Improved Procedural Results of Coronary Angioplasty With Intravascular Ultrasound–Guided Balloon Sizing

Stone, Gregg W.; Hodgson, John McB.; Goar, Frederick G. St.; Frey, Axel W.; Mudra, Harald; Sheehan, Helen; Linnemeier, Thomas J.

doi:10.1161/01.cir.95.8.2044

Cited by 147 publications

(47 citation statements)

References 30 publications

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“…Subsequent dilatation with these traditionally oversized balloons resulted in a significant increase in MLD (from 1.95Ϯ0.49 to 2.21Ϯ0.47 mm) without a corresponding increase in the incidence of angiographic dissection. 54 Measurement of coronary flow reserve using the Doppler guidewire represents another potential end point on which to base the decision of whether to provisionally stent a lesion after balloon angioplasty has been completed. 55 In a preliminary clinical trial, patients in whom normalization of coronary flow reserve did not occur immediately after angiographically successful balloon angioplasty demonstrated an increased risk for recurrent events and may represent a subgroup who would benefit from provisional stent placement.…”

Section: The "Aggressive" Approach To Angioplastymentioning

confidence: 99%

A Call for Provisional Stenting

1998

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During the past 20 years, the equipment used to perform percutaneous coronary revascularization has undergone a dramatic transformation from simple balloon dilatation catheters to sophisticated mechanical devices and endoprostheses. The impetus for this evolution in technology was initially a byproduct of suboptimal immediate and long-term results obtained with standard balloon angioplasty. New techniques, including directional and rotational atherectomy, have resulted in improved procedural success rates, especially for more complex lesion subtypes, although their ability to curtail restenosis remains controversial.1,2 Intracoronary stents have had a dramatic impact on reduction of the incidence of acute complications after failed balloon angioplasty and represent the only currently available strategy shown to limit both clinical and angiographic restenosis. 3-12Based on these advantages, stent implantation is used in approximately half of all percutaneous interventions in the United States. However, despite their proven benefits, coronary stents continue to be accompanied by several theoretical and practical limitations: they are costly, typically associated with a more marked degree of neointimal formation than balloon angioplasty, and difficult to use with some lesion subsets such as bifurcation stenoses, and they have engendered the new and difficult-to-treat entity of in-stent restenosis.Although the major focus in the field of interventional cardiology over the past decade has been on the development of new devices and adjunctive pharmacological therapies, the short-and long-term success rates after standard balloon angioplasty have improved significantly. Part of the improvement is likely a manifestation of enhanced operator experience and better equipment, but the results of balloon angioplasty have also benefited greatly from the availability of coronary stents for both "bailout" (for actual or threatened abrupt closure) or "backup" (for suboptimal balloon results) indications, potentially allowing a strategy of more aggressive balloon dilatation than could be safely performed in the pre-stent era. This report details the forces that resulted in the shift from reliance on balloon angioplasty as the primary mode of therapy for the majority of percutaneous interventions and, with the use of data from several recent clinical trials, will provide the rationale for a potential return to the use of balloon angioplasty (with provisional stent placement) as the predominant means of coronary revascularization.

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Section: The "Aggressive" Approach To Angioplastymentioning

confidence: 99%

A Call for Provisional Stenting

1998

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“…[5][6][7] Prior studies have demonstrated that ICUS provides information not generated by angiography 8 -11 and that the use of sonographic measurements of vascular dimensions improves angiographic results. [12][13][14] The Strategy for ICUS-Guided PTCA and Stenting (SIPS) trial randomized consecutive patients to either a strategy of initial ICUS-guided treatment or use of angiographic guidance (Angio) alone. The primary end point of the study was 6-month angiographic minimal lumen diameter (MLD).…”

mentioning

confidence: 99%

Ultrasound-Guided Strategy for Provisional Stenting With Focal Balloon Combination Catheter

et al. 2000

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Background-Intracoronary ultrasound (ICUS) has provided insights into vascular pathology and interventional therapy.The Strategy for ICUS-Guided PTCA and Stenting (SIPS) trial tested the hypothesis that routine ICUS guidance of coronary interventions improves outcome. Methods and Results-A single-center consecutive-patient randomized design (with 6-month angiographic and 2-year clinical follow-up) was used. Consecutive patients (no chronic total occlusions or emergency procedures) were randomized to ICUS-guided provisional stenting or standard angiographic guidance. Quantitative angiographic minimal lumen diameter (MLD), angiographic restenosis, clinically driven target lesion revascularization, and major adverse cardiac events (MACEs) were evaluated.

