Procedural outcome and follow-up results of balloon angioplasty versus new device interventions for treatment of true bifurcation stenoses

Strategies for dilatation of bifurcation stenoses have continued to evolve over the past several years. However, there is limited experience on the efficacy of various nonballoon interventional devices and their results in comparison with balloon angioplasty. We, therefore, analysed our data in 72 patients of coronary artery disease with true bifurcation stenoses with balloon angioplasty or new device interventions (NDI). All patients underwent dilatation of both the primary vessel and side branch ostial stenosis. Balloon angioplasty using double guidewire with sequential or simultaneous (kissing balloon) balloon inflation in the two vessels was performed in 42 patients. Thirty patients underwent NDI, using directional coronary atherectomy (DCA) in 12, rotablation in 6 and elective coronary stents in 12 patients. There were no significant differences in the baseline clinical and angiographic variables between patients in the two groups. While the preprocedural luminal diameter stenosis was similar, the residual stenosis was significantly less, both in the primary vessel and side branch, after NDI compared to balloon angioplasty. The procedure was successful in 96.6 percent patients treated with NDI and 83.3 percent with balloon angioplasty (p < 0.01) with relief of obstruction in both branches without any major complications. Freedom from subsequent coronary events in the form of angina, myocardial infarction, PTCA, bypass graft surgery of death was significantly more, both at 6 months (92% versus 65.6%, p < 0.001) and 12 months (81.8% versus 53.1%, p < 0.001) in the group of patients treated with NDI compared to balloon angioplasty. It is, therefore, concluded that NDI including DCA, rotablation and elective stenting are associated with higher rate of success, lesser complications and better event-free survival in comparison to balloon angioplasty for treatment of true bifurcation stenoses.     

Long-term angiographic and clinical outcome of patients undergoing multivessel coronary stenting

BACKGROUND: Randomized clinical trials have shown that multivessel coronary angioplasty is feasible and provides similar long-term survival as bypass surgery in selected patients. However, the higher need for repeat intervention, in particular, coronary artery bypass graft surgery, remains a problem. The objective of this study was to test the hypothesis that multivessel stenting is safe and effective in reducing the need for repeat interventions, in particular, the need for bypass surgery. METHODS AND RESULTS: Between March 1993 and June 1995, 100 consecutive patients (243 lesions) had multivessel coronary stenting. High-pressure stent optimization was used in all patients. Procedural success was achieved in 97% of lesions; 2 patients (2%) required emergency bypass surgery. Angiographic follow-up was obtained in 89% of patients at 5.2+/-2.5 months. Angiographic restenosis occurred in 22% of the lesions, but 37% of patients had > or = 1 lesion with restenosis. Clinical follow-up was obtained in all patients at 21 +/- 10 months: target lesion revascularization was needed in 30 patients (30%), repeat angioplasty in 28 patients (28%) and coronary bypass surgery in 2 patients (2%); the overall survival rate was 96% (2% noncardiac death). CONCLUSIONS: Multivessel coronary stenting can be performed with high success rate and low need for emergency bypass surgery. Compared with historical results with multivessel percutaneous transluminal coronary angioplasty, patients who undergo multivessel stenting need less repeat interventions, in particular, less coronary bypass surgery and have similar long-term survival.     

Mechanical debulking versus balloon angioplasty for the treatment of true bifurcation lesions

OBJECTIVES: The purpose of this study was to compare the immediate angiographic and long-term results of debulking versus balloon angioplasty for treatment of true bifurcation lesions. BACKGROUND: Previous studies have shown true bifurcation lesions to be a high risk morphological subset for percutaneous transluminal coronary angioplasty (PTCA). Although atherectomy devices have been used to treat bifurcation lesions, no studies have compared the outcomes of these alternative treatment modalities. METHODS: Between January 1992 and May 1997, we treated 70 consecutive patients with true bifurcation lesions (defined as a greater than 50% stenosis in both the parent vessel and contiguous side branch) with conventional PTCA (n = 30) or debulking (with rotational or directional atherectomy) plus adjunctive PTCA (n = 40). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained in all patients. RESULTS: Acute procedural success was 73% in the PTCA group and 97% in the debulking group (p = 0.01). Major in-hospital complications occurred in two patients in the PTCA group and one in the debulking group. Treatment with atherectomy plus PTCA resulted in lower postprocedure residual stenoses than PTCA alone (16+/-15% vs. 33+/-17% in the parent vessel, and 6+/-15% vs. 39+/-22% in the side branch; p < 0.001 for both comparisons). At 1 year follow-up, the incidence of target vessel revascularization (TVR) was 53% in the PTCA group as compared with 28% in the debulking group (p = 0.05). Independent predictors of the need for repeat TVR were side branch diameter >2.3 mm, longer lesion lengths, and treatment with PTCA alone. CONCLUSIONS: For the treatment of true bifurcation lesions, atherectomy with adjunctive PTCA is safe, improves acute angiographic results, and decreases target vessel revascularization compared to PTCA alone. The benefits of debulking for bifurcation lesions were especially seen in lesions involving large side branches.     

Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996

BACKGROUND: Coronary artery bypass surgery (CABG) has been considered the therapy of choice for patients with unprotected left main (ULMT) coronary stenoses. Selected single-center reports suggest that the results of percutaneous intervention may now approach those of CABG. METHODS AND RESULTS: To assess the results of percutaneous ULMT treatment from a wide variety of experienced interventional centers, we requested data on consecutive patients treated after January 1, 1994, from 25 centers. One hundred seven patients were identified who were treated either electively (n=91) or for acute myocardial infarction (n=16). Of patients treated electively, 25% were considered inoperable, and 27% were considered high risk for bypass surgery. Primary treatment included stents (50%), directional atherectomy (24%), and balloon angioplasty (20%). Follow-up was 98.8% complete at 15+/-8 months. Results varied considerably, depending on presentation and treatment. For patients with acute myocardial infarction, technical success was achieved in 75%, and survival to hospital discharge was 31%. For elective patients, technical success was achieved in 98.9%, and in-hospital survival was strongly correlated with left ventricular ejection fraction (P=.003). Longer-term event (death, infarction, or bypass surgery) -free survival was correlated with ejection fraction (P<.001) and was inversely related to presentation with progressive or rest angina (P<.001). Surgical candidates with ejection fractions > or = 40% had an in-hospital survival of 98% and a 9-month event-free survival of 86+/-5%, whereas patients with ejection fractions < 40% had 67% and 22+/-12% in-hospital and 9-month event-free survivals, respectively. Nine hospital survivors (10.6%) experienced cardiac death within 6 months of hospital discharge. CONCLUSIONS: While results for selected patients appear promising, until early post-hospital discharge cardiac death can be better understood and minimized, percutaneous revascularization of ULMT stenosis should not be considered an alternative to bypass surgery for most patients. When percutaneous revascularization of ULMT is required, directional atherectomy and stenting appear to be the preferred techniques, and follow-up angiography 6 to 8 weeks after treatment is probably advisable.     

Stenting after optimal lesion debulking (sold) registry. Angiographic and clinical outcome

BACKGROUND: Coronary stenting has reduced restenosis in focal de novo lesions, but its impact has been less pronounced in complex lesion subsets. Preliminary data suggest a role for plaque burden in promoting intimal hyperplasia after stent implantation. The aim of this study was to test the hypothesis that plaque removal with directional atherectomy before stent implantation may lower the intensity of late neointimal hyperplasia, reducing the incidence of in-stent restenosis. METHODS AND RESULTS: Seventy-one patients with 90 lesions underwent directional atherectomy before coronary stenting. Intravascular ultrasound-guided stenting was performed in 73 lesions (81%). Clinical success was achieved in 96% of patients. Procedural complications were as follows: emergency bypass surgery in 1 patient (1.4%), who died 2 weeks later; Q-wave myocardial infarction in 2 patients (2.8%); and non-Q-wave myocardial infarction in 8 patients (11.3%). None of the patients had stent thrombosis at follow-up. Angiographic follow-up was performed in 89% of eligible patients at 5.7+/-1.7 months. Loss index was 0.33 (95% CI, 0.26 to 0.40), and angiographic restenosis was 11% (95% CI, 5% to 20%). Clinical follow-up was performed in all patients at 18+/-3 months. Target lesion revascularization was 7% (95% CI, 3% to 14%). CONCLUSIONS: Directional atherectomy followed by coronary stenting could be performed with good clinical success rate. Also, these data point to a possible reduction in angiographic restenosis and a significant reduction in the need for repeated coronary interventions. Therefore, a randomized clinical trial seems appropriate to test the validity of this approach.     

