MINIREVIEW SERIES FOR THE 50TH
VOLUME
Percutaneous coronary intervention: current perspective
Tomoaki Hinohara
Cardiovascular Medicine and Coronary Interventions, Sequoia Hospital, Redwood City and Stanford University
Medical Center, Palo Alto, CA, USA(Received for publication on May 30, 2001)

Abstract. More than 20 years have passed since percutaneous transluminal coronary angioplasty(PTCA) was introduced for the treatment of coronary artery disease. During the ®rst decade, PTCA
outcome had improved signi®cantly. However, acute occlusive complications and restenosis remained
as signi®cant limitations of the procedure. During the second decade, new procedures, such as stents
and atherectomy (directional coronary atherectomy, and Rotablator) had been introduced and had asigni®cant impact on the outcome of percutaneous coronary intervention (PCI). In addition to theimprovements in the equipment, the use of glycoprotein IIb/ IIIa inhibitors to prevent platelet aggregation has reduced procedure-related complications. PCI continues to evolve with new developments
such as distal protection devices to prevent distal embolism, brachytherapy and drug-eluting stents toprevent restenosis. These new technologies may play a signi®cant role in expanding the applications of
PCI in the future. (Keio J Med 50 (3): 152±160, September 2001)
Key words: PTCA (percutaneous transluminal coronary angioplasty), PCI (percutaneous coronary
intervention), stent, atherectomy, restenosis

Introduction
Percutaneous Transluminal Coronary Angioplasty(PTCA), ®rst attempted in humans for the treatment ofcoronary artery disease more than 20 years ago, has
evolved signi®cantly over these past two decades. The
term percutaneous coronary intervention (PCI) became
more appropriate than PTCA because of the use ofvarious non-balloon devices and this is now the mostfrequently performed procedure for the treatment ofcoronary artery disease (CAD). This article summarizes
the evolution of PCI: the past, present and future.
PTCA in the First Decade
The ®rst PTCA using an in¯atable balloon for thetreatment of CAD was attempted by Andreas Gruentzig in 1977. He subsequently published the summary of
his early experiences in the New England Journal of
Medicine.1 Initially he faced many criticisms that thisprocedure was too dangerous and unpredictable. How-ever, within a couple of years, the procedure had
spread worldwide and revolutionalized the treatmentof CAD. During the ®rst several years of PTCA, procedural outcome improved signi®cantly. This occurredwith the enhancement of technical skills and increased
knowledge of operators, as well as signi®cant improvements in the equipment used for PTCA (Fig. 1). These
improvements in equipment included better torque andsupport of the guiding catheters, lower pro®le balloons,
over-the-wire balloon systems and shapeable and torqueable guide wires. Initial PTCA success (usuallyde®ned as <50% residual stenosis without major complication) was approximately 67% in the early experiences published in the ®rst National Institute of Health(NIH) Registry.2 Of note, the NIH Registry was quickly
established to evaluate the ef®cacy, safety and trends ofPTCA in the US. The quick establishment of the NIH
registry helped assess the practice pattern and procedure outcome accurately and this information was extremely educational. The success rate improved from
67% to 88% over the next ten years.3

Reprint requests to: Dr. Tomoaki Hinohara, Cardiovascular Medicine and Coronary Interventions, 2900 Whipple Avenue, Suite 230, Redwood
City, CA 94062, USA
152

Keio J Med 2001; 50 (3): 152±160

Fig. 1

PTCA Balloon.

