Use and misuse of multivariable approaches in interventional cardiology studies on drug-eluting stents: A systematic review

Journal of Interventional Cardiology

Volumn 25, Issue 6, 2012, Pages 611-621

  D'Ascenzo, Fabrizio ^a   Cavallero, Erika ^a   Biondi Zoccai, Giuseppe ^b   Moretti, Claudio ^a   Omedè, Pierluigi ^a   Bollati, Mario ^a   Castagno, Davide ^a   Modena, Maria Grazia ^b   Gaita, Fiorenzo ^a   Sheiban, Imad ^a  

^a UNIVERSITY OF TURIN   (Italy)

^b UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CALIBRATION; CAUSAL ATTRIBUTION; CLINICAL ASSESSMENT; DRUG ELUTING STENT; FOLLOW UP; HUMAN; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; LOGISTIC REGRESSION ANALYSIS; META ANALYSIS (TOPIC); MULTIVARIATE ANALYSIS; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODEL; RELIABILITY; REVIEW; RISK ASSESSMENT; SYSTEMATIC REVIEW; VALIDITY;

DATA INTERPRETATION, STATISTICAL; DRUG-ELUTING STENTS; HUMANS; MULTIVARIATE ANALYSIS; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODELS; RESEARCH DESIGN;

EID: 84871331075     PISSN: 08964327     EISSN: 15408183     Source Type: Journal    
DOI: 10.1111/j.1540-8183.2012.00753.x     Document Type: Review

References (80)

