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EuroPCR 2024 Highlights

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EuroPCR 2024 Top 10 Highlights

21 May 2024
EuroPCR 2024 Highlights

EuroPCR is the annual official congress of the European Association of Percutaneous Cardiovascular Interventions (EACPI) and was held 14-17 May in Paris, France. Hereby is our curated list of the top 10 sessions.

DESyne BDS Plus (NCT05033964):1 Investigators hypothesized that specific antithrombotic therapy can more effectively address ischemic risk while avoiding bleeding risk associated with oral anti-thrombotics. DESyne BDS Plus is the world’s first triple drug-eluting coronary implant with a site-specific antithrombotic therapeutic coating. The coating consists of anticoagulants rivaroxaban and argatroban, and an antiproliferative mTOR inhibitor, sirolimus. Investigators compared the rate of target lesion failure (TLF) of the DESyne BDS Plus with a contemporary polymer drug-eluting stent. At 12 months, TLF was only 2.1% with the DEsyne BDS Plus and 9.3% in the comparator. Data collection will continue for two more years.

The Myval transcatheter heart valve (THV) is available in twice as many sizes as other devices currently on the market. The LANDMARK2 trial (NCT04275726) compared the safety and effectiveness of this THV series with contemporary valves used in aortic stenosis. Investigators used a primary combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3). LANDMARK demonstrated non-inferiority of the Myval series at 30 days as compared with contemporary valves. The availability of intermediate sizes enables more precise matching of a device to an individual patient’s anatomy. However, whether this more precise sizing will correspond to improved clinical outcomes remains unclear. Patients will be followed for up to 10 years to better assess this potential.

NOTION-23 (NCT02825134) compared transcatheter aortic valve implementation (TAVI) with surgical aortic valve replacement (SAVR) in patients ≤75 years of age. Investigators enrolled 370 low-risk patients aged ≤75 years with severe symptomatic aortic stenosis to either TAVI or SAVR. The primary endpoint was the composite rate of all-cause mortality, stroke and rehospitalization within one year post-procedure. The 1-year incidence of the primary endpoint was similar between the two groups (10.2%, TAVI group; 7.1%, SAVR group). Investigators warned that TAVI outcomes in young bicuspid aortic stenosis patients warrant caution and require further investigation.

A secondary analysis of ORBITA-24 investigated the relationship between presenting symptoms and disease severity in stable angina. The analysis also looked at the ability of symptoms to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI). Investigators used a smartphone application and symptom and quality of life questionnaires to assess severity and nature of pre-randomization symptoms. They used quantitative coronary angiography, stress echocardiography, fractional flow reserve (FFR), and instantaneous wave-free ratio to determine disease severity. Disease severity categories consisted of anatomic, non-invasive, and invasive ischemia. The analysis found that symptom severity and nature were poorly associated with disease severity. However, the nature of symptoms powerfully predicted the placebo-controlled efficacy of PCI.

PINNACLE I5: LithiX Hertz Contact IVL System is a transcatheter device comprising multiple discrete metal hemispheres incorporated on a semi-compliant balloon. The intent of the device is to fragment calcium via multiple discrete focal stress contact points. The PINNACLE I study (NCT05828173) evaluated the device’s safety and effectiveness at treating moderate to severely calcified coronary artery lesions. Major adverse cardiovascular events (MACE) through 30 days constituted the primary safety endpoint. Optimal stent expansion after final treatment with no in-hospital MACE defined effectiveness/clinical success. Among its 60 patients, PINNACLE I showed a 98.3% clinical success rate, and a 100% angiographic success rate.

CAGEFREE II6 (NCT04971356) explored de-escalation of dual antiplatelet therapy (DAPT) following drug-coated balloon (DCB) angioplasty in acute coronary syndrome (ACS). CAGEFREE II enrolled patients with ST-elevated myocardial infarction (STEMI), non-STEMI or unstable angina who underwent PCI with DCB only. The study group (n=975) received aspirin plus ticagrelor for one month, then ticagrelor alone for five months. This group then continued with aspirin monotherapy for six more months. The control arm (n=973) received aspirin plus ticagrelor for all 12 months. Net adverse clinical events (NACE) at 12 months comprised the primary endpoint. (NACE is a composite clinical endpoint of all-cause death, any stroke, MI or revascularization and bleeding events). At 1-year, NACE was similar between the two groups. Investigators concluded that de-escalation of DAPT strategy is non-inferior to the standard 12-month DAPT strategy.

