Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial

I-Chih Chen, Cheng-Han Lee, Ting-Hsing Chao, Wei-Kung Tseng, Tsung-Hsien Lin, Wen-Jung Chung, Jen-Kwan Li, Hsuan-Li Huang, Ping-Yen Liu, Ting-Kuang Chao, Chuin-Yuan Chu, Chih-Chan Lin, Po-Chao Hsu, Wen-Huang Lee, Po-Tseng Lee, Yi-Heng Li, Shih-Ya Tseng, Liang-Miin Tsai, Juey-Jen Hwang, I-Chih Chen, Cheng-Han Lee, Ting-Hsing Chao, Wei-Kung Tseng, Tsung-Hsien Lin, Wen-Jung Chung, Jen-Kwan Li, Hsuan-Li Huang, Ping-Yen Liu, Ting-Kuang Chao, Chuin-Yuan Chu, Chih-Chan Lin, Po-Chao Hsu, Wen-Huang Lee, Po-Tseng Lee, Yi-Heng Li, Shih-Ya Tseng, Liang-Miin Tsai, Juey-Jen Hwang

Abstract

Background: The prevalence of significant obstructive coronary artery disease with complex lesions is high in patients who have low extremity artery disease (LEAD). However, intermediate- or long-term cardiovascular prognosis of LEAD patients undergoing percutaneous transluminal angioplasty (PTA) remains poor. Accordingly, prophylactic coronary revascularization may modify short- and long-term cardiovascular outcomes of LEAD patients receiving PTA. Because myocardial ischemic symptoms are often masked in LEAD and the accuracy of non-invasive stress tests is usually limited, a high-quality randomized controlled trial aimed at the investigation of the prognostic role of coronary evaluation strategies before PTA is warranted.

Methods/design: The proposed study is designed as a prospective, multi-center, open-label, superiority, randomized controlled trial. The study is conducted in high-volume centers for PTA and coronary revascularization in Taiwan. To meet the inclusion criteria, the patients must be at least 20 years old, have known LEAD, and have been admitted for elective PTA. We plan to enroll 450 participants who are randomly allocated to a routine group (routine coronary angiography without a previous non-invasive stress test before PTA) and a selective group (selective coronary angiography based on the results of non-invasive stress tests before PTA) with 1:1 ratio. Besides, we expect to enroll about 250 additional participants, who are not willing to be randomly assigned, in the registration group. The choice of revascularization procedure depends on the operator's or cardiovascular team's suggestion and the patient's decision. Clinical follow-up will be performed 30 days after PTA and every 6 months until the end of the 1-year follow-up for the last randomly assigned participant. The primary endpoint is the composite major adverse cardiac event on long-term follow-up. Pre-specified secondary and other endpoints are also evaluated. Those assessing biomarkers and clinical endpoints are all blinded after assignment to interventions.

Discussion: The results of the trial will, for the first time, support better decision-making for coronary evaluation before PTA in LEAD. If favorable, routine coronary angiography followed by revascularization will improve cardiovascular outcomes in LEAD patients undergoing PTA.

Trial registration: ClinicalTrials.gov identifier: NCT02169258 (registered on 21 June 2014); registry name: Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA).

