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CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY

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, MD, PhD, FACC, FESC^*,*, David P. Foley, MRCPI, PhD, FACC, FESC^*, Martin-Jan Suttorp, MD, PhD, Benno J. W. M. Rensing, MD, PhD, Harry Suryapranata, MD, PhD, FESC, Phillipe Materne, MD, Arijan van den Bos, MD^||, Edouard Benit, MD, FESC, FACC^¶, Angelo Anzuini, MD^#, Wolfgang Rutsch, MD, FESC^**, Victor Legrand, MD, PhD, FESC, Keith Dawkins, MD, FRCP, Michael Cobaugh, Marco Bressers, MSc^||||, Bianca Backx, PhD^||||, William Wijns, MD, PhD^¶¶ and Antonio Colombo, MD, FACC, FESC^#

^* Erasmus University, Rotterdam, The Netherlands
Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands
Ziekenhuis De Weezenlanden, Zwolle, The Netherlands
Hôpital de la Citadelle, Liège, Belgium
^|| Medisch Centrum "De Klokkenberg", Breda, The Netherlands
^¶ UZ Virga Jesse, Hasselt, Belgium
^# Centro Cuore Columbus, Milan, Italy
^** Universitätsklinikum Charité, Berlin, Germany
CHU Sart Tilman, Liège, Belgium
Wessex Cardiology Centre, Southampton, United Kingdom
Boston Scientific GmbH, Ratingen, Germany
^|||| Cardialysis, Rotterdam, The Netherlands
^¶¶ Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium.

Manuscript received July 10, 2001; revised manuscript received October 17, 2001, accepted November 1, 2001.

^* Reprint requests and correspondence: Prof. P. W. Serruys, Department of Interventional Cardiology, Heart Center, Erasmus University Rotterdam, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
serruys{at}card.azr.nl

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) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >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.

Abbreviations and Acronyms   MACE   BA   balloon angioplasty   CK   creatine kinase   DS   diameter stenosis   IVUS   intravascular ultrasound   MACE   major adverse cardiac events   MI   myocardial infarction   MLD   minimal lumen diameter   TIMI   Thrombolysis In Myocardial Infarction   TVR   target vessel revascularization   QCA   quantitative coronary angiography

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