Third angioplasty, and after that?

The authors studied retrospectively a series of 39 patients with a documented second restenosis after coronary angioplasty between January 1987 and November 1992, 33 of whom (31 men, 2 women) underwent a third procedure. The artery dilated was the left anterior descending (n = 17 including 9 proximal stenoses), the right coronary (n = 10), the left circumflex or its branches (n = 5) and the left main stem (n = 1). The lesions were confirmed to one vessel in 25 cases (75%) and affected two vessels in 8 cases (25%). The third angioplasty procedure was performed on a single artery in all cases. The average left ventricular ejection fraction was 60% (43%-75%). The diameter of the dilated artery was over 3.25 mm in 24% of cases (8/33). The primary success rate was 100% without any complications. The average period between the first and second angioplasties was 16 +/- 10 weeks, and between the second and third angioplasties 19 +/- 12 weeks. Angioplastic controls of the 3rd angioplasty were performed in 25 cases (75%). A third restenosis (n = 7) was treated by surgical bypass (n = 1), repeat angioplasty (n = 4), endocoronary stenting (n = 1) or medically (n = 1), with a global follow-up of 22 months (2-56 months), 2 patients underwent coronary bypass grafting, 2 have residual angina (contralateral lesion which could not be dilated), 1 had an infarct in the territory of an undilated artery, and 28 (85%) were asymptomatic. The restenosis rate after the third angioplasty procedure was 28% (7/25).(ABSTRACT TRUNCATED AT 250 WORDS)     

Beyond stents: third-generation coronary devices

Despite extraordinary growth in percutaneous transluminal coronary angioplasty (>400,000 cases in United States in 1997) patients are still routinely referred for bypass grafting in large numbers. Why? Second-generation devices (directional coronary atherectomy, high-speed rotational atherectomy [Rotablator], and stents) have expanded the application of percutaneous catheter treatment of coronary disease. Specifically, highly eccentric lesions in large vessels, heavily calcified lesions, and coronary dissections can be effectively treated with these devices. Stents have substantially reduced the incidence of restenosis, but this benefit is largely confined to vessels more than 3 mm in diameter and stenoses less than 20 mm in length. A third generation of coronary devices has evolved in the late 1990s in response to continuing failures of conventional balloon angioplasty, atherectomy, and stenting. The failures of the 1990s were (1) restenosis, including in-stent restenosis, (2) chronic total occlusions, (3) diffuse small-vessel disease, and (4) aged vein graft disease. In response to these challenges novel devices are being developed: (1) for restenosis, intracoronary radiation therapy (brachytherapy); (2) for chronic total occlusions, Prima Laser wire; (3) for diffuse small-vessel disease, percutaneous myocardial laser revascularization; and (4) for aged vein grafts, antiembolization devices. Each of these new catheter technologies will need to be economically and clinically reconciled with the multitude of minimally invasive surgical revascularization techniques that are rapidly evolving.     

Laboratory diagnosis before onset and prediction of Graves'' disease

BACKGROUND: The Canadian Coronary Atherectomy Trial (CCAT) assessed, in a randomized comparison, the clinical and angiographic outcomes following atherectomy with those following balloon angioplasty for the treatment of de novo lesions in the proximal one-third of the left anterior descending artery (LAD). Although the procedural success rate was somewhat higher and the postprocedure lumen larger in patients treated with atherectomy, lumen dimensions, restenosis rates and clinical outcomes were similar in the two groups at six months. To determine whether late differences emerged between the groups, clinical follow-up was obtained at a median of 18 (range 10 to 31) months after randomization. METHODS AND RESULTS: Patients were contacted monthly by telephone for the first six months. Subsequent follow-up information was obtained in 272 (99%) of the 274 randomized patients via a clinic visit or telephone interview with the patient and/or a relative. Additional information was obtained from the referring physician as required. There were no differences in adverse events between the two groups during follow-up. In patients randomized to atherectomy compared with balloon angioplasty, death occurred in 1.5% versus 2.2% (cardiac death 0.7% versus 0.7%); myocardial infarction in 5.1% versus 5.9% (Q wave 1.5% versus 1.5%); coronary bypass surgery in 13.1% versus 12.6%; and repeat target lesion intervention in 22.6% versus 21.5%. Persistent or recurrent Canadian Cardiovascular Society class III/IV angina not treated by a further intervention was present in 1.5% versus 2.2%. The combined end-point of death or nonfatal myocardial infarction occurred in nine (6.6%) versus 11 (8.1%) patients and any adverse cardiac event in 50 (36.5%) versus 53 (39.3%). Multivariate logistic regression indicated that unstable angina, reference vessel size and preprocedure minimum lumen diameter were the only variables independently associated with adverse events. CONCLUSIONS: The initial choice of directional atherectomy or balloon angioplasty had no impact on clinical outcome over a period of 18 months in this patient population. With either technique, just over 60% of patients with proximal LAD disease experienced sustained symptomatic improvement without an adverse event following a single procedure, and 80% achieved this status following a repeat percutaneous intervention.     

