Author + information
- Luca Testa1,
- Sameer Dani2,
- Rashmit Pandya3,
- Apurva Vasavada4,
- Chirag Sheth5,
- Rutvik Trivedi6 and
- Kushal Pujara7
- 1IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy
- 2Life care Institute of Medical Sciences & Research and Apollo Hospitals, Ahmedabad, Gujarat, India
- 3Lifecare Institute of Medical Sciences and Research, Ahmedabad, Gujarat, India
- 4Tristar hospital, Surat, Gujarat, India
- 5Rhythm Heart Institute, Vadodara, Gujarat, India
- 6Zydus Hospitals And Healthcare Research Pvt Ltd, Anand, Gujarat, India
- 7Zydus Hospitals And Healthcare Research Pvt Ltd, Anand, British Indian Ocean Territory
The Abluminus DES+ is an abluminal coated sirolimus eluting stent with coating on stent and exposed parts of balloon. It has shown promising preliminary results in diabetic patients. The multicenter en-ABL registry was designed to assess the safety and efficacy profile of the Abluminus DES+ in a real-world setting. We hereby report on the data specifically concerning diabetic patients.
Overall, 2242 consecutive patients (2661 lesions) treated with Abluminus DES+ between January 2012 and May 2017 were prospectively enrolled. The primary endpoint is the rate of major adverse cardiac events (defined as cardiac mortality, Target Vessel MI, Target lesion revascularization: MACE) at one year. The MACE rate is also evaluated against a pre-specified performance goal based upon a meta-analysis of published studies including: DIABETES, RAVEL DM, SIRIUS DM, TAXUS IV, SCORPIUS, ENDEAVOR DM. Secondary endpoints include Stent Thrombosis (ST), and MACE rates up to three years. Clinical follow-ups of this study are ongoing.
One-year clinical outcome was available for 664 (83.42%) diabetic and 1153 (79.74%) non-diabetic patients. The follow-up of remaining patients is on-going. Overall, a MACE occurred in 44 patients (2.43%), and the rate was similar between the diabetic and non-diabetic cohorts (3.01 vs. 2.08%, respectively, p = 0.214). The 1-year MACE rate of 3.01% in diabetic patients, appears to be significantly lower than the performance goal of 14.5% (p= <0.001). The secondary endpoint ST occurred in 0.66% of the entire population, and similarly in diabetic and non-diabetic patients (0.90 vs. 0.52%, respectively, p=0.373).
The results of this large, real-world, multicenter registry suggest that Abluminus DES+ has similar safety and efficacy profile in diabetic as well as non-diabetic patients. This is of particular importance considering the suboptimal results of current standard of care drug eluting stents.