Stent Placement Compared With Balloon Angioplasty for Small Coronary Arteries

In-Hospital and 6-Month Clinical and Angiographic Results

Koning, René MD
Eltchaninoff, Hélène MD
Commeau, Philippe MD
Khalife, Khalife MD
Gilard, Martine MD
Lipiecki, Janusz MD
Coste, Pierre MD
Bedossa, Marc MD
Lefèvre, Thierry MD
Brunel, Philippe MD
Morice, Marie-Claude MD
Maillard, Luc MD
Guyon, Philippe MD
Puel, Jacques MD
Cribier, Alain MD

From the University Hospital of Rouen, Rouen (R.K., H.E., A.C.); Centre Hospitalier Privé Saint Martin, Caen (P.C.); Hôpital Bon Secours, Metz (K.K.); University Hospital, Brest (M.G.); University Hospital, Clermont-Ferrand (J.L.); University Hospital, Bordeaux (P.C.); University Hospital, Rennes (M.B.); Institut Hospitalier Jacques Cartier, Massy (T.L.); University Hospital, Nantes (P.B.); Clinique du Bois de Verrieres, Antony (M.C.M.); University Hospital, Tours (L.M.); Centre Cardiologique du Nord, Saint Denis (P.G.); University Hospital, Toulouse (J.P.), France.

Received March 15, 2001;

revision received July 17, 2001; accepted July 25, 2001.

*Additional participants in the BESMART Trial are listed in the Appendix.

Correspondence to René Koning, MD, Service de cardiologie; Hôpital Charles-Nicolle, 1 rue de Germont, 76031 Rouen Cedex, France. E-mail [email protected]

Circulation 104(14):p 1604-1608, October 2, 2001.

Background—

Stenting has been demonstrated to be superior to balloon angioplasty in de novo focal lesions located in large native vessels. However, in small vessels, the benefit of stenting remains questionable.

Methods and Results—

A total of 381 symptomatic patients with de novo focal lesion located on a small coronary segment vessel (<3 mm) were randomly assigned to either stent implantation (192 patients; 197 lesions) or standard balloon angioplasty (189 patients; 198 lesions). The primary end point was the angiographic restenosis rate at 6 months, as determined by quantitative coronary angiography. On intention-to-treat analysis, angiographic success rate and major adverse cardiac events were comparable: 97.9% and 4.6% versus 93.9% and 5.8% in the stent group and the balloon group, respectively. After the procedure, a larger acute gain was achieved with stent placement (1.35±0.45 versus 0.94±0.47 mm, P =0.0001), resulting in a larger minimal lumen diameter (2.06±0.42 versus 1.70±0.46 mm, P =0.0001). At follow-up (obtained in 91% of patients), angiographic restenosis rate was 21% in the stent group versus 47% in the balloon group (P =0.0001), a risk reduction of 55%. Repeat target lesion revascularization was less frequent in the stent group (13% versus 25%, P =0.0006).

Conclusions—

Elective stent placement in small coronary arteries with focal de novo lesions is safe and associated with a marked reduction in restenosis rate and subsequent target lesion revascularization rate at 6 months.