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J J Popma

Publications and source records attributed to J J Popma.

At least 73 records · Page 4Linked to original sources

Clinical trials in interventional cardiology.

Several well-designed, randomized trials and registries have recently been completed in patients undergoing percutaneous coronary intervention (PCI) for the treatment of symptomatic coronary artery disease. These studies have further clarified the value of newer pharmacologic and mechanical approaches to patients with atherosclerotic disease and have resulted in improved clinical outcomes in patients undergoing PCI. As a result, many of the older paradigms of lesion-specific device selection have been revised to include the intricate balance of devices and drugs, tailored to the specific clinical presentation and lesion morphology in patients undergoing PCI. This article reviews several recent clinical trials and discusses their impact on early and late outcomes in patients undergoing PCI for symptomatic coronary artery disease.

Cardiology↗

A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators.

BACKGROUND: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspirin and ticlopidine - after coronary stenting. METHODS: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days. RESULTS: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.01). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups. CONCLUSIONS: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.

Aged↗

A subgroup analysis of the Scripps Coronary Radiation to Inhibit Proliferation Poststenting Trial.

INTRODUCTION: In the Scripps Coronary Radiation to Inhibit Proliferation Poststenting (SCRIPPS) Trial, 192Ir significantly reduced angiographic, ultrasonographic, and clinical endpoints of restenosis. The objective of this analysis was to quantitate the impact of patient, lesion and technical characteristics on late angiographic outcome. METHODS: Patients with restenotic, stented coronary lesions were randomized to receive either 192Ir or placebo sources. Late luminal loss and loss index were calculated for several patient subgroups, including patients with diabetes, in-stent restenosis, multiple previous percutaneous transluminal coronary angioplasty (PTCA) procedures, longer lesion lengths, saphenous vein grafts, small vessel diameters, and minimum dose exposures < 8.00 Gy. Two-factor analysis of variance was used to test for an interaction between patient characteristics and treatment effect. RESULTS: In the treated group, late loss was particularly low in patients with diabetes (0.19 mm), in-stent restenosis (0.17 mm), reference vessel diameters < 3.0 mm (0.07 mm), and patients who received a minimum radiation dose to the entire adventitial border of at least 8.00 Gy. The loss index in each of these subgroups was similarly low at -0.02, 0.03, -0.02, and 0.03, respectively. By 2-factor analysis of variance, a significant interaction between subgroup characteristic and treatment effect (late loss) was found in patients with in-stent restenosis (p = 0.035), and patients receiving a minimum dose of 8.00 Gy to the adventitial border (p = 0.009). CONCLUSION: In this pilot study, patient characteristics associated with a more aggressive proliferative response to injury appeared to confer an enhanced response to radiotherapy. Furthermore, a dose threshold response to 192Ir was found with an enhanced response occurring when the entire circumference of the adventitial border was exposed to at least 8.00 Gy.

Analysis of Variance↗

Heparin dosing in patients undergoing coronary intervention.

Unfractionated heparin remains an essential component of the antithrombotic regimen in patients undergoing coronary intervention, although the timing, dosing, and duration of heparin therapy have evolved over the past several years. Complications associated with heparin use include bleeding events, which occur in 3.9-16.4% of patients receiving conventional heparin. Less commonly, clinically significant thrombocytopenia develops, related to the duration of heparin administration. In patients undergoing coronary intervention who do not receive platelet glycoprotein (GP) IIb/IIIa inhibitors, sufficient heparin should be given to achieve an activated clotting time (ACT) of 250-300 seconds with the HemoTec device and 300-350 seconds with the Hemochron device. There is a general trend to use lower, weight-adjusted heparin dosing (70-100 units/kg) to avoid excessive levels of anticoagulation, with additional heparin boluses to achieve a therapeutic ACT level. When GP IIb/IIIa inhibitors are used, weight-adjusted heparin dosing can be decreased to 70 units/kg to achieve a target ACT of 200 seconds with either the HemoTec or Hemochron device. After uncomplicated coronary intervention, there appears to be little value associated with continued heparin therapy, and the risk of bleeding complications clearly increases with longer durations and higher levels of anticoagulation after coronary intervention.

Anticoagulants↗

Clinical, intravascular ultrasound, and quantitative angiographic determinants of the coronary flow reserve before and after percutaneous transluminal coronary angioplasty.

