Mark A. Grise

Five-Year Clinical Follow-Up After Intracoronary Radiation Results of a Randomized Clinical Trial

Background—Several clinical trials indicate that intracoronary radiation is safe and effective for treatment of restenotic coronary arteries. We previously reported 6-month and 3-year clinical and angiographic follow-up demonstrating significant decreases in target lesion revascularization (TLR) and angiographic restenosis after &ggr; radiation of restenotic lesions. The objective of this study was to document the clinical outcome 5 years after treatment of restenotic coronary arteries with catheter-based iridium-192 (192Ir). Methods and Results—A double-blind, randomized trail compared 192Ir to placebo sources in patients with restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to 192Ir and 29 to placebo. At 5-year follow-up, TLR was significantly lower in the 192Ir group (23.1% versus 48.3%;P =0.05). There were 2 TLRs between years 3 and 5 in patients in the 192Ir group and none in patients in the placebo group. The 5-year event-free survival rate (freedom from death, myocardial infarction, or TLR) was greater in 192Ir-treated patients (61.5% versus 34.5%;P =0.02). Conclusions—Despite apparent mitigation of efficacy over time, there remains a significant reduction in TLR at 5 years and an improvement in event-free survival in patients treated with intracoronary 192Ir. The early clinical benefits after intracoronary &ggr; radiation with 192Ir seem durable at 5-year clinical follow-up.

Pilot trial of oral rapamycin for recalcitrant restenosis.

Background—Sirolimus-coated stents are a promising new therapy for restenosis. We treated a select group of patients at especially high risk for restenosis with oral sirolimus. Methods and Results—Patients were treated with an oral sirolimus-loading dose of 6 mg after coronary angioplasty, followed by 2 mg/d for 4 weeks. Serum electrolytes, lipid profile, renal panel, and complete blood cell count were measured at 1, 3, and 5 weeks after drug initiation. Oral sirolimus was prescribed to 22 patients who had a total of 28 lesions and were at high risk for restenosis. Of the 22 study patients, 11 (50%) discontinued oral sirolimus early because of side effects or laboratory abnormalities. Hypertriglyceridemia and leukopenia were the most frequent adverse events, occurring in 3 patients each. All adverse drug effects were reversible after discontinuation. Follow-up was obtained in 100% of patients at a mean of 9.9±1.8 months, ranging from 6.5 to 11.8 months. Target lesion revascularization (TLR) occurred in 15 of 28 lesions (53.6%) and 13 of 22 patients (59.1%). There was no difference in TLR for patients receiving a complete course of sirolimus (n=8; 72.7%) compared with patients who terminated treatment prematurely (n=5; 45.5%;P =NS). Clinically driven repeat cardiac catheterization was obtained in 15 (68.2%) patients; restenosis (>50% diameter stenosis at follow-up) was present in 13 (86.7%). Conclusion—Oral sirolimus does not appear to provide benefit to patients with recalcitrant restenosis. Adverse drug effects are frequent, underscoring the importance of local drug delivery to achieve high tissue concentrations without systemic adverse drug effects.

Endovascular stenting for vertebral artery stenosis.

OBJECTIVESnThe aim of this study was to demonstrate the safety and long-term durability of catheter-based therapy for symptomatic vertebral artery stenosis (VAS).nnnBACKGROUNDnSymptomatic VAS carries with it a 5-year 30% to 35% risk of stroke. The 2-year mortality approaches 30% for medically managed strokes involving the posterior circulation. Surgical bypass is rarely performed, due to high morbidity and mortality. Endovascular revascularization with primary stenting offers an attractive treatment option for these patients.nnnMETHODSnOne-hundred five consecutive symptomatic patients (112 arteries, 71% male) underwent stent placement for extracranial (91%) and intracranial (9%) VAS from 1995 to 2006. Fifty-seven patients (54%) had bilateral VAS, 71 patients (68%) had concomitant carotid disease, and 43 patients (41%) had a prior stroke.nnnRESULTSnProcedural and clinical success was achieved in 105 (100%) and 95 (90.5%) patients, respectively. One-year follow-up was obtained in 87 (82.9%) patients, of which 69 patients (79.3%) remained symptom-free. At 1 year, 6 patients (5.7%) had died and 5 patients (5%) had a posterior circulation stroke. Target vessel revascularization occurred in 7.4% at 1 year. At a median follow-up of 29.1 months (interquartile range 12.8 to 50.9 months), 13.1% underwent target vessel revascularization, 71.4% were alive, and 70.5% remained symptom-free.nnnCONCLUSIONSnIn experienced hands, stenting for symptomatic VAS can be accomplished with a very high success rate (100%), with few periprocedural complications, and is associated with durable symptom resolution in the majority (approximately 80%) of patients. We conclude that endovascular stenting of vertebral artery atherosclerotic disease is safe and effective compared with surgical controls and should be considered first-line therapy for this disease.

A randomized trial of intravenous N-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes

Background: Pharmacokinetic data suggests that the intravenous form of n‐acetylcysteine (NAC) may be more effective than the oral formulation in preventing contrast induced nephropathy (CIN). NAC owing to its anti‐oxidant properties might be beneficial for patients with acute coronary syndromes (ACS) who are at increased risk for CIN. The aim of this prospective randomized, single‐center, double‐blind, placebo controlled trial (NCT00939913) was to assess the effect of high‐dose intravenous NAC on CIN in ACS patients undergoing coronary angiography and/or percutaneous coronary intervention (PCI). Methods: We randomized 398 ACS patients scheduled for diagnostic angiography ± PCI to an intravenous regimen of high‐dose NAC (1,200 mg bolus followed by 200 mg/hr for 24 hr; n = 206) or placebo (n = 192). The primary end‐point was incidence of CIN defined as an increase in serum creatinine concentration ≥25% above the baseline level within 72 hr of the administration of intravenous contrast. Results: There was no difference found for the primary end point with CIN in 16% of the NAC group and in 13% of the placebo group (p = 0.40). Change in serum cystatin‐C, a sensitive marker for renal function, was 0.046 ± 0.204 in the NAC group and 0.002 ± 0.260 in the control group (p = 0.07). Conclusion: In ACS patients undergoing angiography ± PCI, high‐dose intravenous NAC failed to reduce the incidence of CIN.