1. Biondi-Zoccai GGL, Agostoni P, Abbate A,. Parallel hierarchy of scientific studies in cardiovascular medicine. Ital Heart J 2003; 4: 819-820.
2. Schulz KF, Altman DG, Moher D,; CONSORT Group. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332. doi: 10.1136/bmj.c332.
3. Obama B,. Modern health care for all Americans. N Engl J Med 2008; 359 (15): 1537-1541. [Epub 2008 Sep 24. No abstract available].
4. Stroup DF, Berlin JA, Morton SC, et al,. Meta-analysis of observational studies in epidemiology: A proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283 (15): 2008-2012
5. Katz MH,. Multivariable Analysis: A Practical Guide for Clinicians. New York: Cambridge University Press, 2006.
6. Concato J, Feinstein AR, Holford TR,. The risk of determining risk with multivariable models. Ann Intern Med 1993; 118: 201-210.
7. Weitzen S, Lapane KL, Toledano AY, et al,. Principles for modeling propensity scores in medical research: A systematic literature review. Pharmacoepidemiol Drug Saf 2004; 13: 841-853.
8. Weitzen S, Lapane KL, Toledano AY, et al,. Weaknesses of goodness-of-fit tests for evaluating propensity score models: The case of the omitted confounder. Pharmacoepidemiol Drug Saf 2005; 14: 227-238.
9. Austin PC,. Some methods of propensity-score matching had superior performance to others: Results of an empirical investigation and Monte Carlo simulations. Biom J 2009; 51: 171-184.
10. Austin PC,. The performance of different propensity-score methods for estimating relative risks. J Clin Epidemiol 2008; 61: 537-545.
11. Rubin DB,. Estimating causal effects from large data-sets using propensity scores. Ann Intern Med 1997; 127: 757-763.
12. Biondi-Zoccai G, Romagnoli E, Agostoni P, et al,. Are propensity scores really superior to standard multivariable analysis? Contemp Clin Trials 2011; 32 (5): 731-740.
13. Wilczynski NL, Haynes RB, for the Hedges Team. Developing optimal search strategies for detecting clinically sound prognostic studies in MEDLINE: An analytic survey. BMC Med 2004; 2: 23.
14. Kukreja N, Onuma Y, Garcia-Garcia H, et al,. Primary percutaneous coronary intervention for acute myocardial infarction: Long-term outcome after bare metal and drug-eluting stent implantation. Circ Cardiovasc Interv 2008; 1 (2): 103-110. [Epub 2008 Sep 3].
15. Kukreja N, Onuma Y, Garcia-Garcia HM, et al,. Interventional Cardiologists of the Thoraxcenter (2000 to 2005). The risk of stent thrombosis in patients with acute coronary syndromes treated with bare-metal and drug-eluting stents. JACC Cardiovasc Interv 2009; 2 (6): 534-541.
16. Ma HY, Zhou YJ, Dick RJ, et al,. Long-term outcome of patients of over 85 years old with acute coronary syndrome undergoing percutaneous coronary stenting: A comparison of bare metal stent and drug eluting stent. Chin Med J (Engl) 2008; 121 (10): 887-891.
17. Hoffmann R, Klinker H, Adamu U, et al,. The risk of definitive stent thrombosis is increased after "off-label" stent implantation irrespective of drug-eluting stent or bare-metal stent use. Clin Res Cardiol 2009; 98 (9): 549-554. [Epub 2009 Aug 11].
18. Aoki J, Lansky AJ, Mehran R, et al,. Early stent thrombosis in patients with acute coronary syndromes treated with drug-eluting and bare metal stents: The Acute Catheterization and Urgent Intervention Triage Strategy trial. Circulation 2009; 119 (5): 687-698. [Epub 2009 Jan 26].
19. Andron M, Perry RA, Egred M, et al,. The impact of diabetes mellitus on two-year mortality following contemporary percutaneous coronary intervention: Implications for revascularization practice. J Interv Cardiol 2009; 22 (5): 420-426. [Epub 2009 May 7].
20. De Labriolle A, Bonello L, Lemesle G, et al,. Clinical presentation and outcome of patients hospitalized for symptomatic in-stent restenosis treated by percutaneous coronary intervention: Comparison between drug-eluting stents and bare-metal stents. Arch Cardiovasc Dis 2009; 102 (3): 209-217. [Epub 2009 Mar 17].
21. Dzavík V, Buller CE, Devlin G, et al,. Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial. Catheter Cardiovasc Interv 2009; 73 (6): 771-779.
