Targeted vascular drug delivery. A new day for an old way.

Local drug delivery for the treatment of vascular disease has been studied for many years. In coronary artery disease, drug eluting stents are routinely deployed. However, with concerns regarding late thrombosis, and clinical applications where stenting is not desirable, such as peripheral vascular disease, a new direction to "leave nothing behind" has emerged. In Europe, paclitaxel-coated balloons have shown promise in reducing restenosis in both peripheral and coronary applications. However, a number of technical, economic and regulatory limitations of the current devices have been identified. Local or targeted fluid delivery of drugs may offer a relatively simple solution.

Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER multicenter registry.

The BARASTER registry was formed to evaluate the initial success and long-term results of rotational atherectomy in the management of in-stent restenosis. Rotational atherectomy was used in 197 cases of in-stent restenosis: 46 with stand-alone rotational atherectomy or at most 1 atmosphere of balloon inflation (Rota strategy), and 151 with rotational atherectomy and adjunctive balloon angioplasty <1 atmosphere (Combination strategy). These were compared with 107 episodes of in-stent restenosis treated with balloon angioplasty alone. In this observational study, the use of Combination therapy was associated with a slightly higher initial success rate (95% vs. 87% with the Rota strategy and 89% with Balloons, P = 0.08). There was a reduction in one year clinical outcomes (death, myocardial infarction or target lesion revascularization) in the combination group (38% vs. 60% with Rota and 52% with balloons, P = 0.02). These data support a benefit of the strategy of debulking with rotational atherectomy followed by adjunctive balloon angioplasty, in the management of in-stent restenosis.

The PARAGON stent study: a randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions.

A new martensitic nitinol stent with improved flexibility and radiopacity was tested to evaluate whether these differences improve initial or long-term outcome. Patients who underwent percutaneous revascularization of a discrete native coronary lesion were randomly assigned to the new stent (PARAGON, n = 349) or to the first-generation Palmaz-Schatz (PS) stent (n = 339). The primary end point was target vessel failure at 6 months (a composite of cardiac or noncardiac death, any infarction in the distribution of the treated vessel, or clinically indicated target vessel revascularization). Secondary end points were, among others, device and procedural success and angiographic restenosis. Mean age was 62 years; diabetes was present in 21% of patients, prior bypass surgery in 6%, and recent infarction in 22% (p = NS for comparison between the 2 randomized arms). The PARAGON stent group had smaller reference vessels (2.97 vs 3.05 mm, p = 0.05), more prior restenosis (8.0% vs 4.5%, p = 0.07), and a longer average stent length (21.3 vs 19.4 mm, p < 0.05). Device success was significantly higher in the PARAGON arm (99.1% vs 94.3%, p < 0.05). Death and infarction at 6-month follow-up were infrequent in both groups. There was no significant difference in death (2.0% vs 1.2%, p = 0.546), but a higher rate of infarction for the PARAGON cohort (9.2% vs 4.7%, p = 0.025). Although target vessel failure (20.3% vs 12.4%, p = 0.005) and target lesion revascularization (12.0% vs 5.9%, p = 0.005) were higher in the PARAGON group, there was no significant difference in 6-month follow-up in in-stent minimal lumen diameter or in the rate of binary angiographic restenosis. Both PARAGON and PS stents are safe and associated with infrequent adverse events. The PARAGON stent can be delivered more frequently than the first-generation PS stent. Although there was no significant difference in in-stent minimal lumen diameter or the frequency of angiographic restenosis, clinical restenosis was more frequent in the PARAGON group.

Randomized trial of contrast media utilization in high-risk PTCA: the COURT trial.

