Drug-eluting stents, sirolimus-coated balloons (SCBs) and a closer look at instantaneous wave-free ratio (iFR)-guided coronary revascularization vs. fractional flow reserve (FFR)-guided revascularization were the focus of several trials, including PARTHENOPE, BIOSTEMI ES and SWEDEHEART, presented as part of a Late-Breaking Clinical Science session at TCT 2023.

In a randomized study out of China, a novel SCB with a dose of 4 mg/mm2 was shown to be noninferior to a paclitaxel-coated balloon angioplasty with respect to late lumen loss at nine months in patients treated for in-stent restenosis following implantation of a drug-eluting stent (DES). In presenting the findings, Yaling Han, MD, PhD, FACC, said "further clinical trials are warranted to identify the improvement in clinical events by SCB" for this patient population.

In COMPARE 60/80 HBR, researchers found the ultrathin strut Supralex Cruz stent was noninferior compared with the thin strut Ultimaster Tansei stent in patients at high risk for bleeding and with very few restrictions on lesion and treatment complexity. In presenting the findings, Pieter C. Smits, MD, PhD, noted that outcomes in regard to target lesion revascularziation and myocardial infarction were numerically lower for Supraflex Cruz, but did not reach statistical significance, including superiority testing on net adverse clinical events. He added that larger sample-sized studies are needed to show that the ultrathin strut Supraflex Cruz stent can further improve outcomes.

One-year results from the PARTHENOPE trial showed use of polymer-free amphilimus-eluting stents in all-comer patients undergoing PCI was noninferior to biodegradable polymer everolimus-eluting stents (EES) in terms of the device-oriented composite endpoint. According to Giovanni Esposito, MD, PhD, there were no between-group differences at one year in the components of the primary endpoint of cardiovascular death, target-vessel myocardial infarction, and clinically-indicated target lesion revascularization between the two study devices. He did note that early stent thrombosis occurred more frequently in patients randomized to receive the polymer-free DES, however, risk estimates were not significant when adjusted for multiple comparison.

In BIOSTEMI ES, treatment of STEMI patients undergoing primary PCI with biodegradable polymer sirolimus-eluting stents significantly reduced the rate of target lesion failure at five years of follow-up compared with treatment with durable polymer EES. According to researchers, the difference was primarily driven by a lower risk for ischemia-driven target lesion revascularization with biodegradable polymer sirolimus-eluting stents. "To our knowledge, the [BIOSTEMI ES] study is the first head-to-head randomized comparison with long-term follow-up between two newer-generation DES for the treatment of patients with STEMI," the investigators said. "… the study shows the absence of a late catch-up phenomenon with newer-generation biodegradable polymer [DES] in patients with STEMI."

Insights from the SWEDEHEART National Registry presented by Matthias Götberg, MD, found no difference in long-term major adverse events in patients receiving iFR-guided coronary revascularization compared with FFR-guided revascularization. Additionally, no interaction between treatment decision and outcome was observed. Researchers also noted that "the observed difference in mortality between iFR and FFR among treated patients in DEFINE-FLAIR could not be verified in this large nationwide real-world all-comers registry analysis."