Coronary stenting in unstable angina: early and late clinical outcomes

OBJECTIVE: To examine the procedural and long term success of coronary stenting in patients presenting with unstable angina and the effect of warfarin on the clinical outcome of these high risk patients. DESIGN: A nonrandomized, retrospective analysis of patients presenting with unstable angina. SETTING: A tertiary care, Canadian university-affiliated teaching hospital. PATIENTS: Of 1250 patients who underwent percutaneous transluminal coronary angioplasty between January 1994 and June 1995, 365 underwent coronary stenting. The study population consisted of the 156 patients presenting with unstable angina who underwent coronary stenting. Patients with Canadian Cardiovascular Society class IV and postinfarction angina were included. INTERVENTIONS: Stent delivery by standard techniques to the target lesion was successful in all patients. At discharge, 88 patients were prescribed warfarin, ticlopidine and acetylsalicylic acid (ASA); the remaining 68 patients received only ticlopidine and ASA. Late clinical outcomes were assessed by telephone interview. RESULTS: The overall procedural success rate was 96%. One patient died in hospital (0.6%). Other events were abrupt closure (1.9%), myocardial infarction (1.9%) and urgent bypass surgery (1.9%). During follow-up, target vessel reintervention was needed in 19.6% of patients. Early and late clinical outcomes did not differ significantly between anticoagulated patients and those treated with antiplatelet agents alone, but anticoagulated patients had a significantly longer hospital stay. CONCLUSIONS: Coronary stenting in patients with unstable angina was associated with excellent procedural success and favourable late clinical outcomes. Warfarin added no apparent additional clinical benefit to antiplatelet agents in this high risk population.     

Impact of diabetes mellitus on percutaneous revascularization (CAVEAT-I). CAVEAT-I Investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial

We examined the relation between diabetes mellitus and outcomes in patients undergoing percutaneous coronary revascularization in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), a randomized trial comparing treatment with either percutaneous transluminal coronary angioplasty or directional atherectomy for de novo lesions in native coronary arteries. Acute success and complication rates, 6-month angiographic restenosis rates, and 1-year clinical outcomes were compared between diabetic and nondiabetic patients undergoing each procedure. Acute success rates between diabetic (n = 191) and nondiabetic (n = 821) patients were similar for both revascularization techniques. Except for the need for dialysis, complication rates were also similar. Six months after atherectomy, diabetic patients had significantly more angiographic restenosis than nondiabetics (59.7% vs 47.4%) and significantly smaller minimum luminal diameters (1.20 vs 1.40 mm). Diabetics undergoing atherectomy required more frequent bypass surgery (12.8% vs 8.5%) and more repeat percutaneous revascularizations (36.5% vs 28.1%) than nondiabetics undergoing atherectomy. Restenosis rates, minimum luminal diameters and repeat revascularizations between diabetics and nondiabetics undergoing angioplasty were similar. The higher restenosis and repeat revascularization rates and the smaller minimum luminal diameter at follow-up in diabetic patients suggest that atherectomy may provide only modest benefit for these patients. The increased restenosis rate in diabetics undergoing atherectomy (but not angioplasty) requires further evaluation.     

