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- ↵*Reprint requests and correspondence:
Dr. James J. Ferguson, Cardiology Research, Mail Code 1-191, St. Luke's Episcopal Hospital, 6720 Bertner Avenue, Houston, Texas 77030, USA
“A stupid man's report of what a clever man says is never accurate because he unconsciously translates what he hears into something he can understand.”
“You are smart when you only believe half of what you hear. You're wise when you know which half to believe.”
For this year's American College of Cardiology (ACC) meetings, a total of 933 abstracts were reviewed for angiography and interventional cardiology; 308 were accepted for presentation. Last year, the angiography and interventional cardiology highlights (1) included such varied topics as distal protection, new thromboatherectomy devices, inflammation, drug-eluting stents (DES), and peripheral intervention. This year, DES and peripheral intervention continued to be “hot” areas, but added to that was important work on our ever-expanding technologic options, such as bone marrow stem-cell injections, valve repair, novel myocardial infarction (MI) therapies, new diagnostic modalities, and other interventions.
Two late-breaking clinical trials, A randomized comparison of sirolimus-eluting and an uncoated stent in the prevention of restenosis in small coronary arteries (SES-SMART) and Direct Stenting Using the Sirolimus-Eluting Bx Velocity Stent (DIRECT), were presented by Ardissino (2) and Moses (3), respectively. The SES-SMART trial (2) was a randomized trial comparing sirolimus stents with uncoated stents in people with de novo lesions in small coronary vessels (≤2.75 mm), and showed a binary restenosis rate of 9.8% with sirolimus stents versus 53.1% with uncoated stents (p < 0.001). Clinical events of death (0% vs. 1.6%), MI (1.6% vs. 7.8%), and target lesion revascularization (7.0% vs. 21.1%) were also dramatically reduced in the sirolimus stent group. The benefits were present across multiple subgroups and extended the benefits seen with sirolimus stents in other studies. The DIRECT study (3) was a nonrandomized trial comparing direct stenting with a sirolimus-coated stent (n = 225) in historical control subjects treated with sirolimus stents, but using a predilation delivery strategy (n = 412). The results showed no significant differences between the direct and predilated cohorts meeting prespecified criteria for noninferiority for eight-month qualitative coronary angiographic (QCA) late loss and clinical events, and there was no significant difference in eight-month QCA binary restenosis.
Other important data on DES were also presented. A report by Hermiller et al. (4) highlighted the diabetic subset in TAXUS, in whom the benefits seen in the overall population were preserved. Pinto et al. (5) presented long-term follow-up of the First-in-Man experience and showed continued long-term safety and efficacy up to four years. Marks et al. (6) presented a cost-efficacy analysis of DES, in which overall procedural costs were increased, but less than the cost of the stent itself.
In another late-breaking clinical trial session, Dr. Gray presented the results of the overall Acculink for Revascularization of Carotids in High Risk Patients (ARCHeR) experience with carotid stenting and distal protection (7). These studies (ARCHeR I to III) involved a variety of techniques, devices, and end points (ARCHeR I without distal protection devices; ARCHeR II and III with increasingly sophisticated technology). In the overall experience, there was a very low incidence of adverse clinical events for stenting with distal protection in patients otherwise at high surgical risk, achieving prespecified noninferiority in comparison to surgical carotid endarterectomy (using historical controls). The outcomes appeared durable, as witnessed by a low incidence of target lesion revascularization at one year.
Bone marrow stem-cell injections
Three important presentations discussed this exciting new technique. Perin et al. (8) presented their long-term experience with transendocardially injected autologous bone marrow stem cells in 10 patients with ischemic cardiomyopathy. They found no arrhythmias and a sustained improvement in exercise capacity. Fuchs et al. (9) presented their initial feasibility and safety experience with transendocardial injection of stem cells in 27 patients. Tse et al. (10) presented three- and six-month follow-up data on 12 patients; there were no arrhythmias and better perfusion noted on single-photon emission computed tomography (SPECT) with sestamibi.
