First clinical experience with the R Stent: a new highly flexible stainless steel tube intracoronary stent

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.     

Management of calcified lesions in 2004

Calcified lesions are encountered with increasing frequency in the catheterization laboratory. Percutaneous coronary interventions of calcified lesions are associated with a higher complication rate than percutaneous intervention on non-calcified lesions. The review focuses on current management strategies in the drug eluting stent era of this complex lesion subset. Evidence based approaches to treat calcified coronary lesions with balloon based and atherectomy devices as adjunctive modalities in the drug eluting stent era are discussed in this article.     

Coronary stenting using a 6 F. diagnostic catheter: a report of two cases

Standard guiding catheters for coronary interventions may not selectively engage the coronary ostium despite a successful cannulation with a diagnostic catheter of the same curve. This discrepancy is explained by a slight difference in shape between the two catheters (shorter tip of the guiding, absence of tip tapering, etc.). The authors report on the use of 6 F. coronary diagnostic catheters as guiding catheters for coronary angioplasty and stent implantation in two patients with critical stenoses: in the right coronary artery distal to a right internal mammary artery anastomosis in one and in the ostial right coronary artery in the other. In both cases, the use of diagnostic catheters was the key to success despite the vessel orifice being unfavourable for the use of different types of guiding catheters.     

Current concepts in coronary physiology for the interventionalist

Coronary angiography remains the 'gold standard' for the diagnosis of epicardial coronary disease. However, precise quantification of stenosis severity is limited because of the complex three-dimensional geometry of epicardial plaques. To assist the angiographer in lesion assessment, several physiologic measurements have been developed to evaluate stenosis severity, including coronary flow reserve, relative coronary flow reserve and fractional flow reserve. Physiologic lesion assessment can also be an invaluable tool in coronary intervention, evaluating efficacy of angioplasty and stent deployment.     

Provisional stenting in small vessels

Based on the currently available data, the strategy of routine stent placement in unselected lesions located in small coronary arteries provides good immediate results but is still associated with a high incidence of in-stent restenosis. Randomized trials comparing elective stenting with balloon angioplasty have not provided the demonstration that routine stenting is the best strategy for percutaneous intervention in coronary arteries with a reference diameter smaller than 2.75-3.0 mm. This paper describes the rationale for provisional stenting in this clinical setting and reviews the role of quantitative coronary angiography, intracoronary ultrasound and intracoronary Doppler measurements in the identification of lesions that would benefit from adjunctive stent placement after balloon angioplasty and in guiding stent implantation.     

The effects of stenting on coronary endothelium from a molecular biological view: Time for improvement?

Coronary artery stenting following balloon angioplasty represents the gold standard in revascularization of coronary artery stenoses. However, stent deployment as well as percutaneous transluminal coronary angioplasty (PTCA) alone causes severe injury of vascular endothelium. The damaged endothelium is intrinsically repaired by locally derived endothelial cells and by circulating endothelial progenitor cells from the blood, leading to re‐population of the denuded regions within several weeks to months. However, the process of re‐endothelialization is often incomplete or dysfunctional, promoting in‐stent thrombosis and restenosis. The molecular and biomechanical mechanisms that influence the process of re‐endothelialization in stented segments are incompletely understood. Once the endothelium is restored, endothelial function might still be impaired. Several strategies have been followed to improve endothelial function after coronary stenting. In this review, the effects of stenting on coronary endothelium are outlined and current and future strategies to improve endothelial function after stent deployment are discussed.     