The mechanisms of balloon dilatation of stenotic
lesions are multifactorial. High pressure (8±15 atmospheres) balloon dilatation at a stenotic lesion results indissection and laceration of the intima, media and often
adventitia, stretching of the vessel wall and some compression of soft atherosclerotic material.4±6 Thesechanges create a wider lumen size in many lesions. Although the overall success rate was high, there weresigni®cant limitations with this procedure associatedwith uncontrolled balloon injury, such as elastic recoilof dilated segments resulting in suboptimal improvement of vessel size, or uncontrolled dissection causing
acute vessel occlusion.7±9 In addition to these limitations of the acute outcome, restenosis of treated segments occurred in 30±50% despite successful initialdilatation, during the ®rst six months following theprocedure.10±12 To overcome these limitations, many
second generation non-balloon devices were developed.
These included directional coronary atherectomy(DCA), Rotablator and stents. The Food and Drug
Administration (FDA) in the US also approved otherdevices, such as laser and TEC, but these devices are
currently used very infrequently.
Second Generation Devices
Atherectomy
Directional Coronary Atherectomy (DCA) was the®rst non-balloon coronary device that was approvedby the FDA in the US in 1989 (Fig. 2). The device
effectively removes atherosclerotic obstructive tissue(atheroma  removal  atherectomy) with a rotating
cutter within a cylindrical housing. By removing tissue,
a smoother and much wider lumen was obtained

153

Fig. 2 Directional coronary atherectomy catheter. Atherosclerotic
plaque invaginated into the window by low pressure balloon dilatation is excised by a rotating cutter and excised material is stored in the
distal nosecone.

Fig. 3 A case of directional coronary atherectomy (DCA). a)
Angiogram of right coronary artery: pre-treatment. b) Directional
coronary atherectomy device in the artery. c) Angiogram: post DCA.
d) Excised tissue.

(Fig. 3). Early preliminary non-randomized studies
suggested the potential for improving acute outcome
and reducing restenosis.13±15 It was hypothesized thata bigger post interventional lumen retained a wider
lumen in the chronic recovery phase, thus reducing
restenosis. CAVEAT (Coronary Angioplasty Versus
Excisional Atherectomy Trial), which compared DCA
and PTCA, was the ®rst device-related randomized trial
performed.16 The results demonstrated no signi®cant
improvement of the restenosis rate with DCA overconventional PTCA. It was a historical study since thiswas the ®rst device-related multi-center randomized
trial to evaluate ef®cacy in a scienti®c manner. This
study, however, revealed some of the limitations anddif®culties of device-related trials. These include use of

154

Hinohara T: Percutaneous coronary intervention

Fig. 4 Rotablator: The burr, with small particles of diamonds, rotates
at high speed and ablates atherosclerotic plaque.

®rst generation devices that are still in their developmental phase, limited operator experience, and nonestablished operator methods. A subsequent study,
BOAT (Balloon vs. Optimal Atherectomy Trial) withmore experienced operators and established procedural
methods using second generation devices, demonstrated
superior results for acute outcome and restenosis with
DCA compared with PTCA (residual stenosis was 14.7%
vs. 28.1%; p < 0:001 and the restenosis rate was 32%
vs. 40%; p < 0:02).17 These experiences demonstrated
some of the dif®culties of device-related trials, but also
showed the importance of randomized trials to scientifically evaluate ef®cacy without biases.
Another effective device for ablation of atherosclerosis is the Rotablator (Fig. 4). Balloon dilatation
has a limited ef®cacy in heavily calci®ed lesions which
are very hard and non-compliant, due either to a failure
to dilate or from resulting signi®cant dissections. The
Rotablator burr, which is covered with small particles
of diamonds, spins at approximately 150±180,000 rpm
and this procedure effectively ablates calci®ed plaque.
This is an effective method to treat calci®ed lesions andto improve the initial procedural outcome (Fig. 5).18,19
Subsequent studies, however, (including non-calci®edlesions) failed to demonstrate the superiority over
PTCA on the restenosis rate.20
Stent Era
In contrast to the ``debulking'' approach, anotherapproach to overcome the limitations of PTCA wasstent placement in stenotic lesions to support the vessel
wall from inside the lumen. Self-expandable stainlesssteel stents (Wallstent8 ) were implanted in humancoronary arteries in Europe with acceptable intial
results.21 Subsequently, the Gianturco-Roubin stent
was the ®rst stent approved by the FDA for use in theFig. 5 A case of Rotablator. a) Angiogram of right coronary arteryprior to Rotablator. b) Angiogram treated with Rotablator initiallyfollowed by balloon dilatation.

