Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients—A CROSSROAD Study
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
References
- Knuuti, J.; Wijns, W.; Saraste, A.; Capodanno, D.; Barbato, E.; Funck-Brentano, C.; Prescott, E.; Storey, R.F.; Deaton, C.; Cuisset, T.; et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur. Heart J. 2019, 41, 407–477. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Konigstein, M.; Verheye, S.; Jolicœur, E.M.; Banai, S. Narrowing of the coronary sinus—A device-based therapy for persistant angina pectoris. Cardiol. Rev. 2016, 24, 238–243. [Google Scholar] [CrossRef] [PubMed]
- Giannini, F.; Aurelio, A.; Jabbour, R.J.; Ferri, L.; Colombo, A.; Latib, A. The coronary sinus reducer: Clinical evidence and technical aspects. Expert Rev Cardiovasc. Ther. 2017, 15, 47–58. [Google Scholar] [CrossRef] [PubMed]
- Verheye, S.; Jolicœur, E.M.; Behan, M.W.; Pettersson, T.; Sainsbury, P.; Hill, J.; Vrolix, M.; Agostoni, P.; Engstrom, T.; Labinaz, M.; et al. Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina. N. Engl. J. Med. 2015, 372, 519–527. [Google Scholar] [CrossRef] [PubMed]
- Verheye, S.; Agostoni, P.; Giannini, F.; Hill, J.; Jensen, C.; Lindsay, S.; Stella, P.; Redwood, S.; Banai, S.; Konigstein, M. Coronary sinus narrowing for the treatment of refractory angina: A multicentre prospective open-label clinical study (the REDUCER-I study). EuroIntervention 2021, 17, 561. [Google Scholar] [CrossRef] [PubMed]
- Giannini, F.; Baldetti, L.; Ponticelli, F.; Ruparelia, N.; Mitomo, S.; Latib, A.; Montorfano, M.; Jabbour, R.J.; Aurelio, A.; Ferri, L.; et al. Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina. JACC Cardiovasc. Interv. 2018, 11, 784–792. [Google Scholar] [CrossRef] [PubMed]
- Zivelonghi, C.; Konigstein, M.; Azzano, A.; Agostoni, P.; Topilski, Y.; Banai, S.; Verheye, S. Effects of coronary sinus Reducer implantation on oxygen kinetics in patients with refractory angina. EuroIntervention 2021, 16, 1511–1517. [Google Scholar] [CrossRef] [PubMed]
- Kaptchuk, T.J.; Goldman, P.; Stone, D.A.; Stason, W.B. Do medical devices have enhanced placebo effects? J. Clin. Epidemiol. 2000, 53, 786–792. [Google Scholar] [CrossRef] [PubMed]
- Giannini, F.; Tzanis, G.; Ponticelli, F.; Baldetti, L.; Demir, O.M.; Mitomo, S.; Gallone, G.; Banai, S.; Colombo, A. Technical aspects in coronary sinus Reducer implantation. EuroIntervention 2020, 15, 1269–1277. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Al-Lamee, R.; Thompson, D.; Dehbi, H.-M.; Sen, S.; Tang, K.; Davies, J.; Keeble, T.; Mielewczik, M.; Kaprielian, R.; Malik, I.S.; et al. Percutaneous coronary intervention in stable angina (ORBITA): A double-blind, randomised controlled trial. Lancet 2018, 391, 31–40. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Stone, P.H.; Chaitman, B.R.; McMahon, R.P.; Andrews, T.C.; MacCallum, G.; Sharaf, B.; Frishman, W.; Deanfield, J.E.; Sopko, G.; Pratt, C.; et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) Study. Circulation 1996, 94, 1537–1544. [Google Scholar] [CrossRef] [PubMed]