This study evaluated the clinical, intravascular ultrasound (IVUS), and angiographic determinants of the coronary flow reserve (CFR) as measured by guidewire Doppler velocimetry. Using standard methodology, 86 consecutive patients were studied before intervention (n = 73 patients, including the assessment of intermediate stenoses) and/or after intervention (n = 39 patients, including after percutaneous transluminal coronary angioplasty (PTCA) in 27 and post-Palmaz-Schatz stent placement + high-pressure adjunct PTCA in 12). Only 5 patients were studied before intervention, post-PTCA, and poststent. Univariate and multivariate clinical, quantitative coronary angiography (QCA), and IVUS correlates of the CFR were evaluated. There was a linear relation between CFR and IVUS minimum lumen cross-sectional area (CSA): r = 0.771, p <0.0001 for the overall cohort; r = 0.831, p <0.0001 before intervention; r = 0.514, p = 0.0061 post-PTCA; and r = 0.623, p = 0.0306 poststent placement. Overall, an IVUS minimum lumen CSA of > or = 4.0 mm2 had a diagnostic accuracy of 89% in identifying a CFR of > or = 2.0. This diagnostic accuracy increased slightly to 92% when only the preintervention observations were considered. Using multivariate linear regression analysis, the independent determinants of the CFR in the overall cohort of 112 observations were IVUS minimum lumen CSA (p <0.0001), angiographic lesion length (p = 0.0101), and diabetes mellitus (p = 0.0371): r2 = 0.6224. When the subset of preintervention observations were analyzed separately, the independent determinants of the CFR were minimum lumen CSA (p <0.0001) and angiographic lesion length (p = 0.0095); r2 = 0.7176. Thus, the major determinants of the CFR in patients with coronary artery disease are lumen compromise (which is best assessed by the IVUS measurement of the minimum lumen CSA) and lesion length. A minimum lumen CSA > or = 4.0 mm2 has a high diagnostic accuracy in predicting a CFR > or = 2.0, especially before intervention.

Aged↗

Early lumen loss after treatment of in-stent restenosis: an intravascular ultrasound study.

BACKGROUND: Mechanisms of recurrence after treatment of in-stent restenosis are unknown. METHODS AND RESULTS: We prospectively performed quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) in 37 lesions with Palmaz-Schatz stents enrolled in a study of intracoronary radiation for in-stent restenosis. Primary treatment was at the discretion of the operator: PTCA (n=8) or ablation+adjunct PTCA (n=29). Lesions were studied before intervention, immediately after primary intervention, and 42+/-8 minutes later. QCA measurements included minimal luminal diameter and diameter stenosis. Planar IVUS measurements included arterial, stent, lumen, and in-stent tissue areas. Stent, lumen, and in-stent tissue volumes were calculated by use of Simpson's rule. Compared with immediately after intervention, the delayed (42+/-8 minutes) minimal lumen area decreased by 20% (5.8+/-1.9 to 4.5+/-1.3 mm2, P<0.0001) and the lumen volume by 12% (58+/-41 to 52+/-37 mm3, P=0.0001). Ten lesions (27%) had a > or = 2.0-mm2 decrease in minimum lumen area. Lumen loss (1) resulted from increased tissue with the stent, (2) correlated with lesion length and preintervention in-stent tissue, and (3) was not seen angiographically. CONCLUSIONS: There is significant tissue reintrusion shortly after catheter-based treatment of in-stent restenosis. This was greater in longer lesions and those with a larger in-stent tissue burden, was not reflected in the QCA measurements, and may contribute to recurrence.

Aged↗

Impact of stents on clinical outcomes in percutaneous left main coronary artery revascularization.

Despite effective treatment of left main coronary artery (LMCA) disease by coronary bypass, there is still need for treatment of the LMCA due to progression of disease or bypass graft failure. We compared the in-hospital and follow-up (1-year) outcomes of patients with LMCA stenosis treated with stents (n = 88), with a matched group of patients undergoing LMCA non-stent procedures (n = 36). Ninety-seven percent of patients in each group underwent previous coronary bypass. Procedural success (angiographic success without major in-hospital complications) tended to be higher in stent patients than in their non-stent counterparts (98% vs 92%, p = 0.12), and overall procedural complications were higher for the non-stent group (5.4% vs 0%, p = 0.03). The incidence of non-Q-wave myocardial infarction was higher in patients with the LMCA treated with stents than in non-stent patients (13% vs 2.7%, p = 0.09). There was no difference in death or Q-wave myocardial infarction between the 2 groups during follow-up. Overall target lesion revascularization at 1 year was 15% after LMCA stenting, and 18% in non-stent patients (p = 0.71). Also, any cardiac event-free survival (including death, Q-wave myocardial infarction, coronary bypass, or angioplasty) was similar for both groups (78% for stents vs 76% for non-stents, p = 0.85). We conclude that in patients undergoing LMCA interventions, stents reduce major hospital complications, but may not significantly reduce repeat revascularization or major cardiac events at 1 year compared with non-stent LMCA procedures.

Aged↗

Paradoxic decreases in atherosclerotic plaque mass in insulin-treated diabetic patients.

This study assessed the impact of diabetes mellitus on atherosclerotic lesion formation. Seventy insulin-treated diabetics, 150 non-insulin-treated diabetics, and 607 nondiabetics with chronic anginal syndromes and de novo native coronary stenoses were studied using (1) angiography, and (2) intravascular ultrasound (reference and lesion arterial, lumen, and plaque areas; area stenosis [reference-lesion/reference lumen area]; remodeling index [reference-lesion lumen area/lesion-reference plaque area]; and slope of the regression line relating lumen area to plaque burden [plaque/arterial area]). Despite being diabetic for longer and having similar lumen compromise, insulin-treated patients had (1) less reference plaque (8.3 +/- 3.4 vs 10.5 +/- 4.5 mm2, p = 0.0015), (2) less stenosis plaque (13.0 +/- 4.9 vs 16.9 mm2, p <0.0001), (3) smaller reference arterial areas (17.1 +/- 5.4 vs 19.7 +/- 6.2 mm2, p = 0.0063), and (4) smaller stenosis arterial areas (15.3 +/- 4.9 vs 19.5 +/- 6.5 mm2, p <0.0001) than non-insulin-treated diabetics. With use of multivariate linear regression analysis, insulin use was an independent (and negative) predictor of reference plaque and arterial areas (p = 0.0308 and p = 0.0179) and stenosis plaque and arterial areas (p = 0.0117 and p = 0.0066). This was also true when normalized for body surface area. The remodeling index showed that insulin treatment resulted in an exaggerated impact of plaque accumulation on lumen compromise. This was confirmed by the slope of the regression line relating lumen area to plaque burden. Patients with a longer duration of diabetes who were treated with insulin for > or = 1 year had (paradoxically) less reference segment and stenosis plaque accumulation. Possible explanations include impaired adaptive remodeling and/or arterial (and plaque) shrinkage.

Aged↗

Procedural results and late clinical outcomes after placement of three or more stents in single coronary lesions.

BACKGROUND: Previous reports have suggested higher procedural and long-term complications among patients treated with multiple stents for diffuse lesions and/or long dissections. METHODS AND RESULTS: To evaluate procedural success, major complications, and clinical outcomes (> or = 1 year) in a consecutive series of patients treated with multiple (> or = 3) contiguous stents in single lesions, we evaluated in-hospital and long-term (1-year) clinical outcomes in 117 consecutive patients treated with > or = 3 coronary stents compared with a concurrent series of patients treated with 1 or 2 stents (n=1673) between January 1, 1994, and December 31, 1995. Multiple stents were implanted more often in larger vessels, in the right coronary artery or saphenous vein grafts, and for unfavorable lesion characteristics, including long (>20 mm), calcified, ulcerated, thrombotic, and/or flow-obstructing lesions. Overall procedural success was obtained in 97.4% of patients and was similar whether 1 or 2 versus > or = 3 stents were used. Non-Q-wave MI (CK-MB > or = 5 times normal) was more frequent after > or = 3 stents (22.8% versus 13.4%, P=.005). Target lesion revascularization (TLR) was 14.6% for 1 or 2 stents and 13.3% for > or = 3 stents (P=.70). There was no difference in death (2.2% versus 0.9%, P=.34) or Q-wave MI (1.4% versus 0.9%, P=.64) between the two groups (1 or 2 stents versus > or = 3 stents, respectively), and overall cardiac event-free survival was similar during follow-up (P=.70). CONCLUSIONS: Patients treated with multiple (> or = 3) contiguous stents compared with 1 or 2 stents have (1) similar in-hospital procedural success and major complications despite having more unfavorable lesion characteristics, (2) a higher rate of procedural non-Q-wave MI, and (3) similar TLR and overall major cardiac event rates during 1 year of follow-up.

Aged↗

In-stent restenosis: the Washington Hospital Center experience.

