NC EMERGE™

PTCA Dilatation Catheter

Many DES Clinical Trials Require Pre and Post-Dilatation to Optimize Stent-Deployment

STent OPtimization (STOP) Study:  The Impact of Routine and
Intravascular Ultrasound-Guided High-Pressure Post-dilatation 
After Drug-Eluting Stent Deployment1

Objectives:  Drug-eluting stent (DES) implantations with low final cross-sectional area (CSA) are associated with adverse clinical outcomes. However, there is no guidance to facilitate optimal stent deployment (SD). The stent optimization (STOP) study was performed to assess DES routine post-dilatation (PD) following implantation with intravascular ultrasound (IVUS) guidance.
  • Single-center prospective study (48 patients)
  • All DES deployed at 16 atm for 20 seconds and underwent routine non-compliant balloon PD (min 20 atm for 10 seconds)
  • IVUS performed after SD (blinded) and PD (unblinded) measured CSA at 4 stent reference points
  • Optimal deployment defined as distal and proximal stent CSA ≥ 60% distal and proximal reference CSA; mid and minimum stent CSA ≥ 70% of distal reference CSA. All per-protocol criteria were required to define optimal SD
  • Sub-optimally deployed DES underwent further PD with IVUS guidance (IVPD)


Findings:

  • 52 lesions treated in 48 patients – CSA increased by 20% following PD
  • STOP criteria only achieved in 21% of DESs after SD, compared to 54% after PD
  • IVPD performed in 20 DESs, which increased CSA by a further 21%
  • STOP criteria eventually attained in 81% cases (P < 0.001 for all comparisons)
  • Single-center prospective study (48 patients)
  • All DES deployed at 16 atm for 20 seconds and underwent routine non-compliant balloon PD (min 20 atm for 10 seconds)
  • IVUS performed after SD (blinded) and PD (unblinded) measured CSA at 4 stent reference points
  • Optimal deployment defined as distal and proximal stent CSA ≥ 60% distal and proximal reference CSA; mid and minimum stent CSA ≥ 70% of distal reference CSA. All per-protocol criteria were required to define optimal SD
  • Sub-optimally deployed DES underwent further PD with IVUS guidance (IVPD)
  • 52 lesions treated in 48 patients – CSA increased by 20% following PD
  • STOP criteria only achieved in 21% of DESs after SD, compared to 54% after PD
  • IVPD performed in 20 DESs, which increased CSA by a further 21%
  • STOP criteria eventually attained in 81% cases (P < 0.001 for all comparisons)

Conclusion:  DES deployment may lead to sub-optimal deployment, which can be optimized by routine post-dilatation. IVUS identifies DES implantations that benefit from further PD. Optimizing final DES-CSA may have long-term clinical benefits, although a randomized study is required

  • Single-center prospective study (48 patients)
  • All DES deployed at 16 atm for 20 seconds and underwent routine non-compliant balloon PD (min 20 atm for 10 seconds)
  • IVUS performed after SD (blinded) and PD (unblinded) measured CSA at 4 stent reference points
  • Optimal deployment defined as distal and proximal stent CSA ≥ 60% distal and proximal reference CSA; mid and minimum stent CSA ≥ 70% of distal reference CSA. All per-protocol criteria were required to define optimal SD
  • Sub-optimally deployed DES underwent further PD with IVUS guidance (IVPD)
  • 52 lesions treated in 48 patients – CSA increased by 20% following PD
  • STOP criteria only achieved in 21% of DESs after SD, compared to 54% after PD
  • IVPD performed in 20 DESs, which increased CSA by a further 21%
  • STOP criteria eventually attained in 81% cases (P < 0.001 for all comparisons)

Conclusion:  DES deployment may lead to sub-optimal deployment, which can be optimized by routine post-dilatation. IVUS identifies DES implantations that benefit from further PD. Optimizing final DES-CSA may have long-term clinical benefits, although a randomized study is required

Conclusion:  DES deployment may lead to sub-optimal deployment, which can be optimized by routine post-dilatation. IVUS identifies DES implantations that benefit from further PD. Optimizing final DES-CSA may have long-term clinical benefits, although a randomized study is required.

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Indications, Safety, and Warnings

Difference Between Compliant and Non-compliant Balloons During High-pressure Inflation2

  • Semi-compliant balloon demonstrates a “dog-bone” effect at the edge of the cylinder that can damage the vessel wall in vivo
  • Incidence of incomplete stent deployment ranges from 20% to 30% of cases
  • Adjunctive high-pressure balloon dilation is necessary to improve the minimum stent area and the uniform volumetric stent expansion
Bench test showing the different profile between a noncompliant balloon (A)and a semi-compliant stent delivery balloon (B) during high-pressure (> 14 atm) inflation. Bench test results may not necessarily be indicative of clinical performance.

Optimizing Stent Deployment Is a Key Element to Obtain Favorable Immediate and
Long-term Results

  • Incomplete apposition may contribute to thrombosis formation and SATs2,3
  • Stent under-expansion may increase risk for restenosis2,7
  • Post-dilatation reduces target vessel revascularization (TVR)2,7
  • Uniform stent apposition facilitates uniform drug absorption into endothelial tissue3,4,5,6
 
Master the Complex - For Complete Revascularization
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