Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study

Selected in EuroIntervention by S. Brugaletta

References

Authors

Vos N, Dirksen M, Vink M, van Nooijen F, Amoroso G, Herrman J-P, Kiemeneij F, Patterson M, Slagboom T, van der Schaaf R

Reference

EuroIntervention 2014;10:584-590

Published

September 2014

Link

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Aims

In primary percutaneous coronary intervention (PPCI), stenting has been shown to reduce the need for repeat target lesion revascularisation (TLR) compared to balloon angioplasty alone, but did not result in a reduction of recurrent myocardial infarction (MI) or cardiac death. Meanwhile, stent-related adverse events such as stent thrombosis continue to be of concern. Our aim was to evaluate the safety and feasibility of drug-coated balloon (DCB) angioplasty without stenting in PPCI.

Methods and results

One hundred patients presenting with ST-elevation MI were prospectively enrolled in this pilot study. They underwent PPCI with DCB angioplasty; additional stenting was allowed only in case of type C to F coronary dissection or residual stenosis >50%. All patients were treated with i.v. bivalirudin. The primary endpoint was the composite of cardiac death, recurrent MI and TLR. A total of 59 patients received treatment with DCB angioplasty alone, whereas additional stenting was required in 41 patients. One-year clinical follow-up was completed in 98 patients. A total of five major adverse cardiac events were reported (5%). Cardiac death was seen in two patients, while three patients underwent TLR.

Conclusions

This first study of a DCB angioplasty-only strategy in the setting of PPCI showed good one-year clinical results.

My Comment

What is known 

Comparison between conventional metallic stent and balloon angioplasty alone in STEMI did not shown any improvement in recurrent myocardial infarction and death. DES exhibited a reduction in target lesion revascularisation as compared with bare metal stent, but had raised some concerns on stent thrombosis. In this scenario, a simple angioplasty with a drug-coated balloon (DCB) may provide an alternative to metallic scaffolding, potentially decreasing inflammation and preserving coronary vasomotor response and vascular geometry. This pilot study was designed to evaluate prospectively the feasibility and safety of a DCB angioplasty-only strategy in primary PCI (PPCI) for STEMI.

Major findings

  • One hundred patients presenting with STEMI were prospectively enrolled in this pilot study.
  • They underwent PPCI with DCB angioplasty; additional stenting was allowed only in case of type C to F coronary dissection or residual stenosis >50%. All patients were treated with i.v. bivalirudin. The primary endpoint was the composite of cardiac death, recurrent MI and TLR.
  • A total of 59 patients received treatment with DCB angioplasty alone, whereas additional stenting was required in 41 patients.
  • One-year clinical follow-up was completed in 98 patients. A total of five major adverse cardiac events were reported (5%). Cardiac death was seen in two patients, while three patients underwent TLR.

My comments 

Although in this study, the rate of bailout stenting was relatively high, the use of DCB in this setting seems to be safe and feasible. Two major points should be highlighted. First, this study does not represent a randomized comparison between two different strategies (DCB or DES), so that no definite conclusions can be drawn. In addition, the strategy of DCB could be important in those cases where the operators would like to avoid stent implantation. Recent studies have indeed showed that in some STEMI cases a delayed stent implantation (after 1-2 days from the acute event) may be better than an immediate stent implantation, in order to reduce no-reflow rate and number of stent implanted. This refers to those STEMI in which after thrombus aspiration or balloon dilatation, the artery is open with TIMI 3 flow and without a significant stenosis.

2 comments

  • Salvatore Brugaletta 14 Oct 2014

    Thanks for your comment! I think that this field where your group is involved is very interesting and the RCT which is currently ongoing will be of utmost interest for the community

  • From a Linkedin member 14 Oct 2014

    We know now that stenting in STEMI has potential drawbacks: malapposition, distal embolisation, stent thrombosis. Drug-eluting balloons (with provisional bail-out stenting) could be a solution for this group of patients. A RCT study (Revelation) is currently ongoing at our institution (OLVG Amsterdam) to validate this interesting hypothesis.