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PARIS -- Antiplatelet de-escalation worked well following drug-coated balloon (DCB) placement for acute coronary syndrome (ACS), according to the first randomized trial on this subject.

In REC-CAGEFREE II, the strategy of stepwise dual antiplatelet (DAPT) de-escalation − aspirin plus ticagrelor (Brilinta) for 1 month, then 5 months of ticagrelor monotherapy, and finally 6 months of aspirin monotherapy -- showed noninferiority against standard 12-month DAPT in the nearly 2,000-person study, reported Ling Tao, MD, PhD, of Xijing Hospital in Xi'an, China.

The trial's primary endpoint reached 9.0% with DAPT de-escalation and a comparable 8.7% with standard DAPT, counting combined all-cause death, stroke, myocardial infarction (MI), revascularization, and BARC type 3 or 5 bleeding on intention-to-treat analysis (P=0.013 for noninferiority), Tao told the audience here at the annual EuroPCR meeting.

Bleeds were generally reduced by DAPT de-escalation in the DCB setting. Indeed, if counting ischemic and bleeding events on a ranked win-ratio analysis, she said, the de-escalation arm would come out superior (14.4% vs 10.1%, win ratio 1.43, 95% CI 1.12-1.83).

These results therefore support the premise that DCB technology opens the door to less intense antiplatelet therapy after percutaneous coronary intervention (PCI).

DCBs are angioplasty balloons that deliver an antiproliferative drug, leaving no permanent metal behind, and have been around in Europe for over a decade. However, the only became the first DCB to win FDA approval earlier this year, gaining an indication for in-stent restenosis in patients with coronary artery disease.

In REC-CAGEFREE II, investigators mainly used five brands of paclitaxel-coated balloons: SeQuent Please and RESTORE from Germany and Bingo, Swide, and Vesselin from China.

According to , people with ACS are still strongly recommended at least 12 months of DAPT with aspirin and clopidogrel (Plavix), prasugrel (Effient), or ticagrelor after PCI (class I recommendation). For those with high bleeding risk (HBR), discontinuing the P2Y12 inhibitor after 6 months may be reasonable (class IIb). Selected patients may also consider 1-3 months DAPT before switching to P2Y12 inhibitor monotherapy to reduce the risk of bleeding (class IIa).

EuroPCR course director and session panelist Nieves Gonzalo, MD, PhD, of Hospital Clinico San Carlos in Madrid, Spain, pointed out the revascularization rates in the study exceeded 6% in both study arms. Acknowledging that the present trial was not a study comparing DCB and drug-eluting stents (DES), she nevertheless commented on revascularization being higher here than in the older DES studies.

Tao responded by emphasizing that the study was in a population selected for DCB suitability, not a typical ACS population. These were patients with 56% small vessel disease, 45% bifurcations, 19% in-stent restenosis, and 10% diffuse lesions.

Tao's group had conducted REC-CAGEFREE II as an open-label trial at 41 sites in China.

Included were patients with ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), and unstable angina who could be treated with PCI using DCBs exclusively. Exclusion criteria did not permit people requiring long-term oral anticoagulants, showing any in-stent thrombosis, or planning elective surgery in the cohort.

There were 1,948 people randomized to one of the two DAPT strategies after successful DCB implantation. As a whole, the cohort averaged 59 years of age, with 75% men. Approximately 30% had diabetes, 30% prior PCI, and 20% HBR. About 60% had unstable angina and the remaining 40% acute MI.

Tao reported an average 1.3 DCBs used per patient with a mean 2.72-mm diameter.

To ascertain health status and medication compliance, investigators contacted participants monthly by mobile app.

Approximately 85% of either group were deemed compliant to assigned medication at least 80% of study time. This increased to approximately 95% when also counting people who switched to clopidogrel instead of ticagrelor.

Due to nonadherence and crossovers, the per-protocol analysis came out to 1,651 people. Within this cohort, the primary endpoint still placed stepwise DAPT de-escalation favorably against standard DAPT (8.5% vs 9.3%).

Additionally, REC-CAGEFREE II's main results were largely consistent across subgroups. The exception was an observed interaction by HBR, such that people with HBR tended to do better with the stepwise de-escalation.

Session panelist Robert Byrne, MBBCh, PhD, of Mater Private Network in Dublin, Ireland, cautioned that REC-CAGEFREE II largely enrolled people without high HBR, given BARC type 3 or 5 bleeding rates of 0.4% and 1.7% in the de-escalation and control arms. Additionally, he suggested there was an element of selection bias as evidenced by the low death rates of 1.3% and 0.7%, respectively.

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