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STEMI is among the most complex and dramatic clinical presentation of coronary artery disease. The highest risk of mortality and stent thrombosis is observed in the subjects undergoing primary PCI. Choice of the stent is often critical in primary angioplasty in myocardial infarction. GenXsync (MVI Therapeutics India Ltd, Surat India) is a stent having hybrid stent platform biodegradable polymers with the confidence of sirolimus.
73 patients with STEMI undergoing PCI were enrolled from June 2013 to January 2014. The average door to balloon time was 30 ± 0.04 minutes with the minimum being 15 minutes and maximum of 2 hours 44 minutes. Most of the patients (69/73: 94.52%) underwent primary PCI. One patient(1.37%) was taken up for PCI after successful thrombolysis and two patients had to undergo rescue PCI after failed thrombolysis. All subjects underwent PCI with GenXsync Sirolimus Eluting hybrid design stent (MVI Therapeutics India Ltd, Surat India). Total 79 stents were used (average 1.08 ± 0.38 stent per patient). The subjects were followed up till one year after discharge.
There were 80.82% (59) males, 41.09% (30) diabetic, 27.39% (20) hypertensive, 52.05% (38) current smokers and 2 (2.74%), patients with chronic renal disease. The cardiac history was significantly complex, characterized by prior coronary artery disease in 4 (5.48%), prior MI in 5 (6.85%) including prior PCI in 2 (2.74%), congestive heart failure in 1 (1.37%), ST depression in 71 (97.26%), complete heart block in 4 (5.48%) and left bundle branch block 1 (1.37%). At admission, 4 (5.4%) patients had a cardiac arrest. Among the patients 32 (43.84%), 34 (46.58%), 7 (9.59%) had single, double and triple vessel disease respectively. Average Troponin I was 55.20 ± 59.34 and by Killip classification, the subjects with class I, class II and class IV were 65 (89.04%), 4 (5.48%), 4 (5.48%) respectively. At discharge there were 3 (3.34%) major adverse cardiac events and at 1 year, there were 5 (5.48%) major adverse cardiac events. There was no actual stent thrombosis. All subjects received aggressive drug therapy including dual antiplatelet therapy el (Aspirin and one among Clopidogrel, Prasugrel or Ticagrelor at the discretion of the operator). There were total 2 (2.74%) stent thrombosis events between discharge and 1 year, including in 1 subject who discontinued Antiplatelet therapy within 1 year. None of 4 deaths including 2 cardiac were practically unrelated with the device and procedure. These 4 deaths were due to Cardiogenic shock (1), during MVR surgery (1), during surgery on leg, due to TIMI major bleeding (1) and due to pre-existing CHF (1).
In the contemporary practice of percutaneous coronary intervention in ST Elevation Myocardial Infarction, GenXsync stent was associated with low risks of stent thrombosis and MACE.