Randomized Trial of Simple Versus Complex Drug-Eluting
Stenting for Bifurcation Lesions
The British Bifurcation Coronary Study: Old, New, and
David Hildick-Smith, MD, FRCP; Adam J. de Belder, MD, FRCP; Nina Cooter, MSc;
Nicholas P. Curzen, PhD, FRCP; Tim C. Clayton, MSc; Keith G. Oldroyd, MD, FRCP;
Lorraine Bennett, MSc; Steve Holmberg, MD, FRCP; James M. Cotton, MD, FRCP;
Peter E. Glennon, PhD, FRCP; Martyn R. Thomas, MD, FRCP; Philip A. MacCarthy, PhD, FRCP;
Andreas Baumbach, MD, FRCP; Niall T. Mulvihill, MD; Robert A. Henderson, DM, FRCP;
Simon R. Redwood, MD; Ian R. Starkey, BSc, FRCP; Rodney H. Stables, DM, FRCP
Background—The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal
stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have
low rates of restenosis and might offer improved outcomes with complex stenting techniques.
Methods and Results—Patients with significant coronary bifurcation lesions were randomized to either a simple or
complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by
optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or
crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64?10 years old were randomized;
77% were male. Eighty-two percent of lesions were true bifurcations (?50% narrowing in both vessels). In the simple
group (n?250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting.
In the complex group (n?250), 89% of culotte (n?75) and 72% of crush (n?169) cases were completed successfully
with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction,
and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02,
95% confidence interval 1.17 to 3.47, P?0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively
(P?0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P?0.002), respectively.
Procedure duration and x-ray dose favored the simple approach.
Conclusions—When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of
in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural
myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain
the preferred strategy in the majority of cases.
Clinical Trial Registration Information—URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.
Key Words: coronary disease ? bifurcation ? stents ? angioplasty
higher rates of dissection, myocardial infarction, and acute
vessel closure.1The advent of coronary stenting reduced the
oronary bifurcation lesions were considered high risk for
angioplasty in the early interventional era because of
risks, but in-stent restenosis was noted to be frequent at the
ostium of the side branch.2Two-stent techniques were devel-
oped to try to combat this phenomenon2,3but gave inferior
results to the provisional T technique in nonrandomized
Received June 23, 2009; accepted December 14, 2009.
From the Sussex Cardiac Centre (D.H.-S., A.J.d.B., N.C., L.B., S.H.), Brighton and Sussex University Hospitals, Brighton, United Kingdom;
Southampton University Hospitals (N.P.C.), Southampton, United Kingdom; London School of Hygiene & Tropical Medicine (T.C.C.), London, United
Kingdom; Golden Jubilee National Hospital (K.G.O.), Glasgow, United Kingdom; Heart and Lung Centre (J.M.C.), Wolverhampton, United Kingdom;
Walsgrave Hospital (P.E.G.), Coventry, United Kingdom; King’s College Hospital (M.R.T., P.A.M.), London, United Kingdom; Bristol Heart Institute
(A.B.), Bristol, United Kingdom; St James Hospital (N.T.M.), Dublin, Ireland; Nottingham University Hospitals (R.A.H.), Nottingham, United Kingdom;
St Thomas Hospital (S.R.R.), London, United Kingdom; Edinburgh Royal Infirmary (I.R.S.), Edinburgh, United Kingdom; and Liverpool Heart and Chest
Hospital (R.H.S.), Liverpool, United Kingdom. Coordinating center: Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United
Correspondence to David Hildick-Smith, Sussex Cardiac Centre, Royal Sussex County Hospital, Eastern Rd, Brighton, BN8 5QH, United Kingdom.
© 2010 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.orgDOI: 10.1161/CIRCULATIONAHA.109.888297
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studies.4,5For bare-metal stents, therefore, the provisional
T-stent strategy was considered to be the gold standard
Clinical Perspective on p 1243
The introduction of drug-eluting stents restored interest in
more complex bifurcation techniques because of the ex-
tremely low observed rates of restenosis.7The crush and
culotte techniques, respectively, were developed8or refined9
to improve outcomes.
Early studies into the use of drug-eluting stents at bifurca-
tions were reasonably encouraging.10,11We therefore de-
signed a randomized trial to compare the provisional T-stent
strategy with a systematic 2-stent technique using drug-
The study was an investigator-led prospective, randomized, multi-
center trial in the United Kingdom and was funded through the
Cardiac Research Unit at the Sussex Cardiac Centre (including
unrestricted research funding from Boston Scientific) and through a
grant from the Brighton and Sussex University Hospitals NHS Trust.