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“…The strategy of IVUS-guided PTCA, which was initially described in the Clinical Outcomes with Ultrasound Trial, 14 has shown favorable long-term clinical outcomes. 14,15 This strategy has matured into IVUS-guided provisional stenting by using IVUS criteria for stenting in addition to IVUS balloon sizing, 17,21,22 thus leading to better results than with angiography-guided provisional stenting. 19 In this context, the time was right for a randomized comparison of this IVUS-guided strategy with systematic stenting.…”

Section: Methodsmentioning

confidence: 99%

“…14,15,[17][18][19]21 IVUS criteria for crossover to stent (Ͻ30% residual stenosis or Ͻ6 mm 2 minimum L-CSA) were adapted from previous IVUS-guided PTCA studies, 17,19 except regarding non-flow-limiting dissection, because several trials have shown favorable clinical outcomes in these cases. 15,21,25 Crossover to stent was needed in 44% of patients; this rate is comparable to that observed in previous IVUS-guided PTCA studies, 17,19 but it is higher than the usual 30% reported in studies with angiographic guidance alone.…”

Section: Methodsmentioning

confidence: 99%

Intravascular Ultrasound–Guided Balloon Angioplasty Compared With Stent

Schiele¹,

Méneveau²,

Gilard³

et al. 2003

Circulation

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Background-Balloon angioplasty guided by intravascular ultrasound (IVUS) makes it possible to choose the balloon size according to the true vessel diameter and to detect suboptimal results requiring subsequent stent implantation. The Balloon Equivalent to STent (BEST) study aimed to assess whether this strategy would give the same results as systematic stenting. Methods and Results-A total of 132 of 254 patients were randomized to IVUS-guided percutaneous transluminal coronary angioplasty (aggressive PTCA), and 122 were randomized to stenting (stent group). We hypothesized that a difference of Ͻ8% in the 6-month angiographic restenosis rate (primary end point) could be considered noninferior. The aggressive PTCA procedure was longer and had a greater use of contrast medium than stenting. In the aggressive PTCA group, crossover to stent was needed in 58 patients (44%). At 6 months, 20 of 119 patients (16.8Ϯ6.7%) in the aggressive PTCA group and 21 of 116 patients (18.1Ϯ7.0%) in the stent group had restenosis. The difference was Ϫ1.3%, with an upper limit of 95% confidence interval of 7.1% (ie, less than the noninferiority boundary). The in-stent restenosis rate was higher in the stent group (15.5% versus 5%; Pϭ0.02). The differences in minimum lumen diameter, lumen cross-section area, and 1-year event rate were not significant. Conclusions-A strategy of IVUS-guided angioplasty with provisional stenting is feasible and safe. At the cost of a more complex procedure, it reduces the stent rate by half, with similar 6-month angiographic IVUS and clinical outcome compared with stent implantation. (Circulation. 2003;107:545-551.)

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Improved Procedural Results of Coronary Angioplasty With Intravascular Ultrasound–Guided Balloon Sizing

Abstract: The demonstration by IVUS of atheromatous remodeling permits the safe use of balloons traditionally considered oversized, resulting in significantly improved luminal dimensions without increased rates of dissection or ischemic complications.

Cited by 147 publications

References 30 publications

A Call for Provisional Stenting

A Call for Provisional Stenting

Ultrasound-Guided Strategy for Provisional Stenting With Focal Balloon Combination Catheter

Intravascular Ultrasound–Guided Balloon Angioplasty Compared With Stent

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