Six-month clinical outcomes of drug eluting stents in patients with coronary artery disease: an experience in real-world Indian patients

Gaurav Sardarilal Verma


Background: Treatment of patients with coronary artery disease using drug eluting stents (DES) remains a challenge due to stent thrombosis and in-stent restenosis. The present study sought to investigate the safety and clinical performance of DES in real-world Indian patients with coronary artery disease.

Methods: This prospective, non-randomized, single-center study enrolled 114 patients with coronary artery disease who were implanted with DES from January-2005 to September-2007. Clinical and angiographic follow-up were performed at 6 months after the index procedure. The primary endpoints of the study were: (major adverse cardiac events (MACE) defined as a composite of any episode of rest angina, myocardial infarctions (MI), repeat percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), or (angiographic restenosis defined as ≥50% diameter stenosis at the treated site at 6-month follow-up. The secondary endpoints of the study were occurrence of any MACE events and stent vessel occlusion during the first 30 postprocedural days.

Results: A total of 125 lesions were treated by implantation of 130 DES. Only one patient (0.9%) developed minor bleeding during hospitalization. At the 6-month follow-up, MACE was 10%, including 1 (1.3%) MI, 2 (2.5%) unstable angina, 3 (3.8%) stable angina, 1 (1.3%) repeat PCI, and 1 (1.3%) CABG. Angiographic restenosis was found in 7 (8.8%) patients. Comparison of characteristics between patients with and without angiographic restenosis revealed significant effects of presence of diabetes (p<0.012), hyperlipidaemia (p<0.028), and stent length>20 mm (p<0.05).

Conclusions: The study results demonstrated excellent safety and clinical performance of DES in real-world Indian patients with coronary artery disease.


Coronary artery disease, Drug eluting stents, Myocardial infarction, Percutaneous coronary intervention, Restenosis

Full Text:



Roth GA, Johnson C, Abajobir A, Abd-Allah F, Abera SF, Abyu G, et al. Global, regional, and national burden of cardiovascular diseases for 10 causes, 1990 to 2015. Journal of the American College of Cardiology. 2017;70(1):1-25.

Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and re-stenosis after transluminal angioplasty. New England Journal of Medicine. 1987;316(12):701-06.

Schömig A, Kastrati A, Mudra H, Blasini R, Schühlen H, Klauss V, et al. Four-year experience with Palmaz-Schatz stenting in coronary angioplasty complicated by dissection with threatened or present vessel closure. Circulation. 1994;90(6):2716-24.

George BS, Roubin GS, Fearnot NE, Pinkerton CA, Raizner AE, King SB, et al. Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes. Journal of the American College of Cardiology. 1993;22(1):135-43.

Pepine CJ, Holmes DR, Block PC, Mullins CE, Brinker JA, Nissen SE, et al. Coronary artery stents. Journal of the American College of Cardiology. 1996;28(3):782-94.

Roubin GS, Cannon AD, Agrawal S, Macander P, Dean L, Baxley W, et al. Intracoronary stenting for acute and threatened closure complicating percutaneous transluminal coronary angioplasty. Circulation. 1992;85(3):916-27.

Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. New England Journal of Medicine. 1994;331(8):496-501.

Serruys PW, De Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. New England Journal of Medicine. 1994;331(8):489-95.

Gordon PC, Gibson CM, Cohen DJ, Carrozza JP, Kuntz RE, Baim DS. Mechanisms of restenosis and redilation within coronary stents—quantitative angiographic assessment. Journal of the American College of Cardiology. 1993;21(5):1166-74.

Hoffmann R, Mintz GS, Dussaillant GR, Popma JJ, Pichard AD, Satler LF, et al. Patterns and mechanisms of in-stent restenosis: a serial intravascular ultrasound study. Circulation. 1996;94(6):1247-54.

Reimers B, Moussa I, Akiyama T, Tucci G, Ferraro M, Martini G, et al. Long-term clinical follow-up after successful repeat percutaneous intervention for stent restenosis. Journal of the American College of Cardiology. 1997;30(1):186-92.

Savage M. Palmaz-Schatz Stent Study Group: Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. J Am Coll Cardiol. 1994;24:1207-12.

Laham RJ, Carrozza JP, Berger C, Cohen DJ, Kuntz RE, Baim DS. Long-term (4-to 6-year) outcome of Palmaz-Schatz stenting: paucity of late clinical stent-related problems. Journal of the American College of Cardiology. 1996;28(4):820-26.

Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. New England Journal of Medicine. 2003;349(14):1315-23.

Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, et al. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. Jama. 2005;294(10):1215-23.

Camenzind E, Steg PG, Wijns W. Response to Letter Regarding Article,“Stent Thrombosis Late After Implantation of First-Generation Drug-Eluting Stents: A Cause for Concern”. Circulation. 2007;116(16):e390-e90.

Morice M-C, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. New England Journal of Medicine. 2002;346(23):1773-80.

Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, et al. TAXUS I: six-and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003;107(1):38-42.

Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice M-C, et al. Safety and efficacy of sirolimus-and paclitaxel-eluting coronary stents. New England Journal of Medicine. 2007;356(10):998-1008.

Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. European heart journal. 2006;27(23):2784-814.

Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001;103(2):192-95.

Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. New England Journal of Medicine. 2006;354(5):483-95.

Puranik AS, Dawson ER, Peppas NA. Recent advances in drug eluting stents. International journal of pharmaceutics. 2013;441(1-2):665-79.

Wilson GJ, Nakazawa G, Schwartz RS, Huibregtse B, Poff B, Herbst TJ, et al. Comparison of inflammatory response after implantation of sirolimus-and paclitaxel-eluting stents in porcine coronary arteries. Circulation. 2009;120(2):141-9, 1.

Nakazawa G, Otsuka F, Nakano M, Vorpahl M, Yazdani SK, Ladich E, et al. The pathology of neoatherosclerosis in human coronary implants: bare-metal and drug-eluting stents. Journal of the American College of Cardiology. 2011;57(11):1314-22.