In-stent restenosis has become a significant clinical problem. In 1997 alone, it is estimated that up to 100,000 patients world-wide with in-stent restenosis were treated. Serial intravascular ultrasound (IVUS) analysis has shown that tubular-slotted stents almost never chronically recoil and that neointimal hyperplasia is responsible for in-stent restenosis. With the rapid recent explosion in stent use, information about in-stent restenosis has lagged behind, especially on the impact of new stent designs. For example, the true prevalence of in-stent restenosis (1) varies with the lesion and patient subset, being much higher in the "real world" than in the selected patients typically enrolled in many studies; and (2) depends on its definition (i.e., clinical vs angiographic, intralesion vs in-stent). "Conventional" catheter-based treatments have included percutaneous transluminal coronary angioplasty (PTCA), rotational atherectomy, excimer laser coronary angioplasty, directional coronary atherectomy, and additional stent implantation. Rates of recurrence with these approaches are not known and vary considerably among series; however, certain lesions seem likely to recur regardless of the treatment modality. Recently, brachytherapy has emerged as the most promising way to treat in-stent restenosis.

Angioplasty, Balloon, Coronary↗

Lipid-lowering therapy after coronary revascularization: the interventional cardiologist's perspective.

Despite the success of coronary interventions in the treatment of stenosis due to coronary atherosclerosis, it behooves cardiologists to treat the underlying disease by decreasing patients' cholesterol levels. Intravascular ultrasound has made it possible to detect plaque accumulation not visible on angiography. Although advanced lesions that are fibrous and calcific can be treated with atherectomy and lasers, it is the soft, lipid-laden plaque that is particularly vulnerable to rupture and leads to coronary events. Therefore, attention must also focus on decreasing atherosclerotic progression in patients who have undergone coronary interventions. Studies have clearly shown the value of cholesterol reduction in decreasing coronary events. However, a review of cardiologists' practices shows that more aggressive lipid-lowering therapy is needed. One way to achieve this goal is to treat and monitor patients who have undergone revascularization procedures and to encourage patients to become more involved in their own care.

Angioplasty, Balloon, Coronary↗

Comparative early and nine-month results of rotational atherectomy, stents, and the combination of both for calcified lesions in large coronary arteries.

The aim of this study was to determine the preferred treatment modality for calcified lesions in large (> or = 3 mm) coronary arteries, resulting in the largest lumen dimensions and the most favorable late clinical responses. Three hundred six lesions in 306 patients (223 men, mean age 66 +/- 11 years) were treated with either rotational atherectomy plus adjunct balloon angioplasty (n = 147), Palmaz-Schatz stents (n = 103), or a combination of rotational atherectomy plus adjunct Palmaz-Schatz stents (n = 56). The procedural success rate was 98.0% to 98.6% for each treatment modality. Minimal lumen diameter (MLD) before therapy was similar for all therapies. Final MLD after combination of rotational atherectomy plus Palmaz-Schatz stents was larger than after stent therapy or rotational atherectomy plus balloon angioplasty (3.21 +/- 0.49 mm, 2.88 +/- 0.51 mm, and 2.29 +/- 0.55 mm, respectively, p <0.0001). Correspondingly, final percent diameter stenosis was lowest after the combination of rotational atherectomy plus stent therapy, and significantly higher for stents or rotational atherectomy plus balloon angioplasty (4.2 +/- 15.3%, 14.1 +/- 13.3%, and 26.7% +/- 16.9%, respectively, p <0.0001). Event-free survival at 9 months was higher for patients treated with the combination of rotational atherectomy plus stents than either stent therapy or rotational atherectomy alone (85%, 77%, and 67%, respectively, log-rank p = 0.0633). The only significant independent predictor of an event during the 9-month follow-up period was the MLD after intervention (odds ratio 0.495, 95% confidence interval 0.308 to 0.796, p = 0.0037). We conclude that preatheroablation using rotational atherectomy, followed by adjunct stent placement for calcified lesions in large arteries, is associated with infrequent complications, the largest acute angiographic results, and the most favorable late clinical event rates.

Aged↗

Interrelation of coronary angiographic reference lumen size and intravascular ultrasound target lesion calcium.