Acute angiographic and clinical results of long balloon percutaneous transluminal coronary angioplasty and adjuvant stenting for long narrowings

Historically, long coronary artery stenoses undergoing percutaneous transluminal coronary angioplasty (PTCA) are reported to have reduced procedural and clinical success in comparison with shorter lesions. The efficacy of long balloons (30 or 40 mm) in long lesions was evaluated. Eighty-two patients had 84 PTCA procedures with a primary long balloon. In all, 86 lesions were available for analysis. Data were collected prospectively on standard PTCA procedure forms. Coronary angiograms were reviewed and measured with digital calipers. Hospital charts were examined for complications. PTCA was performed in the left anterior descending artery in 44 cases (51%), the right coronary artery in 29 (34%) and the circumflex artery in 13 (15%). With the use of a modified classification system, 47 lesions (55%) were class C, 24 (28%) were class B2 and 15 (17%) were class B1. Mean lesion length was 22 +/- 11 mm (range 10 to 72), and 38 lesions (44%) were > or = 20 mm. Twelve patients received an intracoronary stent. The long balloon alone produced angiographic success (< 50% residual stenosis) in 77 lesions (90%). Angiographic success was achieved ultimately in all stenoses, using a stent in 7 patients and a short balloon in 2. There were 2 deaths (2%) and 1 Q-wave myocardial infarction (1%). One patient needed coronary artery bypass surgery. Clinical success without death, Q-wave infarction or bypass surgery was achieved in 83 of 86 procedures (97%). In conclusion, the use of long PTCA balloons with adjuvant stenting produced excellent results in these long stenoses. Lesion length was not a precursor of poor angiographic or clinical outcome.     

The optimal mode of coronary revascularization for diabetics. A risk-adjusted long-term study comparing coronary angioplasty and coronary bypass surgery

AIMS: Some recent studies have reported-superior outcomes for diabetic patients following coronary bypass surgery compared with coronary angioplasty. However, the available data are conflicting, are based on relatively small numbers of diabetic patients, and have limited duration of follow-up. The aims of this study were to compare risk adjusted long-term survival in diabetic patients following first-time revascularization via either coronary bypass surgery or coronary angioplasty; and, to identify variables independently associated with mortality. METHODS AND RESULTS: This was a two centre database project involving 15809 patients undergoing either coronary angioplasty or coronary bypass surgery as their initial revascularization procedure. Diabetes was present in 1938 (12%). Mean follow-up was 4.6+/-2.7 years for angioplasty and 6.6+/-4.3 years surgery diabetic patients. Multivariable time-related analyses in the hazard function domain for death were performed. Overall ten-year survival for pharmacologically treated diabetics was better after coronary bypass surgery (60%) than angioplasty (46%, <0.0001). However, the risk-adjusted survival advantage conferred by bypass surgery over angioplasty was strongest for patients receiving oral agents for diabetic control (75% vs 62%) and less impressive for diet (84% vs 81%) and insulin-treated diabetics (63% vs 64%). The major factors independently associated with worse outcome after angioplasty were incomplete revascularization, and the use of a sulfonylurea agent. The use of the left internal mammary graft improved survival in surgical patients. CONCLUSIONS: In general, diabetic patients had better long-term survival after bypass surgery than angioplasty. Incomplete revascularization and sulfonylurea therapy worsened outcome after angioplasty, and use of the left internal mammary improved outcome after bypass surgery.     

Ultrastructure and distribution of axon terminals from the reticular thalamic nucleus to the anteroventral thalamic nucleus of the rat

The Bard Atherectomy Catheter is a new rotational atherectomy device that consists of a flexible, hollow, thin-walled cutting catheter that, while rotated at 1,500 revolutions per minute, is advanced across the lesion over a special spiral guidewire system. We report the initial clinical experience with this device in 20 peripheral lesions in ten patients. The majority of patients were treated for limb salvage. All lesions were successfully intervened on by atherectomy followed by adjunctive balloon angioplasty. A reduction to less than 50% stenosis was achieved in 13 of the 20 lesions (65%) after atherectomy but in all 20 lesions (100%) after adjunctive angioplasty for all lesions and stenting for dissections in two. Baseline minimal lesion lumen diameter was 0.8 +/- 0.7 mm with a reference vessel diameter of 4.2 +/- 1.7 mm (75 +/- 21% stenosis). The lumen improved to 2.0 +/- 0.8 mm (45 +/- 19% stenosis) (P < 0.001) following atherectomy and to 3.9 +/- 1.9 mm (13 +/- 16% stenosis) (P < 0.001) after adjunctive angioplasty. The average weight of removed atheroma was 45 +/- 58 mg. All ten patients had initial improvement in symptoms. At 6 months follow-up there was persistent improvement in eight patients and two subjects had undergone amputations. Our early clinical experience with this low profile, flexible atherectomy device, that enables extraction of a large amount of atheroma, suggests that it will become a valuable addition to current atherectomy technologies in small- and medium-sized vessels. The value of this device in coronary vessels is under investigation.     