22. Rathore S, Kinoshita Y, Terashima M, et al,. A comparison of clinical presentations, angiographic patterns and outcomes of in-stent restenosis between bare metal stents and drug eluting stents. EuroIntervention 2010; 5 (7): 841-846.
23. Assali A, Raz Y, Vaknin-Assa H, et al,. Beneficial 2-years results of drug-eluting stents in saphenous vein graft lesions. EuroIntervention 2008; 4 (1): 108-114.
24. Maresta A, Varani E, Balducelli M, et al,; DESSERT Investigators. Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study). Am J Cardiol 2008; 101 (11): 1560-1566. [Epub 2008 Apr 11].
25. De Felice F, Fiorilli R, Parma A, et al,. 3-year clinical outcome of patients with chronic total occlusion treated with drug-eluting stents. JACC Cardiovasc Interv 2009; 2 (12): 1260-1265.
26. Kang S, Yang YJ, Xu B, et al,. Comparison of drug eluting stents with bare metal stents in daily practice for bifurcation lesions in Chinese patients. Chin Med J (Engl) 2006; 119 (14): 1157-1164.
27. Jonas M, Resnic FS, Levin AD, et al,. Transition from bare metal to drug eluting stenting in contemporary US practice: Effect on incidence and predictors of clinically driven target lesion revascularization. Catheter Cardiovasc Interv. 2007; 70 (2): 175-183.
28. Kim YH, Park SW, Lee CW, et al,. Comparison of sirolimus-eluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions. Catheter Cardiovasc Interv 2006; 67 (2): 181-187.
29. Alidoosti M, Salarifar M, Haji-Zeinali AM, et al,. Clinical outcomes of drug-eluting stents compared with bare metal stents in our routine clinical practice. Hellenic J Cardiol 2008; 49 (3): 132-138.
30. Xu B, Li JJ, Yang YJ, et al,. A single center investigation of bare-metal or drug-eluting stent restenosis from 1633 consecutive Chinese Han ethnic patients. Chin Med J (Engl) 2006; 119 (7): 533-538.
31. Bonello L, De Labriolle A, Lemesle G, et al,. Comparison of outcomes of drug-eluting stents versus bare-metal stents in nonostial proximal left anterior descending coronary arteries. Am J Cardiol 2009; 103 (4): 496-500.
32. Domínguez Franco AJ, Alonso Briales JH, Jiménez Navarro MF, et al,. Clinical impact of drug-eluting stents in an unselected population of diabetic patients. Clin Cardiol 2008; 31 (4): 165-171.
33. Gioia G, Matthai W, Benassi A, et al,. Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunction. Catheter Cardiovasc Interv 2006; 68 (3): 392-398.
34. Ortolani P, Balducelli M, Marzaroli P, et al,. Two-year clinical outcomes with drug-eluting stents for diabetic patients with de novo coronary lesions: Results from a real-world multicenter registry. Circulation 2008; 117 (7): 923-930. [Epub 2008 Feb].
35. Hamirani YS, Jibrin I, Abraham D, et al,. Paclitaxel-eluting versus bare-metal stents in acute ST elevation myocardial infarction (STEMI). Crit Pathw Cardiol 2008; 7 (4): 232-238.
36. Jensen J, Lagerqvist B, Aasa M, et al,. Clinical and angiographic follow-up after coronary drug-eluting and bare metal stent implantation. Do drug-eluting stents hold the promise? J Intern Med 2006; 260 (2): 118-124.
37. Onuma Y, Kukreja N, Piazza N, et al,; Interventional Cardiologists of the Thoraxcenter (2000 to 2007). The everolimus-eluting stent in real-world patients: 6-month follow-up of the X-SEARCH (Xience V Stent Evaluated at Rotterdam Cardiac Hospital) registry. J Am Coll Cardiol 2009; 54 (3): 269-276.
38. Pasceri V, Patti G, Pristipino C, et al,. Safety of drug eluting stents in patients on chronic anticoagulation using long-term single antiplatelet treatment with clopidogrel. Catheter Cardiovasc Interv 2010; 75 (6): 936-942.
39. Simsek C, Onuma Y, Magro M, et al,; Interventional Cardiologists of the Thoraxcenter (2000-2005). Four-year clinical outcome of sirolimus- and paclitaxel-eluting stents compared to bare-metal stents for the percutaneous treatment of stable coronary artery disease. Catheter Cardiovasc Interv 2010; 76 (1): 41-46.
40. Singh IM, Filby SJ, El Sakr F, et al,. Drug-eluting stents versus bare-metal stents for treatment of bare-metal in-stent restenosis. Catheter Cardiovasc Interv 2010; 76 (2): 257-262.
