Are Coronary Stents Placebos?

March 5, 2023 Health & Healing No Comments

Only one experimental study has been done to answer this question ― pretty positively in many cases. Meanwhile, much evidence (without placebo groups) shows that coronary stents are of little use in cases of stable angina pectoris. Contrary to this, mind-factors’ influence on angina pectoris is considerable and robustly investigated. Altogether, this calls for more science.

A coronary stent is an artery-widening technique of one or more blood vessels around the heart muscle. It is performed when the artery shows to be blocked partially or totally.

Note that coronary stents save lives. They may save yours.

List of abbreviations

  • GDMT: Guideline-Directed Medical Therapy
  • RCT: Randomized Controlled Trial
  • CCD: Chronic Coronary Disease
  • MI: Myocardial (heart) Infarction
  • PCI: Percutaneous Coronary Intervention

As a background, it is advisable to read my articles on angina pectoris:

Some quotes from other articles (from PubMed journals = high-level medical science)

  • Neither all-cause death nor cardiovascular death were different in the patients who were invasively and conservatively managed in all 4 contemporary RCT trials [COURAGE, BARI 2D, FAME 2, and ISCHEMIA, totaling >10.000 patients with CCD]. Extended follow-up in 52% of patients in COURAGE revealed similar all-cause death at a median of 11.9 years (25% vs 24%; p = 0.77). … The incidence of total MIs (procedural and spontaneous) did not differ between the patients who were invasively and conservatively managed in any of the trials. … [This together has] shown that initial conservative management with GDMT alone is safe, with no excess mortality observed up to approximately 4 years, compared with initial invasive management including GDMT plus revascularization. [1]
  • [concerning ISCHEMIA-study:] Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy [such as stenting], as compared with an initial conservative strategy [GDMT], reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. [2]
  • In patients with medically treated angina and severe coronary stenosis, PCI [stenting] did not increase exercise time by more than the effect of a placebo procedure. … This first placebo-controlled trial of PCI for stable angina suggests that the common clinical observation of symptomatic improvement from PCI might well contain a large placebo component. Placebo-controlled efficacy data could be just as important for assessing invasive procedures, where the stakes are higher, as for assessing pharmacotherapy where it is already standard practice. [3]
  • Careful review of the data demonstrates the limitations of our current knowledge, resulting in a state of community equipoise. [4]
  • Thus, the long-term effect of invasive management strategy on mortality remains unclear. [5]
  • There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years. … The higher rate of noncardiovascular death in the invasive group was unexpected and remains unexplained. [6]

Joint decision making

If your physician advises a stent, you should strive for joint decision-making. Three arguments for doing so:

  • Your physician might know something more about your case that makes stenting preferable.
  • Your physician might otherwise sue me for setting you up.
  • You might make him think and read about this ― hopefully making medicine better.

Other authors also advise joint decision-making as the standard of care in this domain. [1]

The one study with a placebo group (ORBITA)

Researchers at Imperial College London conducted a multi-center, blinded, randomized, and placebo-controlled study on 200 patients with stable angina without having a heart attack. The patients were followed over a 12-week trial period. [7]

The study – of which the results were published in The Lancet – showed no significant additional benefit of coronary stenting. [3] The stents improved blood supply in the heart but didn’t provide relief of symptoms (see the quote) ― pretty puzzling to the researchers.

About the studies without placebo groups

See the quotes above.

In these studies, taken together, the stenting procedure improved symptoms ― caused by what? Note that some other operations have revealed placebo effects that accounted for the full effect of the procedure. Stenting would, in that case, not be an exception.

Mostly excluded from the trials were patients with acute coronary syndromes, severe heart failure symptoms, severe left main coronary artery disease, and increasingly or very symptomatic patients despite medication. So, conclusions about such cases cannot be drawn from the available experimental evidence.

Until now, we have data over a few years, with ISCHEMIA data running over 5 years. Long-term effects of initial stenting versus conservative (GDMT) therapy will be assessed by ISCHEMIA-EXTEND ― projected survival median 10 years, to be followed on https://www.ischemiatrial.org/. An interim analysis at 7 years found no improvement in all-cause mortality. [8]

Overall conclusions

  • There is little to no influence of stenting on mortality in large groups of patients that receive stenting nowadays.
  • We know little for certain about the influence of placebo in stenting, including on the diminishment of symptoms. Also, there is little to no increase of such knowledge foreseeable in the near future.
  • On the other side, there is a clear, strong, and well investigated influence of the mind on the incidence of angina pectoris and heart infarction.
  • Thus, a significant influence of the mind on the results of stenting is highly likely and may well explain the whole (little as may be) positive effect of stenting on symptoms and mortality for patients with stable angina pectoris ― also with moderate or strong heart ischemia.
  • Even more disturbingly, in case of a substantial placebo effect, the result of the stenting procedure by itself may be an increase in adverse effects (including mortality) veiled by the placebo.

