Paclitaxel-coated balloon for the treatment of drug-eluting stent restenosis: subanalysis results from the Valentines I trial.

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 15(1):23-8, 2014 Jan.PMID: 24444473Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Observational StudySubject headings: *Angioplasty, Balloon, Coronary/is [Instrumentation] | *Cardiovascular Agents/ad [Administration & Dosage] | *Coronary Artery Disease/th [Therapy] | *Coronary Restenosis/th [Therapy] | *Drug-Eluting Stents | *Paclitaxel/ad [Administration & Dosage] | *Percutaneous Coronary Intervention/is [Instrumentation] | Aged | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | Coronary Artery Disease/di [Diagnosis] | Coronary Restenosis/di [Diagnosis] | Coronary Restenosis/et [Etiology] | Female | Humans | Kaplan-Meier Estimate | Male | Middle Aged | Percutaneous Coronary Intervention/ae [Adverse Effects] | Prospective Studies | Prosthesis Design | Registries | Risk Factors | Sirolimus/aa [Analogs & Derivatives] | Sirolimus/ad [Administration & Dosage] | Time Factors | Treatment OutcomeLocal holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: BACKGROUND: In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR PCB.CONCLUSION: In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure. 2014.METHODS: Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR PCB were compared.OBJECTIVES: To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis.RESULTS: Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08+0.31 overall), mean PCB diameter (2.99+0.42mm overall), mean PCB length (24.4+11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231+43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015).All authors: Loh JP, Sangiorgi G, Silber S, Stahnke S, Stella PR, Torguson R, von Strandmann RP, Waksman RDigital Object Identifier: Date added to catalog: 2014-11-11
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article Available 24444473

Available in print through MWHC library: 2002 - present

BACKGROUND: In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR PCB.

CONCLUSION: In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure. 2014.

METHODS: Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR PCB were compared.

OBJECTIVES: To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis.

RESULTS: Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08+0.31 overall), mean PCB diameter (2.99+0.42mm overall), mean PCB length (24.4+11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231+43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015).

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