可降解冠状动脉支架的研究进展

冠脉内支架植入是临床上预防PTCA术后再狭窄并发症的有效措施,但金属支架仅在植入早期发生作用,在冠脉内壁修复完成后则成为多余的负担,可能激活血小板及多种凝血因子聚集导致血栓形成及刺激血管壁造成心脏事件及再狭窄的发生。针对上述问题,生物可降解冠状动脉支架的研究得到了相当的发展。本文就可降解支架的发展及现状作一简要综述。     

Exploration par tomodensitométrie multidétecteur du cœur et des artères coronaires

Due to its excellent spatial and temporal resolution, multislice computerized tomography (MSCT) allows visualizing the heart and coronary arteries. Although the indications of MSCT did not reach a consensus level yet, some trends can be stated. The advantages and limitations of MSCT in cardiac exploration are summarized in this article. The indications are mainly based on the excellent negative predictive value of MSCT regarding coronary artery disease. Hence, patients at low to moderate risk of coronary artery disease (CAD) mostly benefit of the technique. MSCT can be an alternate examination in case of non feasible or non contributive stress test. MSCT is highly contributive in the ostial analysis, in detecting abnormal coronary implantation or course, in assessing a reimplanted artery or in analysing bypass grafts. MSCT remains limited in patients with heavily calcified coronary arteries, and in patients with stented distal arteries.     

Preliminary experience with the Tsunami coronary stent: immediate and six-month clinical and angiographic results

The Tsunami is a new, balloon-expandable, stainless steel, tubular coronary stent whose design is based on a number of radial, diamond-shaped cells joined by double connectors. The aim of this two-centre, prospective, nonrandomized study was to examine the procedural, in-hospital, and long-term clinical and angiographic outcomes of patients undergoing angioplasty with the Tsunami stent. Sixty-one consecutive unselected patients were treated by means of the implantation of 74 Tsunami stents in 72 coronary lesions. Most of the patients (64%) had unstable angina or acute myocardial infarction. The baseline lesion morphology was complex in 76% of cases, and the mean lesion length was 14 +/- 6 mm. The procedural success rate was 98%. Mean percentage diameter of the stenosis decreased after the intervention from 79 +/- 12% to 10 +/- 6%. The in-hospital major adverse cardiac event rate was 3.3%. During the six-month follow-up, there was one cardiac death and nine subjects (14.5%) underwent target vessel revascularization. The six-month event-free survival rate was 80%. The angiographic restenosis rate was 17%: a focal or limited pattern (class I or II) was found in 43% of cases, whereas the remaining 57% had a proliferative morphology (class III or IV). In conclusion, this study indicates the good clinical and angiographic performance of the Tsunami coronary stent system in consecutive unselected patients.     

Analysis of the transient expansion behavior and design optimization of coronary stents by finite element method

The percutaneous transluminal coronary angioplasty (PTCA) assisted with stenting technique has become a primary therapy to coronary heart disease. In practice, the structure conditions of both ends of stent/balloon system influence a stent's instantaneous expansion behavior. The transitory nonuniform expansion, the so-called dogboning, of stent/balloon system is one of the main reasons to induce the acute vascular injury at the two edges of a stent. This kind of vascular injury has a close relationship with the in-stent restenosis. In the present paper, the finite element method (FEM) was applied to simulate the transient expansion process of stent/balloon system with different stent structure and balloon length under the internal pressure. And two types of stent and six collocations of stent and balloon were modeled. Modeling results showed that the dogboning phenomenon can be eliminated by improving geometry of a stent or/and varying the length of balloon over stent. The above modeled results were further confirmed by following in situ observation.     

Traumatic ostial stenosis of internal mammary coronary graft

Because of the extensive use of arterial conduits for coronary surgery there is a growing interest in percutaneous intervention in these conduits. This kind of intervention presents a challenge for the interventional cardiologist owing to the anatomic and functional characteristics of this graft. In most cases significant internal mammary artery disease occurs at the distal anastomosis. Ostial stenoses are rare and their pathology uncertain. The authors report a case of an ostial graft lesion, most probably caused by repetitive ostial engagement of the left internal mammary artery in combination with atherosclerosis in the subclavian artery affecting the internal mammary artery.     

