title: A prospective, multi-centric, observational registry to evaluate performance of Excel™ DES in 'real world, all comers' patient population.
abstract: OBJECTIVE
  This study aims to assess the safety and efficacy of a biodegradable polymer-coated Rapamycin-Eluting Stent (Excel) used in conjunction with six-month dual antiplatelet therapy in daily practice.
  
  
  BACKGROUND
  The polymeric material of cardiac stents has been reported to adversely affect the safety profile of the drug-eluting stents and is also suspected to cause serious long-term complications. It has been proposed that the biodegradable polymer coatings may reduce such late-stage adverse effects.
  
  
  METHODS
  This is a prospective, multi-center registry of 654 patients from across 9 cardiology centers in India, who were enrolled and exclusively treated with Excel stents between February 2008 and May 2010. The recommended antiplatelet regimen included clopidogrel and aspirin for 6 months period, followed by lifelong aspirin therapy.
  
  
  RESULTS
  The study population included 46.94% diabetics, 24.31% smokers, 48.93% hypertensives and 14.98% hyperlipidemics. The cumulative rates of major adverse cardiac events were 0.153% at discharge and 1.38% at 12 months. The mean percentage of stenosis was 88.24 ± 9.17% No events occurred between 6 and 12 months.
  
  
  CONCLUSIONS
  This multi-center registry study on "real world, all comers" has, thus, showed that EXCEL™ stent which is PLA-coated biodegradable Rapamycin-Eluting Stent exhibited high efficacy and safety profile in treatment of patients undergoing PCI as evidenced by significantly lower rates of MACE and no case of stent thrombosis. There was no event even after DAPT was discontinued after 6 months.
authors: Ruby Hall Clinic and Research Centre, Pune, India.
authors: Shirish
authors: S
authors: Hiremath
authors: Max Hospital, New Delhi, India.
authors: Praveen
authors: P
authors: Chandra
authors: Shree B. D. Mehta Mahavir Heart Institute, Surat, India.
authors: Devang
authors: D
authors: Desai
authors: Meenakshi Mission Hospital, Madurai, India.
authors: R
authors: R
authors: Sivakumar
authors: Meenakshi Mission Hospital, Madurai, India.
authors: S
authors: S
authors: Selvamani
authors: St. Gregorios Cardio-Vascular Center Parumala, Kerala, India.
authors: Anand
authors: A
authors: Srinivasan
authors: St. Gregorios Cardio-Vascular Center Parumala, Kerala, India.
authors: Madhu
authors: M
authors: Paulose
authors: St. Gregorios Cardio-Vascular Center Parumala, Kerala, India.
authors: Sajy
authors: S
authors: Jose
authors: Zynova Hospital, Mumbai, India.
authors: B C
authors: BC
authors: Kalmath
authors: Seth Nandlal Dhoot Hospital, Aurangabad, India.
authors: Vilas P
authors: VP
authors: Magarkar
authors: Anand Rishiji Hospital, Ahmednagar, India.
authors: Abhijeet
authors: A
authors: Pathak
authors: Assistant Manager, Clinical Research Department, Biosensors Interventional Technologies (India) Pvt. Ltd, India. Electronic address: t.mhetre@biosensorsindia.com.
authors: Tushar
authors: T
authors: Mhetre
keywords: DAPT; DES; Excel; MACE; Rapamycin
references: Circulation. 2004 Feb 17;109(6):701-5
references: 14744976
references: EuroIntervention. 2012 Nov 22;8(7):815-22
references: 23171802
references: Circulation. 2004 Jul 6;110(1):e5-6
references: 15238468
references: Heart. 2001 Sep;86(3):262-4
references: 11514475
references: Circulation. 2002 Nov 19;106(21):2649-51
references: 12438288
references: N Engl J Med. 2003 Oct 2;349(14):1315-23
references: 14523139
references: Lancet. 2004 Aug 14-20;364(9434):583-91
references: 15313358
references: Lancet. 2004 Oct 23-29;364(9444):1519-21
references: 15500897
references: Circulation. 2005 Apr 26;111(16):2107-11
references: 15851617
references: J Am Coll Cardiol. 2005 Jun 21;45(12):2088-92
references: 15963413
references: J Am Coll Cardiol. 2006 Jan 3;47(1):175-81
references: 16386683
references: Circulation. 2006 Mar 21;113(11):1434-41
references: 16534015
references: J Am Coll Cardiol. 2006 Dec 19;48(12):2584-91
references: 17174201
references: Vasc Health Risk Manag. 2005;1(4):263-76
references: 17315599
references: Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83
references: 18655114
references: Eur Heart J. 2008 Aug;29(16):1975-82
references: 18550554
references: Lancet. 2008 Sep 27;372(9644):1163-73
references: 18765162
references: EuroIntervention. 2008 May;4(1):59-63
references: 19112780
references: Eur Heart J. 2009 Oct;30(20):2441-9
references: 19720642
references: EuroIntervention. 2011 Aug;7(4):505-16
references: 21764670
references: Circulation. 2004 Apr 27;109(16):1942-7
references: 15078803