Author + information
- Sameer Dani1,
- Devang Desai2,
- Rashmit Pandya1,
- Apurva Vasavada3,
- Prathap Kumar N. Pillai4,
- Nirav Bhalani5,
- Arvind Sharma5,
- Chirag Sheth5,
- Rutvik Trivedi6,
- Jitendra Singh7 and
- Dinesh Shah8
- 1Lifecare Institute of Medical Sciences and Research and Apollo Hospitals, Ahmedabad, India
- 2Mahavir Hospitals, Surat, India
- 3Tristar Hospital, Surat, India
- 4Meditrina hospitals, Kollam, India
- 5Rhythm Hospital, Baroda, India
- 6Zydus Hospitals and Healthcare Research Pvt Ltd., Anand, India
- 7Lotus Super Speciality Hospital, Agra, India
- 8William Beaumont Hospital, Troy, MI
The aim of this registry is to evaluate the clinical performance the Abluminus DES+ (Envision Scientific), Novel Abluminal coated sirolimus eluting stent coated on stent and parts of balloon in a large patient population.
Between January 2012 and October 2017, 2372 patients were enrolled consecutively in this prospective, multi-center, real world, all-comers ongoing registry employing the Abluminus DES+ in patients with significant stenosis in coronary vessels. Primary endpoint is major adverse cardiac event (MACE), which encompasses cardiac death, target vessel myocardial infarction (TV-MI), and target lesion/vessel revascularization (TLR/TVR) at 1-year follow-up. Also, stent thrombosis (ST) was recorded at 1-year follow-up. A subgroup analysis has been conducted in patients presenting with diabetes, acute myocardial infarction, small vessels, and long lesions.
In this all-comers setting, 1982 (83.56%) and 1498 (63.15%) patients completed 1-year and 2-year follow-up respectively, and follow-up of remaining patients is ongoing. At 1-year follow-up, MACE were reported in 2.67% (53/1982) of patients, comprising 14 (0.71%) cases of cardiac death, 8 (0.40%) cases of TV-MI, and 31 (1.56%) cases of TLR/TVR. Stent thrombosis was reported in 0.66% (13/1982) patients at the end of 1-year follow-up. A MACE rate of 3.60% (54/1498) was observed within the 2-year follow-up for the overall cohort. The low MACE rate was also confirmed for the subgroups at the 1-year follow-up: diabetics (3.31%), acute myocardial infarction (2.97%), small vessels (3.76%), and long lesions (3.54%).
In conclusion, this multi-center, real world, and all-comers registry indicated that the Abluminus DES+ appears to be safe and effective in treating coronary stenosis irrespective of patient complexity.