This year the Transcatheter Cardiovascular Therapeutics (TCT, TCT Connect 2020) congress was held as a virtual event October14 – 18, 2020, broadcasting live case-based transmissions from around the world, late-breaking clinical trials and virtual training in interventional cardiovascular medicine. Here is our curated list of the top 10 highlights of the symposium (TCT 2020).
Mitra-Bridge Registry1: MitraClip is an effective bridge strategy to heart transplantation. 104 of 119 patients (87.5%) evaluated in this international, multi-center registry were successfully implanted with a clip and survived the periprocedural period (30 days). Two-thirds remained free of adverse events at 1 year, and 23.5% were removed from the transplant list. (ClinicalTrials.gov Identifier: NCT04293575)
COMBINE (OCT—FFR) trial2: FFR combined with optical coherence tomography (OCT) can identify the presence of thin cap fibroatheroma (TCFA) lesions. The presence of TCFA correlates with an increased risk of future major adverse cardiovascular events (MACE), particularly in diabetic patients, even in normal fractional flow reserve (FFR) studies. Adding OCT evaluation to FFR studies to identify high risk lesions can improve clinical outcomes. (ClinicalTrials.gov Identifier: NCT02989740)
TICO trial3: Ticagrelor monotherapy after 3 months of dual antiplatelet therapy (DAPT) superior to standard therapy. Participants who had undergone percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) were randomized to ticagrelor monotherapy after 3 months of DAPT versus standard therapy. The ticagrelor monotherapy group showed superior prevention of ischemia and bleeding. (ClinicalTrials.gov Identifier: NCT02494895)
TARGET FFR trial4: no increase in the proportion of patients with a final post-PCI FFR ≥.90 using physiologically-guided incremental optimization strategy (PIOS). PIOS did, however, decrease the proportion of patients with a final FFR ≤.80. (ClinicalTrials.gov Identifier: NCT03259815)
PROSPECT ABSORB trial5: PCI using Absorb bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) shows increased minimum lumen area (MLA) at 25-month follow-up, as compared with GDMT alone. A favorable decrease in lesion-related MACE was also seen in this pilot study of 182, warranting a higher powered study. (ClinicalTrials.gov Identifier NCT02171065)
PROSPECT II / ABSORB natural history study5: near-infrared spectroscopy (NIRS) imaging plus intravascular ultrasound (IVUS) can identify lipid-rich plaques prone to future rupture. Non-obstructive plaques are also be associated with clinical events; early detection can facilitate prophylactic intervention. (ClinicalTrials.gov Identifier: NCT02171065)
SOLVE TAVI trial6 establishes equivalence of the Edwards Sapien S3 valve and the Medtronics CoreValve Evolut R. Conscious sedation is also equivalent to general anesthesia. (ClinicalTrials.gov Identifier: NCT02737150)
VOYAGER PAD trial7 demonstrates no increase in all-cause mortality associated with Paclitaxel drug-coated devices (DCD). Additionally, the use of Rivaroxaban twice daily in addition to low-dose aspirin consistently reduced ischemic limb and cardiovascular outcomes as compared to using only low-dose aspirin. These superior outcomes were found regardless of DCD use. (ClinicalTrials.gov Identifier: NCT02504216)
SCOPE I trial8 fails to demonstrate non-inferiority of the novel, self-expandable Symetis ACURATE neo transcatheter aortic valve replacement (TAVR) to the balloon-expandable Edwards SAPIEN 3 transcatheter aortic valve bioprosthesis at 30 days. SCOPE I’s trial design has longer term follow-ups planned at one year and three years, but these early primary endpoint outcomes will hamper longer term evaluation. SAPIEN 3 valves’ superiority is attributed to lower rates of paravalvular regurgitation and acute renal injury. Researchers acknowledge that this study is single-blinded, and it is not powered for individual clinical endpoints. (ClinicalTrials.gov Identifier: NCT03011346)
ULTIMATE trial9 establishes consistently superior outcomes using IVUS guided PCI as compared to angiographic guidance. Target vessel failure (TVF), repeat vascularization, and stent thrombosis were all consistently lower at three year follow-up in patients who
underwent drug-eluting stent (DEC) implantation guided by IVUS. Investigators insist that these
superior outcomes justify the routine use of IVUS to guide DES implantation. Barriers of cost, availability, expertise, and the extra time required to perform the procedure have to be overcome. This study is ongoing, with a projected end date of May 2022. (ClinicalTrials.gov Identifier: NCT02215915)
The North American COVID Myocardial Infarction (NACMI) Registry10 is a collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, the ACC Interventional Section Leadership Council, and the Midwest STEMI Consortium. It currently includes nearly 600 patients from 64 sites across the U.S. and Canada who presented with ST-elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB) on ECG and who were also either COVID-19 positive or being tested for COVID. Preliminary observations indicate that COVID-19 positive patients with STEMI heart attacks have higher in-hospital mortality and stroke and longer length of hospital stay. More thrombotic lesions are found, including microthrombi; there is also more frequently no culprit lesion identified in patients who are COVID-19 positive than in those who are COVID-19 negative. At the moment, guidelines11 continue to recommend primary PCI as the standard of care, but these may evolve as more observational data is collected.
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Author: Kelly Schoonderwoerd
1. Godina C, et al. J. Heart and Lung Transplant. 17 September 2020.
2. Presented by Dr. Elvin Kedhi at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 14, 2020.
3. Presented by Dr. Byeong-Keuk Kim at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 14, 2020.
4. Presented by Dr. Damien Collison at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 16, 2020.
5. Stone G, et. al. J Am Coll Cardiol. 2020 October 14.
6. Thiele H, et al. Circulation (142), 21 August 2020.
7. Presented by Dr. Connie Hess at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 18, 2020.
8. Presented by Dr. Thomas Walther at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 17, 2020.
9. Xiao-Fei G, et al. JACC: Cardiovascular Interventions. October 2020.
10. Presented by Dr. Timothy Henry at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 14, 2020.
11. Mahmud E, et al. J Am Coll Cardiol. 2020 September 76(11).