Intravascular ultrasound (IVUS) detects target lesion calcium twice as often as does coronary angiography. Target lesions in smaller vessels are thought to be more calcified than target lesions in large vessels. This study determined whether the presence and magnitude of target lesion calcium is related to angiographic reference lumen size. Preintervention IVUS imaging and coronary angiography were performed to study 1,454 non-aortoostial native vessel lesions in 1,342 patients. Target lesions and reference segments were evaluated according to previously published methods and are presented as mean +/- 1 SD. By angiography, 37% of lesions contained calcium, and 68% of calcium-containing lesions were classified as moderately calcified, and 32% as severely calcified. There was no relation between angiographic reference lumen size and angiographic calcium detection (p = 0.7066) or classification (none/mild vs moderate vs severe, p = 0.8135). By IVUS, 73% of lesions contained calcium. There was a consistent relation between decreasing angiographic reference lumen size and increasing IVUS lesion-associated calcium: the presence of any calcium (p = 0.0122), arc of calcium (p = 0.002), percent of lesions with an arc of calcium > 180 degrees (p = 0.0018), length of calcium (p < 0.0001), presence of any superficial calcium (p < 0.0001), arc of superficial calcium (p < 0.0001), percent of lesions with an arc of superficial calcium > 180 degrees (p = 0.0021), and length of superficial calcium (p < 0.0001). This was especially true for arteries with an angiographic reference lumen dimension < 2.00 mm. There is a distinct relation between decreasing angiographic reference lumen size and increasing lesion calcium, most striking in vessels < 2.00 mm. This increased target lesion calcium in small vessels is not seen angiographically.

Aged↗

Final results of the Balloon vs Optimal Atherectomy Trial (BOAT)

BACKGROUND: Previous directional coronary atherectomy (DCA) trials have shown no significant reduction in angiographic restenosis, more in-hospital complications, and higher 1-year mortality than conventional balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]). DCA, however, has subsequently evolved toward a more "optimal" technique (larger devices, more extensive tissue removal, and routine postdilation to obtain diameter stenosis <20%). METHODS AND RESULTS: The Balloon vs Optimal Atherectomy Trial (BOAT) was conducted to evaluate whether optimal DCA provides short- and long-term benefits compared with balloon angioplasty. One thousand patients with single de novo, native vessel lesions were randomized to either DCA or PTCA at 37 participating centers. Lesion success was obtained in 99% versus 97% (P=.02) of patients to a final residual diameter stenosis of 15% versus 28% (P<.0001) for DCA and PTCA, respectively, the latter including stents in 9.3% of the patients. There was no increase in major complications (death, Q-wave myocardial infarction, or emergent coronary artery bypass graft surgery [2.8% versus 3.3%]), although creatine kinase-MB >3X normal was more common with DCA (16% versus 6%; P<.0001). Angiographic restudy (in 79.6% of eligible patients at 7.2+/-2.6 [median, 6.9] months) showed a significant reduction in the prespecified primary end point of angiographic restenosis by DCA (31.4% versus 39.8%; P=.016). Clinical follow-up to 1 year showed nonsignificant 13% to 17% reductions in the DCA arm of the study for mortality rate (0.6% versus 1.6%; P=.14), target-vessel revascularization (17.1% versus 19.7%; P=.33), target-site revascularization (15.3% versus 18.3%; P=.23), and target-vessel failure (death, Q-wave myocardial infarction, or target-vessel revascularization, 21.1% versus 24.8%; P=.17). CONCLUSIONS: Optimal DCA provides significantly higher short-term success, lower residual stenosis, and lower angiographic restenosis than conventional PTCA, despite failing to reach statistical significance for reducing late clinical events compared with PTCA with stent backup.

Aged↗

'Optimal' directional coronary atherectomy: final results of the Optimal Atherectomy Restenosis Study (OARS).

BACKGROUND: Previous clinical trials of directional coronary atherectomy (DCA) have failed to show significant improvement in early or late outcomes compared with balloon angioplasty (PTCA). The present study tested the hypothesis that more aggressive "optimal" atherectomy could be performed safely to produce larger initial lumen diameters and a lower late restenosis rate. METHODS AND RESULTS: The present study was a prospective multicenter registry of consecutive patients undergoing optimal DCA of de novo or restenotic lesions in 3.0- to 4.5-mm native coronary arteries. Optimal DCA was defined as using a 7F atherectomy device and adjunctive PTCA if necessary to achieve a < 15% residual stenosis. Six-month angiographic and 1-year clinical follow-up was planned in all patients. A total of 199 patients with 213 lesions met eligibility criteria for enrollment. Short-term procedural success was achieved in 97.5%, with a major complication rate (death, emergency bypass surgery, or Q-wave myocardial infarction [MI]) of 2.5%. There were no early deaths. Non-Q-wave MI (CK-MB > 3 times normal) occurred in 14% of patients. Mean reference vessel diameter was 3.28 mm. Mean diameter stenosis was reduced from 63.5% to a final stenosis of 7%. Late 1-year clinical follow-up revealed one cardiac death and a target lesion revascularization rate of 17.8%. The angiographic restenosis rate at 6 months was 28.9%, with the major predictor of restenosis being a smaller postprocedure lumen diameter. CONCLUSIONS: Optimal DCA produced a low residual percent diameter stenosis and a lower restenosis rate than seen in previous trials without an increase in early or late major adverse events.