BACKGROUND: Previous in vitro and in vivo studies have suggested an association between thrombus-related events and type of contrast media. Low osmolar contrast agents appear to improve the safety of diagnostic and coronary artery interventional procedures. However, no data are available on PTCA outcomes with an isosmolar contrast agent. METHODS AND RESULTS: A multicenter prospective randomized double-blind trial was performed in 856 high-risk patients undergoing coronary artery intervention. The objective was to compare the isosmolar nonionic dimer iodixanol (n=405) with the low osmolar ionic agent ioxaglate (n=410). A composite variable of in-hospital major adverse clinical events (MACE) was the primary end point. A secondary objective was to evaluate major angiographic and procedural events during and after PTCA. The composite in-hospital primary end point was less frequent in those receiving iodixanol compared with those receiving ioxaglate (5.4% versus 9.5%, respectively; P=0.027). Core laboratory defined angiographic success was more frequent in patients receiving iodixanol (92.2% versus 85. 9% for ioxaglate, P=0.004). There was a trend toward lower total clinical events at 30 days in patients randomized to iodixanol (9.1% versus 13.2% for ioxaglate, P=0.07). Multivariate predictors of in-hospital MACE were use of ioxaglate (P=0.01) and treatment of a de novo lesion (P=0.03). CONCLUSIONS: In this contemporary prospective multicenter trial of PTCA in the setting of acute coronary syndromes, there was a low incidence of in-hospital clinical events for both treatment groups. The cohort receiving the nonionic dimer iodixanol experienced a 45% reduction in in-hospital MACE when compared with the cohort receiving ioxaglate.

Successful coronary stenting in a 4-year-old child.

This report describes a 4-yr-old with critical coronary artery stenosis acquired after surgery for congenital heart disease. The patient was treated successfully with coronary stenting after unsuccessful angioplasty.

Quantitative angiography of coronary artery dimensions 24 hours after rotational atherectomy.

Rotational atherectomy results in platelet activation and heat generation, which may impact artery size immediately after treatment. In addition, arteries treated with balloon angioplasty may exhibit recoil within 24 hours. In this study, arteries treated with rotational atherectomy, with and without adjunctive balloon angioplasty, were analyzed by quantitative coronary angiography to determine the effect of rotational atherectomy on the dynamic behavior of the arterial wall within 24 hours after the procedure. Quantitative coronary angiography was performed at a core laboratory. Coronary angiogram acquisitions were preceded by intracoronary nitroglycerin injections and were repeated using identical angles of projection. Proximal and distal reference vessel diameters were 2.55 +/- 0.60 and 2.28 +/- 0.51 mm, respectively, and did not change from pre- to postprocedure. Both were larger the following day increasing to 2.72 +/- 0.65 and 2.52 +/- 0.52 mm, respectively, (p <0.001). Minimum luminal diameter (MLD) increased from 0.70 +/- 0.28 mm before to 1.49 +/- 0.34 mm after the procedure and to 1.72 +/- 0.37 mm at 24-hour follow-up (p <0.001). Subset analysis of patients treated with rotational atherectomy alone or rotational atherectomy with adjunctive balloon angioplasty revealed that the increase in luminal diameters occurred in both subsets. Patients treated with adjunctive angioplasty had a smaller initial MLD, a larger postprocedure MLD, and no difference in MLD at 24-hour follow-up compared with stand-alone rotational atherectomy. Subset analysis of 100 patients who had 6-month follow-up angiography revealed that both a calculated acute gain and chronic late loss, based on a 24-hour film, differed significantly from values using a film acquired immediately after the procedure. However, the slope of the linear regression between acute gain and chronic late loss did not differ. Coronary arteries treated with rotational atherectomy with or without adjunctive balloon angioplasty increase significantly in size during the first 24 hours after the procedure. This phenomenon has implications for the calculation of absolute gain and chronic late loss, but not for the linear relation between the 2 quantitative outcomes.

High-speed rotational atherectomy of human coronary stenoses: acute and one-year outcomes from the New Approaches to Coronary Intervention (NACI) registry.

High-speed rotational atherectomy (RA) is a new percutaneous procedure for treatment of coronary stenoses that operates by the unique mechanism of plaque abrasion. This article reports acute (in-hospital) outcomes and 1-year follow-up in a large cohort of patients treated with this device by NACI investigators. A total of 525 patients with 670 lesions treated with RA form the substrate of this report. Patients tended to be older (mean age 64.8 years) than those in previously reported series of percutaneous transluminal coronary angioplasty (PTCA), with more extensive disease and more complex lesions. Calcification was present in 54% of lesions, and eccentricity in 41%. Balloon angioplasty postdilation was performed after RA in 88% of cases. Angiographic and procedural success (angiographic success without death, Q-wave myocardial infarction [MI] or emergency coronary artery bypass graft [CABG] surgery) rates were 89% and 88%, respectively. Acute in-hospital events included 4 deaths (1%) and 1 emergency CABG surgery (0.4%). MI occurred in 6% of patients, consisting predominantly of non-Q-wave MI (5%). After RA, angiographic complications included coronary dissection (12%), abrupt closure (5%), side branch occlusion (3%), and distal embolization (3%). Most of these were resolved after postdilation except for coronary dissection, which was present in 15% of lesions treated. Mean length of stay was 3 days. At 1-year follow-up, 27% of patients required target lesion revascularization and 30% had experienced death, Q-wave MI, or target lesion revascularization. Preprocedural characteristics that independently predicted 1-year death, Q-wave MI, or target lesion revascularization were male gender, high risk for surgery, target lesions that were proximal to or in bifurcations, eccentric, long, or highly stenosed. RA, even when applied to lesions of traditionally unfavorable morphology, appears to provide reasonable procedural and angiographic success rates. Restenosis and progression of disease contribute to subsequent clinical and procedural events.

