PAclitaxel-eluting balloon in Primary PCI in Amsterdam: 1-year angiographic evaluation of target lesion patency.

The use of bare-metal coronary stents (BMS) has shown to reduce the need for
repeat target lesion revascularization (TLR) in patients treated with primary
percutaneous coronary intervention (PPCI), compared with balloon angioplasty.
However, in the setting of ST-segment elevation myocardial infarction (STEMI),
the decrease in TLR did not result in a reduction of reinfarction and/or
mortality rate. Studies evaluating the use of drug-eluting stents (DES) versus
BMS in PPCI for STEMI have shown equal rates of mortality and reinfarction.
Although the use of DES in PPCI patients has led to a reduction of TLR, there
have been concerns about long-term delay of arterial healing and the associated
risk of late stent thrombosis. As a novel treatment modality, a drug-eluting
balloon (DEB) may be a therapeutic challenge in STEMI, as it can provide the
potential advantage of delivering an anti-proliferative drug, thereby probably
reducing TLR, without leaving a coronary stent. Therefore the *Paclitaxel-
eluting balloon in Primary PCI in Amsterdam (PAPPA)*-pilot evaluated the use a
DEB only strategy in STEMI patients. Of 100 consecutive STEMI patients, 59
patients were treated with a DEB only strategy; bailout stenting was performed
in 41 patients. All patients were treated with peri-and post-procedural i.v.
bivalirudin, on top of a loading dose aspirin, heparin and prasugrel. One
month follow-up was available for all patients. A total of 3 major adverse
cardiac events (MACE) were reported within one-month follow-up, all events
occurred in the DEB only group. The use of a CE-marked paclitaxel-eluting
balloon in PPCI in patients with STEMI, combined with bivalirudin, appeared to
be a safe treatment modality.

The PAPPA-trial was the first prospective clinical study the feasibility and
safety of a DEB only strategy in PPCI for STEMI. One-year angiographic
follow-up is warranted to evaluate long-term patency of the target lesion. So
far there has not been an angiographic follow-up of this specific treatment in
PPCI-patients. Angiographic follow-up results after elective PCI with the use
of DEB, in in-stent re-stenosis and small vessel disease, have shown sustained
efficacy over a half to one year after application.

General: The original PAPPA-pilot is a prospective, single centre study. From
November 2010 until April 2011, a total of 100 consecutive patients presenting
with STEMI were enrolled in this study. Patients were treated with a
paclitaxel-eluting balloon only strategy. Additional bare metal stenting was
performed in case of a residual stenosis > 50% or coronary artery dissection
type C to F.

Patient sample size: Considering loss to follow-up, repeat revascularization
and refusal of informed consent for this study, we expect to enrol 50-75
patients for coronary angiography.

Duration: The study will start December 2011. With normal clinical practice in
mind, not more than 2-3 diagnostic procedures can be performed every week in
the OLVG. Patient inclusion is therefore assumed to take approximately 6
months.

Study schedule: The study assessments will be performed according to the
following list:
Patient history - Clinical examination - Inclusion/exclusion criteria - ECG -
Laboratory - Current medication
Exercise test - CAG - FFR/IVUS (if indicated)

Study documentation: The Investigator will be provided with an Investigator
File, which contains all documents relevant to the study. A CRF must be
completed for all patients.

Admission to the hospital is indicated for 1 day. Al investigations will take
place during this admission. No further follow-up is necessary. The risks of
participation are listed in section E9.