Coronary stenting versus balloon angioplasty in small vessels: a meta-analysis from 11 randomized studies.

OBJECTIVES A meta-analysis of 11 randomized trials was done to compare stenting versus balloon angioplasty (BA) in small coronary vessels. BACKGROUND Randomized studies on coronary stenting (CS) in small vessels have yielded controversial results. METHODS Eleven randomized trials on CS versus BA in small vessels, including angiographic re-evaluation at six months, were analyzed. RESULTS The BeStent (Medtronic Instent, Minneapolis, Minnesota) was used in four studies, the Multi-Link (Guidant, Advanced Cardiovascular Systems Inc., Santa Clara, California) in three trials, and the NIR (Boston Scientific Corp., Boston, Massachusetts), JoStent (Jomed International AB, Helsingborg, Sweden), Tenax (Biotronik, Berlin, Germany), and BioDivysio (Abbott Vascular Devices, Redwood City, California) in the remaining four trials. Overall, 3,541 patients were included (1,672 allocated to BA and 1,869 to stent). The rate of cross-over from balloon to stent in the pooled population was 19%, and unsuccessful stent deployment occurred in 2% of the patients allocated to stent. The pooled rates of restenosis were 25.8% and 34.2% in patients allocated to stent and balloon, respectively (p = 0.003) (risk ratio [RR] 0.77; 95% confidence interval [CI] 0.65 to 0.92). A smaller reference vessel diameter at baseline was associated with a higher risk reduction in the restenosis rate (y = -3.551 + 1.826 [x]; p = 0.012). Patients allocated to stent had lower rates of major adverse cardiac events (15.0% vs. 21.8%, p = 0.002; RR 0.70; 95% CI 0.57 to 0.87) and new target vessel revascularizations (12.5% vs. 17.0%, p = 0.004; RR 0.75, 95% CI 0.61 to 0.91). CONCLUSIONS Elective stenting is superior to provisional stenting in small coronary arteries. This benefit is more evident in smaller coronary arteries.

[1]  W. Laskey,et al.  Comparison of immediate and one-year outcome after coronary angioplasty of narrowing < 3 mm with those > or =3 mm ( the National Heart, Lung, and Blood Institute Dynamic Registry). , 2001, The American journal of cardiology.

[2]  Hôpital Bon Secours Stent Placement Compared With Balloon Angioplasty for Small Coronary Arteries: In-Hospital and 6-Month Clinical and Angiographic Results , 2001 .

[3]  P W Serruys,et al.  Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group. , 1996, Journal of the American College of Cardiology.

[4]  P. Serruys,et al.  Angiographic Findings of the Multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): Sirolimus-Eluting Stents Inhibit Restenosis Irrespective of the Vessel Size , 2002, Circulation.

[5]  B. Meier,et al.  Indications for intracoronary stent placement: the european view. Working Group on Coronary Circulation of the European Society of Cardiology. , 1999, European heart journal.

[6]  Heparin-Coated Stent Placement for the Treatment of Stenoses in Small Coronary Arteries of Symptomatic Patients , 2003 .

[7]  J. Kjekshus,et al.  Stenting in small coronary arteries (SISCA) trial. A randomized comparison between balloon angioplasty and the heparin-coated beStent. , 2001, Journal of the American College of Cardiology.

[8]  A. Kastrati,et al.  A randomized trial comparing stenting with balloon angioplasty in small vessels in patients with symptomatic coronary artery disease. ISAR-SMART Study Investigators. Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries. , 2000, Circulation.

[9]  C. Di Mario,et al.  Coronary stenting versus balloon angioplasty in small coronary artery with complex lesions , 2000, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[10]  F. Fernández‐Avilés,et al.  Randomized comparison of coronary stent implantation and balloon angioplasty in the treatment of de novo coronary artery lesions (START): a four-year follow-up. , 1999, Journal of the American College of Cardiology.

[11]  I. Olkin,et al.  Improving the Quality of Reports of Meta-Analyses of Randomised Controlled Trials: The QUOROM Statement , 2000, Oncology Research and Treatment.

[12]  J. Moses,et al.  Efficacy of coronary stenting versus balloon angioplasty in small coronary arteries. Stent Restenosis Study (STRESS) Investigators. , 1998, Journal of the American College of Cardiology.

[13]  J. Moses,et al.  Sirolimus-eluting stents vs. standard stents in patients with stenosis in a native coronary artery , 2004 .

[14]  A. Kastrati,et al.  Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial , 2001, Circulation.

[15]  Seung‐Jung Park,et al.  Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries. , 2000, European heart journal.

[16]  AlbertSchömig,et al.  Vessel Size and Long-Term Outcome After Coronary Stent Placement , 1998 .

[17]  P. Teirstein,et al.  A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. , 1994, The New England journal of medicine.

[18]  Gregg W Stone,et al.  A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. , 2004, The New England journal of medicine.

[19]  C. Di Mario,et al.  Angiographic and clinical outcome following coronary stenting of small vessels: a comparison with coronary stenting of large vessels. , 1998, Journal of the American College of Cardiology.

[20]  M. Hadamitzky,et al.  Predictive factors of restenosis after coronary stent placement. , 1997, Journal of the American College of Cardiology.

[21]  Gregg W. Stone,et al.  A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease , 2004 .

[22]  J. Margolis Restenosis after coronary angioplasty: a multivariate statistical model to relate lesion and procedure variables to restenosis. The M-HEART Investigators , 1991 .

[23]  Jeffrey W Moses,et al.  Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. , 2003, The New England journal of medicine.

[24]  W Rutsch,et al.  Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial. , 2001, Journal of the American College of Cardiology.

[25]  C. Di Mario,et al.  In-stent restenosis in small coronary arteries: impact of strut thickness. , 2002, Journal of the American College of Cardiology.

[26]  A Randomized Trial Comparing Stenting With Balloon Angioplasty in Small Vessels in Patients With Symptomatic Coronary Artery Disease , 2000 .

[27]  S Doucet,et al.  Stent Placement to Prevent Restenosis After Angioplasty in Small Coronary Arteries , 2001, Circulation.

[28]  I. Olkin,et al.  Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement , 1999, The Lancet.