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STEMI care in India and the real world: Role of Thrombolysis

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Dr HK Chopra    19 October 2017

The STEMI burden is more than 60.6% of ACS in India, the highest in the world and is seen young individuals. About 3 million STEMIs occur in India every year. 18 million Indians may lose productive year with STEMI by 2030. 400 million Indians are below the poverty line, earning <$1.25/day. Challenges of STEMI care in India and the real world are enormous including lack of awareness, poor transport, lack of EMS protocol, poor ambulance service, PPCI feasible only in 12-15%, delay in time from the First Medical Contact (FMC) after chest discomfort to hospital time, door to needle time and door to balloon time. There is a tremendous need to create a Smart Heart App all over the India to enhance the awareness on s/s of STEMI, emergency heart ambulance services in the vicinity phone no., instantaneous ECG, mobile ambulance, transfer of ECG by telemedicine or WhatsApp to the heart station or the cardiologists concerned and then instantaneous use of TLT and/or PCI depending on the time of reaching the PCI capable centers. There is a huge gap between the guidelines and clinical practice of STEMI care in India. Rapid diagnosis and early reperfusion, irrespective of TLT or PPCI, are pillars of success in STEMI as Time is Muscle. GISSI Trial 1986, ISAM Trial 1986, AIMS Trial 1990, GISSI-2 1990, ISIS-3 Trial 1992, GUSTO Trial I 1993, INJECT Trial 1995, RAPI-1 & RAPID-2 1996, COBALT Trial 1997, GUSTO-III Trial 2002 showed enormous benefits of TLT especially tenecteplase and reteplase. Subsequently Italian Registry 2009, TNK Registry data from India 2013, and French Fast 2014 showed enormous benefits of TNK in STEMI Pre Hospital thrombolysis with Tenecteplase is the best timely reperfusion therapy as shown in TNK Registry Data Vienna STEMI Registry (2006), The Mayo Clinic STEMI Protocol (2007), The French FAST-MI Registry (2008), Italian Registry (27,000 Pts) (2009), Indian Registry (15,222 Pts, 722 Centers) (2013), The French FAST-MI Registry (1500 pts) (2014) have shown superiority of TNK with 96.5 successful reperfusion in < 3 hours. Italian Registry, Indian Registry, Vienna STEMI Registry, The Mayo Clinic STEMI Protocol and French Fast Registry including STREAM Data. Pre-hospital TLT is a real opportunity to offer timely reperfusion to as many patients as possible in an easy way, an opportunity that the health care system cannot miss. Door to Balloon time in PPCI mostly exceeds 90 min. It is therefore not practical everywhere, especially in India where 70% population is rural population and cities are overcrowded with poor transport system. The success rate of tenecteplase and reteplase for thrombolysis in STEMI is 96% in first 3 hours. STREAM trial in 2014 with 1-year follow up data has shown similar (4%) 1-year mortality with pharmacoinvasive and PPCI within 3 hours in AMI. STREAM Trial for one year follow up data in about 2000 patients treated with tenecteplase in AMI. Early tenecteplase in STEMI is strongly recommended as protocol strategy in myocardial salvage window of <3 hours, followed by PCI within 24 hours (as PPCI is feasible in only few centers and not practical <90 min). The French Fast Registry data in 2014 has shown highest survival rate in 5 years with pre hospital Thrombolytic therapy, in-hospital thrombolysis followed by PPCI. Pre-hospital thrombolysis with Tenecteplase/ Reteplase is a strong independent predictor of in-hospital survival. Mortality significantly reduced to 1.1% if TLT is instituted in STEMI <3 hours (same as PPCI). Tenecteplase/Reteplase followed by PCI in 3-24 hours is a strongly recommended protocol. Tenecteplase/ Reteplase may abort AMI, make larger to smaller infarct transmural to subendocardial infarct, decrease REMI, prevent extension and reduce thrombus burden. PPCI is only available for 12-15% STEMI patients. Mortality risk increases by 7.5% with each 30 min delay in PPCI. Mortality benefits of PPCI was lost if it is delayed beyond 90 min. Minimize the time from chest discomfort to ECG < 30 min, ECG to Drug intervention < 60 min and drug intervention to PCI < 90 min. Pharmacoinvasive approach is the only solution for India. STK has less fibrin specificity and fibrin affinity as compared to TNK, administration of IV STK leads to formation of STK antibodies, which inactivate further dose of STK. Hence, IV STK has to be given as IV Infusion for 60 min vs TNK given as bolus in 5 seconds, the reperfusion TIMI flow grade 2/3 55% in STK and 83% in TNK, reperfusion patency rate 32% in STK and 75% in TNK, hypotension, hypersensitivity reactions and higher early re-occlusion is common with STK as compared to TNK. Tenecteplase/ Reteplase followed by PCI in 3-24 hours may salvage the jeopardized myocardium in STEMI and help in reducing the morbidity and mortality. The data including various studies, trials, national and international registries confirm the safety and efficacy of TNK in STEMI as an agent of first choice in pharmacoinvasive intervention.

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