The COMPLETE study, a multinational clinical trial, produced results showing that unlocking additional plaque or cholesterol-clogged coronary arteries using stents post-heart attack—rather than just the one that triggered the heart attack—leads to a reduction in the risk of dying or having another heart attack, reports British Columbia experts at Vancouver General Hospital.
The Vancouver Sun’s Pamela Fayerman recently wrote about the “landmark” study evidencing immediate implications for heart attack patients as interventional cardiologists will post COMPLETE study—stent more coronary arteries with significant narrowing rather than merely the one clogged artery that caused the heart attack.
According to the latest interventional cardiology procedural analysis from iData Research, more than 965,000 angioplasties are undertaken annually in America. Also known as percutaneous coronary intervention (PCI), is a procedure involving stent placement to open blocked or narrowing arteries.
“Over-stenting” was seriously scrutinized with numerous studies positing that 30% of coronary stenting procedures performed were not required. Consequently the average number of stents per PCI procedure declined as the market morphed to the newly presented clinical evidence.
The COMPLETE study launched in 2013 and sponsored by the Population Health Research Institute was designed to determine whether, on a background of optimal medical therapy( including ticagrelor), opening all suitable narrowing or blockings found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.
Sites spanned 31 countries mostly from America to Europe, with 4,041 patients (of which 200 were at Vancouver General Hospital). All patients received standard care (stents in culprit arteries) as an emergency rescue procedure. However, in one arm, half the patients were released from the provider and given standard post-angioplasty medications while in the other study arm, patients went through additional procedure at the provider (hospital) and had their other blocked arteries stented in a procedure known as “revascularization” at time of initial stenting or within 45 days.
The revascularization group experienced significantly less deaths 179 patients (8.9%) as compared to the standard approach (one stent put in) which experienced 339 deaths (16.7%). The risk of another heart attack was lower in the revascularization group at 7.8% while this risk for the standard treatment group was 10.5%.
Dr. David Wood was the co-principal investigator of the COMPLETE study for Vancouver General Hospital Catheterization Lab. He revealed that the “gestalt” for these procedures was “you do an immediate angioplasty to open the culprit blocked artery and then do less with the other ones, put patients on meds and monitor them instead of fixing the additional blockages at the same time or right after.” Dr. Wood continued that, clearly, “in this study, the results show that doing more stenting, even within the first 45 days after the heart attack, was beneficial” with a 26% reduction in the patients risk of death or reoccurrence of heart attack.
The Vancouver Sun article summarized that given the size and scale of the COMPLETE study, not to mention the results, doctors will in fact change how they treat this condition moving forward.
Background of the Sponsor
The Population Health Research Institute (PHRI) is a joint institute of McMaster University and Hamilton Health Sciences, both in Canada. PHRI is a world leader in large clinical trials and population health observational research areas now also include perioperative medicine and heart surgery; population genomics; thrombosis; heart failure; renal disease; obesity; childhood risk factors; and more. To date, they have enrolled over 1 million patients in PHRI trials worldwide. They employ between 250 and 350.
As note on PHRI’s website, the organization evolved from the successful and innovative Preventative Cardiology and Therapeutics Program established by Salim Yusuf in 1992 at the Hamilton Civic Hospitals Research Centre, located in Hamilton, Ontario, Canada. From the 1990s on, PHRI has conducted many large, globally-focused clinical trials such as HOPE, OASIS, and INTERHEART.
For the Vancouver General Hospital
For the Entire Clinical Trial
Dr. Shamir Mehta, PHRI
Call to Action: Will these findings reverse the trend and truly transform how providers are dealing with PCI? Only time will tell, but for those interested in the topic of percutaneous coronary intervention (PCI), and angioplasties should monitor PHRI and the investigators include herein. Contact TrialSite News if you need help in reaching out to Dr. Mehta at PHRI.