Abstract
Background: Over the last 4 years, several newer generation stents have become available, promising to change the scenery of coronary angioplasty (PTCA) with its attendant restenosis rate.
Hypothesis: The aim of this study was to review prospectively the results of a single operator adopting a uniform approach with approximately 0.5 mm stent oversizing and high‐pressure (≥ 12‐16 bar) deployment and compare them with conventional PTCA in a series of 244 consecutive patients.
Methods: The study included 203 men and 41 women, aged 59 ± 11 years, who presented with stable angina and/or positive exercise testing (n = 75), unstable angina (n = 161), or acute myocardial infarction (n = 8). Dilated vessels included the left anterior descending artery (n = 139), the right coronary artery (n = 86), the left circumflex artery (n = 47), the ramus branch (n = 4), or venous grafts (n = 2). Stents were implanted for dissection, suboptimal PTCA result, and electively. Two groups were compared: 83 patients who underwent balloon PTCA alone and 161 patients who also received stent(s).
Results: The two groups had similar demographics, age (58 ± 10 vs. 59 ± 11 years), initial vessel stenosis (92 ± 7 vs. 93 ± 6%), and left ventricular ejection fraction (51 ± 9 vs. 51 ± 8%). Procedural success was also similar (97.6 vs. 99.4%), but as expected the residual stenosis was much lower in the stent group (≤ 0 vs. 17%). The following stents were employed: J & J (n = 1), NIR (n = 117), ACS (n = 59), AVE (n = 9), Inflow GoldFlex (n = 9), Crossflex (n = 5), Wictor (n = 1), Jostent (n = 16), R stent (n = 9), Seaquence (n = 2) and Wallstent (n = 1). Single stents were used in 118 patients, two stents in 31 patients, three in 6 patients, and four in 6 patients. There was one in‐hospital death at 3 days unrelated to the procedure. There were no events of subacute stent thrombosis; all patients in the stent group received combined therapy with aspirin and ticlopidine, the latter for 1 month. During 18 ± 14 months, the clinical rèstenosis rate was significantly lower in the stent group (6.9%) than in the PTCA group (28.4%) (p = 0.001).
Conclusion: In a series of 244 consecutive patients, newer generation stents and a consistent approach of stent oversizing and high‐pressure stent deployment by a single operator resulted in high procedural success (99%), lack of stent thrombosis (0%), and a very low clinical restenosis rate (7%).
Keywords: coronary artery disease, coronary angioplasty, coronary stents, restenosis
Full Text
The Full Text of this article is available as a PDF (1.0 MB).
References
- 1. Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I., Detre K., Veltri L., Ricci D., Nobuyoshi M., Cleman M., Heuser R., Almond D., Teirstein PS, Fish RD, Colombo A., Brinker J., Moses J., Shaknovich A., Hirshfeld J., Bailey S., Ellis S., Rake R., Goldberg S., for the Stent Restenosis Study Investigators : A randomized comparison of coronary‐stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994; 331: 496–501 [DOI] [PubMed] [Google Scholar]
- 2. Serruys PW, de Jaegere P., Kiemeneij F., Macaya C., Rutsch W., Heyndrickx G., Emanuelsson H., Marco J., Legrand V., Materne P., Belardi J., Sigwart U., Colombo A., Goy JJ, Van den Heuvel P., Delcan J., Morel M‐A, for the BENESTENT Study Group : A comparison of balloon‐expandable‐stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994; 331: 489–495 [DOI] [PubMed] [Google Scholar]
- 3. Colombo A., Hall P., Nakamura S., Almagor Y., Maiello L., Martini G., Gaglione A., Goldberg SL, Tobis JM, Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation 1995; 91: 1676–1688 [DOI] [PubMed] [Google Scholar]
