Cover Story | Spring Tour: Highlights from SCAI, HRS, EuroPCR
A wealth of potentially practice-changing studies was presented during the spring meeting season. Some studies were more warmly welcomed by the interventional community than others, but all clearly serve to advance the field closer to its goal of being able to best serve our patients. For attendees at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions, the 2018 Heart Rhythm Society (HRS) Scientific Sessions, and EuroPCR, the late breakers offered new data on coronary and valvular intervention, catheter ablation of atrial fibrillation (AFib), chronic total occlusion (CTO) intervention, renal denervation, and the use of fractional flow reserve (FFR)-guided PCI. Read on for a brief review of just a handful of these new trials.
And watch for the July-August issue of Cardiology: Interventions, where we’ll take a deeper dive into several new datasets with FFR, beyond what’s reviewed here, and the current state of the practice.
A hybrid approach to CTO revascularization – using dual catheter angiography and antegrade and retrograde crossing strategies – can be performed with high success and acceptable complication rates in experienced centers.
The findings of the PROGRESS-CTO International Registry were presented at SCAI 2018 by Peter Tajti, MD, and simultaneously published in JACC: Cardiovascular Interventions.1 Read More >>>
Contemporary outcomes of hybrid PCI of CTOs were examined in 3,055 patients (3,122 CTO interventions) at 20 centers in the U.S., Europe and Russia. The majority of patients were men (85 percent) and symptomatic (88.6 percent). Mean age was 65 years. The CTO target vessels were the right coronary artery (55 percent), left anterior descending coronary artery (24 percent) and left circumflex coronary artery (20 percent).
The overall technical success rate was 87 percent, with a procedural success rate of 85 percent. In-hospital complications were seen in 3.0 percent. Technical success was defined as revascularization with <30 percent residual diameter stenosis and restoration of TIMI antegrade flow grade 3. Procedural success was technical success with no in-hospital complications.
In technically successful cases, the mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO scores were 2.4 and 1.3, respectively, compared with 3.1 and 1.8, respectively, in failed cases (both p<0.001).
More than one crossing strategy was employed in 40.9 percent of CTO intervention. Antegrade wire escalation was the most commonly employed initial approach (in 75 percent), especially in less complex cases. The final successful crossing strategy was antegrade wire escalation in 46.0 percent, a retrograde approach in 24 percent, and antegrade dissection re-entry in 19 percent.
As the J-CTO score rose, so did fluoroscopy time, procedure time, median contrast volume and air kerma radiation dose (all p<0.0001).
“Bridging the gap between what is currently achieved at most centers and what can be achieved should be a major focus of upcoming research and education,” said Tajti.
SCAI: Length of Stay after TF-TAVR
In a first-of-its-kind study, longer hospital stay after transfemoral transcatheter aortic valve replacement (TF-TAVR) was associated with worse one-year outcomes, as reported from an STS/ACC TVT (Transcatheter Valve Therapy) Registry study.
“I believe this represents a nationwide trend,” reported Siddharth Wayangankar, MD, FACC, because all TAVR programs are mandated to share data with the registry. A “minimalist approach” to TAVR that limits direct and indirect procedure costs has been embraced in an effort to make the procedure more cost-effective and this includes limiting length of stay, he said. Read More >>>
A total of 24,285 patients from the STS/ACC TVT Registry (2011-2015) undergoing nonaborted TF-TAVR and alive at discharge were categorized as early discharge (ED <72 hours) or delayed discharge. During the study period, there was a significant decline in the rates of delayed discharge, from 62.2 percent in 2012 Q1 to 34.4 percent in 2015 Q3. This was seen across low and high STS (Society of Thoracic Surgeons) scores. The investigators identified numerous independent predictors of both early and late discharge.
After multivariate adjustment, delayed discharge was associated with higher all-cause mortality (p<0.0001) and a greater risk of bleeding requiring hospitalization (both p<0.0001), which drove a higher risk of the composite of mortality, stroke, myocardial infarction (MI) and bleeding requiring hospitalization. No difference was seen between early and late discharge in the independent risks of stroke or MI. These findings were unchanged in a model that controlled for the occurrence of in-hospital complications.
“...whether we saw postprocedural complications or not, delayed discharge was associated with significantly higher risk of one-year all-cause mortality, compared to early discharge, and the curves diverged immediately post procedure and continued to diverge,” reported Wayangankar.
