De-escalation strategy may be preferred to 12-month DAPT in PCI with drug-coated balloon
Click Here to Manage Email Alerts
Key takeaways:
- In patients with ACS who had PCI with a drug-coated balloon, a stepwise de-escalation strategy was noninferior to 12-month dual antiplatelet therapy.
- A win ratio analysis favored the de-escalation strategy.
In patients with ACS who underwent PCI with a drug-coated balloon, an antiplatelet therapy de-escalation strategy was noninferior to 12-month dual antiplatelet therapy, researchers reported at EuroPCR.
“Compared with [drug-eluting stents], DCBs are typically associated with faster vessel healing and a reduced thrombotic burden, due to the absence of a metallic scaffold and polymer inside the coronary vessel,” Chao “Charlie” Gao, MD, PhD, FESC, professor at Xijing Hospital, Xi’an, China, said on behalf of Ling Tao, MD, PhD, FAHA, also a professor at Xijung Hospital, during a press conference. “Therefore, patients treated with DCB theoretically require less intense antiplatelet therapy. However, to date, there are no randomized data exploring this issue for these patients.”
For the open-label, noninferiority REC-CAGEFREE II trial, Tao and colleagues randomly assigned 1,948 patients with ACS (mean age, 59 years; 75% men) who underwent PCI with a DCB to receive a stepwise de-escalation strategy consisting of 1 month of DAPT followed by 5 months of ticagrelor (Brilinta, AstraZeneca) monotherapy followed by 6 months of aspirin monotherapy or 12-month DAPT with aspirin and ticagrelor. The primary noninferiority outcome was net adverse clinical events, defined as all-cause death, stroke, MI, revascularization and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding, at 1 year.
At 1 year, the primary outcome occurred in 8.7% of the 12-month DAPT group and 9% of the de-escalation group, which was within the noninferiority margin of 3.2% (P for noninferiority = .013), Gao said at the press conference.
BARC type 3 or 5 bleeding rates were lower in the de-escalation group (0.4% vs. 1.7%; difference, –1.24 percentage points; 95% CI, –2.14 to –0.33), whereas there was no difference between the groups in the ischemic endpoints of the primary outcome, according to the researchers.
In a win ratio analysis for the hierarchical components of death, stroke, MI, BARC type 3 bleeding, revascularization and BARC 2 bleeding, the de-escalation strategy had more wins than the 12-month DAPT strategy (14.4% vs. 10.1%; win ratio = 1.43; 95% CI, 1.12-1.83; P = .004), Gao said.
“The current study provides the first piece of evidence investigating a dedicated antiplatelet regimen for patients with DCB,” Gao said at the press conference. “Among patients with STEMI, non-STEMI or [unstable angina] who were successfully treated with a paclitaxel-coated balloon only, a stepwise DAPT de-escalation was noninferior for [net adverse clinical events] compared to standard 12-month DAPT. If all clinically relevant ischemic or bleeding events were considered by hierarchical clinical importance, an overall benefit would have been seen with the stepwise group compared with the standard DAPT group.”
Collapse
Tao L, et al. Major late-breaking trials from EuroPCR 2024. Presented at: EuroPCR; May 14-17, 2024; Paris.
Click Here to Manage Email Alerts