Complex stenosis morphology predicts late reocclusion during follow-up after myocardial infarction in patients with patent infarct-related coronary arteries

BACKGROUND: Whether angiographic morphology of infarct-related residual stenoses continues to affect prognosis after discharge is not known. METHODS: We studied 175 patients after their myocardial infarction who required nonurgent coronary angioplasty for residual myocardial ischemia. The findings at diagnostic coronary angiography were compared with those before angioplasty (mean of 7 months later). Infarct-related stenoses were classified as complex or smooth. Stenosis progression was defined as >0.5 mm diameter reduction. RESULTS: One hundred twenty-one (69%) infarct-related stenoses were complex. At restudy, total occlusion was found in 41 (35%) of the infarct-related complex stenoses compared with 7 (13%) smooth stenoses (P = .001). Reocclusion occurred in 16 (55%) of 29 complex infarct-related stenoses with thrombus, compared with 25 (28%) of 88 without thrombus (P = .01). During follow-up, 46 patients (26%) had cardiac events. Of these, 70% had complex lesions at study entry compared with 30% smooth (P < .05). CONCLUSIONS: Residual angiographically complex stenoses after an uncomplicated myocardial infarction are associated with a greater risk of reocclusion and may predispose to coronary events at follow-up.     

Comparison of balloon angioplasty versus debulking devices versus stenting in right coronary ostial lesions

Angioplasty of aorto-ostial stenosis is associated with lower procedural success and a higher complication rate. The aim of the present study was to compare the acute and long-term results of balloon and new device angioplasty in 110 consecutive patients with right coronary ostial lesions. Patients were divided into 3 groups according to the angioplasty device used: group I (balloon only, n = 26), group II (debulking devices including excimer laser, directional and rotational atherectomy, n = 26), group III (stent, n = 58). Procedural success was highest in group III (96%) followed by group I (88%), and group II (77%). In-hospital complications were similar among the groups (p = NS). Patients in group III achieved the highest acute gain (2.61 mm) followed by groups II (1.92 mm), and I (1.39 mm, p <0.05). During follow up, target lesion revascularization and/or bypass surgery was required in 24% of patients in group III compared with 47% and 40% in groups I and II, respectively (p <0.05). Cardiac-event free survival was highest in the stent group (74%, p <0.005) and was similar between the balloon (39%) and debulking device groups (45%). Thus, among the currently available technologies, stenting of right coronary ostial lesions appears to provide excellent angiographic and long-term results.     

Are directional coronary atherectomy and Palmaz-Schatz stent more efficacious than conventional balloon angioplasty for treating de novo coronary artery lesions?

It is unclear whether new devices such as directional coronary atherectomy (DCA) or Palmaz-Schatz stent implantation improve long-term outcomes compared with conventional balloon angioplasty in patients with stable angina and de novo coronary artery lesions of type A or type B except for complete occlusive lesions investigated by the American College of Cardiology/American Heart Association task force on percutaneous transluminal coronary angioplasty. A total of 146 patients with stable angina and simple lesions were assigned to either conventional balloon angioplasty (62 patients), DCA (50 patients), or Palmaz-Schatz implantation (34 patients). The acute results and late outcomes were assessed by coronary angiography. The results of the three procedures were similar with respect to procedural success and complications. Patients who underwent stenting or DCA had a larger immediate increase in the diameter of the lumen and a larger luminal diameter immediately after the procedure than those who underwent balloon angioplasty. At six months follow-up, the patients treated by stenting continued to have a larger luminal diameter and a lower rate of restenosis than those treated with balloon angioplasty (2.30 +/- 0.66 vs 1.85 +/- 0.83 mm, p < 0.005; 5.9% vs 29%, p < 0.05) and DCA (2.30 +/- 0.66 vs 1.90 +/- 0.96 mm, p < 0.05; 5.9% vs 24%, NS). The patients treated with balloon angioplasty had a smaller late loss than those treated with DCA or Palmaz-Schatz stent. The patients treated with DCA had a larger loss index than those treated with balloon angioplasty or Palmaz-Schatz stent. Stenting was a significant factor in decreasing the rate of restenosis by logistic regression analysis, compared with balloon angioplasty. The angiographic outcomes were better in patients who received a stent than in those who received other treatments. This study suggests that even lesions stable for treatment by balloon angioplasty and DCA can also be treated with Palmaz-Schatz stents.     

