ACC: Real-world CoreValve study demonstrates low stroke, mortality rates
Prior to ADVANCE, neither balloon-expandable nor self-expanding TAVI have been studied in a rigorous, monitored, independently adjudicated, ‘real world’ study, according to the study’s lead investigator Axel Linke, MD, PhD, a professor of cardiology at the University of Leipzig Heart Center in Leipzig, Germany. The study evaluated the performance of the CoreValve system (Medtronic).
Thus, Linke and the CoreValve ADVANCE investigators, created the trial with the objective of evaluating the safety, efficacy and clinical outcome of percutaneous aortic valve implantation using the Medtronic CoreValve System in consecutive ‘real world’ patients with severe aortic stenosis considered inoperable or high risk for conventional AVR by the local heart team
The ongoing trial enrolled 1,015 patients from March 2010 to July 2011 for a goal of a five-year follow-up, and included 44 centers in 12 countries in Western Europe, Asia and South America. All centers had conducted at least 40 TAVI procedures prior to the study and had Heart Team in place, reported Linke, who added that the clinical endpoints reported according to Valve Academic Research Consortium (VARC).
In the study, 996 patients had a valve implanted because 19 patients had no implant attempted. There were 45 deaths in the study period and one patient withdrew. At the 30 day-follow-up, there were 950 patients and at six months, 79 patients had died and nine withdrew, leaving a population of 862 patients.
The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as a composite as all-cause mortality, MI, emergent cardiac surgery or percutaneous reintervention and stroke, at 30 days post-procedure and at six months.
Out of the original 1,015 patients, the average age was 81 years and 49.4 percent were male. For other characteristics, 79.4 percent had Class III or IV heart failure, 20.4 percent had Class I or II heart failure, 30.9 percent had diabetes, 57.6 percent had coronary artery disease, 32.8 percent had atrial fibrillation and 22.6 percent had chronic obstructive pulmonary disease.
At the 30 days, the researchers found that MACCE occurred in 8.3 percent of patients. The rates of total mortality and cardiac mortality were 4.5 percent and 2.2 percent, respectively, and the stroke rate was 2.9 percent. Life-threatening or disabling bleeding was observed in 4 percent of patients. The research team also found a persistent improvement in aortic valve function, accompanied by a better exercise capacity.
Importantly, 26.3 percent of patients received a new pacemaker implantation at 30 days. The researchers are still investigating the data on the number of patients that had a pacemaker implanted during the time of the TAVI procedure and those that received the implantation within the 30 days following the TAVI procedure, according to Linke. However, he said that “in some countries, some physicians are very aggressive in implanting pacemakers, even during the procedure, while others are more reluctant.”
At six months, the cardiovascular survival was 91.6 percent and the all-cause survival rate was 87.2 percent. The freedom from stroke rate at six months was 96.6 percent.
The multicenter, prospective CoreValve ADVANCE study showed that treatment of ‘real world’ inoperable and frail, high-risk patients with the Medtronic CoreValve is safe, and associated with an improvement in aortic valve function, as well as low stroke and mortality rates at one month and six months of follow-up, Linke concluded.
“It’s impressive to see these results with a large number of centers, some of which did not have very high volumes,” said study discussant Ted E. Feldman, MD, NorthShore University Health System in Chicago. All the centers had to have experience with performing a minimum of 40 TAVI procedures, Linke explained.
The study was funded by Medtronic.