Held virtually this past October, the Transcatheter Cardiovascular Therapeutics (TCT) conference spotlighted the latest in cardiovascular treatments and technology. Below are some of the highlights.
On the Structural Side
MitraClip continues to accumulate positive results in different subsets, while transcatheter aortic valve replacement (TAVR) role and limitations in different groups are better defined. On the coronary side, intracoronary imaging continues to accumulate data showing short and long term benefits as an adjunct to percutaneous coronary intervention (PCI) – this despite continuation of its limited practice in the United States. The data presented suggests that physiological evaluation of the vessel might be of benefit both before and after PCI.
Finally, there is now ample data enabling physicians to stop dual antiplatelet therapy (DAPT) early post PCI in patients with stable coronary artery disease who are at high risk of bleed.
Structural Heart Disease
Five-year data from the PARTNER II (Placement of AoRTic TraNscathetER Valves) trial showed similar durability for the Sapien 3 (S3) valve compared to surgical valves in this intermediate risk group.
Sapien 3
The results of ViV (Valve-in-Valve) registry in the PARTNER II trial showed sustained favorable hemodynamics up to five years post implant with S3. Five-year endpoints were similar to the patients with intermediate risk undergoing TAVR in native valve.
Valve-in-Valve
The one-year results of the international TRANSIT registry showed that redo TAVR is safe with relatively good efficacy, even though 30-day mortality remained modestly elevated at 7 % and repeat failure was at 21%. It is conceivable that early failure post TAVR could be due to patient characteristics that make a second TAVR less than optimal as well. This group of patients will benefit from more investigation. View Valve-in-Valve TAVR video.
The SOLVE-TAVI (CompariSon of second-generation self-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial, which was a head to head comparison between balloon expandable SAPIEN 3 and self-expandable Evolut R in the setting of general vs conscious sedation during implant, showed the two valves to be similar in respect to composite endpoint of mortality, stroke, and significant paravalvular leak and need for permanent pacemaker.
Balloon Expandable (SAPIEN 3) (right) and Self-expandable (Evolut R) (left)
However, it also showed almost a seven-fold increase in the rate of post implant stroke with the SAPIEN 3 valve compared to the Evolut R. This finding was received with a lot of skepticism given the fact that the rate of stroke in the Sapien arm was significantly higher than historical cohorts, such as those in PARTNER and other trials. The study also showed conscious sedation to be as safe a modality during these procedures as general anesthesia.
Results from the IREMMI (International Registry MitraClip in acute Myocardial Infarction) registry showed MitraClip to be a viable option in patients presenting with acute myocardial infarction (MI) complicated by acute mitral regurgitation (MR) with or without shock.
Global EXPAND showed positive effects of MitraClip in symptomatic patients with severe MR, including improved quality of life and heart failure symptoms at one-year post implant in both degenerative and functional subpopulations.
MitraClip® System
The SCOPE II (Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II) trial showed the self-expanding ACURATE Neo valve to be inferior to the commonly used and commercially available CoreValve Evolut.
Coronary Artery Disease
Three-year data from the ULTIMATE (intravascular ultrasound-guided versus angiography-guided implantation of drug-eluting stent in all-comers) study showed persistent benefit for patients who undergo IVUS guidance during their PCI. This benefit was mainly driven by target vessel revascularization.
Define-PCI showed that symptomatic patients who undergo PCI do better at one year in terms of anginal relief if their physiological testing post PCI utilizing iFR shows lack of residual ischemia (defined as iFR of >0.95).
XIENCE Short DAPT Program tested patients with stable coronary artery disease but at higher risk for bleed for shortening duration of DAPT. Patients received DAPT for either one or three months followed by Aspirin alone. There was no increased risk in ischemic events compared to historical data from the XIENCE V cohort. But, there were significantly less major bleeding events in patients with short DAPT duration.
The DISRUPT CAD III trial, which is evaluating the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting, showed coronary intravascular lithotripsy to be safe and help optimize PCI in severely calcified vessels.
The HOST-Reduce-Polytech-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial – Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS patients) showed no difference between durable polymer stents vs bioabsorbable-polymer stents in the setting of acute coronary syndrome.
COBRA-REDUCE trial using the Cobra PzF stent and shorter duration of DAPT did not show significant reduction in major bleeding.
The OPTIMIZE trial to assess the procedural and clinical value of a novel system, the Svelte DES, which allowed direct stenting, did not match the current generation of available stents.
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