Clinical outcomes with Biolimus (A9)鈩?eluting stent, 鈥楤ioMatrix鈥?in diabetic patients - interim results from multicenter post market surveillance registry in India

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• 作者：Ashok Seth ; Shirish Hiremath ; Sameer Dani ; Sunil Kapoor ; R.K. Jain ; Rajpal Abhaich ; Shailendra Trivedi ; Upendra Kaul ; Aruna Patil ; Bhushan Khemnar ; Hrishikesh Rangnekar
• 关键词：BioMatrix ; BES ; Diabetes ; MACE ; Stent thrombosis
• 刊名：Indian Heart Journal
• 出版年：September-October, 2013
• 年：2013
• 卷：65
• 期：5
• 页码：586-592
• 全文大小：327 K

文摘

Objective

The objective of this registry is to establish safety and efficacy of BioMatrix, BioMatrix鈩?Biolimus A9鈩?eluting stent in diabetic population in India.

Background

Diabetes mellitus is a major predisposing factor for coronary artery disease. Prognosis for diabetic population patients presenting with coronary artery disease who undergo coronary revascularization is inferior to non diabetics and remains an independent risk factor of restenosis, need for revascularization, and overall mortality. Stent thrombosis is a potential complication of first generation, permanent polymer drug-eluting stents. Biodegradable polymer is a good relief in this era and its utility in diabetic patients will be a major advantage for them.

Methods

334 patients with diabetes mellitus and requiring angioplasty, implanted with BioMatrix stent were followed at 1, 6, 12 and 24 months who entered in a multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, 12 and 24 months.

Results

The mean age was 58.71聽卤聽9.2 years, 81% were males, comorbidity index was 1.6聽卤聽1.02, and 59.1% presented with acute coronary syndrome. The incidence of adverse event rates was: MACE 1.27%. There were no incidences of myocardial infarction (MI) and target vessel revascularization (TVR). Definite stent thrombosis occurred only in 2 patients.

Conclusion

In this registry of diabetic population treated with BioMatrixTM-Biolimus A9TM eluting stent (BioMatrix), the reported incidence of MACE and ST were much lower than previously published results. The 1- and 2-year follow-up result supports favorable clinical outcomes of using BioMatrix stents as a suitable alternative to contemporary DES available during PCI in diabetic patients.