Safety in simple versus complex stenting of coronary artery bifurcation lesions. The Nordic Bifurcation Study 14-month follow-up results

Jensen, Jan Skov; Galløe, Anders; Lassen, Jens Flensted; Ērglis, Andrejs; Kumsārs, Indulis; Steigen, Terje K.; Wiseth, Rune; Narbute, Inga; Gunnes, Pål; Mannsverk, Jan; Meyerdierks, Oliver; Rotevatn, Svein; Niemelä, Matti; Kervinen, Kari; Nikus, Kjell; Vikman, Saila; Ravkilde, Jan; James, Stefan; Aarøe, Jens; Ylitalo, Antti; Helqvist, Steffen; Sjögren, Iwar; Thayssen, Per; Virtanen, Kari; Puhakka, Mikko; Airaksinen, Juhani; Thuesen, Leif

doi:10.4244/eijv4i2a41

Cited by 58 publications

(43 citation statements)

References 14 publications

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“…29 The Nordic trial did not find any significant difference in clinical outcomes between a simple strategy of stenting across and a complex 2-stent technique. 11,30 The Nordic III trial compared specifically the strategy of stenting across (a nonapposed side branchgenerating technique) versus systematic final kissing balloon (a nonapposed side branch-reducing technique) and also failed to find any clinical advantage for any of the strategies. 12 The inherent selection bias of autopsy studies has been thought to explain the discrepancy between pathology and clinical data.…”

Section: Implications For Nonapposed Side-branch Strutsmentioning

confidence: 99%

Delayed Coverage in Malapposed and Side-Branch Struts With Respect to Well-Apposed Struts in Drug-Eluting Stents

et al. 2011

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Background-Pathology studies on fatal cases of very late stent thrombosis have described incomplete neointimal coverage as common substrate, in some cases appearing at side-branch struts. Intravascular ultrasound studies have described the association between incomplete stent apposition (ISA) and stent thrombosis, but the mechanism explaining this association remains unclear. Whether the neointimal coverage of nonapposed side-branch and ISA struts is delayed with respect to well-apposed struts is unknown. Methods and Results-Optical coherence tomography studies from 178 stents implanted in 99 patients from 2 randomized trials were analyzed at 9 to 13 months of follow-up. The sample included 38 sirolimus-eluting, 33 biolimus-eluting, 57 everolimus-eluting, and 50 zotarolimus-eluting stents. Optical coherence tomography coverage of nonapposed side-branch and ISA struts was compared with well-apposed struts of the same stent by statistical pooled analysis with a random-effects model. A total of 34 120 struts were analyzed. The risk ratio of delayed coverage was 9.00 (95% confidence interval, 6.58 to 12.32) for nonapposed side-branch versus well-apposed struts, 9.10 (95% confidence interval, 7.34 to 11.28) for ISA versus well-apposed struts, and 1.73 (95% confidence interval, 1.34 to 2.23) for ISA versus nonapposed side-branch struts. Heterogeneity of the effect was observed in the comparison of ISA versus well-apposed struts (Hϭ1.27; I 2 ϭ38.40) but not in the other comparisons. Conclusions-Coverage of ISA and nonapposed side-branch struts is delayed with respect to well-apposed struts in drug-eluting stents, as assessed by optical coherence tomography. Clinical Trial Registration-http://www.clinicaltrials.gov. Unique identifier: NCT00389220, NCT00617084.

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Section: Implications For Nonapposed Side-branch Strutsmentioning

confidence: 99%

Delayed Coverage in Malapposed and Side-Branch Struts With Respect to Well-Apposed Struts in Drug-Eluting Stents

et al. 2011

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“…Two of the remaining articles pertained to the same study in different follow-up periods. 11,12 Finally, 6 randomized trials fulfilled our inclusion criteria. [7][8][9][10][11][12][13] Patients, Demographic, and Procedural Characteristics Demographic characteristics of the included patients and procedural details of the implemented PCI technique are shown in Tables 1 through 3.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…However, there have been concerns about long-term major adverse cardiac events and, in particular, stent thrombosis with adjacent stents. Among several randomized trials published so far, [7][8][9][10][11][12][13] the deployment of an additional stent on the side branch of a bifurcation lesion has never been shown to result in significantly improved clinical outcomes as initially hypothesized. These trials, however, have been of too limited a sample size to allow robust conclusions, when seen in isolation.…”

