Randomized Study of the Crush Technique Versus Provisional Side-Branch Stenting in True Coronary Bifurcations: The CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study (original) (raw)
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Circulation, 2008
Background— Sirolimus-eluting stents have been reported to be effective in the treatment of coronary bifurcations. Still, it has not been fully clarified which strategy would provide the best results with true bifurcation lesions. Methods and Results— The CACTUS trial (Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents) is a prospective, randomized, multicenter study comparing 2 different techniques of stenting, with mandatory final kissing-balloon inflation, in true bifurcations: (1) elective “crush” stenting and (2) stenting of only the main branch, with provisional side-branch T-stenting. From August 2004 to June 2007, 350 patients were enrolled in 12 European centers. The primary angiographic end point was the in-segment restenosis rate, and the primary clinical end point was the occurrence of major adverse cardiac events (cardiac death, myocardial infarction, or target-vessel revascularization) at 6 months. At 6 months, angiographic rest...
Circulation, 2010
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 64Ϯ10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (Ͼ50% narrowing in both vessels). In the simple group (nϭ250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting.
Catheterization and Cardiovascular Interventions, 2009
Background: The optimal stenting strategy for coronary bifurcation lesions has not yet been defined, especially given the lack of very long-term data (>24 months). We compared our long-term results of a simple vs complex stenting strategy in patients with bifurcation lesions. Methods: We retrospectively selected subjects undergoing percutaneous coronary intervention (PCI) with stenting in a bifurcation lesion between June 2002 and December 2005, comparing those treated with a simple technique vs those treated with a complex one. The primary end-point was the rate of major adverse cardiac events (MACE) at >24 months of follow-up. Results: A total of 326 patients were included, 64.7% treated with a simple technique (Group A) and 35.3% with a complex strategy (Group B). Drug-eluting stents were used in 82.0% and 73.0%, respectively (P 5 0.059), final kissing balloon in 47.9% and 53.0% (P 5 0.37), and procedural success obtained in 99.5% and 99.1% (P 5 0.66). After a median of 34 months, MACE occurred in 52 (26.5%) in Group A and in 32 (31.4%) in Group B (P 5 0.37), cardiac death in six (3.1%) vs four (3.9%, P 5 0.70), myocardial infarction in 13 (6.6%) vs 6 (5.9%, P 5 0.80), target vessel revascularization in 36 (18.4%) vs 29 (28.4%, P 5 0.04), and bypass in five (2.6%) vs two (2%, P 5 0.74). Definite stent thrombosis was adjudicated in two (1%) vs one (0.9%, P 5 0.98). Conclusions: This study, comparing simple and complex stenting strategies for the treatment of coronary bifurcation lesions, shows that both techniques are associated with favorable clinical results and low adverse events rates at long-term follow-up. V C 2009 Wiley-Liss, Inc.
JACC. Cardiovascular interventions, 2015
This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. The optimal bifurcation stenting technique needs to be evaluated. The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non-left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p = 0.064), comprising 15.1% versus 3.7% for the main branch (p = 0.004) and 2.8% versus 5.6% for the SB (p = 0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarc...
Present Status of Coronary Bifurcation Stenting
Clinical Cardiology, 2008
Percutaneous coronary intervention (PCI) for bifurcation lesions is technically limited by the risk of side branch occlusion. In comparison with nonbifurcation interventions, bifurcation interventions have a lower rate of procedural success, higher procedural costs and a higher rate of clinical and angiographic restenosis. The recent introduction of drug-eluting stents (DES) has resulted in reduced incidence of main vessel restenosis compared with historical controls. However, sidebranch ostial residual stenosis and long-term restenosis still remain problematic. In the era of DES, techniques employing two stents have emerged that allow stenting of the large side branch in addition to the main artery. Stenting of the main vessel with provisional side branch stenting seems to be the prevailing approach. This paper reviews outcome data with different treatment modalities for this complex lesion with particular emphasis on the use of DES as well as potential new therapeutic approaches.
Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions
Circulation, 2006
Background— The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. Methods and Results— A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P =NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index proce...
Long-Term Results After Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions
Journal of the American College of Cardiology, 2013
This study sought to report the 5-year follow-up results of the Nordic Bifurcation Study. Background Randomized clinical trials with short-term follow-up have indicated that coronary bifurcation lesions may be optimally treated using the optional side branch stenting strategy. Methods A total of 413 patients with a coronary bifurcation lesion were randomly assigned to a simple stenting strategy of main vessel (MV) and optional stenting of side branch (SB) or to a complex stenting strategy, namely, stenting of both MV and SB. Results Five-year clinical follow-up data were available for 404 (98%) patients. The combined safety and efficacy endpoint of cardiac death, non-procedure-related myocardial infarction, and target vessel revascularization were seen in 15.8% in the optional SB stenting group as compared to 21.8% in the MV and SB stenting group (p ¼ 0.15). All-cause death was seen in 5.9% versus 10.4% (p ¼ 0.16) and non-procedure-related myocardial infarction in 4% versus 7.9% (p ¼ 0.09) in the optional SB stenting group versus the MV and SB stenting group, respectively. The rates of target vessel revascularization were 13.4% versus 18.3% (p ¼ 0.14) and the rates of definite stent thrombosis were 3% versus 1.5% (p ¼ 0.31) in the optional SB stenting group versus the MV and SB stenting group, respectively. Conclusions At 5-year follow-up in the Nordic Bifurcation Study, the clinical outcomes after simple optional side branch stenting remained at least equal to the more complex strategy of planned stenting of both the main vessel and the side branch.
Clinical Outcome After Crush Versus Culotte Stenting of Coronary Artery Bifurcation Lesions
JACC: Cardiovascular Interventions, 2013
Objectives The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions. Background The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study. Methods A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac eventsdthe composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularizationdwere the primary endpoint. Results Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p ¼ 0.32), index lesion restenosis 11.5% versus 6.5% (p ¼ 0.09), and definite stent thrombosis 1.4% versus 4.7% (p ¼ 0.09) in the crush and the culotte groups, respectively. Conclusions At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study.
Circulation, 2006
Background-The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MVϩSB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. Methods and Results-A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MVϩSB 3.4%, MV 2.9%; PϭNS). In the MVϩSB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis Ͼ50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MVϩSB group (PϭNS). Conclusions-Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique. Clinical trial registration information-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00376571. The 6-month clinical results and the 8-month quantitative coronary angiography results of the trial were presented as late-breaking clinical trials at the annual meeting of the American College