US.22 This stent was a balloon-expandable stainlesssteel coil and was indicated as a ``bail-out'' device following failed attempted PTCA. This coil stent had
more elastic recoil because of less than ideal hoop
strength and initial experience suggested a rather highrestenosis rate. The other balloon-expandable stent wasa slotted tube stent (laser cut patterns from stainlesssteel tubing) and this had more hoop strength; the Palmaz-Schatz stent was the ®rst slotted tube stent tested
in humans. This ®rst generation stent was rather rigid
with a larger pro®le and had signi®cant limitations in its

Keio J Med 2001; 50 (3): 152±160
Table 1

155

StentsBalloon Expandable Stents
Penta multilink* (Guidant)
Multilink Ultrastent* (Guidant)
NIR stent, NIR Royal* (Boston Scienti®c)
Velocity* (Cordis)
S660, S670, BeStent* (Medtronic)
Self Expandable Stents
Radius stent* (Boston Scienti®c)
Magic Wallstent* (Boston Scienti®c)* These are primarily second or third generation stents and are notapproved in Japan at the present time.

deliverability. Despite some limitations as a ®rst generation device, stent placement clearly improved acuteoutcome, with fewer acute occlusions and a larger postprocedure lumen size. Subsequently, the ®rst randomized trial using the Palmaz-Schatz stent showed a signi®cant reduction in the restenosis rate compared with
PTCA (31% vs. 42%; p  0:04).23 The BENESTENT(Belgium-Netherland Stent) Trial also con®rmed thisfavorable result.24 Although stents had a signi®cantadvantage over PTCA for reducing the restenosis rate,they did have their own limitations. One of the major
limitations was subacute thrombosis and the requirement of a complex anticoagulation regime that was
associated with bleeding complications at the femoral
access site. To prevent subacute thrombosis, which wasa risk during the ®rst two to three weeks until the stentwas covered by endothelial cells, patients were initiallytreated with aspirin and warfarin. Despite aggressive
anticoagulation, the subacute thrombosis rate was 2±
3%. Major breakthroughs were the use of an additionalanti-platelet agent, ticlopidine, with Aspirin but without
warfarin, as well as high pressure stent delivery forcomplete apposition of the stent struts against the vessel wall, to prevent subacute thrombosis. With theseapproaches, the subacute thrombosis rate was reduced
to <1% and signi®cant groin access site complications
were reduced.25±27 With further improvements of stenttechnology, stents are now more ¯exible, have bettersurface coverage with improved hoop strength andlower pro®le with better deliverability. It is estimatedthat approximately 80% of PCI cases are stented in the
US. More than 20 types of stents are now available in
the world. The stents currently available in the US arelisted in Table 1 (Fig. 6).
Restenosis
Although stents and to a lesser degree DCA, reducethe incidence of restenosis, this remains the Achilles'
heel of PCI. Restenosis is the reactive response to

Fig. 6 Tetra9 stent. (Guidant) a) Collapsed stent mounted on a balloon. b) Stent expanded on tip of balloon. c) Expanded stent.

tissue injury created by a PCI procedure and usuallyoccurs between 2 and 6 months following a procedure.
The restenosis rate following PTCA is 30±45%.10±12
Elastic recoil plays some role in restenosis, but themain cause of restenosis following PTCA or DCA wasconsidered to be intimal hyperplasia associated withsmooth muscle proliferation. Use of intravascular ultrasound, which gives a cross-sectional ultrasonic viewof the vessels from inside the lumen, has provided us
with some surprising ®ndings. In addition to intimal
hyperplasia, remodeling of the artery, causing shrinkage of the whole vessel size, plays as important a role as
intimal hyperplasia in the cause of restenosis.28,29 In
contrast to the restenosis process following PTCA and
DCA, restenosis following stenting is purely due to156

