The EAPCI device success algorithm in the PIONEER IV trial: insights with angiography-derived FFR

Background Device success is a key endpoint in trials of drug-eluting stents (DES). However, inconsistent definitions across trials yield success rates of 91.2%-100%, complicating comparisons across the trials . The European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed our algorithm (Picure 1) to standardize device success, but it has not been prospectively validated with core lab adjudication. Suboptimal post-PCI angiography-derived FFR is linked to poor outcomes. This study applies the EAPCI algorithm with core lab quantitative coronary angiography (QCA) and angiography-derived FFR. Methods We prospectively applied the EAPCI algorithm in the ongoing PIONEER IV trial, a multicenter, all-comers randomized controlled trial comparing PCI outcomes guided by Quantitative Flow Ratio (QFR) versus usual care, with both arms utilizing Healing-Targeted Supreme sirolimus-eluting stents (HT Supreme). An independent core lab adjudicated the device success with post-PCI QCA and analyzed post-PCI angiography-derived FFR using the QFR or Murray law–basedQFR (μFR). The device success rate was compared against a performance index from 45 recent DES trials encompassing 71875 lesions. The post-PCI vessel angiography-derived FFR thresholds included values <0.91 and a delta angiography-derived FFR >0.05 across the stent. Results In the first 1270 patients, 1090 lesions were targeted for treatment with the HT Supreme. Of these, a total of 16 attempts to deploy the first HT Supreme stent in the target lesion were unsuccessful. Of the 1074 lesions where the HT Supreme was successfully deployed, site reports identified 41 lesions with residual stenosis ≥20% (visual/QCA), resulting in a device success rate of 94.8%. When the core lab QCA was applied, 101 lesions had residual stenosis ≥20%, reducing the device success rate to 89.9%. Among the 1074 lesions where the HT Supreme was successfully deployed, post-PCI angiography-derived FFR could be calculated for 1053 lesion. Of these, 806 lesions (76.5%) had a post-PCI angiography-derived FFR ≥0.91, and 1025 lesions (97.3%) achieved a post-PCI angiography-derived delta FFR ≤0.05. In total, 800 lesions (76.0%) satisfied both thresholds. This is an ongoing trial; the results presented here are based on currently available procedural data. The complete dataset including the comparison between the QFR-guided and usual care arms will be presented at ESC 2025. Conclusion The HT Supreme demonstrated a 94.8% device success rate based on operator assessment, while core lab QCA yielded more modest success rates, suggesting underestimated residual stenosis by the operators. To ensure unbiased device comparisons, core lab QCA should be considered mandatory in future algorithm iterations. Additionally, post-PCI angiography-derived FFRmay be integrated into the next device success algorithm to enhance procedural assessment and standardization.