Efficiency of endovascular re-interventions for evolving restenosis of different types of stents

The paper compares the results of different treatment options (balloon angioplasty and restenting) for in-stent restenosis in case of evolving restenosis of drug- and nondrug eluting stents. The investigation enrolled 496 coronary heart disease patients with clinical presentation of angina pectoris and/or signs of myocardial ischemia, as well as hemodynamic restenosis of a previously implanted stent. Of them, 216 and 280 patients had restenosis of previously implanted drug- and nondrug-eluting stents, respectively. In the patients with non-drug-eluting stent restenosis, recurrent angina pectoris and the frequency of repeated restenosis were significantly more frequently observed after balloon dilatation than after drug-eluting stent implantation (28.4 and 10.2%; p < 0.05; 19.9 and 8.7%; p < 0.05). In those with drug-eluting stent restenosis, recurrent angina pectoris and the frequency of repeated restenosis did not differ significantly between balloon dilatation of restenosis and implantation of a second drug-eluting stent.     

Low rates of clinical restenosis with the new flexible stainless steel tube intracoronary stent: the R Stent. A six-month safety and feasibility study

BACKGROUND: Coronary stents have been used with increasing frequency and in increasingly complex coronary lesions for the treatment of symptomatic coronary artery disease. A new stainless steel coronary stent, the R Stent, has been designed to provide maximum flexibility for tracking and high radial strength post-deployment. AIMS: To assess the safety and feasibility of the R Stent in patients with coronary artery disease. Specific objectives were to assess the R Stent's deployment success, angiographic and procedural success (< 20% residual stenosis and TIMI 3 flow), safety (absence of complications), 30-day and six-month clinical follow-up. METHODS: Between April 1998 and January 1999, stent deployment was attempted in 36 lesions in 30 patients with stable (43%) or unstable (57%) angina pectoris and 29/36 of the lesions were anatomically complex. Treated lesions were in the LAD (n = 15), RCA (n = 13) or LCX (n = 8). RESULTS: Stent deployment was achieved in 97% with one crossing failure in a patient with a long, calcified, proximal LAD lesion. After the procedure, patients were scheduled for one- and six-month clinical follow-up. One patient experienced a non-Q-wave myocardial infarction in hospital. At one month, there were no additional complications. Only one patient experienced recurrence of angina (CCS class 2) within the 30 days. At six-month follow-up, one sudden death had occurred. Three (10%) patients had anginal complaints, one of them received target lesion repeat PTCA. All other patients (87%) were event- and angina-free. CONCLUSION: This first clinical experience with the R Stent shows acceptable feasibility and safety with good long-term clinical results.     

Association between coronary lesion severity and distal microvascular resistance in patients with coronary artery disease

Homogeneity of microvascular resistance in different perfusion areas of the same heart is generally assumed. We investigated the effect of the severity of an epicardial stenosis on microvascular resistance in 27 patients with coronary artery disease and stable angina. All patients had an angiographically normal coronary artery, an artery with an intermediate lesion, and an artery with a severe lesion; the latter was treated with angioplasty. In each patient, distal blood flow velocity and pressure were measured during baseline and maximal hyperemia (induced by intracoronary adenosine) using a Doppler and pressure guide wire, respectively. The ratio of mean distal pressure to average peak blood flow velocity was used as an index for the microvascular resistance (MRv). Within patients, the hyperemic MRv was higher in arteries with more severe stenosis (P = 0.021). After percutaneous transluminal coronary angioplasty (PTCA), the hyperemic MRv decreased (pre-PTCA, 2.6 vs. post-PTCA, 1.9 mmHg.cm(-1)s(-1), P < 0.01) toward the value of the reference artery (1.7 mmHg.cm(-1)s(-1); P = 0.67). We conclude that there is a positive association between coronary lesion severity and variability of distal microvascular resistance that normalizes after angioplasty. This study challenges the concept of uniform distribution of hyperemic MRv that is relevant for the interpretation of both noninvasive and invasive diagnostic tests.     