Carotid artery stent placement is safe in the very elderly (>= 80 years)

Background: Carotid artery stent (CAS) placement is an alternative to carotid endarterectomy (CEA) for stroke prevention. Clinical adoption of CAS depends on its safety and efficacy compared to CEA. There are conflicting reports in the literature regarding the safety of CAS in the elderly. To address these safety concerns, we report our single‐center 13‐year CAS experience in very elderly (≥80 years of age) patients. Methods: Between 1994 and 2007, 816 CAS procedures were performed at the Ochsner Clinic Foundation. Very elderly patients, those ≥80 years of age, accounted for 126 (15%) of all CAS procedures. Independent neurologic examination was performed before and after the CAS procedure. Results: The average patient age was 82.9 ± 2.9 years. Almost one‐half (44%) were women and 40% were symptomatic from their carotid stenoses. One‐third of the elderly patients met anatomic criteria for high surgical risk as their indication for CAS. The procedural success rate was 100% with embolic protection devices used in 50%. The 30‐day major adverse coronary or cerebral events (MACCE) rate was 2.7% (n = 3) with all events occurring in the symptomatic patient group [death = 0.9% (n = 1), myocardial infarction = 0%, major (disabling) stroke = 0.9% (n = 1), and minor stroke = 0.9% (n = 1)]. Conclusion: Elderly patients, ≥80 years of age, may undergo successful CAS with a very low adverse event rate as determined by an independent neurological examination. We believe that careful case selection and experienced operators were keys to our success.

Catheter-based therapy of common femoral artery atherosclerotic disease

The objective of this paper is to describe outcomes of endovascular therapy in patients with symptomatic common femoral artery (CFA) lesions. Symptomatic atherosclerotic disease of the common femoral artery is an uncommon clinical entity, and there is no consensus regarding the suitability of catheter-based therapy. We reviewed the records of 26 consecutive patients treated with catheter-based therapy for symptomatic CFA lesions between 1994 and 2009. Angiographic success and procedure success were obtained in all vessels and in all patients. At 1 year, 100% (16/16) of the claudication patients and 70% (7/10) of the critical limb ischemia (CLI) patients maintained clinical success. The ankle— brachial index (ABI) significantly improved from a baseline of 0.47 ± 0.18 to 0.77 ± 0.18 (p < 0.001) after the procedure. At their most recent clinic visit (31 months ± 14 months), clinical success was maintained in 100% of the claudication patients and in 70% (7/10) of the CLI patients. During the follow-up period, femoral vascular access for an unrelated procedure was obtained through the CFA stent. In conclusion, patients with symptomatic CFA atherosclerotic disease obtained excellent clinical outcomes with angioplasty with stenting. We found that angioplasty with stenting of the CFA did not preclude future CFA vascular access. Our data suggest that catheter-based therapies should be considered as an option to open surgery in selected patients with symptomatic CFA disease.

Optimal treatment of renal artery in-stent restenosis: Repeat stent placement versus angioplasty alone

We investigated whether repeat renal artery stent placement compared with treatment with balloon angioplasty alone results in better patency in patients presenting with renal artery in‐stent restenosis (ISR).

A case of an entrapped rotational atherectomy burr.

Rotational atherectomy is a widely used modality in percutaneous coronary revascularization, especially for heavily calcified coronary arteries [1–5]. Due to the unique mechanism of rotational atherectomy, there have been reports of unusual complications, including fracture of coronary wire, guidewire bias, coronary spasm leading to myocardial infarction, and fracture of the drive shaft causing acute ischemia [6–9]. We provide the first case reported of entrapment of an atherectomy burr in the left anterior descending artery (LAD) and a technique for its removal.

Acute stroke intervention by interventional cardiologists

To report the technical success and clinical outcomes of catheter‐based therapy (CBT) for acute ischemic stroke in patients ineligible for intravenous thrombolysis.

Intracoronary radiation to treat in-stent restenosis in six cardiac transplant patients

Transplant vasculopathy significantly limits the survival of cardiac transplant patients and occurs in 50% of patients by 5 years posttransplant. We report our experience with six cardiac transplant patients who underwent intracoronary brachytherapy for in‐stent restenosis. At four centers, six patients underwent intracoronary radiation for in‐stent restenosis. All patients received extended antiplatelet therapy with clopidogrel and aspirin. Follow‐up angiography was performed in all patients. Two of the six patients underwent subsequent target lesion revascularization. Patient 1 presented with total occlusion of her radiated lesion. She had a complex procedure requiring stenting for a dissection after the radiation dwell. Patient 2 had high‐grade restenosis following brachytherapy. Patient 3 had a 50% restenotic lesion. Patients 4, 5, and 6 had follow‐up angiography that showed no evidence of restenosis. There are few good options to treated accelerated transplant vasculopathy. Radiation therapy may be a viable option in this difficult patient population. Catheter Cardiovasc Interv 2003;60:41–44.