Here are some key interventional cardiology takeaways from sessions presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2022 annual meeting in May. The society recently highlighted these points in a newsletter to its members.

No-implant interatrial shunt for heart failure shows promising efficacy

Early clinical evaluation of the Alleviant System to treat heart failure patients with preserved and reduced ejection fraction (HFpEF and HFrEF) demonstrated procedural safety and feasibility with a promising efficacy signal through six months. 

The procedure creates an atrial septal defect (ASD) to help offload left atrial pressure in heart failure patients with both reduced and preserved ejection fraction. The Allegiant device creates a 7 mm ASD with electrocautery and leaves no hardware behind. The ASD was durable and present several months after the index procedure. Patients had lower pulmonary pressures with exercise testing and an improvement in quality of life, said Brian C. Kolski, MD, interventional cardiologist, Orange County Heart Institute, who reviewed the study results. He said in order to recommend this study in heart failure patients, there will likely need to be a randomized sham procedure study. 

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Updated safety assessment of femoropopliteal treatments with paclitaxel-coated devices

New long-term data from the SAFE-PAD study found no meaningful difference in survival between patients treated with a paclitaxel drug-coated device (DCD) and those treated with a non-drug coated device (NDCD) for up to six years after the index procedure. This was regardless of the patient’s mortality risk and device type. 

The SAFE-PAD study was created in collaboration with the U.S. Food and Drug Administration (FDA) to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with PAD. This was done because of a meta analysis study published in late 2017 that appeared to show a higher mortality signal in patients treated with paclitaxel-coated devices. The study was designed to show if there was any increase in adverse events for deaths, explained Chadi Alraies, MD, MPH, medical director, cardiac catheterization laboratory, director, interventional cardiology research, Detroit Medical Center, who summarized the study.

There remained no evidence of harm associated with DCDs, Alraies said. He explained the findings were robust in sensitivity analyses and consistent across all subgroups, in particular those at the lowest risk of mortality.  

Sex differences in clinical characteristics, management and outcomes of STEMI patients with COVID-19

The latest analysis from The North American COVID-19 Myocardial Infarction (NACMI) Registry at SCAI showed clinical characteristics and management strategies differ by gender, but in-hospital mortality rates remained high among both groups.

Of the 585 patients enrolled from March 1, 2020, to December 31, 2021, 26% were female and 74% were men. Women were significantly older, had higher rates of diabetes, stroke and statin use on admission. Women were less likely to present with chest pain versus men, at 47% versus 59%, respectively. Women presenting with STEMI were less likely to have identifiable culprit lesion, at 67% versus 82%, on coronary angiography, explained Gary S. Ledley, MD, FSCAI, Tower Health, who summarized the study findings.

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The primary trends and results of NACMI were presented at the American College of Cardiology (ACC) annual meeting in April. Watch the VIDEO: Vaccines boosted survival among STEMI patients with COVID-19, an interview with Santiago Garcia, MD, lead author of the study and director of the structural heart program at The Christ Hospital in Cincinnati, Ohio.

Clopidogrel monotherapy vs. aspirin monotherapy for chronic maintenance beyond 12 Months after PCI

This real-world study looked at the safety and effectiveness of clopidogrel versus aspirin monotherapy beyond 12 months after percutaneous coronary intervention (PCI) in high-risk bleeding patients during the chronic maintenance period. Clopidogrel monotherapy was associated with a reduced risk of net adverse clinical events (NACE; all-cause death, MI, stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding) and MACCE (death, MI, stent thrombosis, stroke), and a numerical decrease in major or clinically relevant nonmajor bleeding (BARC type 2, 3, or 5 bleeding), compared with aspirin monotherapy.

DAPT (dual antiplatelet therapy) is a cornerstone in the treatment of patients after PCI and ACS. After the course of DAPT is completed, patients are typically managed long term with aspirin as a single antiplatelet, explained Michael P. Savage, MD, MSCAI, director, cardiac cath lab, Jefferson University, in his summary.

This study from the Chinese Fuwai Registry included 7,392 patients who were at high risk of bleeding and thrombosis. They were event free on DAPT one year post PCI. Of these, 3,690 were continued on aspirin monotherapy and 1,540 were continued on clopidogrel monotherapy. The outcomes of these two groups were assessed between 12- and 30-months post PCI. Cardiovascular events were lower in the clopidogrel group, but there was no significant difference in bleeding between the two drugs. 

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Distal vs. proximal radial artery access 30-day outcomes of the DIPRA study

Initial findings from the Distal versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention (DIPRA) study evaluated outcomes of hand function and effectiveness of conventional proximal radial artery (PRA) access compared to distal radial artery (DRA) access for cardiac catheterization. At 30 days, distal radial artery access is safe and is not associated with significant hand dysfunction, said Jordan Safirstein, MD, FSCAI, director of transradial intervention at Morristown, Atlantic Health, who reviewed the study.

The distal radial artery access approach allows the operator to pronate the left hand and work from the right side of the table yielding a clear ergonomic advantage for both patient and operator, Safirstein explained. 

The distal radial approach is a relatively new access technique which gained popularity initially through social media, but has never been directly compared to standard radial approach in terms of safety or procedural success rate, in a randomized fashion. DIPRA is a single center, prospective randomized control trial that enrolled 300 adults at Baylor Scott and White Health - the Heart Hospital Plano. 

The safety and drawbacks of DRA are not well described, so this study used grip strength, pinch strength and a QuickDASH survey score to assess changes in hand function and will be repeated at 12 months.  

The primary outcome was a composite of hand function change.  The DRA group demonstrated worsening hand function, but not to a statistically significant degree. Secondary endpoint of pinch grip strength was significantly worse in the DRA group at 30 days (DRA -0.2 kg [95% CI -1.2, 0.5] vs. PRA 0 kg [95% CI -0.9, 0.9]; p=0.05). There was no significant difference in the secondary endpoint of grip strength at 30 days. 

Rates of bleeding were similar in both groups (DRA 0% vs. PRA 1.4%, p=0.25). Rates of procedural success were similar in both groups as well (DRA 96.7% vs. PRA 98%; p=0.72).