Acute and long-term outcome after Palmaz-Schatz stenting: analysis from the New Approaches to Coronary Intervention (NACI) registry.

The randomized Stent Restenosis Study (STRESS) and Belgium Netherlands Stent (Benestent) trials established that elective use of Palmaz-Schatz stents (PSSs) in native coronary arteries with de novo lesions is associated with increased procedural success and reduced restenosis. However there are other clinical indications for which stents are commonly used (unplanned use, vein grafts, restenosis lesions) that are not addressed in these studies. From 1990-1992, 688 lesions in 628 patients were treated with PSSs in the New Approaches to Coronary Intervention (NACI) registry. Angiographic core laboratory readings were available for 543 patients (595 lesions, of which 106 were stented for unplanned indications, 239 were in saphenous vein bypass grafts, and 296 were previously treated). The cohort of patients in whom stents were placed for unplanned indications had more women, current smokers, and had a higher incidence of recent myocardial infarction (MI). Patients who underwent stenting of saphenous vein grafts were older, had a higher incidence of diabetes mellitus, unstable angina, prior MI, and congestive heart failure. Lesion success was similar in all cohorts (98%), but procedural success was significantly higher for planned stenting (96% vs 87%; p < 0.01). Predictors of adverse events in-hospital were presence of a significant left main stenosis and stenting for unplanned indication. The incidence of target lesion revascularization by 30 days was significantly higher for patients undergoing unplanned stenting due to a higher risk for stent thrombosis. Recent MI, stenting in native lesion, and small postprocedural minimum lumen diameter independently predicted target lesion revascularization at 30 days. Independent predictors of death, Q-wave myocardial infarction, or target lesion revascularization at 1 year included severe concomitant disease, high risk for surgery, left main disease, stenting in the left main coronary artery, and low postprocedure minimum lumen diameter.

Comparison of early and recent results with rotational atherectomy.

OBJECTIVES: We compared an early registry of rotational atherectomy with a recent registry to examine the evolution of patient profiles, lesion characteristics and procedural outcomes for patients treated with rotational atherectomy. BACKGROUND: With increased experience, the selection of patients and lesions treated with a device matures. This study documents the changes in the application of rotational atherectomy. METHODS: The patient characteristics and procedural outcomes from two multicenter patient registries-Registry I: 2,953 procedures, 3,717 lesions from 1988 to 1993; and Registry II: 200 procedures, 268 lesions from 1994-were analyzed and compared. RESULTS: There was an increase in the average age of the patients (63 vs. 65 years, p < 0.02) and the proportion of patients with unstable angina (42.9% vs. 56.5%, p < 0.01) or previous coronary artery bypass graft surgery (18.8% vs. 24.5%, p < 0.05) in Registry II. Registry II included fewer left anterior descending coronary lesions (46.5% vs. 32.8%, p < 0.01), more type B and C lesions (83.1% vs. 91.8%, p < 0.01), more eccentric lesions (69.0% vs. 79.5%, p < 0.01) and more calcified lesions (50.3% vs. 69.4%, p < 0.01). Complications, including urgent bypass surgery, Q and non-Q wave myocardial infarction, dissection, acute occlusion and perforation, were similar in the two groups. However, mortality increased from 1.0% to 3.0% (p < 0.05) in Registry II. CONCLUSIONS: Comparison of recent and early patients treated with rotational atherectomy revealed an increase in the complexity of patients and lesions. Although the rate of death was increased, the overall rate of major complications was not significantly changed (4.7% vs. 6.0%, p = NS).

Comparison of patients with either < 70% diameter narrowing or > or = 70% narrowing of the right coronary artery when performing rotational atherectomy on > or = 1 narrowing in the left coronary arteries.

