Patient Characteristics in the Recording Courses of Vascular Diseases (Reccord) Registry: Comparison with the Voyager Pad Endovascular Cohort
Abstract
:1. Introduction
2. Materials and Methods
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A. RECCORD Registry Collaborators
References
- Song, P.; Rudan, D.; Zhu, Y.; Fowkes, F.J.I.; Rahimi, K.; Fowkes, F.G.R.; Rudan, I. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: An updated systematic review and analysis. Lancet. Glob. Health 2019, 7, e1020–e1030. [Google Scholar] [CrossRef] [Green Version]
- Aboyans, V.; Ricco, J.B.; Bartelink, M.E.L.; Björck, M.; Brodmann, M.; Cohnert, T.; Collet, J.P.; Czerny, M.; De Carlo, M.; Debus, S.; et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Endorsed by: The European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur. Heart J. 2018, 39, 763–816. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Hess, C.N.; Wang, T.Y.; Weleski Fu, J.; Gundrum, J.; Allen LaPointe, N.M.; Rogers, R.K.; Hiatt, W.R. Long-Term Outcomes and Associations With Major Adverse Limb Events After Peripheral Artery Revascularization. J. Am. Coll. Cardiol. 2020, 75, 498–508. [Google Scholar] [CrossRef]
- Hess, C.N.; Bonaca, M.P. Contemporary Review of Antithrombotic Therapy in Peripheral Artery Disease. Circ. Cardiovasc. Interv. 2020, 13, e009584. [Google Scholar] [CrossRef]
- Bonaca, M.P.; Bauersachs, R.M.; Anand, S.S.; Debus, E.S.; Nehler, M.R.; Patel, M.R.; Fanelli, F.; Capell, W.H.; Diao, L.; Jaeger, N.; et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N. Engl. J. Med. 2020, 382, 1994–2004. [Google Scholar] [CrossRef] [PubMed]
- Malyar, N.; Stausberg, J.; Langhoff, R.; Tatò, F.; Kalka, C.; Ito, W.D.; Böhme, J.; Arjumand, J.; Stegemann, J.; Lawall, H.; et al. Demographic and procedural characteristics in the RECording COurses of vasculaR Diseases (RECCORD) registry—The first 1000 patients. Vasa 2020, 49, 382–388. [Google Scholar] [CrossRef] [PubMed]
- Malyar, N.M.; Stausberg, J.; Ito, W.D.; Kölble, H.; Langhoff, R.; Lawall, H.; Lichtenberg, M.; Stegemann, J.; Treitl, M.; Weiss, N.; et al. Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa 2017, 46, 262–267. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Stella, J.; Stausberg, J.; Lichtenberg, M.; Hoffmann, U.; Malyar, N.M. Clinical Characteristics and Current Practice of Endovascular Revascularization in Aorto-Iliac, Femoropopliteal and Infra-Popliteal Lower Extremity Artery Disease-Insights from the RECCORD Registry. J. Clin. Med. 2022, 11, 6074. [Google Scholar] [CrossRef] [PubMed]
- Capell, W.H.; Bonaca, M.P.; Nehler, M.R.; Chen, E.; Kittelson, J.M.; Anand, S.S.; Berkowitz, S.D.; Debus, E.S.; Fanelli, F.; Haskell, L.; et al. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am. Heart J. 2018, 199, 83–91. [Google Scholar] [CrossRef]
- Norgren, L.; Hiatt, W.R.; Dormandy, J.A.; Nehler, M.R.; Harris, K.A.; Fowkes, F.G. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J. Vasc. Surg. 2007, 45 (Suppl. S), S5–S67. [Google Scholar] [CrossRef] [Green Version]
