메뉴 건너뛰기




Volumn 72, Issue 1, 2008, Pages 1-6

Evolving challenges in medical device evaluation

Author keywords

[No Author keywords available]

Indexed keywords

BIOASSAY; CARDIOVASCULAR DISEASE; CORONARY STENT; COST EFFECTIVENESS ANALYSIS; ECONOMIC ASPECT; EVIDENCE BASED MEDICINE; HEALTH CARE COST; INTERVENTION STUDY; MEDICAL INSTRUMENTATION; QUALITY CONTROL; REVIEW; RISK BENEFIT ANALYSIS; SAFETY; STANDARD;

EID: 47549102608     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21541     Document Type: Review
Times cited : (2)

References (39)
  • 1
    • 33644852941 scopus 로고    scopus 로고
    • Postmarket surveillance for drug-eluting coronary stents: A comprehensive approach
    • Baim DS, Mehran R, Kereiakes DJ, et al. Postmarket surveillance for drug-eluting coronary stents: A comprehensive approach. Circulation 2006;113:891-897.
    • (2006) Circulation , vol.113 , pp. 891-897
    • Baim, D.S.1    Mehran, R.2    Kereiakes, D.J.3
  • 2
    • 17144387004 scopus 로고    scopus 로고
    • Surrogates, substudies, and real clinical end points in trials of drug-eluting stents
    • Kereiakes DJ, Kuntz RE, Mauri L, Krucoff MW. Surrogates, substudies, and real clinical end points in trials of drug-eluting stents. J Am Coll Cardiol 2005;45:1206-1212.
    • (2005) J Am Coll Cardiol , vol.45 , pp. 1206-1212
    • Kereiakes, D.J.1    Kuntz, R.E.2    Mauri, L.3    Krucoff, M.W.4
  • 3
    • 33645471387 scopus 로고    scopus 로고
    • Non-inferiority trials: Design concepts and issues-The encounters of academic consultants in statistics
    • D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: Design concepts and issues-The encounters of academic consultants in statistics. Stat Med 2006;25:1097-1099.
    • (2006) Stat Med , vol.25 , pp. 1097-1099
    • D'Agostino Sr, R.B.1    Massaro, J.M.2    Sullivan, L.M.3
  • 4
    • 20244371040 scopus 로고    scopus 로고
    • Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: Analysis from the TAXUS-IV trial
    • Ellis SG, Popma JJ, Lasala JM, et al. Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: Analysis from the TAXUS-IV trial. J Am Coll Cardiol 2005;45:1193-1200.
    • (2005) J Am Coll Cardiol , vol.45 , pp. 1193-1200
    • Ellis, S.G.1    Popma, J.J.2    Lasala, J.M.3
  • 5
    • 4143096183 scopus 로고    scopus 로고
    • A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents
    • Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 2004;364:583-591.
    • (2004) Lancet , vol.364 , pp. 583-591
    • Babapulle, M.N.1    Joseph, L.2    Bélisle, P.3    Brophy, J.M.4    Eisenberg, M.J.5
  • 6
    • 33847741037 scopus 로고    scopus 로고
    • A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents
    • Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:989-997.
    • (2007) N Engl J Med , vol.356 , pp. 989-997
    • Spaulding, C.1    Daemen, J.2    Boersma, E.3    Cutlip, D.E.4    Serruys, P.W.5
  • 7
    • 33847736642 scopus 로고    scopus 로고
    • Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents
    • Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
    • (2007) N Engl J Med , vol.356 , pp. 998-1008
    • Stone, G.W.1    Moses, J.W.2    Ellis, S.G.3
  • 8
    • 33847766568 scopus 로고    scopus 로고
    • Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents
    • Kastrati A, Mehilli J, Pache J, et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:1030-1039.
    • (2007) N Engl J Med , vol.356 , pp. 1030-1039
    • Kastrati, A.1    Mehilli, J.2    Pache, J.3
  • 9
    • 33748690953 scopus 로고    scopus 로고
    • Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention
    • Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 2006;355:1105-1113.
    • (2006) N Engl J Med , vol.355 , pp. 1105-1113
    • Laarman, G.J.1    Suttorp, M.J.2    Dirksen, M.T.3
  • 11
    • 34948904387 scopus 로고    scopus 로고
    • Effectiveness and safety of drug-eluting stents in Ontario