Dr. Feldman presented data from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST)-1 clinical experience with percutaneous mitral valve repair in another of the late-breaking clinical trial sessions (11). This technique involves an edge-to-edge technique that is a percutaneous modification of the single-stitch surgical technique, which involves a stitch linking the anterior and posterior leaflets, and significantly reduces mitral regurgitation (MR). The current experience involves 10 patients (of a total of 20) undergoing percutaneous placement of a clip that is advanced trans-septally. In these 10 patients, MR was reduced to ≤2+ for up to six months' follow-up, with either improvement or no worsening of New York Heart Association functional class. There was one instance where the clip detached from one of the leaflets.
Eltchaninoff et al. (12) documented follow-up on the French percutaneous aortic valve experience in six patients with calcific aortic stenosis who were turned down for surgery. Of the six procedures, five were successful, with one death (related to immediate migration of the prosthesis; two of the six patients are currently alive).
MI: novel therapies
One entire late-breaking clinical trial session focused on novel therapies for acute MI. Dr. Stone presented the results of Enhanced Myocardial Efficacy and Removal by Aspiration of Liberated Debris (EMERALD) (13), which examined the use of a distal protection device for primary percutaneous coronary intervention (PCI) in patients with acute MI. A total of 401 patients were randomized to receive either PCI alone or PCI with the use of a Guardwire PLUS (Medtronic, Minneapolis, Minnesota) for distal protection. The primary end points were complete (>70%) ST-segment resolution and infarct size by technetium-99m SPECT. There was no significant difference in either of the primary end points or in the final corrected Thrombolysis In Myocardial Infarction (TIMI) frame counts between the groups.
Dr. O'Neill presented the results of the Acute Myocardial Infarction With Hyperoxemic Therapy (AMIHOT) study (14), an investigation the use of hyperoxemic reperfusion with aqueous oxygen during primary PCI. Although the procedure was well tolerated, there was no significant reduction in creatine kinase release and no improvement in ST-segment resolution, although there was a trend toward better ST-segment resolution in patients with anterior MI. Final analyses of infarct size and regional wall motion by echocardiography will be forthcoming.
The Calderet in ST-Elevation Myocardial Infarction (CASTEMI) study, presented by Dr. Tzivoni (15), involved 387 patients with acute MI who were randomized to placebo or one of two doses of caldaret (a drug that modulates calcium handling by inhibiting calcium entry into the cell via the Na+/Ca2+ exchanger, removes intracellular calcium into the sarcoplasmic reticulum, and decreases calcium overload during ischemia and/or reperfusion) at 57.5 mg (low dose) or 172.5 mg (high dose). The target study population was 247 of 387 patients with TIMI flow grade 0/1 on the baseline angiogram. The primary end point of the study—SPECT infarct size at day 7—was not different between the groups. There did appear to be differences in the high-dose group in patients with an anterior infarction
The Ongoing Tirofiban in Myocardial Infarction Evaluation (ON-TIME) trial, presented by Dr. de Boer (16), examined the efficacy of facilitated PCI in 457 patients with acute MI who were randomized to early treatment with either placebo or a glycoprotein IIb/IIIa antagonist. The primary end point was TIMI flow grade on the initial angiogram (mean time 59 min, range 11 to 178 min). The TIMI flow grade 3 was not significantly different with pretreatment with a glycoprotein IIb/IIIa antagonist, and there was no difference in clinical events, although there was better TIMI flow grade 2/3.
The Percutaneous Transvenous Transplantation of Autologous Myoblasts in the Treatment of Postinfarction Heart Failure (POZNAN) experience, presented by Dr. Siminiak (17), examined the feasibility and safety of a transvenously accessed delivery of skeletal myoblast cells into the myocardium in a small number of patients (n = 10) with acute MI. Nine of the 10 procedures that were undertaken were successful. One was abandoned for technical delivery reasons. There were no arrhythmias. With these encouraging preliminary feasibility data in hand, additional studies are ongoing.