- Hess, C.N.; Patel, M.R.; Bauersachs, R.M.; Anand, S.S.; Debus, E.S.; Nehler, M.R.; Fanelli, F.; Yeh, R.W.; Secemsky, E.A.; Beckman, J.A.; et al. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J. Am. Coll. Cardiol. 2021, 78, 1768–1778. [Google Scholar] [CrossRef]
- Weissler, E.H.; Wang, Y.; Gales, J.M.; Feldman, D.N.; Arya, S.; Secemsky, E.A.; Aronow, H.D.; Hawkins, B.M.; Gutierrez, J.A.; Patel, M.R.; et al. Cardiovascular and Limb Events Following Endovascular Revascularization Among Patients ≥65 Years Old: An American College of Cardiology PVI Registry Analysis. J. Am. Heart Assoc. 2022, 11, e024279. [Google Scholar] [CrossRef]
- Patel, K.; Liu, Y.; Etaee, F.; Patel, C.; Monteleone, P.; Patel, M.; Amer Alaiti, M.; Metzger, C.; Banerjee, A.; Minniefield, N.; et al. Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry. Circ. Cardiovasc. Interv. 2021, 14, e010635. [Google Scholar] [CrossRef]
- Miyata, T.; Kumamaru, H.; Mii, S.; Kinukawa, N.; Miyata, H.; Shigematsu, K.; Azuma, N.; Ishida, A.; Izumi, Y.; Inoue, Y.; et al. Prediction Models for Two Year Overall Survival and Amputation Free Survival After Revascularisation for Chronic Limb Threatening Ischaemia. Eur. J. Vasc. Endovasc. Surg. 2022, 64, 367–376. [Google Scholar] [CrossRef]
- Li, B.; Rizkallah, P.; Eisenberg, N.; Forbes, T.L.; Roche-Nagle, G. Rates of Intervention for Claudication versus Chronic Limb-Threatening Ischemia in Canada and United States. Ann. Vasc. Surg. 2022, 82, 131–143. [Google Scholar] [CrossRef]
- Anantha-Narayanan, M.; Sheikh, A.B.; Nagpal, S.; Jelani, Q.U.; Smolderen, K.G.; Regan, C.; Ionescu, C.; Ochoa Chaar, C.I.; Schneider, M.; Llanos-Chea, F.; et al. Systematic review and meta-analysis of outcomes of lower extremity peripheral arterial interventions in patients with and without chronic kidney disease or end-stage renal disease. J. Vasc. Surg. 2021, 73, 331–340.e334. [Google Scholar] [CrossRef]
- Hossain, S.; Leblanc, D.; Farber, A.; Power, A.H.; DeRose, G.; Duncan, A.; Dubois, L. Editor’s Choice—Infrainguinal Bypass Following Failed Endovascular Intervention Compared With Primary Bypass: A Systematic Review and Meta-Analysis. Eur. J. Vasc. Endovasc. Surg. 2019, 57, 382–391. [Google Scholar] [CrossRef] [Green Version]
- Vu, M.H.; Sande-Docor, G.M.; Liu, Y.; Tsai, S.; Patel, M.; Metzger, C.; Shishehbor, M.H.; Brilakis, E.S.; Shammas, N.W.; Monteleone, P.; et al. Endovascular Treatment and Outcomes for Femoropopliteal In-Stent Restenosis: Insights from the XLPAD Registry. J. Interv. Cardiol. 2022, 2022, 5935039. [Google Scholar] [CrossRef]
- Søgaard, M.; Nielsen, P.B.; Skjøth, F.; Larsen, T.B.; Eldrup, N. Revascularisation for Symptomatic Peripheral Artery Disease: External Applicability of the VOYAGER PAD Trial. Eur. J. Vasc. Endovasc. Surg. 2021, 63, 285–294. [Google Scholar] [CrossRef]
