SOLACI | Latin American Society of Interventional Cardiology

In-stent restenosis (ISR) remains the primary limitation of percutaneous treatment for coronary artery disease. The strategy to address this limitation involves the use of drug-eluting stents (DES) or drug-coated balloons (DCB), both of which have proven to be effective and safe therapeutic alternatives.

TCT 2023 | SWEDEHEART, evolución a 5 años

Despite current recommendations, treating ISR continues to be a challenge, and clinical trial evidence is limited.

The objective of the Prospective Randomized ISAR-DESIRE 3 Study was to investigate the long-term incidence of recurrent revascularization after the treatment of ISR with drug-eluting stents.

The primary endpoint (PEP) was the need for repeat target lesion revascularization (R-TLR), defined as any repeated revascularization procedure over the 10-year follow-up.

A total of 402 patients were randomized to receive treatment with plain balloon (PB), DCB, or DES. At 10 years, R-TLR was required for 204 lesions, of which 82 were in the PB group, 70 in the DCB group, and 52 in the DES group. During the first year of follow-up, the risk of R-TLR was reduced with the use of DCB (hazard ratio [HR] = 0.36 [95% confidence interval (CI): 0.24-0.54]) and DES (HR = 0.23 [0.14-0.38]) compared with PB.

After the first year, the risk of R-TLR was reduced non-significantly with DCB (HR = 0.77 [0.51-1.16]) and significantly with DES (HR = 0.61 [0.39-0.95]). The risk of DCB versus DES was similar during (HR = 1.54 [0.89-2.69]) and after 1 year (HR = 1.26 [0.82 – 1.92]).

Conclusion

In summary, the total number of R-TLR events after 10 years of DES-ISR treatment is high. The use of DCB and, in particular, of DES, are both alternatives to reduce the need for initial revascularization and recurrent revascularization compared with PB.