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.

ABSTRACT

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.