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Randomized Controlled Trial
. 2024 May 21;13(10):e033556.
doi: 10.1161/JAHA.123.033556. Epub 2024 May 10.

Ten-Year Outcome of Recanalization or Medical Therapy for Concomitant Chronic Total Occlusion After Myocardial Infarction

Anna van Veelen  1 , Casper F Coerkamp  1 , Yvemarie B O Somsen  2 , Truls Råmunddal  3 , Dan Ioanes  3 , Peep Laanmets  4 , René J van der Schaaf  5 , Erlend Eriksen  6 , Matthijs Bax  7 , Maarten Jan Suttorp  8 , Bradley H Strauss  9 , Emanuele Barbato  10 , Koen M Marques  2 , Martijn Meuwissen  11 , Olivier Bertrand  12 , Martin van der Ent  13 , Paul Knaapen  2 , Jan G P Tijssen  1 , Bimmer E P M Claessen  1 , Loes P C Hoebers  1   14 , Joëlle Elias  1 , José P S Henriques  1 ; EXPLORE investigators
Collaborators, Affiliations
Randomized Controlled Trial

Ten-Year Outcome of Recanalization or Medical Therapy for Concomitant Chronic Total Occlusion After Myocardial Infarction

Anna van Veelen et al. J Am Heart Assoc. .

Abstract

Background: The EXPLORE (Evaluating Xience and Left Ventricular Function in PCI on Occlusions After STEMI) trial was the first and only randomized trial investigating chronic total occlusion (CTO) percutaneous coronary intervention (PCI) early after primary PCI for ST-segment-elevation myocardial infarction, compared with medical therapy for the CTO. We performed a 10-year follow-up of EXPLORE to investigate long-term safety and clinical impact of CTO PCI after ST-segment-elevation myocardial infarction, compared with no-CTO PCI.

Methods and results: In EXPLORE, 302 patients post-ST-segment-elevation myocardial infarction with concurrent CTO were randomized to CTO PCI within ≈1 week or no-CTO PCI. We performed an extended clinical follow-up for the primary end point of major adverse cardiac events, consisting of cardiovascular death, coronary artery bypass grafting, or myocardial infarction. Secondary end points included all-cause death, angina, and dyspnea. Median follow-up was 10 years (interquartile range, 8-11 years). The primary end point occurred in 25% of patients with CTO PCI and in 24% of patients with no-CTO PCI (hazard ratio [HR], 1.11 [95% CI, 0.70-1.76]). Cardiovascular mortality was higher in the CTO PCI group (HR, 2.09 [95% CI, 1.10-2.50]), but all-cause death was similar (HR, 1.53 [95% CI, 0.93-2.50]). Dyspnea relief was more frequent after CTO PCI (83% versus 65%, P=0.005), with no significant difference in angina.

Conclusions: This 10-year follow-up of patients post-ST-segment-elevation myocardial infarction randomized to CTO PCI or no-CTO PCI demonstrated no clinical benefit of CTO PCI in major adverse cardiac events or overall mortality. However, CTO PCI was associated with a higher cardiovascular mortality compared with no-CTO PCI. Our long-term data support a careful weighing of effective symptom relief against an elevated cardiovascular mortality risk in CTO PCI decisions.

Registration: URL: https://www.trialregister.nl; Unique identifier: NTR1108.

Keywords: chronic total occlusion; clinical outcome; percutaneous coronary intervention; randomized controlled trial.

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Figures

Figure 1
Figure 1. Flowchart of the study population until 10‐year follow‐up.
CTO indicates chronic total occlusion; FUP, follow‐up; and PCI percutaneous coronary intervention.
Figure 2
Figure 2. Primary end point.
Kaplan‐Meier survival curves depicting the primary end point, consisting of cardiovascular death, myocardial infarction, or coronary artery bypass grafting. HR is calculated with Cox proportional hazard regression with corresponding 95% CI and P value. CTO indicates chronic total occlusion; HR, hazard ratio; and PCI, percutaneous coronary intervention.
Figure 3
Figure 3. Secondary end points.
A, Death from any cause. B, Cardiovascular death. C, Coronary artery bypass grafting. D, Myocardial infarction. Kaplan‐Meier survival curves depicting the secondary end points. HR is calculated with Cox proportional hazard regression with corresponding 95% CI and P value. CTO indicates chronic total occlusion; HR, hazard ratio; and PCI, percutaneous coronary intervention.
Figure 4
Figure 4. Patient‐reported outcomes at 10‐year follow‐up.
A, NYHA class for dyspnea at 10‐year follow‐up. B, CCS class for angina at 10‐year follow‐up. CCS indicates Canadian Cardiovascular Society class for grading angina; CTO, chronic total occlusion; NYHA, New York Heart Association class for grading dyspnea; and PCI, percutaneous coronary intervention.
See this image and copyright information in PMC

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