Clinical-study

SUPERIA – Post Marketing Surveillance Study

Also download results published in INDIAN HEART JOURNAL

Overview

At present, we have conducted a post marketing surveillance study on our product, SUPERIA – Sirolimus Eluting Coronary Stent System (SSECSS).

The study was a prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India i.e.

  • 200 patients at 16 Sites all across India
  • The study was led by Dr. Praveen Chandra, Chairman, Interventional Cardiology at Medanta, the Medicity Hospital
  • Clinical follow-up at 30 days, 180 days, 1 year and 2 year
  • Angiographic follow-up (sub-set of 50 patients) at 180 days
  • Available stent sizes: 2.5, 2.75, 3.0 and 3.5mm diameters in lengths of 12, 13, 16, 19, 20, 24, 28, 29 and 32 mm
  • Inclusion Criteria:-
    • Up to two de novo lesions, each located in a separate native epicardial vessel
    • Maximum lesion length up to 28 mm
    • Stent diameter 2.50mm to 3.50 mm
  • Exclusion Criteria:-
    • LVEF < 30%, Heavy calcification, extreme angulation (>90%), target vessel containing thrombus with re-stenosis of previous intervention
    • CK/CKMB/Troponin more than 2 times URL at the time of index procedure
    • DES treatment within 90 days prior to index procedure

OBJECTIVE

objective

BASELINE DEMOGRAPHICS

baseline

RESULTS

A total of 200 patients enrolled across 16 centers in India. First patients was enrolled in May 2012.  Mean age of patients were 56 yr, 82% were male, 38.5% were diabetic, 46% were hypertensive and 27% were having previous MI. Procedural success was achieved in all patients. At 2 year of follow up TLR was required only in 1 patient, stent thrombosis in 1 patient and there was only 1 cardiac death and MACE was seen in 3 (1.54%).

Angiographic follow was done in 50 patients. Late lumen loss studied at 6 month of follow up. In stent lumen loss was 0.10 mm and in segment lumen loss was 0.14 mm at 6 month of follow up.

End Point Analysis (30 Days, N=200)

 

111

End Point Analysis (2 Year, N = 194)

 

222

Core Lab Analysis (Pre, Post procedure and 6 month Angiographic follow-up, N=50)

 

333

CONCLUSION

First generation DES were better than BMS, sirolimus DES fare better than Paclitaxel DES, thin struts designed stent better than thicker profile stents. When the data from present study compared with other studies, Superia-Sirolimus Eluting Coronary Stent System seems better or equivalent to other in term of MACE, LL and TLR.

Thus we can conclude safely that Superia stent is as safe as other stent system in the market or even slightly better in term of MACE and finally time has come for thin struts design stents with biodegradable stent.