Examine reveals diminished bleeding danger with ticagrelor monotherapy after percutaneous coronary intervention

Individuals who have had a coronary heart assault or who’re in danger for a coronary heart assault and who stopped taking aspirin alongside the P2Y12 inhibitor ticagrelor one month after present process percutaneous coronary intervention (PCI) noticed a considerably diminished danger of clinically significant bleeding with no elevated danger of clotting-related hostile occasions at 12 months in contrast with sufferers who continued taking aspirin and ticagrelor for a full yr, in a examine introduced on the American Faculty of Cardiology’s Annual Scientific Session.

The ULTIMATE-DAPT examine is the primary placebo-controlled trial designed to look at ticagrelor monotherapy following one month of twin antiplatelet remedy (DAPT) after PCI, a process to open blocked arteries. The examine targeted on sufferers who underwent PCI for acute coronary syndromes (ACS)—life-threatening situations which embody coronary heart assaults and chest ache brought on by decreased blood movement to the center—with stents containing medicine to stop additional plaque buildup.

In treating a broad vary of sufferers with acute coronary syndromes within the period of latest drug-eluting stents, amongst those that had been secure after one month of DAPT, persevering with remedy with ticagrelor alone diminished bleeding with no improve in hostile ischemic thrombotic occasions. These information counsel {that a} 12-month length of DAPT isn’t solely not needed in most sufferers with ACS however is dangerous.”

Gregg Stone, MD, professor of cardiology and inhabitants well being sciences at Icahn Faculty of Medication at Mount Sinai, New York and co-chair of the trial

Antiplatelet medicines cut back clotting-related cardiovascular issues akin to coronary heart assaults and strokes by stopping platelets from sticking collectively. To scale back the chance of such occasions after PCI, present pointers suggest that the majority sufferers ought to take two antiplatelet medicines—aspirin and a P2Y12 inhibitor—for a full yr. Nevertheless, the bleeding danger related to antiplatelet medicines has fueled efforts to additional optimize the length of post-PCI antiplatelet remedy and the medicines used to steadiness the advantages and dangers.

For ULTIMATE-DAPT, researchers enrolled 3,400 sufferers who skilled no hostile cardiovascular or bleeding occasions within the first month following PCI for ACS at 58 medical facilities in 4 international locations in Asia and Europe. Through the first 30 days after PCI, all sufferers took aspirin and ticagrelor, a potent P2Y12 inhibitor. Contributors had been then randomly assigned to proceed with this similar routine for 11 extra months or to modify to ticagrelor and a placebo.

The trial met its two main endpoints, one assessing efficacy when it comes to bleeding danger and the opposite assessing security when it comes to clotting-related occasions. The primary endpoint, clinically related bleeding, occurred in 4.6% of sufferers assigned to persevering with DAPT and a couple of.1% of sufferers assigned to take ticagrelor and a placebo, a major discount in favor of ticagrelor alone. The second endpoint, a composite of main hostile cardiovascular occasions and cerebrovascular occasions, confirmed no important distinction between teams, with 3.7% of sufferers who continued DAPT and three.6% of these taking ticagrelor and a placebo experiencing such occasions.

The streamlined remedy of treating sufferers with ACS with ticagrelor alone one month after PCI was equally protected and efficient in sufferers who introduced with a coronary heart assault (the very best danger group) or had been prone to a coronary heart assault. Collectively, these findings counsel that sufferers who stopped taking aspirin after the primary month had a considerably diminished danger of bleeding with none elevated danger of thrombotic occasions, researchers stated.

“The following query is how will physicians incorporate these outcomes into their day by day follow, and what’s going to guideline committees in the end do with these information,” Stone stated. “I consider these outcomes are very convincing and align with prior research completed and not using a placebo; hopefully they’ll impression pointers and result in the routine use of just one month of DAPT adopted by a potent P2Y12 inhibitor akin to ticagrelor in most sufferers with ACS after profitable PCI.”

Because the trial solely concerned ticagrelor, researchers stated that separate research could be needed to research the protection and efficacy of an identical method utilizing different P2Y12 inhibitors, akin to prasugrel and clopidogrel.

The examine was funded by the Chinese language Society of Cardiology, the Nationwide Pure Scientific Basis of China and the Jiangsu Provincial & Nanjing Municipal Scientific Trial Challenge. Stents had been provided by Medtronic Corp. (Minnesota, U.S.) and Microport Medical (Shanghai, China). Examine medicines had been provided by Yung Shin Pharmaceutical Industrial Co. (Kunshan, China) and Shenzhen Salubris Prescription drugs Co., Ltd (Shenzhen, China).

This examine was concurrently revealed on-line in The Lancet on the time of presentation.

Stone will likely be obtainable to the media in a press convention on Sunday, April 7, 2024, at 11:15 a.m. ET / 15:15 UTC in Room B203.

Stone will current the examine, “One-month Ticagrelor Monotherapy After PCI in Acute Coronary Syndromes: Principal Outcomes from the Double-blind, Placebo-controlled Final DAPT Trial,” on Sunday, April 7, 2024, at 9:45 a.m. ET / 13:45 UTC within the Corridor B-1 Important Tent.