“The predictors from our study could have a huge impact on future clinical care of TAVR patients,” he said in a press release. “Pre-TAVR, these predictors could be used to develop bedside risk scores for length of stay. These could help physicians in patient selection and procedural and postprocedural planning based on patient-specific variables. On a much bigger front, these risk scores could be used by administrators, third-party payers and policy makers for formulating coverage for TAVR procedures and evaluating bundle payments.”
The wait for the CABANA findings has been a long one and some might question if it was worth it. CABANA was designed to test the hypothesis that primary catheter ablation for AFib is superior to state-of-the-art drug therapy for reducing AFib recurrence in new-onset or untreated high-risk patients. Well, the trial is completed and the answer appears to be — yes, no, and maybe.
A total of 2,204 patients (mean age 67.5 years; 37 percent female) with paroxysmal, persistent or longstanding persistent AFib were randomly assigned to primary catheter ablation with standard techniques (pulmonary vein isolation/wide area circumferential ablation and ancillary ablations as needed) or drug therapy for either rate or rhythm control. Read More >>>
In the intention-to-treat analysis, for the primary outcome of death, disabling stroke, serious bleeding or cardiac arrest at five years, no difference was seen between ablation and drug therapy (8.0 percent and 9.2 percent; hazard ratio, 0.86; p=0.30). Death rates were 5.2 percent for ablation and 6.1 percent for drug therapy (p=0.38). Serious stroke was seen in 0.3 percent and 0.6 percent, respectively (p=0.19).
However, as noted by Douglas L. Packer, MD, FACC, in his presentation of the findings, the crossover rate from drugs to ablation was 27.5 percent (and 9.2 percent from ablation to drugs). And, in a “treatment-received” analysis, a benefit was seen for catheter ablation for the primary endpoint (7.0 percent vs. 10.9 percent; p=0.006).
All-cause mortality (4.4 percent vs. 7.5 percent; p=0.005) and the composite of death or cardiovascular hospitalization (41.2 percent vs. 74.9 percent; p=0.002) both favored catheter ablation.
This trial will require some time for sorting out. To ablation skeptics, the findings represent the electrophysiology-equivalent of the COURAGE trial, which found no benefit for PCI compared with optimal medical therapy for patients with stable coronary artery disease, and the more recent ORBITA trial, which found no difference in outcomes between PCI and sham PCI in a similar patient group. In response, calls have been made for a sham-controlled trial of catheter ablation to better control for the placebo effect. For those more inclined towards catheter ablation of AFib, the significant reduction in death and cardiovascular hospitalization with ablation and the positive findings in the on-treatment analysis support the existence of a hard-outcome benefit for ablation over drug therapy.
EuroPCR: SPYRAL HTN-ON MED and RADIANCE-HTN SOLO
Renal denervation for blood pressure (BP) control received some much-needed support from two trials presented at EuroPCR (and subsequently published). Both studies showed modest BP reductions from the procedure. The field of renal denervation had been languishing in the shade cast by the negative findings of the SYMPLICITY HTN-3 and SYMPLICITY-FLEX trials, both presented in 2014. The two new trials presented at EuroPCR were both sham-controlled and tested two different devices in two different patient groups.
SPYRAL HTN-ON MED was a patient- and assessor-blinded, proof-of-concept trial designed to test the safety and BP response after renal denervation using the Medtronic Symplicity Spyral renal denervation catheter (vs. sham control).2 The trial was conducted at 25 centers in the U.S., Japan, U.K., Australia, Austria and Greece. Eligible participants (n=467) had office systolic BP between 150-180 mm Hg, a diastolic BP ≥90 mm Hg, a 24-hour ambulatory systolic BP between 140-170 mm Hg at second screening, and were on at least one but not more than three antihypertensive drugs, with stable doses for at least six weeks. Drug surveillance was used to assess medication adherence. Full six-month data were presented on the first 80 patients enrolled. Read More >>>
In his presentation of the findings, David E. Kandzari, MD, FACC, reported a 9.0 mm Hg drop in 24-hour systolic BP at six months in the renal denervation arm, compared with a 1.6 mm Hg reduction in the control arm (p=0.005). Office systolic BP was reduced by 9.4 mm Hg and 2.6 mm Hg, respectively (p=0.02).
Twenty-four-hour diastolic BPs were reduced by 6.0 mm Hg with renal denervation and 1.9 mm Hg in sham controls (p=0.03). The office-based BP equivalents were reduced 5.2 mm Hg and 1.7 mm Hg (p=0.048). Nonadherence to antihypertensive medications was common (about 40 percent) and similar between arms, despite the patients being informed of drug surveillance measures.