Mechanical and hydrodynamic effects of stent expansion in tapered coronary vessels

Percutaneous coronary intervention (PCI) has become the primary treatment for patients with coronary heart disease because of its minimally invasive nature and high efficiency. Anatomical studies have shown that most coronary vessels gradually shrink, and the vessels gradually become thinner from the proximal to the distal end. In this paper, the effects of different stent expansion methods on the mechanical and hemodynamic behaviors of coronary vessels and stents were studied. To perform a structural-mechanical analysis of stent implantation, the coronary vessels with branching vessels and the coronary vessels with large bending curvature are selected. The two characteristic structures are implanted in equal diameter expansion mode and conical expansion mode, and the stress and mechanical behaviors of the coronary vessels and stents are analyzed. The results of the structural-mechanical analysis showed that the mechanical behaviors and fatigue performance of the cobalt-chromium alloy stent were good, and the different expansion modes of the stent had little effect on the fatigue performance of the stent. However, the equal diameter expansion mode increased distal coronary artery stress and the risk of vascular injury. The computational fluid dynamics analysis results showed that different stent expansion methods had varied effects on coronary vessel hemodynamics and that the wall shear stress distribution of conical stent expansion is more uniform compared with equal diameter expansion. Additionally, the vortex phenomenon is not apparent, the blood flow velocity is slightly increased, the hydrodynamic environment is more reasonable, and the risk of coronary artery injury is reduced.

     

Intravascular brachytherapy to prevent restenosis: dosimetric considerations.

Acute myocardial infarction is often the result of occlusion of one or more coronary arteries. Occlusion and restenosis (re-closing of the vessel) are principal reasons that percutaneous transluminal coronary angioplasty (PTCA) may fail to provide long-term benefit. PTCA has been a popular treatment, which is less invasive than surgeries involving revascularization of the myocardium, promising a better quality of life for patients. Unfortunately, the rate of restenosis after balloon angioplasty is high (approximately 30-50% in the first year after treatment). Recent data suggest that intraluminal irradiation of coronary arteries in conjunction with balloon angioplasty and/or stent implantation reduces the proliferation of smooth muscle cells and neointima formation, thereby inhibiting restenosis. In order to study radiation dosimetry in the patient and for this therapy, dose distributions for electrons and photons, with discrete energies, were simulated for blood vessels of diameter 1.5, 3 and 4.5 mm irradiated with balloon and wire sources. Electron and photon transport was performed in a simple model representing the system used for irradiation using the MCNP 4B code (Monte Carlo N-Particles). Specific calculations for balloon and wire sources were also carried out for a few radionuclides. In this work, strengths and drawbacks conceming the use of each radionuclide simulated, as well as source geometries are discussed. The dosimetry performed in this study will improve understanding of the benefit-to-risk ratio in intracoronary brachytherapy.     

Clinical trends in stent treatment of simple and complex coronary disease

This is a retrospective analysis of a consecutive group of patients from a single medical center who underwent stent implantation. It describes 316 patients who constituted 53% of the angioplasty procedures carried out in a single year. The authors describe the complications and their 1-year follow-up. We aimed to study the short and long-term results of stenting in our centre in relation to multiple clinical and angiographic variables. During 1996, 316 consecutive patients were treated with stent implantation for a total of 381 coronary lesions. The pharmacological protocol methods of stent implantation and patient characteristics were used. Clinical variables were: age 59.1 3 10.7 years, diabetes mellitus 25.3%, hypertension 33.0% and angina pectoris 88.7% (unstable in 44.1%). Previous coronary surgery had been undergone by 9.2%. Multivessel disease was present in 56% of the patients. The indications for stenting were: primary 58.5%, suboptimal results 33.0% and threatened or acute occlusion 8.5%. Angiographic success was 98.9% and clinical success 96.8%. The major in-hospital complications were acute myocardial infarction (2.2%), acute revascularization (0.3%) and major bleeding (0.6%). All occurred within 24 h of revascularization. Repeated angiography was performed in 115 cases (30.2%) at 160.3 3 109.4 days after stent procedure for unstable angina (38.7%), stable angina (26.1%) and other causes (35.2%). The restenosis rate in those catheterized was 38.1%, with an overall clinical restenosis rate of 11.3% during the follow-up period. Restenosis was more prevalent among diabetic patients (17.9 vs 9.15%, P 3 0.02) and patients with prior balloon angioplasty (18.6 vs 9.75%, P 3 0.046). Clinical follow-up was available in 90.8% of the patients for 291 3 112 days. The actuarial survival at the end of the follow-up period was 93.8%. Death/myocardial infarction was associated with unstable angina pectoris (P 3 0.006), hypertension (P 3 0.001), smoking (P 3 0.046) and threatened or acute occlusion (P < 0.001). In the first year of extensive stent use, stenting is associated with high technical and clinical success rates. Long-term results after stent implantation are associated with the occurrence of acute or threatened occlusion, and the in-hospital complications diabetes mellitus and hypertension.     

