Clinical Research & Data, Protected PCI
Live from TCT – September 19, 2022
Seth Bilazarian, MD, and Chuck Simonton, MD, recap highlights from day three of the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston, MA.
Key late-breaking clinical trials on day three included the following:
- BEST Trial. Extended (10-year) follow-up outcomes were reported from the BEST Trial, which compared everolimus-eluting stents to CABG in patients with multivessel coronary artery disease. In this well-matched patient population, the primary endpoint of death, MI or TVR was higher in the PCI group (29% compared to 25% for CABG) but the difference was not statistically significant. In addition, repeat revascularization was higher in the PCI group (21.2% compared to 12.4% for CABG). Notably, intravascular ultrasound (IVUS) was used in 71.8% of patients and patients undergoing PCI with IVUS had outcomes very similar to CABG in terms of primary endpoint and death from any cause, while patients who received PCI without IVUS fared worse.
- SCAAR registry. Data from the Swedish SCAAR registry, which compares survival after PCI vs. CABG for left main coronary disease, showed higher all-cause mortality in the PCI group. It is important to note, however, that physicians selected whether patients received PCI or CABG. In these non-randomized patients, those receiving PCI were significantly older and had significantly higher risk factors (e.g., diabetes, impaired renal function, previous MI, previous CABG).
- BYPASS CTCA. BYPASS CTCA data demonstrated that in patients with previous CABG undergoing invasive coronary angiography, adjunctive prior CT angiography (CTCA) shortens procedure duration, improves patient satisfaction and lowers rates of contrast-induced nephropathy. CTCA also resulted in lower procedural complication rates and reduced rates of MACE at 12 months. Thus, when logistically possible, CTCA should be considered in any stable post-bypass patient undergoing invasive coronary angiography.
- FAME 3 substudies. Two FAME 3 substudies shed light on why fractional flow reserve (FFR)-guided PCI using current generation drug-eluting stents (DES) did not meet criteria for noninferiority compared with CABG in patients with triple vessel disease. One substudy reclassified the SYNTAX score based on FFR information and by measuring the functional SYNTAX score; 50% of patients with complex triple vessel CAD had a similar outcome at one year with PCI compared with CABG. Another substudy examined the value of post-PCI FFR and intravascular imaging and demonstrated that low post-PCI FFR was associated with a significantly higher rate of target vessel failure (TVF) on a vessel and patient level and post-PCI FFR was an independent predictor of TVF.
Navin Kapur, MD, presented data from the VENUS-HF Early Feasibility Study of the new preCARDIA system (Abiomed), which is designed to improve decongestion in acutely decompensated heart failure patients. The principal findings were that intermittent occlusion of the superior vena cava (SVC) using preCARDIA achieves reduction of stressed blood volume and filling pressures and enhances sodium excretion during and after intermittent occlusion. preCARDIA is an investigational device, limited by federal law to investigational use only.
In a live interview, Koichi Toda, MD, PhD, discussed the J-PVAD registry in Japan and J-PVAD data presented at TCT. Dr. Toda gave a presentation on his J-PVAD multi-center study of Impella® -supported patients with cardiogenic shock due to myocarditis in Japan, with results showing a 30-day survival of 77%. Results of another J-PVAD study released at TCT was led by Dr. Junya Ako, whose analysis of Impella-supported patients with AMI cardiogenic shock had 81% survival at 30 days.
To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: heartrecovery.com/isi