Randomized Trial of Simple Versus Complex Drug-Eluting Stenting for Bifurcation Lesions The British Bifurcation Coronary Study: Old, New, and Evolving Strategies

Article (PDF Available)inCirculation 121(10):1235-43 · March 2010with30 Reads
DOI: 10.1161/CIRCULATIONAHA.109.888297 · Source: PubMed
Abstract
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. 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. 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.
Interventional Cardiology
Randomized Trial of Simple Versus Complex Drug-Eluting
Stenting for Bifurcation Lesions
The British Bifurcation Coronary Study: Old, New, and
Evolving Strategies
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 6410 years old were randomized;
77% were male. Eighty-two percent of lesions were true bifurcations (50% narrowing in both vessels). In the simple
group (n250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting.
In the complex group (n250), 89% of culotte (n75) and 72% of crush (n169) 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, P0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively
(P0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P0.002), 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.
(Circulation. 2010;121:1235-1243.)
Key Words: coronary disease
bifurcation
stents
angioplasty
C
oronary bifurcation lesions were considered high risk for
angioplasty in the early interventional era because of
higher rates of dissection, myocardial infarction, and acute
vessel closure.
1
The advent of coronary stenting reduced the
risks, but in-stent restenosis was noted to be frequent at the
ostium of the side branch.
2
Two-stent techniques were devel-
oped to try to combat this phenomenon
2,3
but gave inferior
results to the provisional T