Commenting on the study in an editorial, Peter Blankestijn, MD, and Michie Bots, MD, suggested that more needs to be known about which patients are likely to have increased renal nerve activity and how this is affected by the antihypertensive medication they take.
The second trial, RADIANCE-HTN SOLO, tested endovascular ultrasound renal denervation with the Paradise Renal Denervation System (ReCor Medical) for the reduction of ambulatory BP in patients with hypertension not taking antihypertensives.3 ReCor’s RADIANCE-HTN renal denervation study program involves two study cohorts: “SOLO” — whose patients are removed from antihypertensive medication, and “TRIO” — whose patients are put on standardized medication. Both cohorts are randomized, blinded, sham-controlled, and powered independently for efficacy.
The trial, presented by Laura Mauri, MD, MSc, FACC, included 146 patients with ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg after a four-week discontinuation of up to two antihypertensive medications. Participants were recruited from 44 centers in the U.S., France, Belgium, the Netherlands, Germany and the U.K., and randomly assigned to either renal denervation or a sham procedure consisting of renal angiography only.
In the study arm, the reduction in daytime ambulatory systolic BP was significantly greater from baseline to two months compared with controls (−8.5 mm Hg vs. –2.2 mm Hg; p=0.0001). There were no major adverse events reported in either group. In the renal denervation group, 20 percent of patients attained a controlled daytime ambulatory BP of <135/85 mm Hg off antihypertensive medications compared with just 3 percent of patients in the sham group (p=0.001).
Further study is needed to determine patients most likely to respond to renal denervation, but these trials “inject new optimism” and “open a new chapter in renal denervation research and in our view should not be grouped into the meta-analyses of the first wave of studies,” wrote editorialists Sverre Kjeldsen, MD, PhD, FACC, and Murray Esler, MBBS, PhD.
EuroPCR: SYNTAX III REVOLUTION
In the SYNTAX III REVOLUTION trial, coronary computed tomography angiography (CCTA) was compared with coronary angiography for the determination of treatment recommendations by a heart team. Two heart teams used one or the other strategy to make the decision to go with either surgery (CABG) or PCI in 223 patients with left main and three-vessel CAD.
The heart teams were composed of an interventional cardiologist, a cardiac surgeon and a radiologist specialized in cardiac imaging. The team was randomized to receive either the findings from CCTA (using the GE Revolution scanner) or from coronary angiography in addition to the patient’s clinical information. The Cohen’s kappa statistic was employed to indicate the level of agreement between the two heart teams. Read More >>>
“We were looking at the concordance of judgement and the concordance of opinion in the planning of the procedure and discovered that the Cohen’s kappa statistic was very high — 0.82 — which can be called an almost perfect assessment/agreement,” said Patrick W. Serruys, MD, PhD, FACC, in a EuroPCR press release.
Treatment recommendations matched in 92.8 percent of cases and the teams agreed on the coronary segments to be revascularized in 81.1 percent of cases.
“We were amazed to hear participating surgeons telling us that they could see more things on the GE Revolution multislice scan than using conventional angiography,” said Serruys, pointing to a time when “cine-angiography could be dispensed with completely and only the noninvasive multislice scans used” for procedural evaluation.
FFRCT was available for 869 of 1,108 lesions and changed the treatment decision in 7 percent of patients, mostly from a surgical procedure to a percutaneous approach.
“In absence of outcome data, a strategy solely based on noninvasive imaging to select patients for surgery cannot be recommended; an outcome trial with treatment selection based on coronary computed tomography is warranted and is currently in design,” Serruys stressed in his presentation of the findings.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Computed Tomography, Nuclear Imaging, Hypertension
Keywords: ACC Publications, Cardiology Interventions, Aged, Antihypertensive Agents, Angiography, Atrial Fibrillation, Attitude, Blood Pressure, Catheter Ablation, Cohort Studies, Coronary Angiography, Coronary Artery Disease, Coronary Vessels, Denervation, Diastole, Electrophysiology, Fluoroscopy, Heart Arrest, Hypertension, Insurance, Health, Reimbursement, Intention to Treat Analysis, Kidney, Medication Adherence, Myocardial Infarction, Patient Selection, Patient Discharge, Percutaneous Coronary Intervention, Placebo Effect, Pulmonary Veins, Radiation Dosage, Radionuclide Imaging, Registries, Research Personnel, Stroke, Surgeons, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement
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