As in much regarding the psychosomatic field, there is a dire need for more and better science before jumping to conclusions. Nevertheless, there are strong arguments not to leave your mind out of sight.

How-to?

You find some relevant hands-on mental exercises in the free AURELIS app (in the app stores).

You might also first read about how to prevent a heart infarction.

Bibliography

[1] Mavromatis K, Boden WE, Maron DJ, Mancini GBJ, Weintraub WS, Gosselin G, Berman DS, Shaw LJ, Spertus JA, Hochman JS. Comparison of Outcomes of Invasive or Conservative Management of Chronic Coronary Disease in Four Randomized Controlled Trials. Am J Cardiol. 2022 Dec 15;185:18-28. doi: 10.1016/j.amjcard.2022.09.008. Epub 2022 Oct 17. PMID: 36257844.

[2] Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Boden WE, Chaitman BR, Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30. PMID: 32227755; PMCID: PMC7263833.

[3] Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018 Jan 6;391(10115):31-40. doi: 10.1016/S0140-6736(17)32714-9. Epub 2017 Nov 2. Erratum in: Lancet. 2018 Jan 6;391(10115):30. PMID: 29103656.

[4] Stone GW, Hochman JS, Williams DO, Boden WE, Ferguson TB Jr, Harrington RA, Maron DJ. Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise. J Am Coll Cardiol. 2016 Jan 5;67(1):81-99. doi: 10.1016/j.jacc.2015.09.056. Epub 2015 Nov 23. PMID: 26616030; PMCID: PMC5545795.

[5] Anthopolos R, Maron DJ, Bangalore S, Reynolds HR, Xu Y, O’Brien SM, Troxel AB, Mavromichalis S, Chang M, Contreras A, Hochman JS; ISCHEMIA-EXTEND Research Group. ISCHEMIA-EXTEND studies: Rationale and design. Am Heart J. 2022 Dec;254:228-233. doi: 10.1016/j.ahj.2022.09.009. Epub 2022 Oct 4. PMID: 36206950; PMCID: PMC9880872.

[6] Hochman JS, Anthopolos R, Reynolds HR, Bangalore S, Xu Y, O’Brien SM, Mavromichalis S, Chang M, Contreras A, Rosenberg Y, Kirby R, Bhargava B, Senior R, Banfield A, Goodman SG, Lopes RD, Pracoń R, López-Sendón J, Maggioni AP, Newman JD, Berger JS, Sidhu MS, White HD, Troxel AB, Harrington RA, Boden WE, Stone GW, Mark DB, Spertus JA, Maron DJ; ISCHEMIA-EXTEND Research Group. Survival After Invasive or Conservative Management of Stable Coronary Disease. Circulation. 2023 Jan 3;147(1):8-19. doi: 10.1161/CIRCULATIONAHA.122.062714. Epub 2022 Nov 6. PMID: 36335918; PMCID: PMC9797439.

[7] Foley M, Rajkumar CA, Shun-Shin M, Ganesananthan S, Seligman H, Howard J, Nowbar AN, Keeble TR, Davies JR, Tang KH, Gerber R, O’Kane P, Sharp ASP, Petraco R, Malik IS, Nijjer S, Sen S, Francis DP, Al-Lamee R. Achieving Optimal Medical Therapy: Insights From the ORBITA Trial. J Am Heart Assoc. 2021 Feb 2;10(3):e017381. doi: 10.1161/JAHA.120.017381. Epub 2021 Jan 26. PMID: 33496201; PMCID: PMC7955412.

[8] Bradley SM, Gluckman TJ. If the Fates Allow: The Zero-Sum Game of ISCHEMIA-EXTEND. Circulation. 2023 Jan 3;147(1):20-22. doi: 10.1161/CIRCULATIONAHA.122.063033. Epub 2022 Nov 6. PMID: 36335920.

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