- Belardinelli, R.; Lacalaprice, F.; Carle, F.; Minnucci, A.; Cianci, G.; Perna, G.P.; D’Eusanio, G. Exercise-induced myocardial ischaemia detected by cardiopulmonary exercise testing. Eur. Heart J. 2003, 24, 1304–1313. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Chaudhry, S.; Arena, R.; Wasserman, K.; Hansen, J.E.; Lewis, G.D.; Myers, J.; Chronos, N.; Boden, W.E. Exercise-induced Myocardial Ischemia Detected by Cardiopulmonary Exercise Testing. Am. J. Cardiol. 2009, 103, 615. [Google Scholar] [CrossRef][Green Version]
- Boone, J.; Bourgois, J. The oxygen uptake response to incremental ramp exercise: Methodogical and physiological issues. Sport Med. 2012, 42, 511–526. [Google Scholar] [CrossRef]
- Myers, J.; Buchanan, N.; Walsh, D.; Kraemer, M.; McAuley, P.; Hamilton-Wessler, M.; Froelicher, V.F. Comparison of the ramp versus standard exercise protocols. J. Am. Coll. Cardiol. 1991, 17, 1334–1342. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Jonas, W.B.; Crawford, C.; Colloca, L.; Kaptchuk, T.J.; Moseley, B.; Miller, F.G.; Kriston, L.; Linde, K.; Meissner, K. To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials. BMJ Open 2015, 5, e009655. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Chaitman, B.R.; Skettino, S.L.; Parker, J.O.; Hanley, P.; Meluzin, J.; Kuch, J.; Pepine, C.J.; Wang, W.; Nelson, J.J.; Hebert, D.A.; et al. Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina. J. Am. Coll Cardiol. 2004, 43, 1375–1382. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Borer, J.S.; Fox, K.; Jaillon, P.; Lerebours, G.; Ivabradine Investigators Group. Antianginal and antiischemic effects of ivabradine, an I(f) inhibitor, in stable angina: A randomized, double-blind, multicentered, placebo-controlled trial. Circulation 2003, 107, 817–823. [Google Scholar] [CrossRef] [PubMed][Green Version]
- Tardif, J.C.; Ponikowski, P.; Kahan, T.; ASSOCIATE Study Investigators. Efficacy of the I(f) current inhibitor ivabradine in patients with chronic stable angina receiving beta-blocker therapy: A 4-month, randomized, placebo-controlled trial. Eur. Heart J. 2009, 30, 540–548. [Google Scholar] [CrossRef] [PubMed][Green Version]
CSR (n = 13) | Sham (n = 12) | p † | |
---|---|---|---|
Age—years ± SD | 70.3 ± 10.3 | 69.8 ± 11.7 | 0.92 |
Male—n (%) | 11 (84.6%) | 10 (83.3%) | 1 |
Hyperlipidemia—n (%) | 13 (100%) | 11 (91.7%) | 0.48 |
Arterial hypertension—n (%) | 13 (100%) | 10 (83.3%) | 0.22 |
Diabetes—n (%) | 3 (23.1%) | 4 (33.3%) | 0.67 |
oGF—mL/kg/min ± SD | 62.1 ± 16.1 | 66.6 ± 14.0 | 0.47 |
Previous PCI—n (%) | 7 (53.8%) | 9 (75%) | 0.41 |
Previous CABG—n (%) | 12 (92.3%) | 9 (75%) | 0.32 |
X-vessel disease—n (%) | |||
1 | 0 | 2 (16.7%) | 0.22 |
2 | 3 (23.1%) | 2 (16.7%) | 1.0 |
3 | 10 (76.9%) | 8 (66.7%) | 0.67 |
Chronic total occlusion—n (%) | 10 (76.9%) | 9 (75%) | 1.0 |
Ischemia distribution | |||
Anterior | 6 (46.2%) | 7 (58.3%) | 0.54 |
Anterolateral | 6 (46.2%) | 5 (41.7%) | 1.0 |
Inferolateral | 7 (53.8%) | 5 (41.7%) | 0.54 |
Inferior | 3 (23.1%) | 2 (16.7%) | 1.0 |
Septal | 3 (23.1%) | 1 (8.3%) | 0.6 |
Reversible ischemia (%) | 8.92 ± 7.1 | 8.82 ± 6.06 | 0.97 |
Summed difference score | 6.92 ± 6.8 | 6.27 ± 5.75 | 0.81 |
Anti-ischemic therapy | |||
Beta blocker—n (%) | 13 (100%) | 12 (100%) | 1 |
Ca antagonist—n (%) | 2 (15.4%) | 3 (25%) | 0.65 |
Nitrate—n (%) | 4 (33.3%) | 7 (58.3%) | 0.18 |
Trimetazidine—n (%) | 13 (100%) | 10 (83.3%) | 0.22 |
Ranolazine—n (%) | 10 (76.9%) | 12 (100%) | 0.22 |
Ivabradine—n (%) | 2 (15.4%) | 0 | 0.48 |
No. of drugs per patient—mean ± SD | 3.31 ± 0.75 | 3.67 ± 0.78 | 0.32 |
