Session 7: DCB-PCI: Current Indications I - Short update on Cage-Free Trial – Yoshi Onuma

Cage-Free One Trial Update

Overview of the Cage-Free One Trial

• The talk provides an update on the Cage-Free One trial, focusing on patients undergoing non-complex PCI for de novo CAD, including both ACS and chronic coronary syndrome.

• Professor Kumbbo previously presented a detailed analysis of this trial, which involved randomization after predilation. Approximately 20% of patients were included in a nested cohort study due to unsuccessful predilation.

Study Design and Methodology

• Patients who underwent successful predilation were randomized into two groups: one receiving a serum-eluting stent and the other receiving a drug-coated balloon (DCB). The primary endpoint was device-oriented composite endpoints at two years.

• The DCB used was the SWB manufactured in China, which showed non-inferiority to the Sequent B drug-coated balloon regarding in-segment restenosis at nine months. The Firebird 2 was utilized for the drug-eluting stent arm.

Patient Characteristics and Results

• Baseline characteristics indicated that 55% of patients presented with acute coronary syndrome while 45% had chronic coronary syndrome; average syntax score was relatively low at 7.3, indicating less complex disease profiles. Cutting or scoring balloons were used in about 68%-61% of cases before randomization.

• There were no significant differences between the two arms concerning cardiovascular death rates (3% for DCB vs. 2.5% for drug-eluting stent) or target vessel myocardial infarction rates (2% vs. 1.8%). Both arms exhibited similar event rates clinically and physiologically.

Long-term Outcomes and Analysis

• Landmark analysis revealed that differences in device-oriented composite endpoints primarily occurred within the first year post-randomization, with increments observed as follows: DCB (3.7%) versus drug-eluting stent (2%). No significant differences were noted from one to three years post-procedure.

• Revascularization rates significantly favored DCB over drug-eluting stents (8% vs 4.8%), although urgent revascularization showed no difference between groups; interestingly, B3 type events appeared numerically lower with DCB usage despite not reaching statistical significance due to less antiplatelet therapy being administered with DCBs compared to stents.

Subgroup Analysis Insights

• In small vessel disease subgroup analysis, event rates remained comparable between DCB and drug-eluting stents (5.8% vs 7%), aligning with findings from previous trials like Basket Small II at three years without significant p-values indicating differences between arms.

• Device type used during predilation did not show notable differences across treatment arms; cutting balloons yielded better outcomes than non-compliant or semi-compliant balloons when assessing their impact on drug-eluting stents' performance during procedures conducted prior to randomization efforts overall favoring cutting balloons as optimal options for predilation strategies employed in this context.

Conclusion Summary

• At three years post-procedure, there remains a distinction between outcomes associated with prioritized drug-eluting stents driven mainly by elective target region vascularizations; however, differences in device-oriented composite endpoints gradually narrowed over time suggesting evolving efficacy trends among treatment modalities evaluated throughout this trial's duration.