EuroPCR 2022 Highlights

The EuroPCR 2022 Conference occurred from May 17 to 20, 2022, in Paris, France. The EuroPCR 2022 combined onsite and online participation seamlessly. Here is our curated list of some of the top highlights from the EuroPCR 2022 Conference presentations.

ARCH trial¹: Of the 708 patients (N=2,114) with acute coronary syndrome (ACS), post-percutaneous coronary intervention (PCI), 94.8% reached rapid hemostasis within allotted time with the hemostatic patch, compared with 50% (n=703) and 38% (n=703), respectively for the other interventions. Similar adverse events (AEs) occurred, while early discharge time improved significantly in the hemostatic-patch arm. Investigators expect the cost-efficacy analysis may be duplicated in other centers with similar protocols.

The following three presentations were held to coincide with World Hypertension Day, 17 May 2022, to raise awareness about monitoring and treating high blood pressure (HBP) worldwide.

Global SYMPLICITY Registry²: (NCT01534299) The 3-year results reveal trial patients with high BP who underwent radiofrequency renal ablation (Simplicity SPYRAL catheter, Medtronic) and had optimal BP >50% time in therapeutic range (TTR) post-renal denervation had a much lower rate of MACE compared to patients not as well controlled: 2.9% (>50% TTR) vs. 6.2% (<50% TTR) vs. 10.3% (failed TTR; p<0.0001). There is no control arm.

SPYRAL-HTN-ON MED Study³: (NCT02439775) Extended 3-year data using a TTR analysis indicate that study patients undergoing renal denervation who were on antihypertensives (~two), had a greater 24-hour systolic BP (SBP) reduction (–10.0 millimeters mercury [mmHg], p=0.004) than did patients who underwent the sham procedure. These data affirm sustained efficacy of renal denervation.

RADIANCE-HTN SOLO and TRIO Trials⁴: (NCT02649426) Ultrasound (US)-based renal denervation (Paradise, ReCor Medical) reduced SBP by 8.0 mmHg in patients with resistant hypertension (Hx) on 3+ antihypertensives, who were at 150.0+ mmHg daytime SBP compared to 3.0 mmHg reduction in the sham group (p=0.022). There were also significant reductions in 24-hour/nighttime ambulatory SBP, and home-/office-based SBP. 

PARTNER Trials^5,6: (Original study: NCT00530894) Updated study results (N=1,974, pooled from PARTNER 2 and 3 trials) indicate cardiac damage at baseline and its change at 1 year are important prognosticators for patients undergoing aortic valve replacement (AVR). One-year change in cardiac damage was independently associated with mortality, and at 2 years, was associated with a composite of death or HF hospitalization. Investigators urge earlier AS detection and intervention.  

MASTER DAPT trial subanalysis^7,8: Original study: (NCT03023020). For patients with high-risk bleeding (HBR), who were stented for complex and non-complex PCI and/or ACS, discontinuing dual antiplatelet therapy (DAPT) 1-month post-procedure was associated with similar adverse clinical events (ACEs) but with lower bleeding rates than with standard DAPT. These findings are in line with the original MASTER DAPT trial.

MitraClip Bridge Study⁹: (NCT04293575) Updated study data (N=153) establish that for patients with advanced/end-stage chronic heart failure (CHF) requiring a ‘bridging strategy’ to heart transplantation (HTx), who underwent the MitraClip procedure, the 2-year rate of “freedom from death, need for urgent heart HTx or left ventricular assist device (LVAD) transplant, and first hospitalization” was 47%; 55% of patients avoided first hospitalization. The annualized rate of HF hospitalization was 45.5%.  

ROLEX Registry Study Subanalysis¹⁰: Original study: (NCT03316833) Patients with left main coronary artery disease (CAD) treated with a zotarolimus-eluting stent did moderately well; however, when intracoronary imaging (IVUS) was used, which allowed interventional cardiologists (ICs) to use extra-large sized stents (in <50% of cases), patients achieved much better outcomes. The IVUS subanalysis showed when IVUS was not used during PCI, the 1-year mortality rate in ROLEX was 2.7%, a not insignificant rate. 

R-EVOLUTION Trial¹¹: (NCT04163393) The robotic PCI procedure (R-One System; Robocath) may be safe for noncomplex patients with CAD requiring PCI, and may provide operators better technical/clinical success with improved safety (reduced radiation exposure). Data show clinical success (100%), technical success (95.2%) with no MACE, 1-month post-procedure. Median procedure duration was significantly shorter compared with non-robotic procedures (17.5 minutes vs. 37.5 minutes); however, ‘operator learning curve’ did exist but was short. 

UK TAVI Registry¹²: (UK TAVI) Updated long-term data (median 7.0 years) tracking valve function show that 5.9% of patients who received an early generation transcatheter aortic valve implantation (TAVI) subsequently developed severe structural valve degeneration (SVD). Moreover, severe deterioration may be more prevalent with balloon-expandable devices than with self-expanding ones. Even with newer generation devices, the differences, though more modest, may be present.

JenaValve Trilogy Study¹³: (NCT04415047) ‘Transfemoral’ TAVI with the Trilogy device (JenaValve Technology) may be effective and safe in patients with moderate to severe aortic regurgitation (AR), who have aortic valves not yet calcified enough for TAVI anchoring. The primary endpoint was achieved in 100% (N=45) of patients (reduction in AR grade) with minimal bleeding events. No patients died. Post-procedure, most patients had no or trace paravalvular regurgitation.