intimal hyperplasia since remodeling of the vessel isprevented by the stent itself.
Over the last 2 decades, many pharmacologicalagents have been tested to reduce restenosis by preventing intimal hyperplasia from occurring. Unfortunately none of these has been shown to be effective
clinically. At the present time, one of the most potentially effective treatments to prevent restenosis is brachytherapy. Appropriate dosage of b- or g- radiationdelivered through specially designed catheters effectively suppresses the process of intimal hyperplasia
without causing signi®cant radiation injury in the animal model. Gamma radiation was tested ®rst in humans; a single-center randomized trial demonstrated
a signi®cant reduction of intimal hyperplasia and clinical restenosis following PCI. The late loss of lumen size
was reduced from 1.03 mm to 0.38 mm and the restenosis rate reduced from 54% to 17% with radiation.30
This result was con®rmed by a much larger scalerandomized trial (GAMMA I Trial).31 b-radiation wastested for the treatment of in-stent restenosis; a multicenter, placebo-controlled, randomized trial (START:Sr Treatment of Angiographic Restenosis) demonstrated a signi®cant reduction in the restenosis rate
(radiation 29% vs. placebo 45%; p < 0:05) and target
vessel revascularization rate (16% vs. 24%; p < 0:05).32
Based on these data, both g- and b-radiation treatments
were approved by the FDA for the treatment of in-stentrestenosis in coronary arteries in the US.
Although brachytherapy clearly reduces the incidence of restenosis, some unique adverse events havebeen observed. When brachytherapy was utilized during new stent implantation, there was an increase in theincidence of late (>3 month) acute thrombosis, which isan extremely rare event with stent implantation itself
without radiation.33 This is most likely due to the lackof endothelial cell coverage over the stent struts causedby complete suppression of smooth muscle cell proliferation and endothelial cell growth by brachytherapy.
Another unusual effect is the ``candy wrapper'' effect.34
Restenosis at the center of the area treated by radiation
is effectively prevented, but both edges of the radiatedsegment may have signi®cant intimal hyperplasia, creating signi®cant stenoses. Lower dosage of radiation
at the edge of the treated segment may cause stimulation rather than suppression of intimal hyperplasia.
Little is known of the longer-term effects of brachytherapy at the present time. Brachytherapy may only
slow down the process of intimal hyperplasia and restenosis may eventually occur. Another concern is theeffect of radiation on the acceleration of atherosclerosis. Since radiation therapy is very new and potentially hazardous, longer-term information is necessary to evaluate this new therapeutic treatment for amuch wider application.

Hinohara T: Percutaneous coronary intervention

Glycoprotein IIb/IIIa Receptor Inhibitors
Many pharmacological agents have been developed
to improve the outcome of PCI procedures. Aspirin was
the ®rst medication proven to be necessary during
PTCA to prevent acute occlusion associated with platelet aggregation. As described, oral anti-platelet
agents, ticlopidine (Ticlid8 ) and clopidogrel (Plavix8 ),have become important agents in addition to aspirin, in
preventing subacute thrombosis following stenting. Introduction of glycoprotein IIb/IIIa receptor inhibitors,
which block the interaction between the glycoprotein
IIb/IIIa receptor and its principal adhesive ligand,®brinogen, have become important agents for PCI. By
inhibiting the IIb/IIIa receptor site, these agents,
abciximab (ReoPro8 ), epti®batide (Integrilin8 ) andtiro®ban (Aggrastat8 ), inhibit approximately 90% of
platelet activity.35,36 Initially, the ef®cacy of abciximab
was tested during PCI without stenting. This multicenter, placebo-controlled, randomized trial (EPILOG:
Evaluation in PTCA to Improve Long Term Outcome
with Abciximab GP IIb/IIIa Blockade Study Group)
demonstrated a signi®cant reduction of MACE (major
adverse cardiac event: death, myocardial infarction,
revascularization) within 30 days.37,38 There was no
statistical difference in death or reavascularization.
However, myocardial infarction, de®ned by CK elevation associated with the procedure, was signi®cantly
lower with abciximab. This agent was then tested during stenting procedures (EPISTENT: Evaluation in
PTCA to Improve Long Term Outcome with Abciximab GP IIb/IIIa Blockade Study Group). The study
was designed with 3-way randomization; stent alone,stent with abciximab and PTCA with abciximab.
Death or large myocardial infarction (documented bysigni®cant CPK elevation) in the ®rst 30 days was highest in the stent alone group followed by PTCA withabciximab and Stent with abciximab (7.8%, 4.7%,
3.0%).39 This was a somewhat surprising result since it
was generally felt that stenting for uncomplicated cases
did not require abciximab. This result was con®rmed
with a subsequent study using epti®batide (Integrilin)(ESPRIT: Enhanced Suppression of the Platelet IIb/
IIIa Receptor with Intergrilin Therapy).40 Thesestudies demonstrated the importance of scienti®callywell-designed randomized trial to evaluate ef®cacy.
Based on these data, use of IIb/IIIa in the USA has
been rising as a part of routine PCI.
New Devices
In the past, many devices were developed to improve
the outcome of stenotic lesions and to reduce restenosis. Recently, the concept of ``distal protection'' during PCI procedures was introduced. In saphenous vein

