Eleven studies (1,945 patients, range 21 to 996) were included in the review comprising three non-blinded RCTs, three prospective and three retrospective cohort studies, one case-control, and one retrospective case series. Four studies were multi-centred. Of the six studies assessed on quality, all indicated some limitations; the most frequent limitation was lack of blinding.
Adverse events: One case of in-hospital myocardial infarction was reported by a patient with angina treated with standard angioplasty balloon. Two patients suffered from haematoma at a puncture site and contrast reaction. One patient experienced an aneurysm at a puncture site using a stent. Contradictory findings on the occurrence of perforations were reported in the two studies of patients with coronary perforation.
Long term adverse events, including mortality and major adverse cardiac events were reported by one study (as reported in the review).
Procedure complications: Two studies reported no procedure complications using balloon or balloon-coated catheters. Two additional studies reported procedural failure in eight patients using various different devices (as reported in the review).
Device malfunctions: Only one study assessed balloon rupture or failure of delivery and reported no occurrences.