Effectiveness of Intra-arterial Manometry in Guiding Femoral Popliteal Stent Implantation: a Prospective Randomized Controlled Trial

Overview

Journal Am J Transl Res

Specialty General Medicine

Date 2024 Jul 15

PMID 39006283

Authors

Kui Chen

Dongyin Xu

Liangliang Ma

Taoxiang Zheng

Li Shi

Affiliations

Soon will be listed here.

Abstract

Background: Femoropopliteal artery occlusion is a prevalent peripheral arterial disease, and endovascular therapy has become the preferred treatment. Accurate assessment of balloon dilation efficacy is crucial for determining the necessity for subsequent stent implantation. This study aims to investigate the use of interlesion arterial pressure gradients as a novel approach to assess balloon dilation efficacy and guide stent implantation decisions.

Methods: A prospective, randomized, controlled trial was conducted on 100 patients with femoropopliteal artery occlusion. Patients were randomized into a control group (n=50) and an experimental group (n=50). Stent implantation was performed in the control group according to standard indications, while the experimental group underwent stent implantation only if the mean arterial pressure gradient exceeded 10 mmHg or fractional flow reserve (FFR) fell below 0.85. Post-intervention, pressure measurements and angiography were used to evaluate residual stenosis, dissection, and pressure gradients.

Results: Lesions were categorized into stent-indicated and non-indicated groups. In the non-stent-indicated lesions, the experimental group demonstrated significantly higher patency rates for lesions with pFFR < 0.85 or ΔP > 10 mmHg compared to the control group (92.9% vs. 50.0%, P=0.039). There was no significant difference in patency rates between the experimental and control groups for stent-indicated lesions.

Conclusion: Combining pressure measurement with angiography provides a more precise evaluation of balloon dilation efficacy and stent implantation indicators in femoropopliteal artery occlusive disease. Further research is needed to establish optimal pressure threshold values and refine treatment guidelines.

References

Rooke T, Hirsch A, Misra S, Sidawy A, Beckman J, Findeiss L . Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 61(14):1555-70. PMC: 4492473. DOI: 10.1016/j.jacc.2013.01.004. View

Tetteroo E, Haaring C, Van der Graaf Y, van Schaik J, van Engelen A, Mali W . Intraarterial pressure gradients after randomized angioplasty or stenting of iliac artery lesions. Dutch Iliac Stent Trial Study Group. Cardiovasc Intervent Radiol. 1996; 19(6):411-7. DOI: 10.1007/BF02577629. View

Shimada Y, Armstrong E . Primary Stenting: Default Therapy or Landmark Comparator?. J Endovasc Ther. 2019; 26(2):168-171. DOI: 10.1177/1526602819833065. View

Garcia L, Carrozza Jr J . Physiologic evaluation of translesion pressure gradients in peripheral arteries: comparison of pressure wire and catheter-derived measurements. J Interv Cardiol. 2007; 20(1):63-5. DOI: 10.1111/j.1540-8183.2007.00213.x. View

Byrne R, Joner M, Kastrati A . Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014. Eur Heart J. 2015; 36(47):3320-31. PMC: 4677274. DOI: 10.1093/eurheartj/ehv511. View

Antusevas A, Aleksynas N, Kaupas R, Inciura D, Kinduris S . Comparison of results of subintimal angioplasty and percutaneous transluminal angioplasty in superficial femoral artery occlusions. Eur J Vasc Endovasc Surg. 2008; 36(1):101-6. DOI: 10.1016/j.ejvs.2008.02.010. View

Conte M, Pomposelli F, Clair D, Geraghty P, McKinsey J, Mills J . Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. J Vasc Surg. 2015; 61(3 Suppl):2S-41S. DOI: 10.1016/j.jvs.2014.12.009. View

Patel M, Conte M, Cutlip D, Dib N, Geraghty P, Gray W . Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015; 65(9):931-41. PMC: 4874808. DOI: 10.1016/j.jacc.2014.12.036. View

Tetteroo E, van Engelen A, Spithoven J, Tielbeek A, Van der Graaf Y, Mali W . Stent placement after iliac angioplasty: comparison of hemodynamic and angiographic criteria. Dutch Iliac Stent Trial Study Group. Radiology. 1996; 201(1):155-9. DOI: 10.1148/radiology.201.1.8816537. View

10.

De Bruyne B, Fearon W, Pijls N, Barbato E, Tonino P, Piroth Z . Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014; 371(13):1208-17. DOI: 10.1056/NEJMoa1408758. View

11.

Tetteroo E, Van der Graaf Y, Bosch J, van Engelen A, Hunink M, Eikelboom B . Randomised comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac-artery occlusive disease. Dutch Iliac Stent Trial Study Group. Lancet. 1998; 351(9110):1153-9. DOI: 10.1016/s0140-6736(97)09508-1. View

12.

Lotfi A, Sivalingam S, Giugliano G, Ashraf J, Visintainer P . Use of fraction flow reserve to predict changes over time in management of superficial femoral artery. J Interv Cardiol. 2011; 25(1):71-7. DOI: 10.1111/j.1540-8183.2011.00691.x. View

13.

Cejna M, Thurnher S, Illiasch H, Horvath W, Waldenberger P, Hornik K . PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol. 2001; 12(1):23-31. DOI: 10.1016/s1051-0443(07)61397-9. View

14.

Drachman D . Endovascular Treatment of the Superficial Femoral Artery: When Nothing Is Actually Quite Something. J Am Coll Cardiol. 2019; 73(6):680-683. DOI: 10.1016/j.jacc.2018.12.009. View

15.

Archie Jr J . Analysis and comparison of pressure gradients and ratios for predicting iliac stenosis. Ann Vasc Surg. 1994; 8(3):271-80. DOI: 10.1007/BF02018175. View

16.

Kobayashi N, Hirano K, Yamawaki M, Araki M, Sakai T, Takimura H . Ability of Fractional Flow Reserve to Predict Restenosis After Superficial Femoral Artery Stenting. J Endovasc Ther. 2016; 23(6):896-902. DOI: 10.1177/1526602816668306. View

17.

Berguer R, Hwang N . Critical arterial stenosis: a theoretical and experimental solution. Ann Surg. 1974; 180(1):39-50. PMC: 1343607. DOI: 10.1097/00000658-197407000-00007. View

18.

Fujihara M, Takahara M, Sasaki S, Nanto K, Utsunomiya M, Iida O . Angiographic Dissection Patterns and Patency Outcomes After Balloon Angioplasty for Superficial Femoral Artery Disease. J Endovasc Ther. 2017; 24(3):367-375. DOI: 10.1177/1526602817698634. View

19.

May A, Van de Berg L, Deweese J, ROB C . Critical arterial stenosis. Surgery. 1963; 54:250-9. View

20.

Deloose K, Callaert J . Less is more: the "As Less As Reasonably Achievable Stenting" (ALARAS) strategy in the femoropopliteal area. J Cardiovasc Surg (Torino). 2018; 59(4):495-503. DOI: 10.23736/S0021-9509.18.10583-0. View