Finally, the Combined Angioplasty and Pharmacological Intervention Versus Thrombolytics Alone in Acute Myocardial Infarction (CAPITAL-AMI) trial, presented by Dr. Le May (18), looked at 170 MI patients, comparing pretreatment with a fibrinolytic agent and intervention versus fibrinolytic therapy alone. The primary end point of the composite of death, MI, stroke, and recurrent unstable angina was significantly lower in the group treated with the combination of a fibrinolytic agent and PCI. These results were primarily driven by reductions of re-infarction and refractory unstable ischemia. There was no difference in major bleeding.
New diagnostic technologies
Yaneza et al. (19) presented the results of two types of texture analysis of intravascular ultrasound (IVUS) images, using multifractal techniques and wavelet decomposition. They found a significant association between plaque morphology and texture analysis when using both techniques, suggesting that both methods may be useful in further discrimination of plaque composition on IVUS. Dudek et al. (20) performed intracoronary thermography in 23 acute coronary syndrome (ACS) patients showing that the procedure is safe and showing more heterogeneity in the culprit segment than in the nonculprit segment. Belardi et al. (21) investigated a new thermal sensing catheter that is used in conjunction with temporary interruption of coronary for a brief duration of time (30 to 60 s). This technique appears feasible and safe in this preliminary experience and able to detect differences in temperature in the vessel wall.
MacNeill et al. (22) utilized optical coherence tomography (OCT) techniques to indirectly image macrophages or macrophage deposition in atherosclerotic plaques, using the standard deviation of the optical signal from OCT images and deriving an index of macrophage density. They made the intriguing observation that while superficial macrophage density is similar for ST-segment elevation MI and ACS, the patterns vary significantly, with greater heterogeneity found in the ACS group (22).
Mintz et al. (23) presented an IVUS technique of “virtual histology,” using spectral analysis of back-scattered IVUS images to classify plaque composition as calcium, fibrotic, fibro-fatty, or lipid core. This was the first in vivo demonstration of this in humans in an experience of 50 patients and 68 arteries, and, intriguingly, there were correlations noted between virtual histology images and high-density lipoprotein, although no correlation existed with low-density lipoprotein, an interesting visual biologic linkage.
Other interventional techniques
The initial results of the new percutaneous left atrial appendage transcatheter occlusion (PLAATO) technique were presented by Bayard et al. (24). This intriguing technique involves the percutaneous closure of the left atrial appendage in patients with atrial fibrillation to reduce the risk of thrombus formation and stroke. The overall experience includes 103 patients whose age spanned the spectrum but shifted more toward older patients. The primary outcomes in these patients indicate a very low incidence of neurologic outcomes with the use of this device.
At the ACC this year, a tremendous amount of information was presented. As Martin Fisher once said, “Knowledge is the process of piling up facts. Wisdom lies in their simplification.” The world of interventional cardiology has moved beyond coronary artery disease and peripheral vascular disease. We are exploring techniques of adjunctive pharmacology, myocardial salvage, and valvular disease. Furthermore, these horizons continue to expand. In many ways, interventional cardiology is a microcosm of cardiology as a whole. There has been a lot of overlap among the various different compartmentalized sessions at these meetings; this overlap is part of the larger world of cardiology that moves beyond the borders of the individual disciplines, and interventional cardiology is an integral part of this larger world. According to Confucius, “the essence of knowledge is: having it—to apply it; not having it—to confess our ignorance.” Also, as Satchel Paige says, “It's not just what you don't know that hurts you, it's what you think you know that just ain't so.”
↵1 Working Group: John S. Douglas, MD, FACC, David R. Holmes, MD, FACC, Gary S. Roubin, MD, FACC, Karen M. Smith, MD, FACC
- American College of Cardiology Foundation
- Zidar J.P.
- 2.↵Ardessino D. SES-SMART. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
- 3.↵Moses J. DIRECT. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
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- 13.↵Stone G. EMERALD. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
- 14.↵O'Neill W. AMIHOT. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
- 15.↵Tzivoni D. CASTEMI. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
- 16.↵de Boer MJ. On-TIME. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
- 17.↵Siminiak T. POZNAN. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
- 18.↵Le May M. CAPITAL-MI. Paper presented at: American College of Cardiology Annual Scientific Sessions, New Orleans 2004–Late Breaking Trial; March 7 to 10, 2004; New Orleans, LA
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