P2Y12 inhibitor monotherapy after PCI similar to prolonged DAPT, new 3-year analysis confirms
Long-term P2Y12 inhibitor monotherapy after an initial three months of dual antiplatelet therapy (DAPT) is associated with three-year percutaneous coronary intervention (PCI) outcomes similar to prolonged DAPT, according to new research published in JAMA Cardiology.[1] The study’s authors noted that this strategy was also associated with a lower risk of bleeding events than prolonged DAPT.
“A recent randomized clinical trial comparing aspirin and clopidogrel as chronic maintenance therapy after PCI demonstrated that clopidogrel monotherapy was superior to aspirin monotherapy in preventing both ischemic events and major bleeding,” wrote first author Ki Hong Choi, MD, a cardiologist with Samsung Medical Center and the Sungkyunkwan University School of Medicine in Seoul, South Korea, and colleagues. “Nevertheless, no randomized clinical trial has compared the long-term clinical outcomes of P2Y12 inhibitor monotherapy and prolonged DAPT after the stabilization of patients who underwent PCI with a second-generation drug-eluting stent (DES).”
Choi et al. evaluated outcomes from the SMART-CHOICE clinical trial after three years. SMART-CHOICE compared PCI patients who were randomized to either receive P2Y12 inhibitor monotherapy after three months of DAPT or just prolonged DAPT. All patients underwent PCI from March 2014 to July 2017 at one of 33 sites in Korea.
PCI was performed with “standard techniques,” the authors wrote. While each procedure was performed using a second-generation DES, there were no restrictions on the length or diameter of each stent. Before the procedure, all patients received 300 mg of aspirin and a P2Y12 inhibitor to start. The P2Y12 inhibitors used were clopidogrel (300-600 mg), prasugrel (60 mg) and ticagrelor (180 mg). After the procedure, all patients received aspirin plus one of those three P2Y12 inhibitors for the initial three months. At that point, the monotherapy group stopped regularly taking aspirin.
“All patients were advised to receive optimal medical treatment, including statins, beta blockers, or renin-angiotensin system blockers, as appropriate under current guidelines,” the authors added.
Overall, after three years, the study’s primary endpoint—major adverse cardiac and cerebrovascular events, including death, myocardial infarction and stroke—was seen in 6.3% of patients from the P2Y12 inhibitor monotherapy group and 6.1% of patients from the prolonged DAPT group. P2Y12 inhibitor monotherapy, however, was linked to a “significantly lower risk” of overall bleeding events and major bleeding events during that same three-year time period. P2Y12 inhibitor monotherapy was also associated with a lower risk of overall bleeding or major bleeding when specifically looking at the time between those first three months and the end of the three-year analysis.
“Among patients with coronary artery disease undergoing PCI with a current-generation DES, three months of DAPT followed by long-term P2Y12 inhibitor monotherapy is associated with a significantly lower rate of major bleeding for up to three years of follow-up,” the authors wrote.
Two prominent interventional cardiologists share their thoughts
Ajay J. Kirtane, MD, of the Columbia University Irving Medical Center, and Roxana Mehran, MD, of the Icahn School of Medicine at Mount Sinai, wrote a separate editorial, also published in JAMA Cardiology, reviewing this three-year update.[1]
Kirtane and Mehran highlighted the group’s finding that ischemic outcomes were comparable between the P2Y12 inhibitor monotherapy group and the prolonged DAPT group.
“These data should lead clinicians to consider a strategy of monotherapy after a short period of DAPT as a viable one to mitigate bleeding risk, although SMART-CHOICE was underpowered to rigorously assess ischemic differences, so caution is warranted,” they wrote. “For patients at greatest risk for recurrent ischemic events, the role of continued DAPT is always an option, but these data (and other consistent trials) give clinicians more options to pursue individualized treatment decisions.”
The two interventional specialists also wrote that the multiple antiplatelet therapy options after PCI could potentially be seen as “dizzying” by some clinicians. In their eyes, however, “every patient is different, and thoughtful evidence-based consideration is increasingly possible for many of our treatment decisions.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.