41. Yan BP, Ajani AE, New G, et al,; Melbourne Interventional Group Investigators. Are drug-eluting stents indicated in large coronary arteries? Insights from a multi-centre percutaneous coronary intervention registry. Int J Cardiol 2008; 130 (3): 374-379. [Epub 2008 Aug 15].
42. Brodie BR, Wilson H, Stuckey T, et al,; STENT Group. Outcomes with drug-eluting versus bare-metal stents in saphenous vein graft intervention results from the STENT (strategic trans-catheter evaluation of new therapies) group. JACC Cardiovasc Interv 2009; 2 (11): 1105-1112.
43. Ajani AE, Reid CM, Duffy SJ, et al,. Outcomes after percutaneous coronary intervention in contemporary Australian practice: Insights from a large multicentre registry. Med J Aust 2008; 189 (8): 423-428.
44. Applegate RJ, Sacrinty MT, Kutcher MA, et al,. Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death. Am J Cardiol 2007; 99 (3): 333-338. [Epub 2006 Dec 1].
45. Bangalore S, Vlachos HA, Selzer F, et al,. Percutaneous coronary intervention of moderate to severe calcified coronary lesions: Insights from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv 2011; 77 (1): 22-28. doi: 10.1002/ccd.22613.
46. Brodie BR, Stuckey T, Downey W, et al,; STENT (Strategic Transcatheter Evaluation of New Therapies) Group. Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group. Catheter Cardiovasc Interv 2008; 72 (7): 893-900.
47. Dou KF, Xu B, Yang YJ, et al,. Two-year clinical outcome after successful implantation of drug-eluting and bare metal stents in diabetic patients: Results from a real-world single center registry. Chin Med J (Engl) 2009; 122 (6): 612-616.
48. Ferenc M, Gick M, Kienzle RP, et al,. Long-term outcome of percutaneous catheter intervention for de novo coronary bifurcation lesions with drug-eluting stents or bare-metal stents. Am Heart J 2010; 159 (3): 454-461.
49. Flores-Ríos X, Abugattás-de Torres JP, Campo-Pérez R, et al,. Effect of stent thrombosis on the risk-benefit balance of drug-eluting stents and bare metal stents. Rev Esp Cardiol 2010; 63 (5): 528-535.
50. Goswami NJ, Gaffigan M, Berrio G, et al,. Long-term outcomes of drug-eluting stents versus bare-metal stents in saphenous vein graft disease: Results from the Prairie "Real World" Stent Registry. Catheter Cardiovasc Interv 2010; 75 (1): 93-100.
51. Gurvitch R, Lefkovits J, Warren RJ, et al,. Clinical outcomes of drug-eluting stent use in patients with ST elevation myocardial infarction. Int J Cardiol 2010; 143 (3): 283-288. [Epub 2009 Apr 2].
52. Kukreja N, Onuma Y, Garcia-Garcia HM, et al,; Interventional Cardiologists of the Thoraxcenter (2000-5). Am J Cardiol 2009; 103 (2): 203-211. [Epub 2008 Nov 19].
53. Marzocchi A, Saia F, Piovaccari G, et al,. Long-term safety and efficacy of drug-eluting stents: Two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) multicenter registry. Circulation 2007; 115 (25): 3181-3188. [Epub 2007 Jun 11].
54. Ortolani P, Solinas E, Guastaroba P, et al,. Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions. Results from the REAL (REgistro Regionale AngiopLastiche Emilia-Romagna) multicenter registry. Int J Cardiol 2010 Jan 6. [Epub ahead of print.
55. Saia F, Piovaccari G, Manari A, et al,. Patient selection to enhance the long-term benefit of first generation drug-eluting stents for coronary revascularisation procedures. Insights from a large multicentre registry. EuroIntervention 2009; 5 (1): 57-66.
56. Varani E, Guastaroba P, Di Tanna GL, et al,. Long-term clinical outcomes and cost-effectiveness analysis in multivessel percutaneous coronary interventions: Comparison of drug-eluting stents, bare-metal stents and a mixed approach in patients at high and low risk of repeat revascularisation. EuroIntervention 2010; 5 (8): 953-961. doi: 10.4244/.
57. Austin D, Oldroyd KG, McConnachie A, et al,. Drug-eluting stents versus bare-metal stents for off-label indications: A propensity score-matched outcome study. Circ Cardiovasc Interv 2008; 1 (1): 45-52.
