Abstract
BackgroundAngioplasty is a fundamental treatment for atherosclerotic disease in the cardiac, cerebrovascular, and peripheral vascular beds. However, the optimal duration of balloon inflation has not been identified. Our study will investigate whether prolonged angioplasty balloon inflation of at least 1 min duration, when compared with brief inflation, affects residual stenosis after arterial angioplasty.MethodsIn compliance with PRISMA, two independent reviewers will conduct a systematic review of EMBASE, MEDLINE, CENTRAL, trial registries, grey literature, and ancestry and citation search. Data abstraction, quantitative, and quantitative meta-analysis will be performed according to pre-specified criteria. The primary outcome is residual stenosis immediately after initial angioplasty; however, secondary outcomes will include multiple short and long term pre-specific clinical and radiographic outcomes. Risk of bias, subgroup analyses, and sensitivity analyses are planned.DiscussionDespite the ubiquitous use of angioplasty in atherosclerotic disease and multiple trials investigating the ideal balloon inflation duration, there are no systematic reviews evaluating prolonged angioplasty balloon inflation. Currently synthesized evidence is insufficient to confidently direct clinical decision-making, and the current variation in operator preference of balloon angioplasty duration suggests ongoing clinical equipoise. Given the known availability of current primary evidence, our study intends to synthesize the evidence and guide future clinical decision making and investigation.Systematic review registrationPROSPERO CRD42018092702
Highlights
Angioplasty is a fundamental treatment for atherosclerotic disease in the cardiac, cerebrovascular, and peripheral vascular beds
Various techniques have been proposed to minimize restenosis following angioplasty; many have not been thoroughly evaluated in randomized trials
While a meta-regression to determine the relative impact of angioplasty inflation duration on restenosis could theoretically demonstrate an ideal inflation duration, this will not be feasible due to the anticipated breadth of disease and reporting variability
Summary
Angioplasty is a fundamental treatment for atherosclerotic disease in the cardiac, cerebrovascular, and peripheral vascular beds. Various techniques have been proposed to minimize restenosis following angioplasty; many have not been thoroughly evaluated in randomized trials One such technique is prolonged angioplasty balloon inflation time, which is theorized to reduce post-interventional dissection and induce smooth muscle dysfunction, thereby reducing vasospasm and resulting stenosis. While animal studies have not revealed short-term mechanical advantage for prolonged balloon inflation [3], smooth muscle dysfunction has been observed [4]. Prolonged balloon inflation may incur risk to the patient by mask flow-limiting dissections, which could have been identified if only transient balloon inflation was used Identification of these dissections is relevant as they are at high risk of causing target lesion occlusion and necessitate stent placement
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