Safety and efficacy of hybrid platform design sirolimus eluting stent system in percutaneous coronary intervention in ST elevation myocardial infarction patients at 1 year after treatment

Louie Fisher, Anoop Mathew, Eapen Punnose, Ashish Indani, Poonam Bhutada


Background: 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 stent is often critical in Primary Angioplasty in Myocardial Infarction. GenXsync (MIV Therapeutics India Ltd, Surat India) is a stent having hybrid stent platform biodegradable polymers with the confidence of Sirolimus. The primary objective of this study was to establish safety and efficacy of GenXsync Sirolimus Eluting hybrid design stent in STEMI.

Methods: A total of 73 patients of STEMI undergoing PCI were enrolled from June 2013 to January 2014. The average door to balloon time was 30±0.04 minutes with the minimumbeing15 minutes and maximum of 2 hours 44min. 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. Total 79 stents were used (average 1.08±0.38 stent per patient).  The subjects were followed up for one year after discharge.

Results: 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 branchblock 1 (1.37%). At admission, 4 (5.4%) patients had 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 III 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 were no acute stent thromboses. All subjects received dual antiplatelet therapy for one year (Aspirin and one among Clopidogrel, Prasugrel or Ticagrelor at the discretion of the operator). There were total of 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 related with the device and procedure. These 4 deaths were due to cardiogenic shock (1), during MVR surgery (1), During surgery on leg, due to major bleeding (1) and Due to pre-existing CHF (1).

Conclusions: In contemporary practice of percutaneous coronary intervention in ST Elevation Myocardial Infarction, Genxsync stent was associated with low risks of stent thrombosis and MACE.


GenXsync, STEMI, Drug eluting stent, MACE, Acute coronary syndrome, Stent thrombosis

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