TCT 2022
RIVARAD: Post-Procedural Rivaroxaban Use After Radial Access for Coronary Procedures Reduces Radial Artery Occlusion at 30 Days
Key Points:
- Radial artery occlusion (RAO) is the most common complication after radial access for coronary procedures; while routine intra-procedural heparin administration is a protective factor, the role of post-procedural anticoagulation has not been established.
- In the RIVARAD study, patients undergoing trans-radial access for coronary procedures were randomized to a week of post-procedural rivaroxaban vs no additional treatment. The primary outcome of interest was 30-day incidence of RAO by ultrasound.
- Patients receiving rivaroxaban experienced a 50% reduction in RAO by ultrasound and a 52% reduction in RAO by palpation compared to the control group. Rivaroxaban use was safe with no increase in overall hemorrhagic complications relative to the control arm.
EPIC-STEMI: Early Routine PCSK-9 Use Added to High Intensity Statin Reduces LDL after Primary PCI for STEMI
Key Points:
- Early high-intensity statin therapy is standard of practice in acute STEMI patients, but this is often insufficient to achieve LDL targets. PCSK-9 therapy has never been tested as routine therapy in STEMI.
- In the EPIC STEMI trial, routine PCSK-9 initiation in addition to high-intensity statin prior to primary PCI resulted in a 22% LDL reduction at 6 weeks relative to sham, with a higher proportion of patients achieving therapeutic LDL targets.
Extended outcomes of BEST: No difference in MACE between PCI and CABG in MVD at 12 years, but higher repeat revascularization and spontaneous MI in PCI arm
Key Points:
- Previous studies have demonstrated the superiority of CABG over PCI in the treatment of multivessel disease; however, most studies were performed without the use of newer second-generation stents.
- The two-year outcomes of the BEST trial demonstrated superiority of CABG compared to PCI with second-generation everolimus-eluting DES; however, the authors then pursued an extended outcome analysis up to a median follow-up of 11.8 years.
- There was no difference between PCI and CABG at extended follow-up in the primary outcome composite of all-cause death, MI, and total revascularization. However, the rate of spontaneous MI and repeat revascularization was higher in the PCI arm.
- IVUS use reduced the incidence of the primary composite amongst patients undergoing PCI.
FLASH: The FlowTriever system has an excellent safety profile in the treatment of pulmonary embolism
Key Points:
- Mortality for acute PE remains high. While percutaneous mechanical thrombectomy has been used in patients with hemodynamic instability, safety and effectiveness data from large clinical trials are needed.
- In the single-arm FLASH study, patients with acute lobar or main PA pulmonary embolism received the FlowTriever System (percutaneous mechanical thrombectomy), and both short-term and 6 month safety and effectiveness outcomes were assessed. This was perfomed as part of the FLASH multicenter, prospective registry enrolling up to 1,000 US and European PE patients.
- The FlowTriever had an excellent safety profile with only 1.8% risk of MAE and all-cause mortality of 0.8% at 30 days. Additionally, FlowTriever use was associated with substantial immediate improvements in hemodynamics, sustained improvement in echocardiographic measures of RV function, and improvement in quality of life and dyspnea at 6 months relative to presentation.
UNIVERSAL: Routine ultrasound guidance of femoral vascular access did not reduce bleeding or vascular complications but did facilitate access
Key Points:
- Femoral access is used for 30% of all coronary procedures, and femoral access site complication can be catastrophic. Since the development of ultrasound-guided vascular access, many institutions have adopted ultrasound-guidance as the standard of care for femoral access. However, there is a paucity of randomized data to understand the role of ultrasound in improving the safety of coronary procedures via femoral access.
- In the UNIVERSAL study, patients randomized to ultrasound-guided femoral access did not experience a reduction in major bleeding or vascular complications at 30 days; however, ultrasound guidance did improve first attempt success and reduce the number of attempts and accidental venipuncture.
PADN-CFDA: Pulmonary artery denervation in addition to PDE-5i therapy improves exercise capacity in patients with pulmonary arterial hypertension
Key Points:
- Pulmonary artery denervation (PADN) has never been studied with a randomized trial in the treatment of pulmonary arterial hypertension (PAH). The PADN-CFDA study was a sham-control randomized trial conducted in China evaluating PADN in addition to phosphodiesterase inhibitor (PDE-5i) therapy in patients with PAH compared to PDEi therapy with a sham procedure.
- In the primary analysis, PADN with PDE-5i therapy resulted in substantial increase in 6-minute walk distance (a measure of exercise capacity) at 6 months. PADN also reduced PVR, NT-pro BNP, and mPAP, as well as improved echocardiographic measures of RV function compared to sham treatment.
RADIANCE II: Endovascular ultrasound denervation met primary/secondary efficacy BP lowering endpoints at 2 months
Key Points:
- Endovascular ultrasound denervation (uRDN) is a potentially useful technique in the management of hypertension; however, its effect in patients with mild to moderate HTN has not been well studied. The RADIANCE II study was a sham-controlled RCT aimed at determining the efficacy and safety of uRDN on patients with mild-moderate HTN.
- uRDN resulted in substantial reductions in daytime ambulatory sBP compared to sham and led to a higher percentage of time spent in therapeutic BP range.
- uRDN was a safe procedure, with no major adverse events at 30 days.
Amulet IDE: Continued safety and effectiveness of the Amulet LAA occluder device at three years in patients with nonvalvular atrial fibrillation
Key Points:
- In 2021, the Amulet IDE study demonstrated that the novel Amulet left atrial appendage occluder device was noninferior to the standard Watchman device for stroke prevention in patients with nonvalvular atrial fibrillation. The study investigators have now pursued an analysis of the three year outcomes.
- The Amulet device continued to demonstrate safety and effectiveness through 3 years of follow up.
CLASP IID: The PASCAL system is a safe and beneficial therapy for severe degenerative mitral regurgitation
Key Points:
- The MitraClip system has been established as a robust platform for transcatheter repair of both degenerative and functional mitral regurgitation. However, it has not been compared against more novel therapies (such as the PASCAL system). The CLASP IID trial is the first RCT to directly compare two transcatheter valve repair therapies for degenerative MR.
- The PASCAL system met the primary safety and effectiveness endpoints of this pivotal noninferiority trial. There was a low composite MAE rate (3.4%) at 30 days, and 97.7% of patients achieved sustained reduction of MR (≤ 2+) at 6 months.
- This trial establishes the PASCAL system as a safe, beneficial therapy for patients with significant symptomatic DMR and prohibitive surgical risk.
PROTECTED TAVR: No Overall Stroke Reduction With Embolic Protection Devices in TAVR, But Fewer Disabling Strokes
Key Points:
- Stroke is a feared complication of TAVR. However, the potential impact of cerebral embolic protection (CEP) devices is unclear. The PROTECTED TAVR study was a post-market RCT to examine the utility of CEP devices in TAVR patients across all risk categories.
- CEP device use did not result in a significant difference in all strokes at 72 hours or discharge, but it did reduce the rate of disabling strokes in secondary analysis.
- CEP device use was safe, with no difference in the safety composite of all-cause mortality and stroke and only a 0.1% risk of vascular complication related to CEP.