- Rammos, C.; Steinmetz, M.; Lortz, J.; Mahabadi, A.A.; Petrikhovich, O.; Kirsch, K.; Hering, R.; Schulz, M.; Rassaf, T. Peripheral artery disease in Germany (2009-2018): Prevalence, frequency of specialized ambulatory care and use of guideline-recommended therapy—A population-based study. Lancet Reg. Health Eur. 2021, 5, 100113. [Google Scholar] [CrossRef]
- Katsanos, K.; Spiliopoulos, S.; Kitrou, P.; Krokidis, M.; Karnabatidis, D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J. Am. Heart Assoc. 2018, 7, e011245. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Freisinger, E.; Koeppe, J.; Gerss, J.; Goerlich, D.; Malyar, N.M.; Marschall, U.; Faldum, A.; Reinecke, H. Mortality after use of paclitaxel-based devices in peripheral arteries: A real-world safety analysis. Eur. Heart J. 2020, 41, 3732–3739. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Dinh, K.; Limmer, A.M.; Chen, A.Z.L.; Thomas, S.D.; Holden, A.; Schneider, P.A.; Varcoe, R.A. Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. J. Endovasc. Ther. Off. J. Int. Soc. Endovasc. Spec. 2021, 28, 755–777. [Google Scholar] [CrossRef] [PubMed]
- Wong, K.H.F.; Bosanquet, D.C.; Ambler, G.K.; Qureshi, M.I.; Hinchliffe, R.J.; Twine, C.P. The CLEAR (Considering Leading Experts’ Antithrombotic Regimes around peripheral angioplasty) survey: An international perspective on antiplatelet and anticoagulant practice for peripheral arterial endovascular intervention. CVIR Endovasc. 2019, 2, 37. [Google Scholar] [CrossRef] [PubMed]
- Aboyans, V.; Bauersachs, R.; Mazzolai, L.; Brodmann, M.; Palomares, J.F.R.; Debus, S.; Collet, J.P.; Drexel, H.; Espinola-Klein, C.; Lewis, B.S.; et al. Antithrombotic therapies in aortic and peripheral arterial diseases in 2021: A consensus document from the ESC working group on aorta and peripheral vascular diseases, the ESC working group on thrombosis, and the ESC working group on cardiovascular pharmacotherapy. Eur. Heart J. 2021, 42, 4013–4024. [Google Scholar] [CrossRef] [PubMed]
- Hiatt, W.R.; Bonaca, M.P.; Patel, M.R.; Nehler, M.R.; Debus, E.S.; Anand, S.S.; Capell, W.H.; Brackin, T.; Jaeger, N.; Hess, C.N.; et al. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation 2020, 142, 2219–2230. [Google Scholar] [CrossRef]
- Ducrocq, G.; Wallace, J.S.; Baron, G.; Ravaud, P.; Alberts, M.J.; Wilson, P.W.; Ohman, E.M.; Brennan, D.M.; D’Agostino, R.B.; Bhatt, D.L.; et al. Risk score to predict serious bleeding in stable outpatients with or at risk of atherothrombosis. Eur. Heart J. 2010, 31, 1257–1265. [Google Scholar] [CrossRef] [Green Version]
- Costa, F.; van Klaveren, D.; James, S.; Heg, D.; Räber, L.; Feres, F.; Pilgrim, T.; Hong, M.K.; Kim, H.S.; Colombo, A.; et al. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: A pooled analysis of individual-patient datasets from clinical trials. Lancet 2017, 389, 1025–1034. [Google Scholar] [CrossRef]
- Behrendt, C.A.; Kreutzburg, T.; Nordanstig, J.; Twine, C.P.; Marschall, U.; Kakkos, S.; Aboyans, V.; Peters, F. The OAC(3)-PAD Risk Score Predicts Major Bleeding Events one Year after Hospitalisation for Peripheral Artery Disease. Eur. J. Vasc. Endovasc. Surg. 2022, 63, 503–510. [Google Scholar] [CrossRef]