Figures

Fig. 1
Fig. 1
Participant flow diagram. PTA percutaneous transluminal angioplasy

References

    1. Duran NE, Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992;326:381–6. doi: 10.1056/NEJM199202063260605.
    1. Duran NE, Duran I, Gürel E, Gündüz S, Göl G, Biteker M, et al. Coronary artery disease in patients with peripheral artery disease. Heart Lung. 2010;39:116–20. doi: 10.1016/j.hrtlng.2009.07.004.
    1. Rohani M, Jogestrand T, Ekberg M, van der Linden J, Källner G, Jussila R, et al. Interrelation between the extent of atherosclerosis in the thoracic aorta, carotid intima-media thickness and the extent of coronary artery disease. Atherosclerosis. 2005;179:311–6. doi: 10.1016/j.atherosclerosis.2004.10.012.
    1. Lekakis JP, Papamichael C, Papaioannou TG, Stamatelopoulos KS, Cimponeriu A, Protogerou AD, et al. Intima-media thickness score from carotid and femoral arteries predicts the extent of coronary artery disease: intima-media thickness and CAD. Int J Cardiovasc Imaging. 2005;21:495–501. doi: 10.1007/s10554-004-8165-x.
    1. Sukhija R, Yalamanchili K, Aronow WS, et al. Prevalence of left main coronary artery disease, of three- or four-vessel coronary artery disease, and of obstructive coronary artery disease in patients with and without peripheral arterial disease undergoing coronary angiography for suspected coronary artery disease. Am J Cardiol. 2003;92:304–5. doi: 10.1016/S0002-9149(03)00632-5.
    1. Monaco M, Stassano P, Di Tommaso L, Pepino P, Giordano A, Pinna GB, et al. Systematic strategy of prophylactic coronary angiography improves long-term outcome after major vascular surgery in medium- to high-risk patients: a prospective, randomized study. J Am Coll Cardiol. 2009;54:989–96. doi: 10.1016/j.jacc.2009.05.041.
    1. Hussein AA, Uno K, Wolski K, Kapadia S, Schoenhagen P, Tuzcu EM, et al. Peripheral arterial disease and progression of coronary atherosclerosis. J Am Coll Cardiol. 2011;57:1220–5. doi: 10.1016/j.jacc.2010.10.034.
    1. Dávila-Román VG, Waggoner AD, Sicard GA, Geltman EM, Schechtman KB, Pérez JE, et al. Dobutamine stress echocardiography predicts surgical outcome in patients with an aortic aneurysm and peripheral vascular disease. J Am Coll Cardiol. 1993;21:957–63. doi: 10.1016/0735-1097(93)90353-3.
    1. Wolf YG, Landersberg G, Mosseri M, Schechter D, Anner H, Weissman C, et al. Preoperative dipyridamole-thallium scanning, selective coronary revascularization and long-term survival in patients with critical lower limb ischemia. J Cardiovasc Surg (Torino) 2001;42:89–95.
    1. Landesberg G, Mosseri M, Wolf YG, Bocher M, Basevitch A, Rudis E, et al. Preoperative thallium scanning, selective coronary revascularization, and long-term survival after major vascular surgery. Circulation. 2003;108:177–83. doi: 10.1161/01.CIR.0000080292.11186.FB.
    1. Landesberg G, Berlatzky Y, Bocher M, Alcalai R, Anner H, Ganon-Rozental T, et al. A clinical survival score predicts the likelihood to benefit from preoperative thallium scanning and coronary revascularization before major vascular surgery. Eur Heart J. 2007;28:533–9. doi: 10.1093/eurheartj/ehl390.
    1. Massie MT, Rohrer MJ, Leppo JA, Cutler BS, et al. Is coronary angiography necessary for vascular surgery patients who have positive results of dipyridamole thallium scans? J Vasc Surg. 1997;25:975–82. doi: 10.1016/S0741-5214(97)70120-4.
    1. McFalls EO, Ward HB, Moritz TE, Goldman S, Krupski WC, Littooy F, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2795–804. doi: 10.1056/NEJMoa041905.
    1. Schouten O, van Kuijk JP, Flu WJ, Winkel TA, Welten GM, Boersma E, et al. Long-term outcome of prophylactic coronary revascularization in cardiac high-risk patients undergoing major vascular surgery (from the randomized DECREASE-V Pilot Study) Am J Cardiol. 2009;103:897–901. doi: 10.1016/j.amjcard.2008.12.018.
    1. Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, et al. ACCF/AHA focused update on perioperative beta blockade incorporated into the ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery. J Am Coll Cardiol. 2009;54:e13–118. doi: 10.1016/j.jacc.2009.07.010.
    1. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC) Eur Heart J. 2011;32:2851–906. doi: 10.1093/eurheartj/ehr211.
    1. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, et al. 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;58:2020–45. doi: 10.1016/j.jacc.2011.08.023.
    1. Chen IC, Chao TH, Fang CC, Wu IH, Yu CL, Lam CY. Prognostic determinants of intermediate-term outcome in patients with peripheral artery disease undergoing percutaneous transluminal angioplasty in southern Taiwan---a single operator’s experience. Acta Cardiol Sin. 2013;29 Suppl:58.
    1. Abularrage CJ, Conrad MF, Hackney LA, Paruchuri V, Crawford RS, Kwolek CJ, et al. Long-term outcomes of diabetic patients undergoing endovascular infrainguinal interventions. J Vasc Surg. 2010;52:314–22.e1-4.
    1. Chen IC, Yu CC, Wu YH, Chao TH. Elevated neutrophil-to-lymphocyte ratio predicts intermediate-term outcomes in patients who have advanced chronic kidney disease with peripheral artery disease receiving percutaneous transluminal angioplasty. Acta Cardiol Sin. (in press)
    1. Huang HL, Chou HH, Wu TY, Chang SH, Tsai YJ, Hung SS, et al. Endovascular intervention in Taiwanese patients with critical limb ischemia: patient outcomes in 333 consecutive limb procedures with a 3-year follow-up. J Formos Med Assoc. 2014;113:688–95. doi: 10.1016/j.jfma.2012.10.022.
    1. Parmar JH, Aslam M, Standfield NJ, et al. Percutaneous transluminal angioplasty of lower limb arteries causes a systemic inflammatory response. Ann Vasc Surg. 2009;23:569–76. doi: 10.1016/j.avsg.2009.02.004.
    1. Yassin MM, Harkin DW, Barros D'Sa AA, Halliday MI, Rowlands BJ, et al. Lower limb ischemia-reperfusion injury triggers a systemic inflammatory response and multiple organ dysfunction. World J Surg. 2002;26:115–21. doi: 10.1007/s00268-001-0169-2.
    1. Yassin MM, Barros D’Sa AA, Parks G, Abdulkadir AS, Halliday I, Rowlands BJ, et al. Mortality following lower limb ischemia-reperfusion: a systemic inflammatory response? World J Surg. 1996;20:961–6. doi: 10.1007/s002689900144.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346 doi: 10.1136/bmj.e7586.
    1. Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367:1355–60. doi: 10.1056/NEJMsr1203730.
    1. Valgimigli M, Sabaté M, Kaiser C, Brugaletta S, de la Torre Hernandez JM, Galatius S, et al. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis. BMJ. 2014;349:g6427. doi: 10.1136/bmj.g6427.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir