VIEWPOINT
European Heart Journal (2024) 00, 1–3
https://doi.org/10.1093/eurheartj/ehae110
Interventional cardiology
Emanuele Barbato
1
*, Margaret McEntegart2, and Tommaso Gori
3
1
Department of Clinical and Molecular Medicine, Sapienza University, Piazzale Aldo Moro 5, 00185 Rome, Italy; 2Department of Cardiology, Columbia University Medical Center,
New York, NY, USA; and 3Kardiologie I, Center for Cardiology, University Medical Centre Mainz and DZHK Standort Rhein-Main, Mainz, Germany
Graphical Abstract
Ten interventional cardiology papers
from 2023 that may change our practice
Coronary
artery disease
ORBITA-2
PCI versus placebo
improves outcome
FIRE
Physiology-guided
PCI in older patients
improves outcomes
ILUMIEN-IV
OCT reduces stent
thrombosis but does
not change other
outcomes
Resistant
hypertension
Peripheral
interventions
PARTNER-3
TAVI vs SAVR in
intermediate risk
SIMPLICITY-3
Catheter-based
renal artery
denervation more
Meta-analysis
DCBs associated
with higher patency
rate than POBA
outcomes at 5 years
sham at 3 years
Cardiogenic shock
Valve disease
ECLS-SHOCK
Increased bleeding
and peripheral
complications
TRILUMINATE
Percutaneous
therapy of
regurgitation
mproves Qol
OCTOBER
OCT improves
outcome in
bifurcation lesions
DAPT de-escalation
Reduces bleeding
and ischaemic events
Our selected papers. PCI, percutaneous coronary intervention; OCT, optical coherence tomography; DAPT, dual anti-platelet therapy; TAVI,
transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement; DCB, drug-coated balloon; POBA, plain old balloon angioplasty;
Qol, quality of life.
* Corresponding author. Email: emanuele.barbato@uniroma1.it
© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
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The year in cardiovascular medicine 2023:
the top 10 papers in interventional cardiology
2
The year 2023 brought tremendous innovation in interventional cardiovascular medicine, with numerous publications from long-awaited
trials that were designed to provide definitive answers regarding the
role of physiology, imaging, novel devices, and novel applications of
structural interventions. While the 10 papers presented below admittedly represent an arbitrary choice (Graphical Abstract), there are thousands of other ones equally worthy of mention.
setting of acute coronary syndromes, but the concern remains regarding a possible increase in ischaemic events. To address this concern,
Kang et al. performed a patient-level meta-analysis of four trials
(TROPICAL-ACS, POPular Genetics, HOST-REDUCE-POLYTECHACS, and TALOS-AMI trials) including 10 133 acute coronary syndrome patients.5 De-escalation was found to be superior for both
ischaemic [HR 0.76 (95% CI 0.60–0.97), P = .029] and bleeding events
[HR = 0.70 (95% CI 0.61–0.81), P < .001].
Cardiogenic shock
The primary purpose of percutaneous coronary intervention itself was
under investigation in the most recently published trial on this list,
ORBITA-2, presented at the 2023 American Heart Association
Scientific Sessions.1 In this randomized controlled trial, specifically designed to isolate the treatment effects in patients with stable angina
and objective evidence of ischemia not taking anti-anginal medication,
interventional therapy significantly reduced the mean angina symptom
score compared to a sham placebo procedure [2.9 vs. 5.6; odds ratio
2.21, 95% confidence interval (CI) 1.41–3.47, P < .001]. While coronary
interventions have been performed for almost five decades, this trial
was the first to formally demonstrate beyond any doubt the effectiveness of PCI in reducing anginal frequency and exercise times.
Cardiovascular emergencies are a particularly complex setting for research, with evidence lacking in many aspects of patient care. In the
ECLS-SHOCK randomized controlled trial, Thiele et al. assigned 420
patients in cardiogenic shock undergoing early revascularization with
or without extracorporeal life support. They reported no impact on
30-day mortality [relative risk 0.98 (5% CI 0.80–1.19); P = .81], but increased bleeding and peripheral complications.6 While this is consistent
with previous trials showing no benefit of systematic use of intra-aortic
balloon pumps and microaxial devices, the use of these costly devices in
selected cases of advanced instability can hardly be investigated.
Coronary physiology and imaging
The treatment of valvular heart diseases is becoming the domain of interventionalists. Two of the many papers published in 2023 demonstrate how these indications are continuously expanding. Mack et al.
reported the 5-year outcomes of the PARTNER-3 trial, randomizing
patients with severe, symptomatic aortic stenosis, and low surgical
risk to undergo either transcatheter aortic valve implantation or surgery. Rates of both clinical co-primary endpoints, and parameters of
hemodynamic valve performance, were essentially similar between
groups.7
Nonetheless, the most innovative field in percutaneous valve intervention consists in the treatment of tricuspid valve regurgitation.
Severe tricuspid regurgitation is under-treated and associated with an
under-recognized rate of morbidity and poor quality of life. In addition,
surgical correction is complex and associated with an elevated rate of
complications. While showing effectivity in reducing tricuspid regurgitation, in the TRILUMINATE randomized controlled trial, no difference
between transcatheter repair and medical therapy was observed
in any of the outcomes, including the incidence of death or tricuspid
valve surgery and the rate of hospitalization for heart failure except
for an improvement in patient-reported quality of life (Kansas City
Cardiomyopathy Questionnaire scores, 12.3 ± 1.8 vs. 0.6 ± 1.8 points,
P < .001).8
The second paper of this list reports on the results of the FIRE randomized controlled trial presented at the 2023 European Society of
Cardiology Congress.2 The incidence of cardiovascular diseases increases with age, as does the prevalence of comorbidities and frailty
in patients with myocardial infarction. Despite that, older patients are
poorly represented in clinical trials, and clinical decisions regarding complete revascularization balance an increased risk of complications with
technical challenges. In this context, Biscaglia et al. enrolled 1445 patients with a median age of 80 (interquartile range 77–84) years presenting with an acute myocardial infarction and multivessel disease.
After successful intervention of the culprit lesion, patients were randomized to physiology-guided complete revascularization or no further
intervention. During one year follow-up, the composite endpoint
(death, myocardial infarction, stroke, or any revascularization) occurred
significantly less frequently in the physiology-guided group [hazard ratio
(HR) 0.73, 95% CI 0.57–0.93; P = .01], demonstrating a benefit of
physiology-guided complete revascularization also in the elderly.
Following on from the publications and growing interest in intracoronary imaging in 2022, two eagerly anticipated randomized controlled trials,
ILUMIEN IV and OCTOBER, were presented at the 2023 European
Society of Cardiology Congress.3,4 While ILUMIEN IV, enrolling patients
at higher risk for ischemic events and/or with complex lesions, showed no
difference in target lesion failure at 2-year follow-up between optical coherence tomography-guided and angiography-guided interventions despite a larger minimum stent area and a reduced incidence of stent
thrombosis in the imaging arm,3 OCTOBER, which specifically focused
on bifurcation lesions, reported a significant reduction in major adverse
events at 2 years [10% vs. 14%; HR 0.70 (95% CI 0.50–0.98), P = .035]
with imaging-guided.4
Dual-antiplatelet therapy
De-escalation of dual-antiplatelet therapy has been established itself as
a strategy to reduce bleeding risk after coronary interventions in the
Structural heart disease
Peripheral and hypertension
intervention
The last two papers selected deal with the expanding field of percutaneous intervention of peripheral artery disease and arterial
hypertension.
The burden of peripheral artery disease is increasing, and optimal endovascular management remains under-investigated. In a meta-analysis
of 51 randomized controlled trials and 8430 patients/lesions, drugcoated balloons demonstrated a higher likelihood of long-term primary
patency when used in femoropopliteal disease [odds ratio 2.47 (95% CI
1.93–3.16)] compared with balloon angioplasty. Interestingly, unlike in
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Percutaneous coronary
intervention
Viewpoint
3
Viewpoint
Conclusions
There were several important publications this year in interventional
cardiology, all of which have a direct clinical impact. The selection
above, admittedly arbitrary, was drawn by the interventional cardiology
editorial team of the Journal among the most quoted papers of the year
to reflect the multidisciplinarity of our environment. While there has
been confirmation of the treatment effect of coronary interventions,
the benefit of imaging and physiology, antiplatelet de-escalation, drugcoated balloon for peripheral disease, and the durability of valve interventions and renal denervation, they also highlight the need for future
trials further exploring therapeutic strategies in cardiogenic shock and
non-aortic valve interventions.