    • Tu JV, Bowen J, Chiu M, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 2007;357:1393-1402.
    • (2007) N Engl J Med , vol.357 , pp. 1393-1402
    • Tu, J.V.1    Bowen, J.2    Chiu, M.3
  • 12
    • 3543064732 scopus 로고    scopus 로고
    • Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: Results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial
    • Cohen DJ, Bakhai A, Shi C, et al. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: Results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation 2004;110:508-514.
    • (2004) Circulation , vol.110 , pp. 508-514
    • Cohen, D.J.1    Bakhai, A.2    Shi, C.3
  • 13
    • 0028358762 scopus 로고
    • The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit and the hypercholesterolemic Yucatan micropig
    • Post MJ, Borst C, Kuntz RE. The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit and the hypercholesterolemic Yucatan micropig. Circulation 1994;89:2816-2821.
    • (1994) Circulation , vol.89 , pp. 2816-2821
    • Post, M.J.1    Borst, C.2    Kuntz, R.E.3
  • 15
    • 0027312777 scopus 로고
    • Defining coronary restenosis. Newer clinical and angiographic paradigms
    • Kuntz RE, Baim DS. Defining coronary restenosis. Newer clinical and angiographic paradigms. Circulation 1993;88:1310-1323.
    • (1993) Circulation , vol.88 , pp. 1310-1323
    • Kuntz, R.E.1    Baim, D.S.2
  • 16
    • 0037132635 scopus 로고    scopus 로고
    • Clinical restenosis after coronary stenting: Perspectives from multicenter clinical trials
    • Cutlip DE, Chauhan MS, Baim DS, et al. Clinical restenosis after coronary stenting: Perspectives from multicenter clinical trials. J Am Coll Cardiol 2002;40:2082-2089.
    • (2002) J Am Coll Cardiol , vol.40 , pp. 2082-2089
    • Cutlip, D.E.1    Chauhan, M.S.2    Baim, D.S.3
  • 17
    • 19944430230 scopus 로고    scopus 로고
    • Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents
    • Mauri L, Orav EJ, O'Malley AJ, et al. Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents. Circulation 2005;111:321-327.
    • (2005) Circulation , vol.111 , pp. 321-327
    • Mauri, L.1    Orav, E.J.2    O'Malley, A.J.3
  • 18
    • 0035003536 scopus 로고    scopus 로고
    • Statistical methods for comparison to placebo in active-control trials
    • Hasselblad V, Kong DF. Statistical methods for comparison to placebo in active-control trials. Drug Inform J 2001;35:435-449.
    • (2001) Drug Inform J , vol.35 , pp. 435-449
    • Hasselblad, V.1    Kong, D.F.2
  • 19
    • 0033004225 scopus 로고    scopus 로고
    • Some issues in the design and analysis of equivalence trials
    • Hauck WW, Anderson S. Some issues in the design and analysis of equivalence trials. Drug Inform J 1999;33:109-118.
    • (1999) Drug Inform J , vol.33 , pp. 109-118
    • Hauck, W.W.1    Anderson, S.2
  • 20
    • 8744294856 scopus 로고    scopus 로고
    • Comparison of late luminal loss response pattern after sirolimus-eluting stent implantation or conventional stenting
    • Lemos PA, Mercado N, van Domburg RT, Kuntz RE, O'Neill WW, Serruys PW. Comparison of late luminal loss response pattern after sirolimus-eluting stent implantation or conventional stenting. Circulation 2004;110:3199-3205.
    • (2004) Circulation , vol.110 , pp. 3199-3205
    • Lemos, P.A.1    Mercado, N.2    van Domburg, R.T.3    Kuntz, R.E.4    O'Neill, W.W.5    Serruys, P.W.6
  • 21
    • 33845337615 scopus 로고    scopus 로고
    • Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: A randomized controlled trial
    • Kandzari DE, Leon MB, Popma JJ, et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: A randomized controlled trial. J Am Coll Cardiol 2006;48:2440-2447.
    • (2006) J Am Coll Cardiol , vol.48 , pp. 2440-2447
    • Kandzari, D.E.1    Leon, M.B.2    Popma, J.J.3
  • 22
    • 0027934377 scopus 로고
    • A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators
    • Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med 1994;331:496-501.
    • (1994) N Engl J Med , vol.331 , pp. 496-501
    • Fischman, D.L.1    Leon, M.B.2    Baim, D.S.3
  • 23
    • 0032477766 scopus 로고    scopus 로고
    • Final results of the Balloon vs Optimal Atherectomy Trial (BOAT)
    • Baim DS, Cutlip DE, Sharma SK, et al. Final results of the Balloon vs Optimal Atherectomy Trial (BOAT). Circulation 1998; 97:322-331.
    • (1998) Circulation , vol.97 , pp. 322-331
    • Baim, D.S.1    Cutlip, D.E.2    Sharma, S.K.3
  • 24
    • 0022650533 scopus 로고
    • Coronary thrombolysis with human single-chain, urokinase-type plasminogen activator (pro-urokinase) in patients with acute myocardial infarction
    • Van de Werf F, Nobuhara M, Collen D. Coronary thrombolysis with human single-chain, urokinase-type plasminogen activator (pro-urokinase) in patients with acute myocardial infarction. Ann Intern Med 1986;104:345-348.
    • (1986) Ann Intern Med , vol.104 , pp. 345-348
    • Van de Werf, F.1    Nobuhara, M.2    Collen, D.3
  • 25
    • 0026527437 scopus 로고
    • A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. Veterans Affairs ACME Investigators
    • Parisi AF, Folland ED, Hartigan P. A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. Veterans Affairs ACME Investigators. N Engl J Med 1992;326:10-16.
    • (1992) N Engl J Med , vol.326 , pp. 10-16
    • Parisi, A.F.1    Folland, E.D.2    Hartigan, P.3
  • 26
    • 0030011472 scopus 로고    scopus 로고
    • Quality of life, employment status, and anginal symptoms after coronary angioplasty or bypass surgery. 3-year follow-up in the Randomized Intervention Treatment of Angina (RITA) trial
    • Pocock SJ, Henderson RA, Seed P, Treasure T, Hampton JR. Quality of life, employment status, and anginal symptoms after coronary angioplasty or bypass surgery. 3-year follow-up in the Randomized Intervention Treatment of Angina (RITA) trial. Circulation 1996;94:135-142.
    • (1996) Circulation , vol.94 , pp. 135-142
    • Pocock, S.J.1    Henderson, R.A.2    Seed, P.3    Treasure, T.4    Hampton, J.R.5
  • 27
    • 47549110186 scopus 로고    scopus 로고
    • Bowen J, Hopkins R, He Y, et al. Systematic review and cost-effectiveness analysis of drug eluting stents compared to bare metal stents for percutaneous coronary interventions in Ontario: Interim report. Report no. HTA002-0512, prepared for the Ontario Ministry of Health and Long-term Care. Hamilton, ON, Canada: Program for Assessment of Technology in Health, McMaster University, December 2005:170. Available at http:// www.path-hta.ca/DESreport.pdf. Accessed on September 7, 2007.
    • Bowen J, Hopkins R, He Y, et al. Systematic review and cost-effectiveness analysis of drug eluting stents compared to bare metal stents for percutaneous coronary interventions in Ontario: Interim report. Report no. HTA002-0512, prepared for the Ontario Ministry of Health and Long-term Care. Hamilton, ON, Canada: Program for Assessment of Technology in Health, McMaster University, December 2005:170. Available at http:// www.path-hta.ca/DESreport.pdf. Accessed on September 7, 2007.
  • 28
    • 0017347943 scopus 로고
    • Foundations of cost-effectiveness analysis for health and medical practices
    • Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med 1977;296:716-721.
    • (1977) N Engl J Med , vol.296 , pp. 716-721
    • Weinstein, M.C.1    Stason, W.B.2
  • 29
    • 1242340310 scopus 로고    scopus 로고
    • Can we afford to eliminate restenosis? Can we afford not to?
    • Greenberg D, Bakhai A, Cohen DJ. Can we afford to eliminate restenosis? Can we afford not to? J Am Coll Cardiol 2004;43: 513-518.
    • (2004) J Am Coll Cardiol , vol.43 , pp. 513-518
    • Greenberg, D.1    Bakhai, A.2    Cohen, D.J.3
  • 30
    • 0035910110 scopus 로고    scopus 로고
    • Cost-effectiveness of coronary stenting in acute myocardial infarction: Results from the stent primary angioplasty in myocardial infarction (stent-PAMI) trial