Preliminary experience with adjunct directional coronary atherectomy after high-speed rotational atherectomy in the treatment of calcific coronary artery disease

A high-speed rotational atherectomy was performed followed by adjunct directional atherectomy in 10 patients with symptomatic coronary artery disease and calcified target lesions and the results were evaluated using quantitative coronary arteriography and intravascular ultrasound. Target lesion calcium is common in obstructive coronary artery disease. High-speed rotational coronary atherectomy preferentially abrades noncompliant atherosclerotic plaque material, especially calcium, but often requires adjunct balloon angioplasty to achieve optimal lumen dimensions. Directional coronary atherectomy has limited efficacy in heavily calcified plaque; usually, it is a definitive primary procedure in large arteries with noncalcified target lesions. Neither of these devices alone is effective in treating calcified target lesions in large coronary arteries. Before intervention, after rotational and adjunct directional atherectomy, these measurements were obtained: quantitative coronary arteriographic measurements of minimal lumen diameter and percent diameter stenosis and intravascular ultrasound measurements of external elastic membrane, lumen, and plaque+media cross-sectional areas; percent cross-sectional narrowing; minimal lumen diameter; and target-lesion arc of calcium. With use of quantitative coronary arteriography, the preintervention minimal lumen diameter measured 0.7 +/- 0.4 mm, increased to 1.5 +/- 0.5 mm after rotational atherectomy (p = 0.0013) and to 2.5 +/- 0.3 mm after adjunct directional atherectomy (p < 0.001). The preintervention percent diameter stenosis measured 78 +/- 15%, decreased to 50 +/- 17% after rotational atherectomy (p = 0.0011), and to 17 +/- 11% (p < 0.001) after adjunct directional coronary atherectomy.(ABSTRACT TRUNCATED AT 250 WORDS)     

Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes

OBJECTIVES: This study reports on the initial experience with the Gianturco-Roubin flexible coronary stent. The immediate and 6-month efficacy of the device and the incidence of the complications of death, myocardial infarction, emergency coronary artery bypass surgery and recurrent ischemic events are presented. BACKGROUND: Abrupt or threatened vessel closure after coronary angioplasty is associated with increased risk of myocardial infarction, emergency coronary artery bypass graft surgery and in-hospital death. When dissection or prolapse of dilated plaque into the lumen is unresponsive to additional or prolonged balloon catheter inflation, coronary stenting offers a nonsurgical mechanical means to rapidly restore stable vessel geometry and adequate coronary blood flow. METHODS: From September 1988 through June 1991, 518 patients underwent attempted coronary stenting with the 20-mm long Gianturco-Roubin coronary stent for acute or threatened vessel closure after angioplasty. In 494 patients, one or more stents were deployed. Thirty-two percent of patients received stents for acute closure and 69% for threatened closure. RESULTS: Successful deployment was achieved in 95.4% of patients. Overall, stenting resulted in an immediate angiographic improvement in the diameter stenosis from 63 +/- 25% before stenting to 15 +/- 14% after stenting. Emergency coronary artery bypass graft surgery was required in 4.3% (21 of 493 patients). The incidence of in-hospital myocardial infarction (Q wave and non-Q wave) was 5.5% (27 of 493 patients). At 6 months, myocardial infarction was infrequent, occurring in 1.6% (8 of 493 patients). The incidence of in-hospital death was 2.2% (11 of 493 patients). Late death occurred in 7 patients (1.4%) and 34 patients (6.9%) required later bypass graft surgery. Complications included blood loss, primarily from the arterial access site, and subacute thrombosis of the stented vessel in 43 patients (8.7%). CONCLUSIONS: The early multicenter experience suggests that this stent is a useful adjunct to coronary angioplasty to prevent or minimize complications associated with flow-limiting coronary artery dissections previously correctable only by surgery. Although this study was not randomized, it demonstrated a high technical success rate and encouraging results with respect to the low incidence of emergency coronary artery bypass graft surgery and myocardial infarction.     

