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(Circulation. 2000;102:2930.)
© 2000 American Heart Association, Inc.

Clinical Investigation and Reports

Randomized Comparison of Primary Stenting and Provisional Balloon Angioplasty Guided by Flow Velocity Measurement

Patrick W. Serruys, MD; Bernard de Bruyne, MD; Stéphane Carlier, MD; José Eduardo Sousa, MD; Jan Piek, MD; Toshiya Muramatsu, MD; Chris Vrints, MD; Peter Probst, MD; Ricardo Seabra-Gomes, MD; Ian Simpson, MD; Vasilis Voudris, MD; Olivier Gurné, MD; Nico Pijls, MD; Jorge Belardi, MD; Gerrit-Anne van Es, PhD; Eric Boersma, PhD; Marie-Angèle Morel, MS; Ben van Hout, PhD; on behalf of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II Study Group

From the Thoraxcenter, Rotterdam, the Netherlands (P.W.S., S.C.); the Cardiovascular Center, OLV Hospital, Aalst, Belgium (B.d.B.); Instituto Dante Pazzanese, Sao Paulo, Brazil (J.E.S.); Academisch Medisch Centrum, Amsterdam, the Netherlands (J.P.); Kawasaki Central Hospital, Kawaka-Shi Kanagawa, Japan (T.M.); University Hospital Antwerp, Edegem-Antwerp, Belgium (C.V.); Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria (P.P.); Hospital Santa Cruz, Linda-A-Velha, Portugal (R.S.-G.); Wessex Cardiology Center, Southampton, United Kingdom (I.S.); Onassis Cardiac Surgery Center, Athens, Greece (V.V.); Hôpital Universitaire de Mont-Godinne, Yvoir, Belgium (O.G.); Catharina Hospital, Eindhoven, the Netherlands (N.P.); Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina (J.B.); Cardialysis, Rotterdam, the Netherlands (G.-A.v.E., M.-A.M.); Erasmus University, Rotterdam, the Netherlands (E.B.); and the Institute for Medical Technology Assessment, Rotterdam, the Netherlands (B.v.H.).

Background—Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive.

Methods and Results—To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P=0.066).

Conclusions—After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.

Key Words: stents • angioplasty • balloon • random allocation • cost-benefit analysis

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