This study compares the complication rates of patients undergoing rotational atherectomy of the left coronary system who had either minimal or significant narrowing of the right coronary artery (RCA). A series of 1,872 patients from a multicenter registry who were treated for left coronary artery disease were divided into <70% diameter stenosis (mild) and > or = 70% stenosis (severe) of the RCA. The patient demographics, lesion characteristics, and frequency of procedural complications for each group were compared. Of the 1,872 patients undergoing rotational atherectomy of the left coronary system, 86.3% (n = 1,616) had mild RCA disease and 13.7% (n = 256) had severe RCA disease. Comparing the mild and severe groups, death (0.8% vs 3.1%, p <0.005), non-Q-wave myocardial infarction (5.1% vs 8.6%, p <0.04), and bypass surgery (2.7% vs 5.8%, p <0.02) were increased in the severe group. Within the severe group, 7 of 8 deaths were in the 128 patients with total occlusion of the RCA. Multivariate analysis demonstrated that RCA stenosis increases the risk of death by 4.9, bypass surgery by 2.6, and non-Q-wave myocardial infarction by 1.8. Patients treated for left coronary disease who have > or = 70% stenosis of the RCA have increased complications during rotational atherectomy.

Incidence, predictors, and consequences of coronary dissection following high-speed rotational atherectomy.

The incidence of dissection following rotational atherectomy was 12.8%. By multivariate analysis tortuosity, primary and non-type B lesions were correlated with an increased incidence of dissection. The procedural success rate was reduced in the presence of dissection (86% vs 96%; p = 0.0001) primarily because patients with dissection required coronary bypass more frequently than those without dissection.

Femoral artery hemostasis using an implantable device (Angio-Seal) after coronary angioplasty.

Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 +/- 94 sec (range 97-503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 +/- 8.9 min (range 0-45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). the incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safety when used in anticoagulated patients after coronary interventional procedures.

Role of intraaortic balloon pump counterpulsation in high risk coronary rotational atherectomy.

OBJECTIVES: This study sought to evaluate the role of intraaortic balloon pump counterpulsation in preventing hemodynamic instability and promoting a successful outcome during percutaneous transluminal coronary rotational atherectomy in high risk patients. BACKGROUND: The application of rotational atherectomy has widened to include patients with complex lesions and left ventricular dysfunction. Although intraaortic balloon pumping has been successfully used to provide hemodynamic support during balloon angioplasty, its role in high risk rotational atherectomy has not yet been defined. METHODS: In a retrospective review of 159 consecutive high risk patients who underwent rotational atherectomy, 28 had an intraaortic balloon pump placed electively before the procedure (Group 1) whereas 131 did not (Group 2). RESULTS: Group 1 was older and more likely to have multivessel disease and left ventricular dysfunction. Augmented diastolic pressure was maintained > 90 mm Hg in all Group 1 patients, and significant procedure-related hypotension was encountered in nine Group 2 patients, requiring an emergency intraaortic balloon pump in five. Procedural success was achieved in all 28 patients in Group 1 and in 118 in Group 2 (p = 0.07). Slow flow occurred in 18% and 17% of Group 1 and 2 patients, respectively. Among patients with slow flow, non-Q wave myocardial infarction occurred only in Group 2 (0% vs. 27%). On multivariate analysis, elective intraaortic balloon pump placement was the only variable to correlate with a successful procedure uncomplicated by hypotension (p < 0.05). Hospital stay and vascular complications were similar in both groups. CONCLUSIONS: Elective placement of an intraaortic balloon pump before coronary rotational atherectomy in selected high risk patients promotes both procedural hemodynamic stability and a successful outcome.

High speed rotational atherectomy: outcome in calcified and noncalcified coronary artery lesions.