- Dreyer, N.A.; Garner, S. Registries for robust evidence. Jama 2009, 302, 790–791. [Google Scholar] [CrossRef] [PubMed]
- Phillips, S.P.; Hamberg, K. Doubly blind: A systematic review of gender in randomised controlled trials. Glob. Health Action 2016, 9, 29597. [Google Scholar] [CrossRef] [Green Version]
- Mathes, T.; Buehn, S.; Prengel, P.; Pieper, D. Registry-based randomized Control. trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials. J. Clin. Epidemiol. 2018, 93, 120–127. [Google Scholar] [CrossRef]
RECCORD n = 2.498 | VOYAGER PAD Endovascular Cohort n = 4.293 | |
---|---|---|
Age, years (mean ± SD) | 70.3 ± 10.4 | 67.6 ± 8.6 |
Age ≥ 75 years, n (%) | 942 (37.7) | 966 (22.5) |
Female sex, n (%) | 852 (34.1) | 1.238 (28.8) |
Weight, kg (mean ± SD) | 78.5 ± 17.1 | 76.2 ± 16.5 |
BMI, kg/m2 (mean ± SD) | 26.0 ± 4.7 | 26.6 ± 4.7 |
Diabetes mellitus, n (%) | 909 (36.4) | 1.920 (44.7) |
Arterial hypertension, n (%) | 2.036 (81.5) | 3.517 (81.9) |
Dyslipidemia, n (%) | 1.715 (68.7) | 2.766 (64.4) |
Current smoking, n (%) | 1.294 (51.8) | 1.442 (33.6) |
eGFR < 30 mL/min, n (%) | 75 (3.0) | 36 (0.8) |
Known CVD, n (%) | 396 (15.9) | 1.409 (32.8) |
Known CAD, n (%) | 834 (33.4) | 1.387 (32.3) |
History of heart failure, n (%) | 208 (8.3) | 320 (7.5) |
Index ABI (mean ± SD) | 0.65 ± 0.3 | 0.57 ± 0.18 |
Critical limb ischemia, n (%) | 607 (24.3) | 837 (19.5) |
Prior amputation, n (%) | 101 (4.0) | 260 (6.0) |
Prior limb revascularization, n (%) | 1.267 (50.7) | 1.663 (38.7) |
Prior surgical bypass, n (%) | 323 (12.9) | 283 (6.6) |
Prior endovascular revascularization, n (%) | 1.183 (47.4) | 1.510 (35.2) |
RECCORD n = 2.498 | VOYAGER PAD Endovascular Cohort n = 4.293 | |
---|---|---|
Dual antiplatelet therapy, n (%) | 1.611 (64.5) | 2.299 (53.6) |
Statins, n (%) | 1.760 (70.5) | 3.509 (81.7) |
ACE-inhibitors/ARB-antagonists, n (%) | 1.451 (58.1) | 2.806 (65.4) |
ß-Blockers, n (%) | 1.226 (49.1) | 1.876 (43.7) |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Czihal, M.; Malyar, N.; Stausberg, J.; Hoffmann, U., on behalf of the RECCORD Investigators. Patient Characteristics in the Recording Courses of Vascular Diseases (Reccord) Registry: Comparison with the Voyager Pad Endovascular Cohort. J. Cardiovasc. Dev. Dis. 2023, 10, 115. https://doi.org/10.3390/jcdd10030115
Czihal M, Malyar N, Stausberg J, Hoffmann U on behalf of the RECCORD Investigators. Patient Characteristics in the Recording Courses of Vascular Diseases (Reccord) Registry: Comparison with the Voyager Pad Endovascular Cohort. Journal of Cardiovascular Development and Disease. 2023; 10(3):115. https://doi.org/10.3390/jcdd10030115
Chicago/Turabian StyleCzihal, Michael, Nasser Malyar, Jürgen Stausberg, and Ulrich Hoffmann on behalf of the RECCORD Investigators. 2023. "Patient Characteristics in the Recording Courses of Vascular Diseases (Reccord) Registry: Comparison with the Voyager Pad Endovascular Cohort" Journal of Cardiovascular Development and Disease 10, no. 3: 115. https://doi.org/10.3390/jcdd10030115