- 4. Itoh A., Hall P., Maiello L., Di Mario C., Moussa I., Blengino S., Ferraro M., Martini G., Di Francesco L., Finci L., Colombo A.: Intracoronary stent implantation in native coronary arteries and saphenous vein grafts: A consecutive experience with six types of stents without prolonged anticoagulation. Mayo Clin Proc 1997; 72: 101–111 [DOI] [PubMed] [Google Scholar]
- 5. Berger PB: Stents with high‐pressure balloon inflations and intravascular ultrasonography—applicable in all patients? Mayo Clin Proc 1997; 72: 185–187 [DOI] [PubMed] [Google Scholar]
- 6. Serruys PW, Emanuelsson H., Van der Giessen W., Lunn AC, Kiemeneij F., Macaya C., Rutsch W., Heyndrickx G., Suryapranata H., Legrand V., Goy JJ, Materne P., Bonnier H., Morice M‐C, Fajadet J., Belardi J., Colombo A., Garcia E., Ruygrok P., de Jaegere P., Morel M‐A, on behalf of the Benestent‐II Study Group : Heparin‐coated Palmaz‐Sehatz stents in human coronary arteries: Early outcome of the Benestent‐II Pilot Study. Circulation 1996; 93: 412–422 [DOI] [PubMed] [Google Scholar]
- 7. Schoemig A., Neumann F‐J, Kastrati A., Schuehlen H., Zitzmann‐Roth E‐M, Richardt G., Alt E., Schmitt C., Ulm K., A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary‐artery stents. N Engl J Med 1996; 334: 1084–1089 [DOI] [PubMed] [Google Scholar]
- 8. Bertrand ME, Legrand V., Boland J., Fleck E., Bonnier J., Emmanuelson H., Vrolix M., Missault L., Chierchia S., Casaccia M., Niccoli L., Oto A., White C., Webb‐Peploe M., Van Belle E., McFadden EP, Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting: The FANTASTIC Study. Circulation 1998; 98: 1597–1603 [DOI] [PubMed] [Google Scholar]
- 9. Urban P., Macaya C., Rupprecht H‐J, Kiemeneij F., Emanuelsson H., Fontanelli A., Pieper M., Wesseling T., Sagnard L., for the MATTIS Investigators : Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high‐risk patients: The Multicenter Aspirin and Ticlopidine Trial after Intracoronary Stenting (MATTIS). Circulation 1998; 98: 2126–2132 [DOI] [PubMed] [Google Scholar]
- 10. Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KKL, Giambartolomei A., Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE, for the Stent Anticoagulation Restenosis Study Investigators : A clinical trial comparing three antithrombotic‐drug regimens after coronary‐artery stenting. N Engl J Med 1998; 339: 1665–1671 [DOI] [PubMed] [Google Scholar]
- 11. Holmes DR, Hirshfeld J. Jr., Faxon D., Vliestra RE, Jacobs A., King SB III, ACC expert consensus document on coronary artery stents. J Am Coll Cardiol 1998; 32: 1471–1482 [DOI] [PubMed] [Google Scholar]
- 12. Ryan TJ, Faxon DP, Gunnar RM, Kennedy JW, King SB III, Loop FD, Peterson KL, Reeves TJ, Williams DO, Winters WL Jr., Guidelines of the American College of Cardiology/American Heart Association Task Force on assessment of diagnostic and therapeutic cardiovascular procedures. circulation 1988; 78: 486–502 [DOI] [PubMed] [Google Scholar]
- 13. Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G., Deligonul U., Topol EJ, Bulle TM: Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease: Implications for patient selection. Circulation 1990: 82: 1193–1202 [DOI] [PubMed] [Google Scholar]
- 14. Rankin JM, Penn IM, Coronary stenting: A global perspective. ACC Curr Rev 1998: 7 (6): 22–25 [Google Scholar]
- 15. Holmes DR, Kip KE, Yeh W., Kelsey SF, Detre KM, Williams DO, for the Investigators of the NHLBI PTCA Registry : Long‐term analysis of conventional coronary balloon angioplasty and an initial “stent‐like” result. J Am Coll Cardiol 1998; 32: 590–595 [DOI] [PubMed] [Google Scholar]
- 16. Antoniucci D., Santoro GM, Bolognese L., Valenti R., Trapani M., Fazzini PF, A clinical trial comparing primary stenting of the infarct‐related artery with optimal primary angioplasty for acute myocardial infarction: Results from the FRESCO trial. J Am Coll Cardiol 1998; 31: 1234–1239 [DOI] [PubMed] [Google Scholar]
