Improved amputation-free survival in unreconstructable critical limb ischemia and its implications for clinical trial design and quality measurement
Tài liệu tham khảo
Eskelinen, 2006, Major amputation incidence decreases both in non-diabetic and in diabetic patients in Helsinki, Scand J Surg, 95, 185, 10.1177/145749690609500311
Feinglass, 1999, Rates of lower-extremity amputation and arterial reconstruction in the United States, 1979 to 1996, Am J Public Health, 89, 1222, 10.2105/AJPH.89.8.1222
Suding, 2008, Increased endovascular interventions decrease the rate of lower limb artery bypass operations without an increase in major amputation rate, Ann Vasc Surg, 22, 195, 10.1016/j.avsg.2007.12.002
Al-Omran, 2003, Use of interventional procedures for peripheral arterial occlusive disease in Ontario between 1991 and 1998: a population-based study, J Vasc Surg, 38, 289, 10.1016/S0741-5214(03)00273-8
Anderson, 2004, Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000, J Vasc Surg, 39, 1200, 10.1016/j.jvs.2004.02.039
Egorova, 2010, An analysis of the outcomes of a decade of experience with lower extremity revascularization including limb salvage, lengths of stay, and safety, J Vasc Surg, 51, 878, 10.1016/j.jvs.2009.10.102
Goodney, 2009, National trends in lower extremity bypass surgery, endovascular interventions, and major amputations, J Vasc Surg, 50, 54, 10.1016/j.jvs.2009.01.035
Kudo, 2006, Changing pattern of surgical revascularization for critical limb ischemia over 12 years: endovascular vs. open bypass surgery, J Vasc Surg, 44, 304, 10.1016/j.jvs.2006.03.040
Nowygrod, 2006, Trends, complications, and mortality in peripheral vascular surgery, J Vasc Surg, 43, 205, 10.1016/j.jvs.2005.11.002
Rowe, 2009, Patterns of treatment for peripheral arterial disease in the United States: 1996-2005, J Vasc Surg, 49, 910, 10.1016/j.jvs.2008.11.054
Norgren, 2007, Inter-society consensus for the management of peripheral arterial disease (TASC II), J Vasc Surg, 45, S5, 10.1016/j.jvs.2006.12.037
Lawall, 2010, Stem cell and progenitor cell therapy in peripheral artery disease, Thromb Haemost, 103, 696, 10.1160/TH09-10-0688
Novo, 2004, Critical limb ischemia: definition and natural history, Curr Drug Targets Cardiovasc Haematol Disord, 4, 219, 10.2174/1568006043335989
Nehler, 2003, Is revascularization and limb salvage always the best treatment for critical limb ischemia?, J Vasc Surg, 37, 704, 10.1067/mva.2003.142
Conte, 2006, Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery, J Vasc Surg, 43, 742, 10.1016/j.jvs.2005.12.058
Adam, 2005, Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial, Lancet, 366, 1925, 10.1016/S0140-6736(05)67704-5
Bradbury, 2010, Bypass versus angioplasty in Severe ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received, J Vasc Surg, 51, 18S, 10.1016/j.jvs.2010.01.074
Kumar, 2009, FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia, J Vasc Surg, 50, 1474, 10.1016/j.jvs.2009.09.045
Chuang-Stein, 1995, Multiple comparisons procedures for comparing several treatments with a control based on binary data, Stat Med, 14, 2509, 10.1002/sim.4780142302
Lau, 1992, Cumulative meta-analysis of therapeutic trials for myocardial infarction, N Engl J Med, 327, 248, 10.1056/NEJM199207233270406
Lau, 1997, Quantitative synthesis in systematic reviews, Ann Intern Med, 127, 820, 10.7326/0003-4819-127-9-199711010-00008
van Houwelingen, 2002, Advanced methods in meta-analysis: multivariate approach and meta-regression, Stat Med, 21, 589, 10.1002/sim.1040
Lepäntalo, 1996, Outcome of unreconstructed chronic critical leg ischaemia, Eur J Vasc Endovasc Surg, 11, 153, 10.1016/S1078-5884(96)80044-X
Marston, 2006, Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization, J Vasc Surg, 44, 108, 10.1016/j.jvs.2006.03.026
Jivegård, 1995, Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study, Eur J Vasc Endovasc Surg, 9, 421, 10.1016/S1078-5884(05)80010-3
Claeys, 1996, Transcutaneous oxygen pressure as predictive parameter for ulcer healing in endstage vascular patients treated with spinal cord stimulation, Int Angiol, 15, 344
Klomp, 1999, Spinal-cord stimulation in critical limb ischaemia: a randomised trial, Lancet, 353, 1040, 10.1016/S0140-6736(98)05069-7
Spincemaille, 2000, Technical data and complications of spinal cord stimulation: data from a randomized trial on critical limb ischemia, Stereotact Funct Neurosurg, 74, 63, 10.1159/000056465
Amann, 2003, Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral Vascular Disease Outcome Study (SCS-EPOS), Eur J Vasc Endovasc Surg, 26, 280, 10.1053/ejvs.2002.1876
Brass, 2006, Parenteral therapy with lipo-ecraprost, a lipid-based formulation of a PGE1 analog, does not alter six-month outcomes in patients with critical leg ischemia, J Vasc Surg, 43, 752, 10.1016/j.jvs.2005.11.041
Nikol, 2008, Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia, Mol Ther, 16, 972, 10.1038/mt.2008.33
Hiatt, 2010
Powell, 2010, Safety and efficacy of patient specific intramuscular injection of HGF plasmid gene therapy on limb perfusion and wound healing in patients with ischemic lower extremity ulceration: results of the HGF-0205 trial, J Vasc Surg, 52, 1525, 10.1016/j.jvs.2010.07.044
Conte, 2001, Impact of increasing comorbidity on infrainguinal reconstruction: a 20-year perspective, Ann Surg, 233, 445, 10.1097/00000658-200103000-00021
Conte, 2009, Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia, J Vasc Surg, 50, 1462, 10.1016/j.jvs.2009.09.044
Goodney, 2011, Validation of the Society for Vascular Surgery's objective performance goals for critical limb ischemia in everyday vascular surgery practice, J Vasc Surg, 54, 100, 10.1016/j.jvs.2010.11.107
Goshima, 2004, A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage, J Vasc Surg, 39, 330, 10.1016/j.jvs.2003.10.020
Hong, 2011, Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design, Circulation, 123, 2111, 10.1161/CIRCULATIONAHA.109.934786
Kent, 2009, Therapeutic innovations, diminishing returns, and control rate preservation, JAMA, 302, 2254, 10.1001/jama.2009.1679
Benoit, 2011, The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design, J Translational Med, 9, 165, 10.1186/1479-5876-9-165
Schanzer, 2009, Validation of the PIII CLI risk score for the prediction of amputation-free survival in patients undergoing infrainguinal autogenous vein bypass for critical limb ischemia, J Vasc Surg, 50, 769, 10.1016/j.jvs.2009.05.055
Arvela, 2010, Finnvasc score and modified Prevent III score predict long-term outcome after infrainguinal surgical and endovascular revascularization for critical limb ischemia, J Vasc Surg, 52, 1218, 10.1016/j.jvs.2010.06.101