Top Interventional Trials of 2020

Last year was another exciting year of trial results that potentially shape the way interventionalists practice. We wanted to assess ACC.org users' interest in the interventional trials from 2020, so we reviewed the frequency of website visits. Based on user interest, we ranked the 10 most popular interventional trials of 2020 in the following list:

  1. PARTNER 3 (Placement of Aortic Transcatheter Valves 3)
  2. SPYRAL HTN-OFF MED Pivotal (Efficacy of Catheter-Based Renal Denervation in the Absence of Antihypertensive Medications)
  3. ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches–Chronic Kidney Disease)
  4. ULTIMATE (A Multicenter, Prospective, Randomized Trial Comparing Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers)
  5. DEFINITION II (Two-Stent vs. Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions)
  6. HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients)
  7. REFLECT II (A Randomized Evaluation of the TriGUARD3 Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation)
  8. PROSPECT ABSORB (Providing Regional Observations to Study Predictors of Events in the Coronary Tree II study combined with a randomized, controlled, intervention trial)
  9. DEFINE-FLOW (Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses)
  10. Global EXPAND (Contemporary Outcomes with MitraClip™ [NTR/XTR] System in Primary Mitral Regurgitation)

By far the most accessed trial was the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial, which compared 1-year outcomes for low-risk patients randomized to either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). At 1 year, death, stroke, or hospitalization for valve-related conditions were nearly half as frequent for the TAVR group compared to the SAVR group. It is not surprising that this trial was ranked highly because it represents a significant breakthrough for percutaneous aortic valve management. Although longer term data are needed, it is an interesting early finding.

Second on the list was the SPYRAL HTN-OFF MED Pivotal (Efficacy of Catheter-Based Renal Denervation in the Absence of Antihypertensive Medications) trial, which showed significant reductions in untreated hypertensive patients' systolic and diastolic pressures measured in office and average 24 hour blood pressure measurements when treated with renal artery ablation compared to sham treatment. Again, later follow-up will be important, but if the effects are persistent, this therapy appears to be a potential adjunct to medical therapy in achieving better blood pressure control.

Third on the list was a subgroup of ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) focused on patients with chronic kidney disease showing that an invasive interventional approach failed to improve outcomes.

The first three studies on the list highlighted diverse interest in all aspects of invasive treatment including peripheral, coronary, and structural (valve) disease. Other studies focused more on optimal procedure management, such as ULTIMATE (A Multicenter, Prospective, Randomized Trial Comparing Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers), for optimal coronary stent outcomes, bifurcation strategies, and antiplatelets.

Ranked 8th on the list, PROSPECT ABSORB (Providing Regional Observations to Study Predictors of Events in the Coronary Tree II study combined with a randomized, controlled, intervention trial) focused on the possible advantage of identifying by intravascular imaging high-risk, hemodynamically insignificant lesions that potentially have less future risk if stented prophylactically. A large, randomized trial will likely ensue to formally assess this hypothesis. Also included in the top 10 were studies of a cerebral protection device to reduce stroke risk during TAVR and a mitral clip, valve repair study to improve outcomes for mitral insufficiency.

In all, it is a collection of very diverse studies that reflect the varied interests of interventionalists. The encouraging outcomes of most of these studies provide hope for expanding efficacy of percutaneous coronary, structural, and peripheral techniques.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Echocardiography/Ultrasound, Nuclear Imaging, Mitral Regurgitation

Keywords: Coronary Angiography, Transcatheter Aortic Valve Replacement, Mitral Valve Insufficiency, Blood Pressure, Drug-Eluting Stents, Antihypertensive Agents, Aortic Valve, Coronary Artery Disease, Renal Artery, Prospective Studies, Heart Valve Prosthesis, Ultrasonography, Blood Pressure Determination, Embolic Protection Devices, Coronary Stenosis, Stroke, Angiography, Renal Insufficiency, Chronic, Catheters, Ischemia, Hospitalization, Percutaneous Coronary Intervention, Ultrasonography, Interventional, Denervation


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