- 17. Stone GW, Brodie BR, Griffin JJ, Morice MC, Constntini C., St. Goar FG, Overlie PA, Popma JJ, McDonnell J., Jones D., Oneill WW, Grines CL, for the PAMI Stent Pilot Trial Investigators : Prospective, multicenter study of the safety and feasibility of primary stenting in acute myocardial infarction: In‐hospital and 30‐day results of the PAMI Stent Pilot Trial. J Am Coll Cardiol 1998; 31: 23–30 [DOI] [PubMed] [Google Scholar]
- 18. Sirnes PA, Golf S., Myreng Y., Molstad P., Emanuelsson H., Albertsson P., Brekke M., Mangschau A., Endresen K., Kjekshus J., Stenting in chronic coronary occlusion (SICCO): A randomized controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol 1996; 28: 1444–1451 [DOI] [PubMed] [Google Scholar]
- 19. The study group Clinical Issues, working group Coronary Circulation, of the European Society of Cardiology : Recommendations for training and quality control in coronary angioplasty. Eur Heart J 1996; 17: 1477–1481 [DOI] [PubMed] [Google Scholar]
- 20. Weaver WD, Litwin PE, Martin JS, for the Myocardial Infarction Triage and Intervention Project Investigators : Use of direct angioplasty for treatment of patients with acute myocardial infarction in hospitals with and without on‐site cardiac surgery. Circulation 1993; 88: 2067–2075 [DOI] [PubMed] [Google Scholar]
- 21. Smyth DW, Richards AM, Elliott JM, Direct angioplasty for myocardial infarction: One‐year experience in a center with surgical back‐up 220 miles away. J Invas Cardiol 1997; 9: 324–332 [PubMed] [Google Scholar]
- 22. Steinhubl SR, Lauer MS, Mukherjee DP, Moliterno DJ, Lincoff AM, Ellis SG, Topol EJ, The duration of pretreatment with ticlopidine prior to stenting is associated with the risk of procedure‐related non‐Q‐wave myocardial infarctions. J Am Coll Cardiol 1998; 32: 1366–1370 [DOI] [PubMed] [Google Scholar]
- 23. Mishkel GJ, Aguire FV, Ligon RW, Rocha‐Singh KJ, Lucore CL, Clopidogrel as adjunctive antiplatelet therapy during coronary stenting. J Am Coll Cardiol 1999; 34: 1884–1890 [DOI] [PubMed] [Google Scholar]
- 24. Berger PB, Bell MR, Rihal CS, Ting H., Bareness G., Garratt K., Bellot V., Mathew V., Melby S., Hammes L., Grill D., Holmes DR: Clopidogrel versus ticlopidine after intracoronary stent placement. J Am Coll Cardiol 1999: 34: 1891–1894 [DOI] [PubMed] [Google Scholar]
- 25. Investigators EPIC: Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high‐risk coronary angioplasty. N Engl J Med 1994; 330: 956–961 [DOI] [PubMed] [Google Scholar]
- 26. Topol EI, Califf RM, Weisman HF, Ellis SG, Tcheng JE, Worley S., Ivanhoe R., George BS, Fintel D., Weston M., Sigmon K., Anderson KM, Lee KL, Willerson JT, on behalf of the EPIC Investigators : Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: Results at six months. Lancet 1994; 343: 881–886 [DOI] [PubMed] [Google Scholar]
- 27. The EPISTENT Investigators: Randomized placebo‐controlled and balloon‐angioplasty‐controlled trial to assess safety of coronary stenting with use of platelet glycoprotein‐IIb/IIIa blockade Lancet 1998; 352: 87–92 [DOI] [PubMed] [Google Scholar]
- 28. Serruys PW, Sousa E., Belardi J., Nobuyoshi M., Probst P., Gulba DC, Brachmann J., Almagor Y., Bos HS, Van den Heuvel P., BENESTENT‐II Trial: Subgroup analysis of patients assigned either to angiographic and clinical follow‐up or clinical follow‐up alone (abstr). Circulation 1997: 96 (suppl I): I–653 [Google Scholar]
- 29. Deshpande NV, Serruys PW, Asymptomatic restenosis: Should we (re) intervene? An unresolved dilemma. Am Heart J 1998; 136: 576–577 [DOI] [PubMed] [Google Scholar]
- 30. Vaitkus PT, Adele C., Wells SK, Zehnacker JP, The evolving costs of intracoronary stents. Am Heart J 1998; 136: 132–135 [DOI] [PubMed] [Google Scholar]