The standard coronary stent implantation technique requires routine predilatation of the target lesion with a balloon catheter. In this study, we prospectively studied the feasibility and efficiency of elective coronary stent implantation without predilatation. In 94 patients who presented with various ischemic syndromes, direct implantation of 100 balloon expandable ACS MultiLink stents (7 over-the-wire, 93 rapid exchange) was attempted in 100 coronary lesions selected to have favorable characteristics. The stent crossed the lesion without predilatation in 97 cases (97%) and was successfully deployed in 93 (95.8%). In 4 patients, adjunctive high-pressure postdilatation was necessary to achieve optimal stent expansion. Reference vessel diameter was 3.12 ± 0.77 mm and lesion length 8.8 ± 2.7 mm. Minimal luminal diameter increased from 0.95 ± 0.38 mm to 2.98 ± 0.28 mm and diameter stenosis decreased from 71 ± 11% to 8 ± 11% after stenting. One occlusive dissection was treated by a second stent. There were no major in-hospital complications. At 1 month follow-up, 1 subacute thrombotic occlusion occurred. These results indicate that in a carefully selected coronary lesion subset, elective stent implantation without predilatation can be safely and effectively performed. The long-term results of this approach and possible advantages over the conventional implantation techniques remain unclear and need to be evaluated in further clinical studies.

Direct stent implantation without predilatation using the multilink stent

An expandable space frame is manufactured by linking a plurality of flexible joints through spacing arms to form a closed structure. The spacing arms are sterically offset, linking the bottom of one joint to the top of the next joint in an stepwise fashion. The offset allows the frame to be collapsed with minimal steric hindrance between the centered joints. This lack of steric hindrance permits a very high ratio of the expansion to compression diameters for the frame. The space frame forms the basis for different types of stents. A spiral frame, or a series of individual frames are linked to each other to form a luminal stent, or are linked to longitudinal struts to form the support structure for a stent. The stents formed from the expandable space frame can be designed to have a number of additional features as set forth herein.

Expandable space frame

Rational and objectives The purpose of this study was to evaluate the effects of variation in design parameters on the resultant radial force. We evaluated the influence of wire gauge, leg length, and number of bends on the radial force produced by z stents and compared these with radial forces produced by commercial stents. A second goal was to develop an engineering model for predicting radial forces generated by z stents. Methods Z stents were fashioned by hand using stainless steel wire and solder that connected the ends. The radial force was measured as a function of wire gauge, vessel diameter, leg length, and number of bends and compared with the theoretical values of radial force calculated by combining Castigliano's theorem and the law of Laplace. Results Theoretically predicted radial forces were within 8% of each observed value of radial force up to 70% spring compression. Conclusions These results suggest that the z-stent model can be used to build custom stents with preselected values of radial force for clinical use. In addition, they can be used to design model investigational stents made of similar materials and surface areas to test the effects of radial force on biological response.

Characterization of radial forces in Z stents.

OBJECTIVES: To review the currently available data from studies assessing feasibility, safety, clinical outcome and cost-effectiveness of direct stenting. BACKGROUND: With technical advances of stent designs and their delivery systems a new strategy has become increasingly popular: direct stent implantation without prior balloon dilatation. METHODS: The Medline database was searched from January 1996 to March 2001 for clinical trials investigating direct stenting using the index terms direct stenting, coronary intervention, percutaneous transluminal coronary angioplasty (PTCA), PCI, angioplasty and ischemic heart disease. Studies were chosen based on the number of patients involved and endpoints mentioned. Data not yet published but presented at recent international meetings were also included. A comparison between direct stenting and stenting with predilatation was performed using for the latter results of the randomized trials supplemented with Benestent II data. RESULTS: At least 26 studies have invest...

Direct coronary stenting compared with stenting after predilatation is feasible, safe, and more cost-effective in selected patients: evidence to date indicating similar late outcomes.

We compared the outcome of the self-expanding Radius stent and the balloon-expandable Multilink stent serially by angiography and intravascular ultrasound Successful stent deployment was achieved in 66 lesions of 56 stable angina patients (34 lesions with Radius stents and 32 lesions with Multilink stents) At follow-up, there were no significant differences in minimal lumen diameter or percent diameter stenosis between the groups, nor in restenosis rates, although the Radius stent group rate was slightly lower (235% vs 313%) In the Radius stent group, stent cross-sectional area (CSA) increased gradually after implantation until the 6-month follow-up (837 ± 183 to 1016 ± 259 mm 2 ; n = 15), giving a larger CSA (P = 003) than the Multilink stent group, which decreased (900 ± 205 to 827 ± 215 mm 2 ; n = 17) The lumen CSA was also slightly larger (682 ± 306 vs 584 ± 185 mm 2 ; P = 029) in the Radius stent group These findings indicated that the Radius stent enlarged progressively after implantation, which might be useful for prevention of restenosis

Comparison of the self-expanding Radius stent and the balloon-expandable Multilink stent for elective treatment of coronary stenoses: A serial analysis by intravascular ultrasound

The Multi-Link coronary stent (Advanced Cardiovascular Systems, Santa Clara, CA) is a balloon expandable stent carved from a stainless steel cylinder and is composed of 12 corrugated rings connected by multiple links. This design gives the stent great flexibility and conformity as well as radial strength. For the 3 month period from November 1995 to January 1996, all patients undergoing stent implantation in our institution were treated with this device, except for vessels smaller than 2.7 mm or larger than 3.7 mm in diameter, left main disease, or those who could not tolerate anticoagulation therapy. Forty patients, with a total of 42 arteries or 44 lesions, were treated with 56 stents, or 1.33 stents per artery. Clinical presentation included stable angina in 13 (32.5%), unstable angina in 24 (60%), acute myocardial infarction in 2 (5%), of whom 1 was in cardiogenic shock, and atypical symptoms with an abnormal thallium stress test in 1 (2.5%). According to the American College of Cardiology/American Heart Association (ACC/AHA) classification, 8 lesions (18%) were type A, 14 (32%) type B1, 11 (25%) type B2, and 11 (25%) type C. Forty-three lesions (97.7%) were de novo and 1 (2.3%) restenotic. Stent delivery was successful in all patients. Complications included 1 balloon rupture at 7 atm but without sequelae, and 2 patients in whom the coronary guide wire became kinked and locked inside the catheter shaft of the stent delivery system but stent delivery was eventually successful. Mean diameter stenosis was reduced from 76 ± 13% prestenting to 2 ± 9% poststenting and minimal lumen diameter increased from 0.87 ± 0.38 to 2.82 ± 0.34 mm. There were no acute-subacute stent thromboses, bleeding/vascular complications, or major cardiac events such as myocardial infarction, coronary artery bypass surgery, or death during a follow-up period of 2–5 months (mean 3.6 months). In conclusion, our early clinical experience with the Multi-Link stent is very encouraging, with a very high rate of successful delivery and minimal complications. © 1996 Wiley-Liss, Inc.

Early clinical experience with the Multi-Link coronary stent.

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Early clinical experience with the Multi-Link coronary stent.