Aged↗

Quantitative coronary angiographic and intravascular ultrasound assessment of a new nonarticulated stent: report from the Advanced Cardiovascular Systems MultiLink stent pilot study.

OBJECTIVES: The purpose of this study was to evaluate the safety, feasibility, optimal deployment technique and 1-year clinical outcome for the Advanced Cardiovascular Systems (ACS) MultiLink stent. BACKGROUND: Optimal stent deployment assessed by quantitative coronary angiography and intravascular ultrasound (IVUS) is associated with improved clinical outcome. METHODS: Forty-nine consecutive patients with a discrete stenosis in a native coronary artery 3 to 4 mm in diameter were treated with the new, balloon-expandable ACS MultiLink stent. Stent expansion was assessed in all patients using quantitative coronary angiography and serial IVUS imaging after 8-, 12- and 16-atm inflations. Clinical follow-up was obtained at 30 days and 1 year. RESULTS: All 49 patients had successful placement of a MultiLink stent without death, emergency coronary artery bypass graft surgery or Q wave myocardial infarction. After placement of the MultiLink stent, the minimal lumen diameter increased from 1.24 to 2.98 mm (p < 0.001), and diameter stenosis decreased from 61% to 7% (p = 0.001). Minimal lumen cross-sectional area by IVUS increased progressively after 8, 12 and 16 atm (5.6 to 6.8 to 7.4 mm2, respectively, p < 0.001). However, only 64% of stents achieved a lumen/reference area ratio > or = 70%. No adverse clinical events occurred by 30 days, and by 1 year only one patient (2.0%) required revascularization of the stented artery. CONCLUSIONS: Treatment of stenoses in native coronary arteries with the MultiLink stent is associated with a high success rate and a low incidence of adverse events by 1 year, despite the fact that the majority of stents did not meet IVUS-defined criteria for "optimal stenting" derived from first-generation devices.

Aged↗

Intravascular ultrasound predictors of angiographic restenosis in lesions treated with Palmaz-Schatz stents.

OBJECTIVES: This study sought to evaluate the clinical, procedural, preinterventional and postinterventional quantitative coronary angiographic (QCA) and intravascular ultrasound (IVUS) predictors of restenosis after Palmaz-Schatz stent placement. BACKGROUND: Although Palmaz-Schatz stent placement reduces restenosis compared with balloon angioplasty, in-stent restenosis remains a major clinical problem. METHODS: QCA and IVUS studies were performed before and after intervention (after stent placement and high pressure adjunct balloon angioplasty) in 382 lesions in 291 patients treated with 476 Palmaz-Schatz stents for whom follow-up QCA data were available 5.5 +/- 4.8 months (mean +/- SD) later. Univariate and multivariate predictors of QCA restenosis (> or = 50% diameter stenosis at follow-up, follow-up percent diameter stenosis [DS] and follow-up minimal lumen diameter [MLD]) were determined. RESULTS: Three variables were the most consistent predictors of the follow-up angiographic findings: ostial lesion location, IVUS preinterventional lesion site plaque burden (plaque/total arterial area) and IVUS assessment of final lumen dimensions (whether final lumen area or final MLD). All three variables predicted both the primary (binary restenosis) and secondary (follow-up MLD and follow-up DS) end points. In addition, a number of variables predicted one or more but not all the end points: 1) restenosis (IVUS preinterventional lumen and arterial area); 2) follow-up DS (QCA lesion length); and 3) follow-up MLD (QCA lesion length and preinterventional MLD and DS and IVUS preinterventional lumen and arterial area). CONCLUSIONS: Ostial lesion location and IVUS preinterventional plaque burden and postinterventional lumen dimensions were the most consistent predictors of angiographic in-stent restenosis.

Adult↗