Intracoronary stenting for acute and threatened closure complicating percutaneous transluminal coronary angioplasty.

BACKGROUND. Acute closure remains a significant limitation of percutaneous transluminal coronary angioplasty (PTCA) and underlies the majority of ischemic complications. This study details the clinical and angiographic characteristics of a series of patients receiving an intracoronary stent device to manage acute and threatened closure and presents the early clinical results. METHODS AND RESULTS. From October 1989 through June 1991, 115 patients undergoing PTCA received intracoronary stents to treat acute or threatened closure in 119 vessels. Sixty-three percent had multivessel coronary disease, 33 (29%) had undergone prior coronary artery bypass grafting (CABG), and 52 (45%) had had previous PTCA. Using the American College of Cardiology/American Heart Association (ACC/AHA) classification, 15% of lesions were class A, 55% were class B, and 30% were class C. Eight patients were referred with severe coronary dissection and unstable angina after PTCA at other institutions. Acute closure was defined as occlusion of the vessel with TIMI (Thrombolysis in Myocardial Infarction) 0 or 1 flow immediately before stent placement. Threatened closure required two or more of the following criteria: 1) a residual stenosis greater than 50%, 2) TIMI grade 2 flow, 3) angiographic dissection comprising extraluminal dye extravasation and/or a length of greater than 15 mm, 4) evidence of clinical ischemia (either typical angina or ECG changes). Twelve vessels (10%) met the criteria for acute closure, and 87 vessels (73%) satisfied the criteria for threatened closure. Twenty vessels (17%) failed to meet two criteria. Stenting produced optimal angiographic results in 111 vessels (93%), with mean diameter stenosis (+/- 1 SD) reduced from 83 +/- 12% before to 18 +/- 29% after stenting. Overall, in-hospital mortality was 1.7% and CABG was required in 4.2%; Q wave myocardial infarction (MI) occurred in 7% and non-Q wave MI in 9%. Stent thrombosis occurred in nine patients (7.6%). For the 108 patients who presented to the catheterization laboratory without evolving MI, Q wave MI occurred in 4% and non-Q wave MI occurred in 7%. Angiographic follow-up has been performed in 81 eligible patients (76%), and 34 patients (41%) had a lesion of greater than or equal to 50%. CONCLUSIONS. This stent may be a useful adjunct to balloon dilatation in acute or threatened closure. Randomized studies comparing this stent with alternative technologies are required.     

Mid-term results of conventional bypass surgery for complex proximal left anterior descending coronary artery stenoses.

BACKGROUND: The significant involvement of proximal left anterior descending (LAD) coronary artery affects patient prognosis and must be treated. Recently, as alternative methods to conventional coronary bypass (CABG), minimally invasive direct coronary artery bypass grafting (MIDCAB) and percutaneous transluminal coronary angioplasty with stent implantation (PTCA/S) have been proposed to reduce costs and patient discomfort. The aim of this study was to obtain early and medium-term results of CABG in patients with complex LAD disease in whom the expected results with PTCA/S or MIDCAB would have been suboptimal. METHODS: We retrospectively examined one hundred consecutive patients subjected to isolated CABG who received either a single graft to LAD or several grafts to LAD and diagonal branches. The choice of CABG was due to poor expectable results with PTCA/S or MIDCAB because of anatomical characteristics of the lesion, inclusion in ongoing randomized study comparing surgical versus non-surgical revascularization, or preference on the part of the cardiologist or patient. RESULTS: Left internal mammary artery (LIMA) was grafted to LAD in 99 (99%) patients; 65 (65%) patients received at least one saphenous graft to the diagonal branches. No death was observed within 30 days from the operation. One (1%) patient had a perioperative non-Q myocardial infarction (MI). At a mean follow-up time of 38 +/- 16 months (range 2-60), there were no cardiac deaths and no new MI. Six patients complained of recurrent angina: in all cases but one (vein graft failure to a diagonal branch), there were no clinical or diagnostic signs suggesting other graft failures. The probability of freedom from early and late events, including cardiac death, MI and recurrence of angina regardless of site, was 99% at 1 year and 86% at 5 years. CONCLUSIONS: At present, conventional CABG seems to be the "gold standard palliation" of LAD disease in most cases. It can be performed safely with excellent early and medium-term results in terms of freedom from cardiac events. Its comparison with percutaneous transluminal techniques and MIDCAB needs to be addressed in further prospective studies.     