The REVIVED-BCIS2 trial7 (NCT01920048) sought to identify the impact of complete revascularization in patients with severe left ventricular (LV) dysfunction. Patients with heart failure (HF) from coronary disease received PCI plus optimal medical therapy (OMT) (n=317) or OMT alone (n=353). All-cause death or hospitalization or hospitalization for HF over a minimum follow-up of 24 months comprised the primary outcome measure. There was no difference in the likelihood of the primary outcome between the groups. Investigators concluded that their findings do not support complete revascularization in patients with ischemic cardiomyopathy and stable coronary disease.

The SMART trial8 (NCT04722250) compared the performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter heart valves. Specifically, the trial compared these valves in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. The percentage of patients with mortality, disabling stroke or rehospitalization for HF formed part of the primary outcome measure. The other component of the primary outcome measure was the percentage of patients with bioprosthetic valve dysfunction. A subgroup analysis of women (n=637) with small annuli showed better hemodynamic outcomes with SE over BE valves, one year post-TAVI.

SOLVE-TAVI9 (NCT02737150) aimed to demonstrate equivalence of second-generation SE valves to second-generation BE valves in TAVI. It also compared local anesthesia with conscious sedation to general anesthesia in high-risk patients with severe aortic stenosis undergoing TAVI. The primary end point consisted of all cause death, stroke, moderate to severe regurgitation, and pacemaker implantation at 5 years. Outcomes did not differ between the valves when considering all cause death, valvular regurgitation or pacemaker implantation at 5 years. However, patients who received a BE valve experienced a higher incidence of stroke than patients who received a SE valve. Outcomes did not differ between those who received conscious sedation versus general anesthesia.

The Transcatheter Valves and Vessels trial10 (NCT03424941) compared SAVR plus coronary artery bypass grafting (CABG) and PCI plus TAVI. Patients in this trial had both obstructive coronary artery disease and symptomatic severe aortic stenosis. The primary endpoint was a composite of all-cause mortality, stroke, MI, coronary or valve re-intervention and life-threatening or disabling bleeding at one year. The trial had to be stopped early due to a mortality difference between the study arms. Patients receiving SAVR plus CABG experienced a fivefold higher risk of major adverse events than patients receiving PCI plus TAVI. At one year, the primary endpoint had occurred in only 4.4% of patients treated with combined PCI plus TAVI. In contrast, it had occurred in 22.9% of patients treated with combined SAVR plus CABG.

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Author: Kelly Schoonderwoerd

References

  1. Abizaid A. Site-Specific Antithrombotic Therapy: DESyne BDS Plus Trial 12-month Outcomes. Presented at EuroPCR 2024. May 14, 2024. Paris, France.
  2. Serruys P. Early outcomes of a randomized non-inferiority trial comparing TAVI devices: the LANDMARK trial. Presented at EuroPCR 2024. May 15, 2024. Paris, France.
  3. Jørgensen TH et al. Eur Heart J. May 15 2024. DOI: https://doi.org/10.1093/eurheartj/ehae331
  4. Simader FA et al. J Am Coll Cardiol. May 15, 2024. DOI: 10.1016/j.jacc.2024.04.016
  5. Verheye S. Hertz contact intravascular lithotripsy: PINNACLE I Trial Primary Outcomes. Presented at EuroPCR 2024. May 16, 2024. Paris, France.
  6. Tao L. Stepwise dual antiplatelet therapy de-escalation in patients after drug-coated balloon angioplasty (REC-CAGEFREE II trial). Presented at EuroPCR 2024. May 15, 2024. Paris, France.
  7. Ezad SM et al. J Am Coll Cardiol. May 15, 2024. DOI: 10.1016/j.jacc.2024.04.043
  8. Mehran R. Small aortic annuli patients treated with TAVI: outcomes in women in the SMART trial. Presented at EuroPCR 2024. May 14, 2024. Paris, France.
  9. Feistritzer HF. Impact of valve type and anesthesia strategy for TAVI – 5-year results of the SOLVE-TAVI trial. Presented at EuroPCR 2024. May 14, 2024. Paris, France.
  10. Kedhi E, on behalf of the TCW Trial investigators. Percutaneous versus surgical treatment for patients with aortic stenosis and coronary disease: the TCW trial. Presented at EuroPCR 2024. May 14, 2024. Paris, France.

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