Effective vascular therapeutics for critical limb ischemia: A role for registry-based clinical investigation

Circulation: Cardiovascular Interventions

Volumn 6, Issue 1, 2013, Pages 8-11

  Hirsch, Alan T ^a   Duval, Sue ^a  

^a UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

Author keywords

Amputation; Critical limb ischemia; Editorials; Peripheral artery disease

Indexed keywords

CILOSTAZOL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; POLITEF;

AMPUTATION; ANGIOPLASTY; CRITICAL LIMB ISCHEMIA; DISEASE CLASSIFICATION; HUMAN; INCIDENCE; MEDICAL RESEARCH; PERIPHERAL OCCLUSIVE ARTERY DISEASE; POLITEF IMPLANT; PREVALENCE; PRIORITY JOURNAL; REGISTER; REVIEW; SURVIVAL RATE; TREATMENT OUTCOME;

ARTERIES; ENDOVASCULAR PROCEDURES; EXTREMITIES; FEMALE; HUMANS; ISCHEMIA; MALE; PERIPHERAL ARTERIAL DISEASE;

EID: 84879159613     PISSN: 19417640     EISSN: 19417632     Source Type: Journal    
DOI: 10.1161/CIRCINTERVENTIONS.113.000127     Document Type: Review

References (27)

1. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006;113:1474-1547.
2. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45:S5-S67.
3. Second European consensus document on chronic critical leg ischemia. Eur J Vasc Surg. 1992;6(Suppl A):1-32.
4. Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996-2005. J Vasc Surg. 2009;49:910-917.
5. Li Y, Burrows NR, Gregg EW, Albright A, Geiss LS. Declining rates of hospitalization for nontraumatic lower-extremity amputation in the diabetic population aged 40 years or older: U.S. 1988-2008. Diabetes Care. 2012;35(2):273-277.
6. Abola MT, Bhatt DL, Duval S, Cacoub PP, Baumgartner I, Keo H, Creager MA, Brennan DM, Steg PG, Hirsch AT; REACH Investigators. Fate of individuals with ischemic amputations in the REACH Registry: three-year cardiovascular and limb-related outcomes. Atherosclerosis. 2012;221:527-535.
7. Mahoney EM, Wang K, Keo HH, Duval S, Smolderen KG, Cohen DJ, Steg G, Bhatt DL, Hirsch AT; Reduction of Atherothrombosis for Continued Health (REACH) Registry Investigators. Vascular hospitalization rates and costs in patients with peripheral artery disease in the United States. Circ Cardiovasc Qual Outcomes. 2010;3:642-651.
8. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366:1925-1934.
9. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, Namini H, Hamdan AD, Roddy SP, Belkin M, Berceli SA, DeMasi RJ, Samson RH, Berman SS; PREVENT III Investigators. 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. 2006;43:742-751; discussion 751.
10. Dehmer GJ, Weaver D, Roe MT, Milford-Beland S, Fitzgerald S, Hermann A, Messenger J, Moussa I, Garratt K, Rumsfeld J, Brindis RG. A contemporary view of diagnostic cardiac catheterization and percutaneous coronary intervention in the United States: a report from the CathPCI Registry of the National Cardiovascular Data Registry, 2010 through June 2011. J Am Coll Cardiol. 2012;60:2017-2031.
11. Mehta RH, Roe MT, Chen AY, Lytle BL, Pollack CV, Jr, Brindis RG, Smith SC, Jr, Harrington RA, Fintel D, Fraulo ES, Califf RM, Gibler WB, Ohman EM, Peterson ED. Recent trends in the care of patients with non-ST-segment elevation acute coronary syndromes: insights from the CRUSADE initiative. Arch Intern Med. 2006;166:2027-2034.
12. Ohman EM, Bhatt DL, Steg PG, Goto S, Hirsch AT, Liau CS, Mas JL, Richard AJ, Röther J, Wilson PW; REACH Registry Investigators. The REduction of Atherothrombosis for Continued Health (REACH) Registry: an international, prospective, observational investigation in subjects at risk for atherothrombotic events-study design. Am Heart J. 2006;151:786.e1-786.10.
13. Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, Evangelista A, Fattori R, Suzuki T, Oh JK, Moore AG, Malouf JF, Pape LA, Gaca C, Sechtem U, Lenferink S, Deutsch HJ, Diedrichs H, Marcos y Robles J, Llovet A, Gilon D, Das SK, Armstrong WF, Deeb GM, Eagle KA. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000;283:897-903.
14. Olin JW, Froehlich J, Gu X, Bacharach JM, Eagle K, Gray BH, Jaff MR, Kim ES, Mace P, Matsumoto AH, McBane RD, Kline-Rogers E, White CJ, Gornik HL. The United States Registry for Fibromuscular Dysplasia: results in the first 447 patients. Circulation. 2012;125:3182-3190.
15. Mukherjee D, Munir K, Hirsch AT, Chetcuti S, Grossman PM, Rajagopalan S, Nallamothu BK, Moscucci M, Henke P, Kassab E, Sohal C, Riba A, Person D, Luciano AE, DeGregorio M, Patel K, Rutkowski KC, Eagle KA. Development of a multicenter peripheral arterial interventional database: the PVD-QI2. Am Heart J. 2005;149:1003-1008.
16. Jämsén T, Manninen H, Tulla H, Matsi P. The final outcome of primary infrainguinal percutaneous transluminal angioplasty in 100 consecutive patients with chronic critical limb ischemia. J Vasc Interv Radiol. 2002;13:455-463.
17. Ramaiah V, Gammon R, Kiesz S, Cardenas J, Runyon JP, Fail P, Walker C, Allie DE, Chamberlin J, Solis M, Garcia L, Kandzari D; TALON Registry. Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection. J Endovasc Ther. 2006;13:592-602.
18. Lenti M, Cieri E, De Rango P, Pozzilli P, Coscarella C, Bertoglio C, Troiani R, Cao P. Endovascular treatment of long lesions of the superficial femoral artery: results from a multicenter registry of a spiral, covered polytetrafluoroethylene stent. J Vasc Surg. 2007;45:32-39.
19. Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimuseluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol. 2009;20:1141-1150.
20. Kandzari DE, Kiesz RS, Allie D, Walker C, Fail P, Ramaiah VG, Cardenas J, Vale J, Chopra A, Gammon RS. Procedural and clinical outcomes with catheter-based plaque excision in critical limb ischemia. J Endovasc Ther. 2006;13:12-22.
21. Malmstedt J, Leander K, Wahlberg E, Karlström L, Alfredsson L, Swedenborg J. Outcome after leg bypass surgery for critical limb ischemia is poor in patients with diabetes: a population-based cohort study. Diabetes Care. 2008;31:887-892.
22. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011;58:2020-2045.
23. Iida O, Nakamura M, Yamauchi Y, Kawasaki D, Yokoi Y, Yokoi H, Soga Y, Zen K, Hirano K, Suematsu N, Inoue N, Suzuki K, Shintani Y, Miyashita Y, Urasawa K, Kitano I, Yamaoka T, Murakami T, Uesugi M, Tsuchiya T, Shinke T, Oba Y, Ohura N, Hamasaki T, Nanto S, on behalf of the OLIVE investigators. Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up. Circ Cardiovasc Interv. 2013;6:68-76.
24. Garimella PS, Hart PD, O'Hare A, DeLoach S, Herzog CA, Hirsch AT. Peripheral artery disease and CKD: a focus on peripheral artery disease as a critical component of CKD care. Am J Kidney Dis. 2012;60:641-654.
25. Schanzer A, Mega J, Meadows J, Samson RH, Bandyk DF, Conte MS. Risk stratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes data. J Vasc Surg. 2008;48:1464-1471.
26. US Renal Data System, USRDS 2012 Annual Data Report. Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
27. O'Hare AM, Bertenthal D, Shlipak MG, Sen S, Chren MM. Impact of renal insufficiency on mortality in advanced lower extremity peripheral arterial disease. J Am Soc Nephrol. 2005;16:514-519.