Treatment of in-stent restenosis with excimer laser coronary angioplasty

Diffuse in-stent restenosis remains an important problem in percutaneous transluminal coronary angioplasty (PTCA). In this trial, we studied the early and mid-term outcomes of excimer laser coronary angioplasty (ELCA) on diffuse in-stent restenosis. ELCA was performed in 23 patients (19 males). The mean length of the lesions was 14.3 +/- 3 mm and the mean age was 58 +/- 7 years. The minimal lumen diameter (MLD) was measured by on-line quantitative coronary angiography. Before the procedure, MLD was 0.9 +/- 0.4. The Q/non-Q-wave myocardial infarction (MI), coronary artery bypass graft (CABG), PTCA, and mortality were recorded during the procedure and at 6 months follow up. The fluence of laser emission was 45 mj/m2 and the repetition rate was 25 pulses per second. Adjunctive balloon angioplasty was performed in all of the cases at a mean 7 +/- 2 atm pressure. The procedure was successfully performed in all of the cases. Type-B dissection developed, after ELCA in 1 patient (4%). Perforation, death, cerebrovascular accidents, emergency CABG, PTCA or Q/non-Q wave myocardial infarction were not observed. MLD was 0.9 +/- 0.4 mm before ELCA, 1.8 +/- 0.9 mm (P<0.05) after ELCA, and 3.1 +/- 0.7 mm after PTCA. At 6 months follow up, there were 2 (8.7%) Q-wave myocardial infarctions and 2 (8.7%) recurrent anginal pain cases. Control angiography was obtained in 20 cases (87%). Control angiography was not accepted by 3 patients. Their maximal exercise test was negative. Angiographic restenosis was observed in 6 cases (30%). The rate of target lesion revascularization (TLR) was 5 of 23 (22%) in the patients treated with ELCA. It is concluded, ELCA is a safe and efficient debulking technology for treating diffuse in-stent restenosis.     

Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: six-year clinical follow-up of the GISSOC trial

OBJECTIVES: We investigated whether the benefits of stent implantation over balloon percutaneous transluminal coronary angioplasty (PTCA) for treatment of chronic total coronary occlusions (CTO) are maintained in the long term. BACKGROUND: Several randomized trials have shown that in CTO, stent implantation confers clinical and angiographic mid-term outcomes superior to those observed after PTCA. However, limited information on the long-term results of either technique is available. METHODS: Six-year clinical follow-up of patients enrolled in the Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche (GISSOC) trial was performed by direct visit or telephone interview. Major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, target lesion revascularization (TLR), and anginal status, were recorded. RESULTS: Freedom from MACE at six years was 76.1% in the stent group, compared with 60.4% in the PTCA group (p = 0.0555). This difference was due mainly to TLR-free survival rates (85.1% vs. 65.5% for the stent and PTCA groups, respectively; p = 0.0165). Eleven patients underwent TLR after the nine-month follow-up visit (stent group: n = 5; PTCA group: n = 6); however, in most cases, restenosis of the study occlusion was evident at nine-month angiography. CONCLUSIONS: This study represents the longest reported clinical follow-up of patients after percutaneous recanalization of CTO and demonstrates that the superiority of stent implantation over balloon PTCA is maintained in the long term. Stent and PTCA results appear to remain stable after nine-month angiographic follow-up. Stent implantation in CTO that can be recanalized percutaneously is therefore a valuable long-term therapeutic option.     

Long-term (> 3 years) clinical and angiographic outcomes of coronary multilink stent implantations: a single center experience

The ACS Multilink (ML) stent is a novel second-generation stent. The largest amount of information available on the long-term outcome of coronary stenting is based on the use of Palmaz-Schatz stents. Fewer data exist on long-term follow-up results of ML coronary stents implantations. The authors present the long-term (> 3 years) clinical and angiographic follow-up results of the ACS Multilink coronary stents implanted in their institution. From May 1996 to December 1997, 125 patients underwent 133 coronary ML stent implantations. Stented vessels were as follows: 49% left anterior descending artery, 31% right coronary artery, and 20% left circumflex coronary artery. Indications for stent implantations were elective in 64%, because of suboptimal result from percutaneous transluminal coronary angioplasty (PTCA) in 26%, and bailout from PTCA in 10% of patients. The mean reference diameter of stented vessels was 3.2 +/- 0.2 mm. The mean percentage stenosis was 80 +/- 11% and 3 +/- 5% before and after stent implantation, respectively. Long-term clinical follow-up was completed in 75% (80 men, mean age 53 +/- 10 years) of the patients (either by interview or phone), and angiographic follow-up (37 +/- 12 months) was completed in 58% of the patients. There were no baseline clinical or angiographic differences between those angiographically followed up and the remaining patients. Angiographic restenosis (> 50% diameter stenosis) was detected in 22% of stents. Target lesion revascularization was 12%, nontarget lesion revascularization was 14% in angiographically followed up patients. During the follow-up period death and new myocardial infarction occurred in 12% and 6% of patients, respectively, and survival rate was 88%. This study provides long-term follow-up results of intracoronary Multilink stent implantations for native coronary artery lesions. These data show that clinical and angiographic benefits of ML stents are comparable to those of the first-generation stents, especially to the Palmaz-Schatz stents, of which results have been reported previously. A considerable rate of nontarget lesion revascularization occurs during the follow-up period.     

