Restenosis after directional coronary atherectomy and balloon angioplasty: Comparative analysis based on matched lesions

Umans, Victor; Hermans, Walter R.M.; Foley, David P.; Strikwerda, Sipke; Brand, Marcel van den; Jaegere, Peter de; Feyter, Pim J. de; Serruys, Patrick W.

doi:10.1016/0735-1097(93)90313-p

Cited by 53 publications

(38 citation statements)

References 32 publications

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“…The Cardiovascular Angiographic Analysis System II (Pie Medical) was used for the angiographic analysis at the core laboratory, using a well-described methodology. 2,3,14,16 …”

Section: Angiographic Procedures and Quantitative Coronary Angiographmentioning

confidence: 99%

“…14 -16 Stenting was in the early phase of clinical evaluation: the Belgian Netherlands Stent Study (BENESTENT) and Stent Restneosis Study (STRESS) had not yet been completed; thus, stenting was only performed as a bailout procedure, which indicated a failed DCA. The mean luminal loss observed after DCA by the core laboratory was 0.81 mm, 14,16 which is Ͼ2 times the average after balloon angioplasty. 2,3,14,16 Before intravascular ultrasound (IVUS) studies, which changed our perception of restenosis, [21][22][23] we assumed this renarrowing was due to neointimal hyperplasia.…”

Section: Appropriateness Of Dca-treated Patients For This Trialmentioning

confidence: 99%

“…The mean luminal loss observed after DCA by the core laboratory was 0.81 mm, 14,16 which is Ͼ2 times the average after balloon angioplasty. 2,3,14,16 Before intravascular ultrasound (IVUS) studies, which changed our perception of restenosis, [21][22][23] we assumed this renarrowing was due to neointimal hyperplasia. 24 For this reason, the investigation of an agent with antioxidant, antichemotactic, and direct antiproliferative effects seemed ideally suited to an atherectomytreated patient population.…”

Section: Appropriateness Of Dca-treated Patients For This Trialmentioning

confidence: 99%

“…Sample size calculation was based on a postulated difference in MLD at follow-up between the placebo and carvedilol groups of 0.20Ϯ0.62 mm (mean MLD: control group, 1.76 mm 14 and carvedilol group, 1.96 mm), which is equivalent to a 30% reduction in restenosis rate. A sample size of 152 patients per group would be required to detect such a difference with a power of 0.80 and a 2-sided ␣ of 0.05.…”

Section: Methodsmentioning

confidence: 99%

“…2,3,14,16 After intracoronary nitrate bolus injection, the target stenosis was filmed in a minimum of 2 projections before and after the procedure; these projections were repeated identically at follow-up. The Cardiovascular Angiographic Analysis System II (Pie Medical) was used for the angiographic analysis at the core laboratory, using a well-described methodology.…”

Section: Angiographic Procedures and Quantitative Coronary Angiographmentioning

confidence: 99%

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Carvedilol for Prevention of Restenosis After Directional Coronary Atherectomy

et al. 2000

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on behalf of the EUROCARE study groupBackground-In addition to its known properties as a competitive, nonselective ␤ and ␣-1 receptor blocker, carvedilol directly inhibits vascular myocyte migration and proliferation and exerts antioxidant effects that are considerably greater than those of vitamin E or probucol. This provides the basis for an evaluation of carvedilol for the prevention of coronary restenosis. Methods and Results-In a prospective, double-blind, randomized, placebo-controlled trial, 25 mg of carvedilol was given twice daily, starting 24 hours before scheduled directional coronary atherectomy and continuing for 5 months after a successful procedure. The primary end point was the minimal luminal diameter as determined during follow-up angiography 26Ϯ2 weeks after the procedure. Of 406 randomized patients, 377 underwent attempted atherectomy, and in 324 (88.9%), a Յ50% diameter stenosis was achieved without the use of a stent. Evaluable follow-up angiography was available in 292 eligible patients (90%). No differences in minimal luminal diameter (1.99Ϯ0.73 mm versus 2.00Ϯ0.74 mm), angiographic restenosis rate (23.4% versus 23.9%), target lesion revascularization (16.2 versus 14.5), or event-free survival (79.2% versus 79.7%) between the placebo and carvedilol groups were observed at 7 months. Conclusions-The maximum recommended daily dose of the antioxidant and ␤-blocker carvedilol failed to reduce restenosis after successful atherectomy. These findings are in contrast to those of the Multivitamins and Probucol Trial, which raises doubts regarding the validity of the interpretation that restenosis reduction by probucol was via antioxidant effects. The relationship between antioxidant agents and restenosis remains to be elucidated. (Circulation.

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“…The Cardiovascular Angiographic Analysis System II (Pie Medical) was used for the angiographic analysis at the core laboratory, using a well-described methodology. 2,3,14,16 …”

Section: Angiographic Procedures and Quantitative Coronary Angiographmentioning

confidence: 99%