoinvasive arm (arm 'A') -

45 patients

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.

bleeding outcomes • 2.2% vs. 2.6%, 'p' not significant). • efficacy end points are studied at 30 days, 3 months, 6 months, 1 year, and

2 years-no difference • There is trend of benefit for arm B in the initial few months • Primary endpoint at 30 days -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 orrestenosis.

• 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 comprehensive evidence.

CONCLUSION• fibrinolysis followed by an early coronary angiogram within 3–24 h with PCI, if appropriate, resulted in similar outcomes whencompared to primary PCI in patients with STEMI at 2-yearfollow-up.

• These findings lend further support to the adoptionof a pharmacoinvasive strategy where patient and system related delays are inherent

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