Coronary angioplasty was first introduced by Andreas
Gruentzig in 1977 (1)
as a nonsurgical method for coronary arterial revascularization.
Fundamentally, the technique involved advancing a balloon
tipped catheter to an area of coronary narrowing, inflating
the balloon and then removing the catheter following
deflation. Early reports demonstrated that balloon angioplasty
could reduce the severity of coronary stenosis and diminish
or eliminate objective and subjective manifestations
of ischemia (2-4).
Although angioplasty was clearly feasible and effective,
the scope of coronary disease to be treated was quite
narrow. Also, since angioplasty could result in sudden
arterial occlusion and subsequent myocardial infarction
(MI), immediate access to coronary bypass surgery was
essential (5).
With experience and time, however, the cognitive and
technical aspects as much as the equipment used to perform
angioplasty became more refined. Observational reports
of large numbers of patients confirmed that coronary
angioplasty could be applied to broad groups of coronary
patients with higher rates of success and lower rates
of complications when compared to initial experiences
(6,7).
More than 500,000 PCI procedures are performed yearly
in the United States (8),
and it has been estimated that more than 1,000,000 procedures
are performed annually worldwide.
The value of coronary angioplasty was further defined
by comparing its results to those of alternative methods
of treatment. Randomized clinical trials have assessed
the outcomes of patients treated by a strategy of initial
angioplasty to one of medical therapy alone or to coronary
artery bypass surgery (9-14).
The results of these trials have clarified the utility
of angioplasty in terms of effectiveness, complications,
and patient selection. The technique of coronary angioplasty
has also been expanded by the development of devices
that replace or serve as adjuncts to the balloon catheter.
These “new devices” have been thoroughly evaluated
and have had a critical impact in enhancing the immediate-
and long-term efficacy and safety of coronary angioplasty.
The following section of this report expands on this
background and describes the practice of PCI as it is
applied today.
New coronary devices have expanded the clinical and
anatomical indications for revascularization initially
limited by balloon catheter angioplasty. For example,
stents reduce both the acute risk of major complications
and late-term restenosis. The success of new coronary
devices in meeting these goals is in part represented
by the less frequent use of balloon angioplasty alone
(<30%) and the high (>70%) penetration of coronary stenting
in the current practice of interventional cardiology
(Figure 1). Atherectomy devices
and stenting, associated with improved acute angiographic
and clinical outcomes compared to balloon angioplasty,
in specific subsets, continue to be applied to a wider
patient domain that includes multivessel disease and
complex coronary anatomy. However, strong evidence (level
A data from multiple randomized clinical trials) is
only available for stenting in selected patients undergoing
single-vessel PCI.
The range of new, non-balloon revascularization technology
approved by the Food and Drug Administration (FDA) for
use in native or graft coronary arteries includes balloon
expandable stents, atherectomy by the Transluminal Extraction
Catheter (TEC), Directional Coronary Atherectomy (DCA),
rotational atherectomy, angiojet thrombolysis catheter,
and Excimer Laser Coronary Atherectomy (ELCA). A variety
of devices is under investigation including new designs
of balloon or self-expanding stents, mechanical thrombectomy
devices, and local radiation devices intended to reduce
restenosis. These guidelines will focus on the FDA-approved
balloon related and non-balloon coronary revascularization
devices.