mentioning

confidence: 99%

Double Versus Single Stenting for Coronary Bifurcation Lesions

Katritsis

Siontis

Ioannidis

2009

Circ: Cardiovascular Interventions

123

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Background-Several trials have addressed whether bifurcation lesions require stenting of both the main vessel and side branch, but uncertainty remains on the benefits of such double versus single stenting of the main vessel only. Methods and Results-We have conducted a meta-analysis of randomized trials including patients with coronary bifurcation lesions who were randomly selected to undergo percutaneous coronary intervention by either double or single stenting. Six studies (nϭ1642 patients) were eligible. There was increased risk of myocardial infarction with double stenting (risk ratio, 1.78; Pϭ0.001 by fixed effects; risk ratio, 1.49 with Bayesian meta-analysis). The summary point estimate suggested also an increased risk of stent thrombosis with double stenting, but the difference was not nominally significant given the sparse data (risk ratio, 1.85; Pϭ0.19). No obvious difference was seen for death (risk ratio, 0.81; Pϭ0.66) and target lesion revascularization (risk ratio, 1.09; Pϭ0.67). Key Words: angioplasty Ⅲ coronary bifurcation Ⅲ PCI Ⅲ stents Ⅲ meta-analysis P ercutaneous coronary intervention (PCI) of bifurcation lesions remains a subject of debate in terms of optimum treatment technique. Balloon angioplasty and bare metal stents have gradually been replaced by drug-eluting stents. [1][2][3][4][5][6] When stenting is used, a major question is whether both the main vessel and the side branch should be stented. Such double stenting is appealing because it produces attractive postprocedural angiographic results. However, there have been concerns about long-term major adverse cardiac events and, in particular, stent thrombosis with adjacent stents. Among several randomized trials published so far, 7-13 the deployment of an additional stent on the side branch of a bifurcation lesion has never been shown to result in significantly improved clinical outcomes as initially hypothesized. These trials, however, have been of too limited a sample size to allow robust conclusions, when seen in isolation. A synopsis of 3 randomized and 3 observational comparisons failed to detect any significant differences between double and single stenting in a bifurcation. 14 However, several other trials have appeared recently. We have, therefore, performed a meta-analysis of randomized trials to examine the relative outcomes of the double versus single stenting strategies for bifurcation lesions in terms of mortality, myocardial infarction, stent thrombosis, and target lesion revascularization. Conclusions-Stenting Clinical Perspective on p 415 Methods Study Eligibility and SelectionWe have conducted a meta-analysis of randomized trials including patients with coronary bifurcation lesions who were randomly selected to undergo PCI by either single stenting of the main vessel only (simple strategy) or double stenting of both the main vessel and the side branch (complex strategy) with any PCI technique. For study selection, we searched PubMed, using the terms bifurcation, coronary, and stent (last update, February 26, 2009). In...

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“…This replicates findings from previous studies. [1][2][3][4][5][6][7][8] Periprocedural MI was numerically more prevalent after culotte stenting. This probably relates to repeat instrumentation and dilatation of vessels in the more complex procedure.…”

Section: Discussionmentioning

confidence: 99%

The EBC TWO Study (European Bifurcation Coronary TWO)

Hildick‐Smith

Behan²,

Lassen

et al. 2016

Circ: Cardiovascular Interventions

105

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T reatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be fully established. Randomized trials of all-comer bifurcation lesions have demonstrated that there is no advantage to systematic dual drugeluting stent strategies. However, these trials included a high proportion of patients with no disease in the side branch (SB) or relatively small SB vessels. 1-10 See Editorial by De LucaExpert consensus suggests that large caliber bifurcation lesions with significant ostial SB disease probably warrant an upfront 2-stent strategy, but this consensus has not been tested.11 This trial was designed to assess the hypothesis that large true bifurcations with significant SB ostial disease are Background-For the treatment of coronary bifurcation lesions, a provisional strategy is superior to systematic 2-stent techniques for the most bifurcation lesions. However, complex anatomies with large side branches (SBs) with significant ostial disease length are considered by expert consensus to warrant a 2-stent technique upfront. This consensus view has not been scientifically assessed. Methods and Results-Symptomatic patients with large caliber true bifurcation lesions (SB diameter ≥2.5 mm) and significant ostial disease length (≥5 mm) were randomized to either a provisional T-stent strategy or a dual stent culotte technique. Two hundred patients aged 64±10 years, 82% male, were randomized in 20 European centers. The clinical presentations were stable coronary disease (69%) and acute coronary syndromes (31%). SB stent diameter (2.67±0.27 mm) and length (20.30±5.89 mm) confirmed the extent of SB disease. Procedural success (provisional 97%, culotte 94%) and kissing balloon inflation (provisional 95%, culotte 98%) were high. Sixteen percent of patients in the provisional group underwent T-stenting. The primary end point (a composite of death, myocardial infarction, and target vessel revascularization at 12 months) occurred in 7.7% of the provisional T-stent group versus 10.3% of the culotte group (hazard ratio, 1.02; 95% confidence interval, 0.78-1.34; P=0.53). Procedure time, x-ray dose, and cost all favored the simpler procedure. Conclusions-When treating complex coronary bifurcation lesions with large stenosed SBs, there is no difference between a provisional T-stent strategy and a systematic 2-stent culotte strategy in a composite end point of death, myocardial infarction, and target vessel revascularization at 12 months. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT 01560455.(Circ Cardiovasc Interv. 2016;9:e003643.

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Safety in simple versus complex stenting of coronary artery bifurcation lesions. The Nordic Bifurcation Study 14-month follow-up results

Cited by 58 publications

References 14 publications

Delayed Coverage in Malapposed and Side-Branch Struts With Respect to Well-Apposed Struts in Drug-Eluting Stents

Delayed Coverage in Malapposed and Side-Branch Struts With Respect to Well-Apposed Struts in Drug-Eluting Stents

Double Versus Single Stenting for Coronary Bifurcation Lesions

The EBC TWO Study (European Bifurcation Coronary TWO)

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