Optimal burr and adjunctive balloon sizing reduces the need for target artery revascularization after coronary mechanical rotational atherectomy

We analyzed the effect of differing burr and balloon sizes during mechanical rotational atherectomy on the need for target vessel revascularization at 6 months. The ideal burr/artery ratio and adjunctive balloon/artery ratio for optimizing acute luminal results and minimizing restenosis is unknown. Six-month clinical follow-up was obtained in 311 patients (339 lesions) treated with rotational atherectomy from August 1993 to September 1994, to determine whether procedural results or technique were related to the need for target vessel revascularization. Target vessel revascularization, defined as repeat percutaneous intervention or bypass surgery within 6 months after rotational atherectomy, occurred in 19% of patients. Larger burr/artery ratios, defined as the final burr size divided by the reference artery size, were correlated with decreased postatherectomy diameter stenosis (p <0.009) and decreased final diameter stenosis (p <0.03). However, there was no statistical association between postatherectomy or final diameter stenosis with need for revascularization (p = not significant [NS]). The need for revascularization was lowest for burr/artery ratio between 0.6 to 0.85 (15%) versus burr/artery <0.6 or >0.85 (25%) (p <0.04). Postatherectomy, smaller balloon/artery ratios, defined as the final balloon size divided by the reference artery size, were correlated with lower repeat revascularization rates. Balloon/artery ratios <0.95 (target vessel revascularization = 11% vs 25% in balloon/artery >0.95) were associated with the best luminal results and the least risk for clinical restenosis (p <0.006). For rotational atherectomy, despite improvement in acute luminal results with increased burr/artery ratio, the use of a moderate burr/artery ratio correlated with the lowest revascularization rates. There was no correlation between postatherectomy or final diameter stenosis and need for repeat interventions. However, the use of large balloon/artery ratios after rotablator was associated with higher target vessel revascularization rates.     

Restenosis rates in diabetic patients: a comparison of coronary stenting and balloon angioplasty in native coronary vessels

BACKGROUND: Diabetes is a major risk factor for restenosis after coronary balloon angioplasty. Recent studies have shown that coronary stenting significantly reduces restenosis compared with balloon angioplasty alone. However, limited information is available on the effect of coronary stenting in diabetic patients. METHODS AND RESULTS: We designed this study to analyze the effect of diabetes on restenosis in patients treated with either balloon angioplasty or coronary stenting who were enrolled in a 6-month angiographic follow-up program. Three hundred consecutive patients, 19% of whom were diabetics, who underwent coronary stent implantation during a single-vessel procedure on native coronary vessels and who had 6-month angiographic follow-up constituted the study group (stent group). Three hundred consecutive patients who underwent 6-month angiographic follow-up after single-vessel conventional balloon angioplasty served as control patients (balloon group). Preprocedural, postprocedural, and follow-up angiograms were analyzed with quantitative angiography. In the balloon group, the restenosis rate was almost twofold higher in diabetic than in nondiabetic patients (63% versus 36%; P=.0002) owing to both a greater late loss (0.79+/-0.70 versus 0.41+/-0.61 mm, respectively; P<.0001) and a higher rate of late vessel occlusion (14% versus 3%, respectively; P<.001). In the stent group, restenosis rates were similar in diabetics and nondiabetics (25% versus 27%, respectively). Furthermore, in the stent group, late loss (0.77+/-0.65 versus 0.79+/-0.57 mm, respectively) and the rate of late vessel occlusion (2% versus 1%, respectively) did not differ significantly between diabetic and nondiabetic patients. CONCLUSIONS: Although diabetics have increased rates of restenosis and late vessel occlusion after simple balloon angioplasty, they have the same improved outcome with coronary stenting that has been documented in nondiabetic patients.