Revascularization after treatment of in-stent restenosis high after 10 years
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Key takeaways:
- Ten years after PCI for restenosis of a drug-eluting stent, the repeat revascularization rate was over 40%.
- Repeat revascularization was most likely if initial restenosis treatment was with an uncoated balloon.
SAN FRANCISCO — Among patients treated for drug-eluting in-stent restenosis, the revascularization rate at 10 years was high, according to the results of a post hoc analysis of the ISAR-DESIRE 3 trial presented at TCT 2023.
“The objective was to investigate the long-term incidence of recurrent revascularization events after PCI for drug-eluting stent restenosis,” Tobias Koch, MD, from Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany, said during a press conference.
ISAR-DESIRE 3 was a trial conducted from 2009 to 2011 that compared plain balloon angioplasty, drug-coated balloons and drug-eluting stents for the treatment of in-stent restenosis from drug-eluting stents (DES-ISR). The trial included 402 patients with 500 lesions.
The primary endpoint of the post hoc analysis was repeat target lesion revascularization, defined as PCI or CABG of the index lesion. The results were simultaneously published in JACC: Cardiovascular Interventions.
At 10 years, repeat TLR occurred in 40.8% of lesions, 25.6% requiring a single repeat TLR and 15.2% requiring multiple repeat revascularizations, Koch said at the press conference.
Repeat DES implantation was the treatment of choice in 40% of repeat TLRs, followed by DCB (36%), plain balloon angioplasty (23%) and CABG (1%), Koch said.
At 1 year, compared with patients initially treated for DES-ISR with plain balloon angioplasty, those treated with DES (HR = 0.2; 95% CI, 0.14-0.38) and DCB (HR = 0.36; 95% CI, 0.24-0.54) had reduced risk for any repeat TLR, according to the researchers.
After 1 year, compared with patients initially treated for DES-ISR with plain balloon angioplasty, those treated with DES had reduced risk for any repeat TLR (HR = 0.61; 95% CI, 0.39-0.95) and those treated with DCB trended toward reduced risk (HR = 0.77; 95% CI, 0.51-1.16) up to 10 years, Koch said.
There were no differences between the DES and DCB groups in risk for any repeat TLR at 1 year (HR = 1.54; 95% CI, 0.89-2.69) and between 1 and 10 years (HR = 1.26; 95% CI, 0.82-1.92), he said.
“The drug-coated balloon and in particular the drug-eluting stent are able to reduce the need of both first and recurrent revascularization as compared to a plain balloon, and the addition of total repeat TLR in the analysis has enabled us to capture treatment effects in the entire 10-year follow-up that were not observable in the analysis confined to first repeat TLR only,” Koch said.
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Perspective
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I always say we can do better, but in-stent restenosis is a very, very difficult situation. It has gotten better as use of imaging has increased, so that we can do better stent expansion and enhance the first procedure that is done well. Over the last 10 years, we have finally been able to show that, at the baseline, imaging will improve your outcomes. Hopefully, we will see a big uptake of that.
But once a patient comes back with in-stent restenosis, it’s a very difficult issue, especially if the first stent is not well-placed, such as if it is underexpanded. That does limit the options.
The fact that 10 years ago, coronary DCBs were available in Europe, and were given a Class I indication for in-stent restenosis in the 2014 European Society of Cardiology guidelines, and yet we in the United States still don’t have them available, is problematic. I hope that we will now move the needle with several pivotal trials that are ongoing with multitudes of different DCBs. These devices have met what the FDA is looking for in terms of their preclinical data, and will now be tested in randomized, well-designed clinical trials.
We are always disappointed when we fail, and patients return with recurrence. What we can do to improve this is to use imaging at baseline to optimize stent placement. But also, we have to do better outside of the cath lab in terms of the cardiometabolic health of our patients, which we ignored for so long.
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Koch T, et al. Late-breaking clinical science: Session III, in collaboration with European Heart Journal/EuroIntervention. Presented at: TCT Scientific Symposium, Oct. 23-26, 2023, San Francisco (hybrid meeting).
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