Keio J Med 2001; 50 (3): 152±160

grafts, the incidence of distal embolism causing myocardial infarction or slow ¯ow was high. Distal embolism is normally caused by dislodgement of friableatherosclerotic material or thrombus when lesions areintervened with PTCA or stenting. Distal protection
devices prevent distal embolisms by capturing debris
from the lesions during interventions; this is either accomplished by a basket on a wire or a distal occlusion
balloon with aspiration of material. The randomized
trial (SAFER: Saphenous Vein Graft Angioplasty Freeof Emboli Randomized Study) using an occlusion balloon with an aspiration catheter (PercuSurge) demonstrated a signi®cant reduction of peri-procedural myocardial infarction during stenting procedures (8.4%
with protection device vs. 16.5% with control) (Fig.
7).41 Captured material, with this protective device, isusually ®ne atherosclerotic debris or thrombus. The
FDA in the US recentry approved this device. In addition to intervention of SVG, distal protection devices
will play a pivotal role for carotid stenting since any
small dislodgement of material can cause stroke during
carotid intervention. Currently, use of distal protection
devices during emergency PCI for evolving acute myocardial infarctions are under investigation. Distal protection devices are likely to play a signi®cant role, forboth coronary and non-coronary vascular intervention,in the future.
One of the most exciting recent developments is
drug-eluting stents to prevent restenosis. The stents areused as the vehicle of drug delivery for a prolonged
time. The stents are coated with a thin layer of polymer
that carries a pharmacological agent. The drugs are thengradually released to the lesion over periods (usually 30days). Stents coated with sirolimus (Rapamycin8 ), an
immunosuppressive agent used for post renal transplants, demonstrated a signi®cant reduction of neointimal hyperplasia in the animal model. Early humanstudies using Rapamycin-coated stents (< 50 patients)
showed very favorable results in preventing restenosis
following stenting.42 Other agents, such as an antiproliferative agent (Taxol), have also been tested inhumans. These early and favorable data need to becon®rmed with a large-scale randomized trial in the
future. This approach may be a major breakthrough forthe prevention of restenosis that remains the Achilles'
heel of PCI. If this approach signi®cantly reduces
restenosis, the indications and use of stents will bemuch wider than current use and an increasing numberof patients will be treated with PCI rather than CABG.
Current Trends in the US
In the US, the number of PCIs continues to increase
and it is estimated that more than 600,000 cases were
performed in 1999. The estimated number of CABG

157

Fig. 7 A case of stenting using a distal protection device. a) Angiogram of saphenous vein graft to the left anterior descending coronary
artery, pre-stent. b) 4 mm  23 mm length Tetra8 stent deployment
with balloon in¯ation ("). This procedure was performed using a Percusurge distal protection device (""). c) Angiogram post stenting.

operations is approximately 350,000/year, thus the estimated ratio of PCI/CABG is about 2 : 1. Of note, thisratio is much lower than that of 6±7 : 1 in Japan.
Currently available devices in the US are listed inTable 2. Most of the lesions which are accessible withstents and have a reference vessel size of b2.5 mm, are158
Table 2

Hinohara T: Percutaneous coronary intervention
Devices Currently Available in the U.S.

1. PTCA balloon
2. Cutting Balloon
3. Stents
4. Directional Coronary Atherectomy (DCA)
5. Rotablator
6. Laser
7. Transluminal Extraction Catheter (TEC)
8. Angiojet (thrombus aspiration catheter)
9. Beta and gamma radiation catheters
10. Distal protection device (Guardwire)

treated with stenting and it is estimated that currently
more than 80% of PCI are stent procedures. Other
devices such as DCA, Rotablator and the cutting balloon are considered to be ``niche'' devices, their use
being limited to selective cases and speci®c indications.
DCA is indicated for left anterior descending (LAD)
ostial lesions or bifurcation lesions involving a largeside branch. Debulking prior to stenting is an attractive strategy to prevent restenosis. Based on an
initial observational study,43 two randomized studies(AMIGO: Atherectomy before Multilink Improves
Lumen Gain Outcome, in the US and DESIRE:
Debulking and Stenting in Restenosis Elimination, inJapan) are currently under investigation. The resultsfrom these trials will soon be available to evaluate therole of debulking prior to stenting. Rotablator is generally used for heavily calci®ed lesions and is very effective in this setting. This device is used as a standalone with post balloon dilatation or as an adjunctive
treatment prior to stenting to improve stent expansion.
The cutting balloon, which has small blades on the balloon, was introduced in the US recently. It is still too
early to determine what role this device will play. Currently, the cutting balloon is used mostly for in-stentrestenosis, ostial lesions or diffuse disease.
Although radiation (b and g) has been approved in
the US recently, it is dif®cult to predict how widely thisprocedure will be accepted. Due to logistical reasons(isotope license, need for radiation oncologist andphysicist) the institutions that will allow brachytherapy
to be performed will be limited. In addition, longerterm information is limited and this is a rather signi®cant concern. Most likely, this procedure will be used
for refractory in-stent restenosis or diffuse in-stentrestenosis, which have a known high recurrent restenosis rate with any other interventional approaches.
The quality of operators is important to obtain excellent PCI outcome. Similar to coronary artery bypass
surgery, the experience of the operators and the institution has a signi®cant impact on its outcome. Evaluation of more than 60,000 PTCA cases in New Yorkstate between 1991 and 1994, demonstrated the striking
relationship between institutional and operator volume

and PTCA outcome.44 Institutions with less than 600
cases/year, particularly less than 200/year, were associated with higher signi®cant complication rates. Similarly, operators with less than 75 cases/year had ahigher complication rate. No de®nitive statistics areavailable but it is estimated that the number of averagecases per physician is less than 50 cases/year.
To improve the outcome and to maintain the highquality of the PCI procedure, recent guidelines fromthe American Heart Association and the American
College of Cardiology recommend the minimum of 250
cases/year for the institution and 75 cases/year for theoperator. Recently, the Interventional Cardiology Subspecialty Board was established by the American Boardof Internal Medicine and the ®rst certi®cation examination was offered in 1999. To be quali®ed for the ``appropriate experience and training'', either at least morethan 500 life-time experience or >75/year for two consecutive years or one year of interventional cardiology
training at an accredited program with at least 250 procedures are required. Although these guidelines andsubspecialty do not have legal restraint on the institutions or physicians, these will help to improve theoverall outcome of PCI.
Summary
Since the introduction of PTCA in 1977, PCI has
evolved signi®cantly. PCI treatment has become mainstream for the treatment of CAD. In addition to significant improvements of basic PTCA equipment, newgeneration procedures such as DCA, Rotablator andmost signi®cantly stents, have improved the outcome of
PCI procedures. Although restenosis remains one of
the major limitations of this procedure, new approaches
including radiation have improved its outcome. Exciting technologies such as drug-eluting stents will havesigni®cant impact on outcome. It is likely the indications for PCI will continue to expand and PCI will
become more effective in the future. Evidence-based
medicine will play a more important role to evaluate
and guide PCI procedures in the future.
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