Hot Line 6: SWEDEPAD 1 and 2, PULSE, AQUATIC, DUAL-ACS and OPTION-STEMI
31 Aug 2025
Hot Line ESC Congress 2025 Hot Line 6 answered some important questions related to the optimal treatment of peripheral arterial disease (PAD), left main disease, chronic coronary syndrome (CCS), acute coronary syndrome (ACS) and multivessel disease.
Professor Mårten Falkenberg (Sahlgrenska University Hospital and the University of Gothenburg - Sweden) presented results from registry-based trials comparing drug-coated and uncoated devices in approximately 3,500 patients with PAD. In SWEDEPAD 1, in patients with chronic limb-threatening ischaemia (Rutherford stage 4–6), there was no significant difference in the primary endpoint of time to ipsilateral above-ankle amputation with drug-coated vs. uncoated devices (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.87 to 1.27) over 5-year follow-up. In SWEDEPAD 2, in patients with intermittent claudication (Rutherford stage 1–3), there was no difference in the primary efficacy endpoint of quality of life between the drug-coated and uncoated groups at 12 months (mean difference in VascuQoL-6 scores: –0.02; 95% CI –0.66 to 0.62). There was no difference in all-cause mortality between the groups in either trial. Almost all of the drug-coated devices delivered paclitaxel and Prof. Falkenberg concluded that “devices incorporating antiproliferative agents other than paclitaxel warrant further investigation in PAD.”
The PULSE trial, presented by Doctor Ovidio De Filippo (Hospital Citta Della Salute e della Scienza di Torino - Turin, Italy), was the first randomised trial to evaluate the potential benefit of routine coronary computed tomography (CCT)-based follow-up at 6 months compared with standard symptom- and ischaemia-driven management in patients after percutaneous coronary intervention (PCI) for left main disease. There was no reduction in the primary composite endpoint of all-cause death, spontaneous myocardial infarction (MI), unstable angina or stent thrombosis at 18 months. However, spontaneous MI was significantly lower and there was an increase in imaging-triggered target-lesion revascularisation in the CCT arm. Dr. De Filippo stated that “while universal CCT-based follow-up may not be useful, this approach may be worth investigating further in selected patients with complex anatomies and over longer follow-up.”
Next, Professor Martine Gilard (Hospital Cavale Blanche - Brest, France) described the AQUATIC trial, which investigated the efficacy and safety of aspirin in patients with CCS and stent implantation (>6 months prior), at high atherothrombotic risk who required long-term oral anticoagulation (OAC). The primary efficacy endpoint was cardiovascular death, MI, stroke, systemic embolism, coronary revascularisation and acute limb ischaemia. The trial was stopped early on the advice of the independent Data Safety Monitoring Board after a median follow-up of 2.2 years with 872 patients enrolled, due to an excess of all-cause mortality in the aspirin group. The primary efficacy outcome occurred in significantly more patients in the aspirin group than the placebo group (16.9% vs. 12.1%; adjusted HR 1.53; 95% CI 1.07 to 2.18; p=0.019) with the risk of major bleeding more than three-fold higher in the aspirin group. “Giving aspirin is common practice in this setting but had not been formally tested. Our trial findings indicate that the use of aspirin should be discouraged and the results can now be considered in future guidelines,” commented Prof. Gilard.
Presented by Professor David Newby (University of Edinburgh - Edinburgh, UK), the DUAL-ACS trial compared 3 months vs. 12 months of dual antiplatelet therapy (DAPT) in a real-world, all-comer population of more than 5,000 patients with MI. After 15 months follow-up, the primary endpoint of all-cause mortality occurred in 2.7% of patients in the 3-month DAPT group and 3.4% of patients in the 12-month DAPT group (HR 0.78; 95% CI 0.57 to 1.07; p=0.1232) with no difference in cardiovascular death or non-fatal MI (HR 1.04; 95% CI 0.87 to 1.26; p=0.6149). Fatal and non-fatal major bleeding occurred in 3.2% of patients in the 3-month DAPT group and 4.0% in the 12-month DAPT group (HR 0.78; 95% CI 0.58 to 1.06; p=0.0977). Prof. Newby explained: “This all-comer real-world trial recruited only 30% of the planned participants and was unable to address the primary question definitively. However, there was no evidence that DAPT given for 12 months conferred any additional benefit. Indeed, the trends for lower mortality and bleeding risk with 3 months of DAPT are consistent with prior meta-analyses and suggest that limiting DAPT duration to 3 months may be safer in a real-world contemporary population.”
Finally, the OPTION-STEMI trial, presented by Professor Youngkeun Ahn (Chonnam National University Hospital - Gwangju, South Korea) compared immediate and in-hospital staged complete revascularisation in 994 patients with STEMI and multivessel disease undergoing PCI. At 1 year, the primary endpoint of death, MI and any unplanned revascularisation occurred in 13.1% of patients in the immediate group and 10.8% in the staged group (HR 1.24; 95% CI 0.86 to 1.79Íž p for noninferiority=0.24), with noninferiority not established. Immediate complete revascularisation was associated with more harm in patients with Killip class ≥II (HR 1.79; 95% CI 1.05 to 3.05) than in patients with Killip class I (HR 0.84; 95% CI 0.50 to 1.41; p for interaction=0.04). Concluding, Prof. Ahn said: “Given our findings in patients with signs of heart failure, it seems prudent to limit immediate complete revascularisation to stable STEMI patients with multivessel disease at low clinical risk.”