58. Applegate RJ, Sacrinty M, Kutcher M, et al,. Late outcomes of drug-eluting versus bare metal stents in saphenous vein grafts: Propensity score analysis. Catheter Cardiovasc Interv 2008; 72 (1): 7-12.
59. Alahmar AE, Grayson AD, et al,. Reduction in mortality and target-lesion revascularisation at 2 years: A comparison between drug-eluting stents and conventional bare-metal stents in the "real world". Int J Cardiol 2009; 132 (3): 398-404. [Epub 2008 Apr 24].
60. Gao RL, Xu B, Chen JL, et al,. Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation: Results from a large single-center database. Chin Med J (Engl). 2009; 122 (19): 2261-2267.
61. Garg P, Normand SL, Silbaugh TS, et al,. Drug-eluting or bare-metal stenting in patients with diabetes mellitus: Results from the Massachusetts Data Analysis Center Registry. Circulation 2008; 118 (22): 2277-2285, 7p following 2285. [Epub 2008 Nov 10].
62. Groeneveld PW, Matta MA, Greenhut AP, et al,. Drug-eluting compared with bare-metal coronary stents among elderly patients. J Am Coll Cardiol 2008; 51 (21): 2017-2024.
63. Kim KH, Koo BK, Min HS, et al,. Comparison of drug-eluting versus bare-metal stent implantation in ST-elevation myocardial infarction patients with renal insufficiency: Results from the national registry in Korea. Int J Cardiol 2012; 154 (1): 71-77.
64. Ko DT, Chiu M, Guo H, et al,. Safety and effectiveness of drug-eluting and bare-metal stents for patients with off- and on-label indications. J Am Coll Cardiol 2009; 53 (19): 1773-1782.
65. Ko DT, Chiu M, Austin PC, et al,. Safety and effectiveness of drug-eluting stents among diabetic patients: A propensity analysis. Am Heart J 2008; 156 (1): 125-134. [Epub 2008 May 6].
66. Mauri L, Silbaugh TS, Garg P, et al,. Drug-eluting or bare-metal stents for acute myocardial infarction. N Engl J Med 2008; 359 (13): 1330-1342.
67. Mauri L, Silbaugh TS, Wolf RE, et al,. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation 2008; 118 (18): 1817-1827. [Epub 2008 Oct 13].
68. Park KW, Kang SH, Chung WY, et al,. 'Real world' comparison of drug-eluting stents vs bare metal stents in the treatment of unselected patients with acute ST-segment elevation myocardial infarction. Circ J 2010; 74 (6): 1111-1120. [Epub 2010 Apr 20].
69. Ouldzein H, Roncalli J, Zouaoui W, et al,. Drug-eluting or bare-metal stents in subjects over 75 years of age: What is the best therapeutic strategy? Data from 460 consecutive patients with 1-year outcome. Cardiovasc Revasc Med 2009; 10 (2): 94-102.
70. Roy P, Buch AN, Javaid A, et al,. Impact of "off-label" utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. Am J Cardiol 2008; 101 (3): 293-299. [Epub 2007 Dec 21].
71. Ruiz-Nodar JM, Marín F, Sánchez-Payá J, et al,. Efficacy and safety of drug-eluting stent use in patients with atrial fibrillation. Eur Heart J 2009; 30 (8): 932-939. [Epub 2009 Feb 26].
72. Tamburino C, Di Salvo ME, Capodanno D, et al,. Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry. Eur Heart J 2009; 30 (10): 1171-1179. [Epub 2009 Mar 10].
73. Tu JV, Bowen J, Chiu M, et al,. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 2007; 357 (14): 1393-1402.
74. Concato J, Peduzzi P, Holford TR, et al,. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol 1995; 48: 1495-1501.
75. Peduzzi P, Concato J, Feinstein AR, et al,. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol 1995; 48: 1503-1510.
76. Hosmer DL, Lemeshow S,. Applied Logistic Regression. New York: John Wiley and Sons, 2000.
77. Campbell EG, Rao SR, DesRoches CM, et al,. Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Arch Intern Med 2010; 170 (20): 1820-1826.
78. Harrington RA, Califf RM,. There is a role for industry-sponsored education in cardiology. Circulation 2010; 121 (20): 2221-2227.
79. Kirtane AJ, Gupta A, Iyengar S,. Safety and efficacy of drug-eluting and bare metal stents: Comprehensive meta-analysis of randomized trials and observational studies. Circulation 2009; 119 (25): 3198-3206. [Epub 2009 Jun 15].
80. Roukoz H, Bavry AA, Sarkees ML, et al,. Comprehensive meta-analysis on drug-eluting stents versus bare-metal stents during extended follow-up. Am J Med 2009; 122 (6): 581.e1-10.