Purple Medical Solution Pvt ltd.

LifeCare Registry

LONG TERM AND INTERMEDIATE RESULTS OF GENXSYNC: A NEW LOWEST STRUT SIROLIMUS ELUTING STENT SYSTEM WITH BIODEGRADABLE POLYMER

INTRODUCTION: Drug eluting stent (DES) are a major breakthrough in interventional cardiology. genXSync stent is cobalt chromium stent with biodegradable polymer & sirolimus drug coating with thinnest strut thickness (65 μm). It has got a uniform sinusoidal platform with zero foreshortening & <4 % recoil and it is 5 Fr catheter compatible.

OBJECTIVE:  To assess safety & efficacy of genXSync sirolimus eluting coronary stent in the real world lesions and patients with obstructive cad.

DESIGN: single centre, non-randomized study where all patients (n=153) were clinically followed at 30 days, 180 days (angiographic f/up), one year and two years. First 50 patients consecutively will be followed for IVUS.

A total of 180 genXSync stents were implanted in 153 patients of whom 138 were male and 15 female. 23 patients had suffered a previous MI, 33 had DM, 57 were HT and 19 were smoker. Single vessel diseases were 126 while double vessel diseases were 27 patients.  The mean vessel size was 3.2 mm. 2.5 mm stents were implanted in 33 patients, 2.75 mm stents were implanted in 37 patients, 3mm in 76 patients and 3.5 mm in 34 patients, length of the ranging from 13mm to 40mm. We deployed 115 stents in LAD, 20 in Lcx and 45 in RCA.  65 patients received gp iib iiia inhibitors (abciximab, tirofiban, eptifibatide) as per description of the physician.

PRIMARY ENDPOINTS

  • mace ( major adverse cardiac events) defined as death, mi, emergent bypass surgery, or target lesion revascularization (repeat pci or cabg) at 30 days
  • in-stent and in-segment late loss at 6-month as measured by quantitative coronary analysis (qca)

SECONDARY ENDPOINTS: endpoint:

  • Device success rate [%]
  • Clinically driven target lesion revascularization (TLR) at 1- 6-12 and 24- month.
  • Target vessel failure (TVF) at 1-, 6-, 12 and 24-month clinical follow-up defined as: cardiac death, myocardial infarction, and target lesion revascularization (repeat PTCA or coronary bypass surgery for recurrent symptoms related target-lesion renarrowing).  Neointimal Hyperplasia volume

PROCEDURAL CHARACTERISTICS & RESULTS:
The mean stent length was 22mm, mean no of stent is 1.12 with 0% SAT & 100% procedural success rate. IVUS have been used in all patients.
The target vessel was lad (68%), in stent MLD was 3.08 mm & in stent late loss was 0.22mm. Restenosis was 4.19% on f/up. In hospital and 6 months follow up mace was zero & 1% (death-92 yr old patient).

Major Adverse Cardiac Events and Stent Thrombosis:

  • All patients completed the 30-day primary end-point and were followed up to One year and two year with 0% MACE.
  • Zero per cent stent thrombosis from acute to late phase follow-up was observed, demonstrating a high standard of safety.
  • One of the major concerns of DES has been stent thrombosis at various time-points after implantation.
  • Most of the time, malapposition, polymer-related inflammation, lack of optimal endothelialization and inadequate healing are the reasons for stent thrombosis.
  • No other complications occurred during this time frame, demonstrating the high safety profile of this new generation of genXSync.

CONCLUSION:
Several randomized clinical trials and registries have proven effectiveness of Sirolimus drug in CAD patients. GenXSync with its unique uniform symmetrical expansion and thin strut cobalt chromium platform (65 µm) has given excellent post deployment and twenty four month results.
IVUS of 50 patients have given encouraging outcomes

THUS, WITH THIS NEW INDIGENOUS SIROLIMUS ELUTING STENT, WE HAVE SUCCESSFULLY COMPLETED THE FIRST EVER HUMAN TRIAL SHOWING THAT ITS IMPLANTATION IS SAFE AND FEASIBLE ESPECIALLY WITH IVUS SUPPORT.