CCS (baseline) | |||
II—n (%) | 7 (53.8%) | 5 (41.7%) | |
III—n (%) | 6 (46.2%) | 7 (58.3%) | |
IV—n (%) | 0 | 0 | 0.54 |
CSR (n = 13) | Sham (n = 12) | p † | |||
---|---|---|---|---|---|
CPET (baseline) | |||||
Oxygen consumption -ml/kg/min ± SD | 15.56 ± 4.05 | 15.04 ± 3.63 | 0.74 | ||
Workload—W ± SD | 107 ± 50 | 106 ± 35 | 0.94 | ||
Time—s ± SD | 445 ± 84 | 485 ± 72 | 0.23 | ||
Respiratory exchange ratio (±SD) | 1.12 ± 0.15 | 1.13 ± 0.13 | 0.85 | ||
Anaerobic threshold (IQR) | 11.3 (8.3–12.8) | 9 (8.4–11.1) | 0.46 | ||
Oxygen pulse—ml/beat ±SD | 11.6 ± 5.1 | 13.2 ± 2.9 | 0.37 | ||
Double product (±SD) | 19,292 ± 4539 | 16,710 ± 4390 | 0.16 | ||
VE/VCO2 (±SD) | 28.6 ± 6.2 | 28.9 ± 3.5 | 0.88 | ||
dVO2/dWR (IQR) | 8.2 (6.2–11.2) | 7.9 (6.6–11.7) | 1 | ||
CPET (6 months) | p * | p * | |||
Oxygen consumption—mL/kg/min ± SD | 18.4 ± 5.2 | 0.03 | 14.52 ± 3.61 | 0.53 | 0.03 |
Workload—W ± SD | 116 ± 50 | 0.03 | 100 ± 37 | 0.14 | 0.01 |
Time—s ±SD | 467 ± 74 | 0.06 | 460 ± 107 | 0.15 | 0.02 |
Respiratory exchange ratio (±SD) | 1.11 ± 0.12 | 0.64 | 1.09 ± 0.14 | 0.38 | 0.59 |
Anaerobic threshold (±SD) | 12.4 ± 2.9 | 0.15 | 10.2 ± 1.7 | 0.96 | 0.36 |
Oxygen pulse—mL/beat ±SD | 12.9 ± 4.8 | 0.31 | 13.5 ± 3.5 | 0.6 | 0.58 |
Double product (±SD) | 18600 ± 4793 | 0.41 | 15968 ± 3693 | 0.48 | 0.89 |
VE/VCO2 (±SD) | 28.0 ± 5.7 | 0.79 | 27.7 ± 7.6 | 0.39 | 0.76 |
dVO2/dWR (±SD) | 9.3 ± 2 | 0.8 | 8.7 ± 2 | 0.84 | 0.82 |
CSR (n = 13) | Sham (n = 12) | p † | |||
---|---|---|---|---|---|
SAQ (baseline) | |||||
Physical limitation (±SD) | 34.6 ± 12 | 29.6 ± 15.3 | 0.38 | ||
Angina frequency (±SD) | 37.8 ± 21.1 | 40.9 ± 23.9 | 0.73 | ||
Angina stability (IQR) | 40 (40–40) | 40 (5–40) | 0.54 | ||
Quality of life (IQR) | 33.3 (23.4–36.7) | 33.4 (8.4–45) | 0.98 | ||
Treatment satisfaction (IQR) | 57.1 (47.6–71.4) | 57.1 (50.0–61.9) | 0.69 | ||
SAQ (6 months) | p * | p * | |||
Physical limitation (±SD) | 46.9 ± 10.6 | <0.01 | 37.5 ± 17.6 | 0.07 | 0.59 |
Angina frequency (±SD) | 59.0 ± 15.7 | <0.01 | 59.8 ± 21.3 | 0.02 | 0.84 |
Angina stability (±SD) | 50.0 ± 20.0 | 0.11 | 47.3 ± 16.2 | 0.04 | 0.84 |
Quality of life (±SD) | 44.4 ± 10.4 | 0.01 | 47.9 ± 24.9 | 0.02 | 0.54 |
Treatment satisfaction (±SD) | 64.7 ± 9.4 | 0.19 | 63.2 ± 9.3 | 0.02 | 0.43 |
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
Mrak, M.; Pavšič, N.; Žižek, D.; Ležaić, L.; Bunc, M. Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients—A CROSSROAD Study. J. Cardiovasc. Dev. Dis. 2023, 10, 235. https://doi.org/10.3390/jcdd10060235
Mrak M, Pavšič N, Žižek D, Ležaić L, Bunc M. Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients—A CROSSROAD Study. Journal of Cardiovascular Development and Disease. 2023; 10(6):235. https://doi.org/10.3390/jcdd10060235
Chicago/Turabian StyleMrak, Miha, Nejc Pavšič, David Žižek, Luka Ležaić, and Matjaž Bunc. 2023. "Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients—A CROSSROAD Study" Journal of Cardiovascular Development and Disease 10, no. 6: 235. https://doi.org/10.3390/jcdd10060235
APA StyleMrak, M., Pavšič, N., Žižek, D., Ležaić, L., & Bunc, M. (2023). Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients—A CROSSROAD Study. Journal of Cardiovascular Development and Disease, 10(6), 235. https://doi.org/10.3390/jcdd10060235