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      Clinical Value "Stent-less" PCI

      SeQuent® Please vs. DES (EES) in de novo lesions

      Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease

      Nishiyama N et al. Int. J. Cardiol. 2016; 222; 113-8

      Key findings

      In the DCB group, not a single case of TLR reported (0.0 %), in contrast to the DES group with a TLR rate of 6.1 % at 8-month follow-up. The authors conclude that “stent-less” PCI could be useful with regards to the reduction of DAPT and a discontinuation of DAPT than after DES implantation.

      Description

      Design: Randomised | Open-label | Prospective | Single centre

      Indication: De novo

      Primary endpoint: TLR @ 8-month follow-up

      Secondary endpoint: LLL @ 8-month follow-up

      Results

      Patients: 60 consecutive patients were enrolled in this trial and randomised into the DCB or DES group. After lesion preparation with NSE Alpha, three patients in the DCB group had an unacceptable angiographic result and were moved into the DES group. Therefore, a total of 27 patients were in the DCB group, 33 patients in the DES group.

      Baseline characteristics: The two treatment groups were well-balanced, there were no statistically significant differences between the two treatment groups.

      Primary endpoint:

       DCB
      n = 27      		DES
      n = 33      		p-value
      TLR0.0 %6.1 %0.193

      Secondary endpoint:

       DCB
      n = 27      		DES
      n = 33      		p-value
      LLL0.25 ± 0.25 mm0.37 ± 0.40 mm0.11

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