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Randomized controlled trial for de-novo

Treatment of coronary de novo lesions by a sirolimus- or paclitaxel-coated balloon

First in Man Trials in Malaysia
Ahmad WAW et al. Cardiovascular Interventions 15.7 (2022): 770-779.


Primary endpoints:

  • SCB is non-inferior to PCB in terms of LLL after 6 months
  • LLL was 0.01 +/- 0.33 mm in the PCB group versus 0.10 +/- 0.32 mm in the SCB group (p=0.08)

Secondary endpoints:

 PCB (n=35)SCB (n=35)P value
Stent thrombosis001.000
Death2 (6)00.493
TV MI001.000
Unscheduled angiography2 (6)3 (9)1.000
MACE2 (6)00.493


No difference in clinical endpoints after 12 months.
Not any event of TLR, Stent thrombosis, TV-MI.