OBJECTIVES: This study sought to determine the success and complication rates of high speed rotational coronary atherectomy in calcified and noncalcified lesions. BACKGROUND: Percutaneous transluminal coronary angioplasty and directional coronary atherectomy of calcified lesions are associated with reduced procedural success and increased complications. Rotational atherectomy using the Rotablator catheter abrades noncompliant plaque and may improve outcome in calcified lesions. METHODS: Data from the completed Multicenter Rotablator Registry of 2,161 rotational atherectomy procedures in single lesions were analyzed to determine the relative efficacy of rotational atherectomy for 1,078 calcified and 1,083 noncalcified lesions. The power of the study was 0.86 to detect a significant difference in outcome, if the true success rates in the noncalcified and calcified lesions were 96% and 93%, respectively. RESULTS: Patients with calcified lesions were older (mean [+/- SD] age 66.2 +/- 10.3 vs. 60.5 +/- 11.0 years, p = 0.0001) than those with noncalcified lesions. Calcified lesions were more frequently new (75% vs. 64%, p = 0.0001), angulated (27% vs. 22%, p = 0.02), eccentric (75% vs. 64%, p = 0.0001) and long (32% vs. 27%, > 10 mm in length, p = 0.01). They were also more often complex (57% vs. 46%, p = 0.001) and located in the left anterior descending coronary artery (51% vs. 44%, p = 0.001). Adjunctive coronary angioplasty was used in 82.9% of calcified and 66.9% of noncalcified lesions. Procedural success, defined as < 50% residual stenosis without major complications, was achieved in 94.3% of calcified and 95.2% of noncalcified lesions (p = 0.32). Major complication rates were 4.1% in calcified and 3.1% in noncalcified lesions (p = 0.24). Non-Q wave myocardial infarction was documented in 10.0% of calcified and 7.7% of noncalcified lesions (p = 0.054). Mean postprocedural residual stenosis was 21.6 +/- 13.9% in calcified and 23.3 +/- 15% in noncalcified lesions (p = 0.39). CONCLUSIONS: In this review of data from a large multicenter registry, the success rate of rotational atherectomy was not reduced by calcification despite the more frequent complex nature of the calcified lesions. The Rotablator catheter is likely to be the device of choice for percutaneous intervention in calcified lesions, but definitive conclusions await the results of randomized trials.

Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.

OBJECTIVES: This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath. BACKGROUND: Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal. METHODS: We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II). RESULTS: There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group. CONCLUSIONS: This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

Rotational ablation. The Rotablator catheter.

High-speed rotational ablation addresses specific limitations inherent in conventional methods of percutaneous revascularization. The Rotablator system represents an alternative mechanism to achieve restoration of luminal dimensions by removing atherosclerotic plaque. This article summarizes results, identifies indications, and discusses potential applications of rotational ablation in the treatment of coronary artery disease.

Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients.

OBJECTIVES: The purpose of this study was to describe data collected for an industry-sponsored multicenter registry of rotational atherectomy. BACKGROUND: Several new devices are in use or under development for coronary atherectomy. The clinical role for each is in part defined by descriptive registry data. METHODS: We describe results in 709 consecutive patients undergoing 743 procedures representing 874 lesions. The majority of lesions were in the left anterior descending coronary artery. Lesion morphology was described as eccentric (61.1%), calcified (32%), tortuous (26.6%) and long (24.9%), with previous intervention in 32.7%. RESULTS: Overall procedural success rate, including lesions treated with rotational atherectomy alone and with balloon angioplasty was 94.7% and did not vary between lesion type, location, characteristics or severity. Previously treated lesions had a significantly higher success rate (97.4%, p = 0.04) than new lesions. Major complications, including death 0.8% (95% confidence interval [CI] 0.3% to 1.7%), Q wave myocardial infarction 0.9% (95% CI 0.4% to 1.9%) and emergent coronary artery bypass surgery 1.7% (95% CI 0.9% to 3.0%), were similar to other reported devices and were associated with length and number of lesions treated. Non-Q wave myocardial infarction occurred in 3.8% of patients and was significantly associated with female gender and history of previous myocardial infarction. Abrupt occlusion occurred in 3.1% of patients and was significantly associated with bifurcated lesions and the use of adjunctive therapy. Angiographic evidence of dissection was seen in 10.5% (95% CI 8.3% to 12.7%) of patients and was significantly associated with more complex lesions, such as eccentric, long, calcified and American College of Cardiology/American Heart Association type C lesions. Overall restenosis rate was 37.7%, determined with 6-month angiography, representing 64% of treated lesions. Higher restenosis rates were associated only with poorer initial treatment outcome, diabetes and lower follow-up angiographic rate per reporting center. CONCLUSIONS: Rotational atherectomy appears to be a safe method of treatment with a high success rate in a broad spectrum of lesion types, with restenosis rates similar to other techniques. Further conclusions will require randomized trials.

Relation of clinical presentation, stenosis morphology, and operator technique to the procedural results of rotational atherectomy and rotational atherectomy-facilitated angioplasty.

