Hot Line 11: OCCUPI, INFINITY-SWEDEHEART and REC-CAGEFREE I
02 Sep 2024
Novel approaches to improve percutaneous coronary intervention (PCI) were assessed in the ground-breaking trials featured in Hot Line 11.
Whether the use of optical coherence tomography (OCT) to guide PCI of anatomically complex coronary lesions improves clinical outcomes as compared with angiographic guidance has not been fully studied. As presented by Professor Byeong-Keuk Kim (Severance Cardiovascular Hospital, Yonsei University College of Medicine - Seoul, South Korea), the OCCUPI trial compared OCT with angiography in 1,604 patients with anatomically complex lesions requiring PCI using drug-eluting stents (DES). At 1 year follow-up, patients who received OCT guidance experienced a 38% reduction in the combined risk of cardiac death, myocardial infarction (MI), stent thrombosis and target-vessel revascularisation (4.6% vs. 7.4%, respectively). Notably, patients who received OCT guidance were 64% less likely to experience a spontaneous MI (excluding periprocedural MI) or require target-vessel revascularisation than those in the angiography-guided group (0.9% vs. 2.4% and 1.5% vs. 4.1%, respectively). The study also found that the incidence of contrast-induced nephropathy was not significantly different between two groups (1.3% vs. 0.9%). “Our findings provide more evidence that OCT guidance of PCI procedures in patients with complex lesions improves outcomes over conventional angiography guidance,” said Prof. Kim. “We now need to establish detailed standard for optimal use of OCT for the improvement of clinical outcomes of PCI for complex cases based on the OCCUPI trial,” he concluded.
Secondly, Professor David Erlinge (Lund University - Lund, Sweden) described the INFINITY-SWEDEHEART registry-based randomised trial with the DynamX bioadaptor, which has been designed with a mechanism of action that involves uncaging the vessel 6 months after PCI. INFINITY-SWEDEHEART compared the bioadaptor with a contemporary DES in a broad population of 2,400 patients requiring PCI with de novo coronary artery disease (CAD). The primary endpoint was the target lesion failure rate, defined as a composite of CV death, target-vessel MI and ischaemia-driven target lesion revascularisation at 1 year. There was an 18% reduction in the primary endpoint with the bioadaptor compared with the DES (2.35% vs. 2.77%), demonstrating non-inferiority (p<0.001), which was driven by lower rates of target-vessel MI and ischaemia-driven target lesion revascularisation compared with DES. Further prespecified powered landmark analyses showed a significant reduction and plateau in target lesion failure (0.2% vs. 1.3%, p=0.003) after 6 months. “INFINITY-SWEDEHEART is the largest, most rigorous trial of the bioadaptor to date,” concluded Prof. Erlinge. “The results confirm the novel impact of the bioadaptor in CAD treatment through its unique design and mechanism of action of restoring the physiology of a diseased artery in a population representative of everyday clinical practice.”
Primary drug-coated balloon (DCB) angioplasty with provisional stenting has been shown to be non-inferior to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of a DCB strategy vs. primary stenting in de novo lesions without vessel diameter restrictions remain uncertain. The REC-CAGEFREE I trial, presented by Professor Ling Tao (Xijing Hospital of the Fourth Military Medical University - Xi'an, China), was designed to answer this question. The trial was conducted in 2,272 patients with non-complex CAD requiring PCI who had achieved a successful target lesion pre-dilatation. The primary endpoint – 2-year combined rate of cardiac death, target vessel MI and clinically and physiologically indicated target lesion revascularisation – was 6.4% in the DCB group and 3.4% in the DES group, with an absolute risk difference of 3.04% (which was above the prespecified 2.68% threshold for non-inferiority). Rates were particularly high with DCB vs. DES for clinically and physiologically indicated target lesion revascularisation (3.1% vs. 1.2%). In subgroup analyses, DES was more favourable in non-small vessel disease (device diameter >3.0 mm), while in those with small vessel disease, the results were in line with previous studies showing non-inferiority between DCB and DES. It was concluded that DES implantation should continue to be the standard of care in de novo non-complex CAD.