Declarations
Disclosure of Interest
T.G. has received speaker´s honoraria from Astra Zeneca, Abbott
Vascular, Neovasc/Shockwave, Bayer, Novartis, BMS, Insightful/
Lifetech and research funding from Abbott Vascular and Neovasc/
Shockwave. M.M. has received speaker´s honoraria or consulting fees
from Shockwave Medical, Teleflex, Boston Scientific, Biosensors, and
research funding from Boston Sci. E.B. has received research funding
from Insightful Lifetech, Abbott Vascular, and Boston Sci. All are not related to the present work.
References
1. Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Nowbar AN, Simader FA, Davies JR, et al. A
placebo-controlled trial of percutaneous coronary intervention for stable angina. N Engl
J Med 2023;389:2319–30. https://doi.org/10.1056/NEJMoa2310610
2. Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, et al. Complete or
culprit-only PCI in older patients with myocardial infarction. N Engl J Med 2023;389:
889–98. https://doi.org/10.1056/NEJMoa2300468
3. Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, et al.
Optical coherence tomography-guided versus angiography-guided PCI. N Engl J Med
2023;389:1466–76. https://doi.org/10.1056/NEJMoa2305861
4. Holm NR, Andreasen LN, Neghabat O, Laanmets P, Kumsars I, Bennett J, et al. OCT or
angiography guidance for PCI in complex bifurcation lesions. N Engl J Med 2023;389:
1477–87. https://doi.org/10.1056/NEJMoa2307770
5. Kang J, Rizas KD, Park KW, Chung J, van den Broek W, Claassens DMF, et al. Dual antiplatelet therapy de-escalation in acute coronary syndrome: an individual patient
meta-analysis. Eur Heart J 2023;44:1360–70. https://doi.org/10.1093/eurheartj/ehac829
6. Thiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, et al. Extracorporeal life
support in infarct-related cardiogenic shock. N Engl J Med 2023;389:1286–97. https://
doi.org/10.1056/NEJMoa2307227
7. Mack MJ, Leon MB, Thourani VH, Pibarot P, Hahn RT, Genereux P, et al. Transcatheter
aortic-valve replacement in low-risk patients at five years. N Engl J Med 2023;389:
1949–60. https://doi.org/10.1056/NEJMoa2307447
8. Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, et al. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med 2023;388:1833–42. https://
doi.org/10.1056/NEJMoa2300525
9. Koeckerling D, Raguindin PF, Kastrati L, Bernhard S, Barker Jo, Quiroga Centeno AC,
et al. Endovascular revascularization strategies for aortoiliac and femoropopliteal artery
disease: a meta-analysis. Eur Heart J 2023;44:935–50. https://doi.org/10.1093/eurheartj/
ehac722
10. Bhatt DL, Vaduganathan M, Kandzari DE, Leon MB, Rocha-Singh K, Townsend RR, et al.
Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 trial. Lancet 2022;400:
1405–16. https://doi.org/10.1016/S0140-6736(22)01787-1
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coronary circulation, mid-term patency rates were similar for bare metal and drug eluting stents.9
Finally, Bhatt et al. reported the long-term outcomes after catheterbased renal artery denervation for resistant hypertension. Of the original 535 patients in the Simplicity-3 randomized controlled trial,
36-month follow-up data were available for 219 patients in the denervation group and 99 patients in the sham group (of whom 63 crossed
over to denervation). The change in the office and ambulatory systolic
blood pressure was significantly larger in the renal artery denervation
group than the sham control group [adjusted treatment difference
−22.1 (95% CI −27.2, −17.0) mmHg; P ≤ .0001].10