Nanoparticulate carriers for the treatment of coronary restenosis

The current treatment for coronary restenosis following balloon angioplasty involves the use of a mechanical or a drug-eluting stent. Despite the high usage of commercially-available drug-eluting stents in the cardiac field, there are a number of limitations. This review will present the background ofrestenosis, go briefly into the molecular and cellular mechanisms of restenosis, the use of mechanical stents in coronary restenosis, and will provide an overview of the drugs and genes tested to treat restenosis. The primary focus of this article is to present a comprehensive overview on the use of nanoparticulate delivery systems in the treatment of restenosis both in-vitro and in-vivo. Nanocarriers have been tested in a variety of animal models and in human clinical trials with favorable results. Polymer-based nanoparticles, liposomes, and micelles will be discussed, in addition to the findings presented in the field of cardiovascular drug targeting. Nanocarrier-based delivery presents a viable alternative to the current stent based therapies.     

Use of Rtrade mark stent in the percutaneous coronary intervention of coronary bifurcation lesions

BACKGROUND: Percutaneous Coronary Intervention (PCI) of coronary bifurcation lesion is technically quite demanding. It has been associated with a lower procedural success, higher rates of complication and restenosis. Side-branch occlusion and plaque shifting or 'snow plow' effect are not uncommon. Stenting of the main vessel may cause 'stent jail' of the side-branch. Modern stent design may allow passage of a balloon or stent into the side-branch through the struts of the stent placed in the main vessel. A newly developed 316 stainless steel tubular stent, the Rtrade mark stent is uniquely designed to provide flexibility, radial strength on deployment and conformability. Its large cell size facilitates PCI of bifurcation lesion. AIM: To assess the feasibility of R(trade mark) stent in the treatment of symptomatic patients with bifurcation coronary lesions. The main objective was to assess the ease of deployment, side-branch access and overall success of the R(trade mark) stent in this group of patients without any major adverse events. METHODS: Between December 1998 and September 2000 the R(trade mark) stent was used as a main stent in 28 consecutive patients with coronary bifurcation lesions, 46% of which had unstable angina. The mean age was 59 +/- 10 and 89% were male. Adjunctive medical therapy included clopidrogel, aspirin and intraprocedure heparin. Abciximab (ReoPro) was given to 9 patients. RESULTS: Successful stent deployment was achieved in all patients. Thirty-four R Stents and 16 other stents were used. Two patients had post-procedure rise in cardiac enzymes. There were no major adverse events at 30 days. LAD/D1 with LAD/diagonal was the target lesion in the majority of patients. Stenting of the side-branch was done in 18 and balloon dilatation in 9 patients. At 3-23 months (mean 11.8) follow-up, repeat angiography was done in 18 patients with restenosis in 4, two of them had repeat PCI and one had coronary artery bypass graft (CABG). CONCLUSION: Coronary bifurcation lesions are not uncommon. Current advances in stent technology offer a safe and effective revascularisation strategy for such complex lesions. The R(trade mark) stent appears to be a suitable device that provides good wall coverage, radial strength, conformability and easy side-branch access.