The study protocol was approved by the UK National Research
Ethics Service and the Medicines and Healthcare Products
Patients were eligible for the study if they were at least 18 years old
and had bifurcation coronary artery disease that required percutane-
ous coronary intervention (PCI) in which the main-vessel reference
diameter was ?2.5 mm and the side-branch reference diameter was
?2.25 mm. Main exclusion criteria were unprotected left main stem
narrowing ?50%, primary angioplasty for acute ST-elevation myo-
cardial infarction, cardiogenic shock, chronic total occlusion of
either vessel, additional type C or bifurcation lesion that required
PCI, left ventricular ejection fraction ?20%, platelet count
?50?109/mm3, patient life expectancy ?12 months, or known
relevant allergies. Patients who consented to participate in the study
were randomized via a secure World Wide Web site by use of
standard random-number-generation methodology with stratification
Patients were assessed for angina status (Canadian Cardiovascular
Society) and antianginal medication. Aspirin 75 mg/d was continued
if the patient was established (?3 days) on this medication. If not,
aspirin 300 mg was given ?3 hours before PCI. Clopidogrel 75 mg/d
was continued if the patient was established (?3 days) on this
medication. If not, clopidogrel 600 mg was given ?3 hours before
PCI. Intravenous unfractionated heparin 70 IU/kg was given at the
start of the procedure and to keep the activated clotting time
?200 seconds during the procedure. Glycoprotein IIb/IIIa inhib-
itors were used at the discretion of the operator. Blood for serum
creatine kinase (CK) and troponin levels was taken at the start of
Percutaneous Coronary Intervention Procedure
PCI was undertaken via the access site of choice of the operator.
TAXUS paclitaxel-eluting stents (Boston Scientific Corp, Natick,
Mass) were used. Only operators with a minimum annual volume of
150 cases were allowed to participate.
Patients randomized to the simple arm of the study underwent a
provisional T-stent strategy with strict rules for progression through
Stage 1. Coronary guidewires were passed to the main vessel and,
where desired, the side branch. The main and side vessels were
pretreated at the operator’s discretion. The main vessel was stented
with or without wire protection of the side branch according to
operator preference. The side branch was not treated further unless
there was Thrombolysis In Myocardial Infarction (TIMI) flow ?3 in
the side branch, severe ostial pinching of the side branch (?90%),
threatened side-branch vessel closure, or side-branch vessel dissec-
tion greater than type A. If 1 of these criteria existed, the operator
could progress to the next stage, but this was not mandatory.
Stage 2. The side branch was rewired, and a kissing balloon inflation
was undertaken with anatomically appropriate sizing for each vessel.
The side branch was not then treated further unless there was TIMI
flow ?3 in the side branch, persistent ostial pinching of the side
branch (?70%), threatened side-branch vessel closure, or side-
branch vessel dissection greater than type A.
Stage 3. If 1 of these situations applied, T stenting of the side branch
could be undertaken, with mandatory kissing balloon inflation.
Patients who were randomized to the complex arm of the study
underwent a crush or a culotte procedure according to operator
Crush Technique. Both vessels were wired, with lesion preparation as
for the simple strategy. For a 6F guiding catheter approach, a stent in the
side branch was positioned adjacent to a balloon in the main branch.
With 7F/8F guiding catheters, 2 stents could be placed simultaneously.
The side-branch stent was deployed first, with struts overhanging into
the main vessel to ensure full coverage of the side-branch ostium. After
removal of the side-branch wire and balloon, the main vessel was
ballooned and stented sequentially (6F) or stented (7F/8F). The side
branch was rewired, and a mandatory attempted kissing balloon dilata-
tion was undertaken to optimize stent-to-wall apposition.
Culotte Technique. Bothvesselswerewired,withlesionpreparationas
then stented first with a wire jailed in the main vessel. The main vessel
side-branch wire) stented. The side branch was rewired, and mandatory
attempted final kissing balloon inflations were undertaken.
For both groups, at any stage, proximal or distal dissections could
be treated with further stenting. Postdilations could be undertaken to
optimize stent expansion. In all cases, an additional vessel with type
A or B lesion could be treated if required.
Hemostatic technique and use of vascular closure devices were at the
were removed when the activated clotting time was ?175 seconds. CK
and troponin were taken 16 to 22 hours after PCI. Aspirin 75 mg/d and
clopidogrel 75 mg/d were given for a minimum of 9 months.
Adverse event tracking began at randomization and continued to the end
of the 9-month follow-up period. Patients underwent either telephone or
hospital follow-up at 3 and 6 months, followed by a final hospital
follow-up visit at 9 months. At the 9-month visit, Canadian Cardiovas-
cular Society grade and antianginal medication were assessed.
The primary end point of the study was a composite of all-cause
death, myocardial infarction, and target-vessel failure by 9 months.
Secondary end points were the individual components of the primary
end point, angina status (Canadian Cardiovascular Society; angina
medication score), and repeat angiography at 9 months. Procedural
end points were procedural success, completion of final kissing
balloon inflations where mandated, in-hospital major adverse car-
diovascular events (MACE), in-hospital non-MACE serious adverse
events, procedure duration, fluoroscopy time, and x-ray dose.
March 16, 2010
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Henderson, Simon R. Redwood, Ian R. Starkey and Rodney H. Stables
Martyn R. Thomas, Philip A. MacCarthy, Andreas Baumbach, Niall T. Mulvihill, Robert A.
Keith G. Oldroyd, Lorraine Bennett, Steve Holmberg, James M. Cotton, Peter E. Glennon,
David Hildick-Smith, Adam J. de Belder, Nina Cooter, Nicholas P. Curzen, Tim C. Clayton,
Lesions: The British Bifurcation Coronary Study: Old, New, and Evolving Strategies
Randomized Trial of Simple Versus Complex Drug-Eluting Stenting for Bifurcation
Print ISSN: 0009-7322. Online ISSN: 1524-4539
Copyright © 2010 American Heart Association, Inc. All rights reserved.
is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231
2010;121:1235-1243; originally published online March 1, 2010;
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