TriCLASP Study (Phase 4)¹⁴: Original study: (NCT04614402) The post-market study (PASCAL/PASCAL Ace valve repair systems, Edwards) enrolled 74 patients with severe tricuspid regurgitation (TR; 83%) and atrial fibrillation (AF; 96%). For 67% of patients, for whom 30-day follow-up data were available, total composite “massive AE (MAE) rate” was 3.0%. Patients reported marked improvement in TR (>90% have achieved <moderate TR [p < 0.001]; 88% decreased a TR grade. The study investigators stated they will be reporting out to 5 years.

TriClip bRIGHT Study¹⁵: (NCT03745313) Additional 30-day study data (N=300) reveal a 98% implant success rate for TriClip and TrClip G4 repair devices (Abbott) for patients with severe TR, with 71%-75% of patients reporting moderate or lower TR (p<0.0001) (depending on which device). AEs were minimal.   

CLASP-TR Study¹⁶: (NCT03745313) Data show that at 30 days post procedure, patients with severe TR, who had undergone PASCAL device implantation, 77% did not have MAEs, with 75% of patients reducing their TR grades; at one year, 100% of patients had improved at least one TR grade, 75% by two, and 86% reached moderate or less TR.

Fibromuscular dysplasia in SCAD¹⁷: For patients with spontaneous coronary artery dissection (SCAD), ten years of data suggest a further diagnosis of coronary fibromuscular dysplasia (CFMD) may predict poorer prognosis (recurrent MI, overall major adverse cardiovascular events [MACE]), after the original SCAD event. Only 60%-70% of patients with SCAD are screened for CFMD, yet 50% to 80% of those are subsequently diagnosed with CFMD. Active CFMD screening should conducted with catheter-based angiography rather than computer tomography [CT] angiography.  

MITRA-TUNE Registry Study^18,19: (NCT02033811) Patients with mitral regurgitation (MR) and/or HF with preserved ejection fraction (HFpEF) may benefit from edge-to-edge leaflet repair (Mitra-Clip; Abbott). In 87 elderly patients (median age 81 years) with AF and MR (A-FMR; MR grade 4+; NYHA class III/IV), the 30-day cumulative risk of all-cause mortality was 5.0%. At median follow-up (489 days), 79% of remaining patients (48/61) were NYHA class I/II. As well, the device is associated with significant positive remodeling of left atrium/mitral annulus

DISCO RADIAL Study^20,21: (NCT04171570) Though distal radial access (DTRA) and conventional trans radial access (CTRA) for coronary angiography (AC) and PCI both reduced risk of radial artery occlusion (RAO), DTRA did not provide an advantage over CTRA. Both procedures resulted in very low RAO rates (–1.0%); however, DTRA’s benefits must be weighed against a more difficult arterial puncture.

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Author: Saskia van Tetering

References:

1. Presented by Dr. Carlos Proscia at the EuroPCR 2022 Conference, Paris, France, 17 May 2022.
2. Presented by Dr. Felix Mahfoud at the EuroPCR 2022 Conference, Paris, France, 17 May 2022.
3. Presented by Dr. David Kandzari at the EuroPCR 2022 Conference, Paris, France, 17 May 2022.
4. Presented by Dr. Ajay Kirtane at the EuroPCR 2022 Conference, Paris, France, 17 May 2022.
5. Presented by Dr. Philippe Généreux at the EuroPCR 2022 Conference, Paris, France, 17 May 2022. 
6. Généreux P et al. J Am Coll Cardiol. 2022. 
7. Presented by Dr. Marco Valgimigli at the EuroPCR 2022 Conference, Paris, France, 17 May 2022.
8. Valgimigli M et al. Eur Heart J. 2022;ehac284.
9. Presented by Dr. Andrea Raffaele Munafò at the EuroPCR 2022 Conference, Paris, France, 18 May 2022.
10. Presented by Dr. Giuseppe Tarantini at the EuroPCR 2022 Conference, Paris, France, 18 May 2022.
11. Presented by Dr. Eric Durant at the EuroPCR 2022 Conference, Paris, France, 18 May 2022.
12. Presented by Dr. Noman Ali at the EuroPCR 2022 Conference, Paris, France, 18 May 2022.
13. Presented by Dr. Alexander R. Tamm at the EuroPCR 2022 Conference, Paris, France, 18 May 2022.
14. Presented by Dr. Stephan Baldus at the EuroPCR 2022 Conference, Paris, France, 19 May 2022.
15. Presented by Dr. Phillipp Lurz at the EuroPCR 2022 Conference, Paris, France, 19 May 2022.
16. Presented by Dr. Rebecca Hahn at the EuroPCR 2022 Conference, Paris, France, 19 May 2022.
17. Presented by Dr. Jackie Saw at the EuroPCR 2022 Conference, Paris, France, 19 May 2022.
18. Rubbio AP et al. Int J Cardiol. 2022;349:39-45.
19. Presented by Dr. Antonio Popolo Rubbio at the EuroPCR 2022 Conference, Paris, France, 19 May 2022.
20. Presented by Dr. Adel Aminian at the EuroPCR 2022 Conference, Paris, France, 19 May 2022.
21. Aminian A et al. J Am Coll Cardiol Intv. 2022.