title: First clinical experience with the R Stent: a new highly flexible stainless steel tube intracoronary stent.
abstract: BACKGROUND: Coronary stents have been used with increasing frequency and in increasingly complex coronary disease. A new 316 LVM stainless steel coronary stent, the R Stent, has been designed to provide maximum flexibility for tracking and high radial strength post-deployment. PURPOSE: To assess the clinical feasibility of the R Stent in a tertiary referral population of patients with coronary heart disease. Specific objectives are to assess the R Stent's deployment success, angiographic and procedural success (<20% residual stenosis and >TIMI 2 flow), safety (absence of complications), and 30-day clinical success (angiographic/procedural success plus no major adverse coronary events). METHODS: Between April and November 1998, stent deployment was attempted in 27 patients with stable (46%) or unstable (54%) angina pectoris who qualified for percutaneous transluminal coronary angioplasty. Eighty per cent of patients had a pre-existing history of myocardial infarction, coronary bypass surgery or percutaneous transluminal coronary angioplasty, and several of the lesions were anatomically complex (totally occluded, n 32; thrombus present, n 32; heavily calcified, n 33; ostial, n 31; >20 mm long, n 39; angulation >45 degrees, n 37). Lesions in aortocoronary saphenous vein grafts were excluded. Adjunctive medical management included intraprocedural aspirin and heparin and post-procedural aspirin and ticlopidine. After deployment, patients were followed up in the hospital and at 30 days post procedure. RESULTS: Stent deployment was achieved in 32 of 33 attempts (26 of 27 patients). There was one deployment failure in a long, calcified ostial and proximal left coronary lesion. In the 26 successful deployments, TIMI 3 flow was achieved. One other patient experienced a painless increase in creatine kinase to 375 (CK-MB of 59) at 12 h without ECG changes. At 30 days, there were no deaths, no myocardial infarctions, no subacute thromboses, no repeat interventions, no bypass surgeries and no bleeding complications. Only the patient with post-procedural CK-MB elevation experience recurrence of CCS class 2 angina within the 30 days. CONCLUSION: The R Stent is a promising new device for the treatment of complex coronary heart disease. A larger, more broadly-based study is warranted.
authors.affiliation: The Department of Interventional Cardiology, Thoraxcenter, University Hospital Dijkzigt, Dr., Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
authors.forename: Michael JB
authors.initials: MJ
authors.lastname: Kutryk
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Wardeh
authors.forename: Arie HM
authors.initials: AH
authors.lastname: Knook
authors.forename: David P
authors.initials: DP
authors.lastname: Foley
authors.forename: Willem J van der
authors.initials: WJ
authors.lastname: Giessen
authors.forename: Jaap N
authors.initials: JN
authors.lastname: Hamburger
authors.forename: Marcel van den
authors.lastname: Brand Mv
authors.forename: Pim J de
authors.initials: PJ
authors.lastname: Feyter
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Becker
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys