A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: Final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study

Patrick W. Serruys, David P. Foley, Martin Jan Suttorp, Benno J W M Rensing, Harry Suryapranata, Phillipe Materne, Arijan Van den Bos, Edouard Benit, Angelo Anzuini, Wolfgang Rutsch, Victor Legrand, Keith Dawkins, Michael Cobaugh, Marco Bressers, Bianca Backx, William Wijns, Antonio Colombo

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Abstract

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) 50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p <0.02). Among the 288 randomized patients, the mean lesion length was 27 ± 9 mm, and the vessel diameter was 2.78 ± 0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p <0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.

Original languageEnglish
Pages (from-to)393-399
Number of pages7
JournalJournal of the American College of Cardiology
Volume39
Issue number3
DOIs
Publication statusPublished - Feb 6 2002

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Coronary Balloon Angioplasty
Stents
Balloon Angioplasty
Infarction
Therapeutics
Pathologic Constriction
Angiography
Arteries
Control Groups

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A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions : Final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study. / Serruys, Patrick W.; Foley, David P.; Suttorp, Martin Jan; Rensing, Benno J W M; Suryapranata, Harry; Materne, Phillipe; Van den Bos, Arijan; Benit, Edouard; Anzuini, Angelo; Rutsch, Wolfgang; Legrand, Victor; Dawkins, Keith; Cobaugh, Michael; Bressers, Marco; Backx, Bianca; Wijns, William; Colombo, Antonio.

In: Journal of the American College of Cardiology, Vol. 39, No. 3, 06.02.2002, p. 393-399.

Research output: Contribution to journalArticle

Serruys, PW, Foley, DP, Suttorp, MJ, Rensing, BJWM, Suryapranata, H, Materne, P, Van den Bos, A, Benit, E, Anzuini, A, Rutsch, W, Legrand, V, Dawkins, K, Cobaugh, M, Bressers, M, Backx, B, Wijns, W & Colombo, A 2002, 'A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: Final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study', Journal of the American College of Cardiology, vol. 39, no. 3, pp. 393-399. https://doi.org/10.1016/S0735-1097(01)01760-0
Serruys, Patrick W. ; Foley, David P. ; Suttorp, Martin Jan ; Rensing, Benno J W M ; Suryapranata, Harry ; Materne, Phillipe ; Van den Bos, Arijan ; Benit, Edouard ; Anzuini, Angelo ; Rutsch, Wolfgang ; Legrand, Victor ; Dawkins, Keith ; Cobaugh, Michael ; Bressers, Marco ; Backx, Bianca ; Wijns, William ; Colombo, Antonio. / A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions : Final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study. In: Journal of the American College of Cardiology. 2002 ; Vol. 39, No. 3. pp. 393-399.
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abstract = "OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) 50{\%} DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34{\%}) and was associated with a significantly increased risk of peri-procedural infarction (p <0.02). Among the 288 randomized patients, the mean lesion length was 27 ± 9 mm, and the vessel diameter was 2.78 ± 0.52 mm. The procedural success rate was 90{\%} for the 143 patients assigned to BA alone (control group), as compared with 93{\%} in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p <0.001) and led to reduced angiographic restenosis (27{\%} vs. 42{\%}, p = 0.022). Freedom from MACE at nine months was 77{\%} in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.",
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T1 - A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions

T2 - Final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study

AU - Serruys, Patrick W.

AU - Foley, David P.

AU - Suttorp, Martin Jan

AU - Rensing, Benno J W M

AU - Suryapranata, Harry

AU - Materne, Phillipe

AU - Van den Bos, Arijan

AU - Benit, Edouard

AU - Anzuini, Angelo

AU - Rutsch, Wolfgang

AU - Legrand, Victor

AU - Dawkins, Keith

AU - Cobaugh, Michael

AU - Bressers, Marco

AU - Backx, Bianca

AU - Wijns, William

AU - Colombo, Antonio

PY - 2002/2/6

Y1 - 2002/2/6

N2 - OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) 50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p <0.02). Among the 288 randomized patients, the mean lesion length was 27 ± 9 mm, and the vessel diameter was 2.78 ± 0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p <0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.

AB - OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) 50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p <0.02). Among the 288 randomized patients, the mean lesion length was 27 ± 9 mm, and the vessel diameter was 2.78 ± 0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p <0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.

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