    • Cohen DJ, Taira DA, Berezin R, et al. Cost-effectiveness of coronary stenting in acute myocardial infarction: Results from the stent primary angioplasty in myocardial infarction (stent-PAMI) trial. Circulation 2001;104:3039-3045.
    • (2001) Circulation , vol.104 , pp. 3039-3045
    • Cohen, D.J.1    Taira, D.A.2    Berezin, R.3
  • 31
    • 0037031295 scopus 로고    scopus 로고
    • Gamma-l Investigators. Cost-effectiveness of γ radiation for treatment of in-stent restenosis: Results from the γ-1 trial
    • Cohen DJ, Cosgrove RS, Berezin RH, Teirstein PS, Leon MB, Kuntz RE;Gamma-l Investigators. Cost-effectiveness of γ radiation for treatment of in-stent restenosis: Results from the γ-1 trial. Circulation 2002;106:691-697.
    • (2002) Circulation , vol.106 , pp. 691-697
    • Cohen, D.J.1    Cosgrove, R.S.2    Berezin, R.H.3    Teirstein, P.S.4    Leon, M.B.5    Kuntz, R.E.6
  • 32
    • 33745708066 scopus 로고    scopus 로고
    • Cost effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: Results from the TAXUS-IV trial
    • Bakhai A, Stone GW, Mahoney E, et al. Cost effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: Results from the TAXUS-IV trial. J Am Coll Cardiol 2006;48:253-261.
    • (2006) J Am Coll Cardiol , vol.48 , pp. 253-261
    • Bakhai, A.1    Stone, G.W.2    Mahoney, E.3
  • 33
    • 0032578319 scopus 로고    scopus 로고
    • Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)
    • Serruys PW, van Hout B, Bonnier H, et al. Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II). Lancet 1998;352:673-681.
    • (1998) Lancet , vol.352 , pp. 673-681
    • Serruys, P.W.1    van Hout, B.2    Bonnier, H.3
  • 34
    • 4444225432 scopus 로고    scopus 로고
    • Beyond restenosis: Five-year clinical outcomes from second-generation coronary stent trials
    • Cutlip DE, Chhabra AG, Baim DS, et al. Beyond restenosis: Five-year clinical outcomes from second-generation coronary stent trials. Circulation 2004;110:1226-1230.
    • (2004) Circulation , vol.110 , pp. 1226-1230
    • Cutlip, D.E.1    Chhabra, A.G.2    Baim, D.S.3
  • 35
    • 33745285306 scopus 로고    scopus 로고
    • Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: Results from the TAXUS-IV trial
    • Pinto DS, Stone GW, Ellis SG, et al. Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: Results from the TAXUS-IV trial. J Am Coll Cardiol 2006;48:32-36.
    • (2006) J Am Coll Cardiol , vol.48 , pp. 32-36
    • Pinto, D.S.1    Stone, G.W.2    Ellis, S.G.3
  • 36
    • 17844409064 scopus 로고    scopus 로고
    • Conducting economic evaluations alongside multinational clinical trials: Toward a research consensus
    • Reed SD, Anstrom KJ, Bakhai A, et al. Conducting economic evaluations alongside multinational clinical trials: Toward a research consensus. Am Heart J 2005;149:434-443.
    • (2005) Am Heart J , vol.149 , pp. 434-443
    • Reed, S.D.1    Anstrom, K.J.2    Bakhai, A.3
  • 37
    • 4744339654 scopus 로고    scopus 로고
    • The effect of erectile dysfunction on quality of life following treatment for localized prostate cancer
    • Penson DF. The effect of erectile dysfunction on quality of life following treatment for localized prostate cancer. Rev Urol 2001; 3:113-119.
    • (2001) Rev Urol , vol.3 , pp. 113-119
    • Penson, D.F.1
  • 38
    • 4444267310 scopus 로고    scopus 로고
    • Willingness to pay for avoiding coronary restenosis and repeat revascularization: Results from a contingent valuation study
    • Greenberg D, Bakhai A, Neumann PJ, Cohen DJ. Willingness to pay for avoiding coronary restenosis and repeat revascularization: Results from a contingent valuation study. Health Pol 2004;70:207-216.
    • (2004) Health Pol , vol.70 , pp. 207-216
    • Greenberg, D.1    Bakhai, A.2    Neumann, P.J.3    Cohen, D.J.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.