BACKGROUND: Rotational atherectomy using the Rotablator has recently become available to treat coronary stenoses. This study was performed to determine the relation of patient characteristics, stenosis morphology, and operator technique to procedural outcome to gain insight into which patients might be best treated with this device. METHODS AND RESULTS: Four hundred stenoses from 316 patients randomly selected from the initial Rotablator experience at three major referral institutions were analyzed. Angiographic data were assessed at a central angiographic laboratory using standardized morphological criteria and caliper measurement. Patients were somewhat more elderly than most percutaneous transluminal coronary angioplasty (PTCA)-treated groups (mean age, 64 +/- 11 years), 74% were men, and the lesions treated were often complex (modified American College of Cardiology/American Heart Association lesion type A, 24%; B1, 40%; B2, 30%; and C, 6%). Elective adjunctive PTCA was used for 82% of stenoses treated. Procedural success was achieved in 89.8% of stenoses (93.5% if results with creatine kinase two to three times normal are not counted as failures), and major ischemic complications (death, 0.3%; non-Q-wave myocardial infarction, 5.7%; Q-wave myocardial infarction, 2.2%; or emergency bypass surgery, 0.9%) occurred in 8.9% of patients. Complications were due to epicardial coronary obstruction in 3.8% of patients and to delayed coronary runoff ("slow reflow") in 5.1% of patients. Procedural failure was correlated independently with outflow obstruction (success rate, 64%; odds ratio for failure, 5.4; multivariate P = .002), lesion irregularity (76%; odds ratio, 3.3; P = .003), stenosis bend > or = 60 degrees (73%; odds ratio, 3.7; P = .03), and female sex (84%; odds ratio, 2.4; P = .03). Ischemic complications were correlated independently with lesion length (> or = 50% narrowing) > or = 4 mm (complication rate, 12%; odds ratio, 3.6; multivariate P = .005), right coronary artery stenosis (13%; odds ratio, 2.4; P = .02), stenosis bend > or = 60 degrees (27%; odds ratio, 6.1; P = .03), and female sex (13%; odds ratio, 3.0; P = .04). Slow reflow was correlated with total burring duration (odds ratio, 1.005/s; multivariate P = .001), right coronary artery stenosis (incidence, 17%; odds ratio, 4.5; P = .009), and to a lesser extent with recent myocardial infarction in the treated territory (44%; odds ratio, 4.3; P = .08). CONCLUSIONS: The procedural outcome of rotational atherectomy is highly correlated with stenosis morphology and location and sex of the patient. After stratification for these parameters, overall outcome with the Rotablator appears to be similar to that with balloon angioplasty and other competing techniques. Short-term outcome with specific subsets of patients may be superior with the Rotablator (calcified stenoses), but this technique might best be avoided in some patients (those with irregular or possibly thrombus-containing stenoses, highly angulated stenoses, and possible right coronary artery stenoses or those associated with impaired distal runoff caused by a recent myocardial infarction or manifest by a fixed thallium defect).

Baseline characteristics and therapeutic goals in the New Approaches to Coronary Intervention (NACI) registry.

BACKGROUND: The New Approaches to Coronary Intervention (NACI) voluntary registry was designed to study the use, safety, and efficacy of new percutaneous transluminal interventional devices including directional coronary atherectomy, the transluminal extraction catheter, the rotablator, the Palmaz-Schatz stent, the Gianturco-Roubin stent, the Advanced Interventional Systems (AIS) laser, and the spectranetics laser. METHODS: To date, more than 3800 consecutive patients treated for the first time with a new device at 41 centers have been entered into the registry. Complete detailed information about the patient, lesions, device characteristics, reasons for device selection, and procedural data, such as adjunctive use of conventional balloon angioplasty (PTCA), was available for the first 2835 patients. RESULTS: The registry shows that 88% of the 3233 attempts with a new device were intended as a definitive treatment of target lesions, frequently in combination with adjunctive PTCA. The remaining 12% of attempts with a new device were unplanned, prompted by unexpected complications, unsuccessful attempts, or suboptimal results with PTCA. Although there was some overlap in the indications for selecting a given interventional device, the variation from device to device was sufficiently large to caution users against any direct comparison of either safety or efficacy between devices without careful attention to the differences in baseline patient and lesion characteristics, treatment plans, and the circumstances of device use. CONCLUSION: This report provides the first comprehensive overview of how new interventional devices are currently being used in the treatment of coronary artery lesions at the 41 centers participating in the NACI registry.