Stent design related neointimal tissue proliferation in human coronary arteries; an intravascular ultrasound study.

AIMS: Histological restenosis models in animals have indicated that stent design has a significant impact on vessel trauma during stent implantation and on the amount of subsequent neointimal tissue proliferation. The impact of different stent designs on intimal hyperplasia in human atherosclerotic coronary arteries has not been determined. METHODS AND RESULTS: Angiographic and intravascular ultrasound studies were performed at the 6 month follow-up in 131 consecutive native coronary lesions of 131 patients treated with 50 Multi-Link stents, 40 InFlow stents and 41 Palmaz-Schatz stents. Lumen and stent cross-sectional areas (CSA) were measured at 1 mm axial increments. Mean intimal hyperplasia cross-sectional area (stent CSA-lumen CSA) and mean intimal hyperplasia thickness were calculated. Intravascular ultrasound demonstrated different levels of intimal hyperplasia proliferation for the three stents. Mean intimal hyperplasia thickness was 0.16+/-0.08 mm for Multi-Link stents, 0.26+/-0.19 mm for Palmaz-Schatz stents and 0.39+/-0.14 mm for Inflow stents (P<0.001). Multivariate analysis proved that stent type was the only independent predictor of intimal hyperplasia thickness at follow-up (P<0.001). CONCLUSION: Coronary stent design has a significant impact on subsequent intimal hyperplasia after implantation into atherosclerotic human coronary arteries. The corrugated ring design of the Multi-Link stent proved to result in less tissue proliferation at 6-month follow-up than the tubular slotted design of Palmaz-Schatz and InFlow stents.     

Intravascular ultrasound-guided percutaneous transluminal coronary angioplasty with provisional spot stenting for treatment of long coronary lesions.

OBJECTIVES: The purpose of this study was to evaluate the approach of intravascular ultrasound (IVUS)-guided percutaneous transluminal coronary angioplasty (PTCA) with spot stenting (SS) for the treatment of long coronary lesions. BACKGROUND: Treating long coronary lesions with balloon angioplasty results in suboptimal short- and long-term outcomes. Full lesion coverage with traditional stenting (TS) has been associated with a high restenosis rate. METHODS: We prospectively evaluated a consecutive series of 130 long lesions (>15 mm) in 101 patients treated with IVUS-guided PTCA and SS. The results were compared with those of TS in a matched group of patients. Coronary angioplasty was performed with a balloon to vessel ratio of 1:1, according to the IVUS media-to-media diameter of the vessel at the lesion site, to achieve prespecified IVUS criteria: lumen cross-sectional area (CSA) > or =5.5 mm(2) or > or =50% of the vessel CSA at the lesion site. The stents were implanted only in the vessel segment where the criteria were not met. RESULTS: In the SS group, stents were implanted in 67 of 130 lesions, and the mean stent length was shorter than that of lesions in the matched TS group (10.4 +/- 13 mm vs. 32.4 +/- 13 mm, p < 0.005). The 30-day major adverse cardiac event (MACE) rate was similar (5%) for both groups. Angiographic restenosis was 25% with IVUS-guided SS, as compared with 39% in the TS group (p < 0.05). Follow-up MACE and target lesion revascularization rates were lower in the SS group than in the TS group (22% vs. 38% [p < 0.05] and 19% vs. 34% [p < 0.05], respectively). CONCLUSIONS: Intravascular ultrasound-guided SS for the treatment of long coronary lesions is associated with good acute outcome. Angiographic restenosis and follow-up MACE rates were significantly lower than those with TS.     

Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry

We sought to explore the immediate clinical and angiographic results of the Titan^? stent implantation in diabetic patients, as well as the major adverse cardiac events (MACE) at 6-month follow-up. We enrolled 156 consecutive diabetic patients admitted to undergo percutaneous intervention for at least one significant (50%) coronary lesion. All lesions were treated with the Titan^? stent implantation according to the contemporary interventional techniques. Patients were prospectively followed-up for at least 6?months. The primary endpoint was MACE at 6-month follow-up [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, TLR at 6-month follow-up, and stent thrombosis. The mean age was 66.7?±?9.6?years, (68.4% males). A total of 197 Titan^? stents were implanted in 163 lesions. Direct stenting was performed in 45.2% of the cases. The mean stent diameter was 3.1?±?0.61?mm, and the mean length was 18.0?±?8.9?mm. Average stent deployment pressure was 13.9?±?4.2 bars. Angiographic procedural success was achieved in 154 (98.7%) cases, and clinical procedural success was achieved in 153 (98.1%) cases. One patient developed in-hospital non-Q-wave MI following the procedure. Clinical follow-up was completed in 155 (99.4%) patients. Three patients (1.9%) died of a cardiac or unknown cause, and two (1.3%) developed MI. TLR was performed in 11 patients (7.1%). Cumulative MACE at 6-month follow-up occurred in 16 (10.3%) patients. No patient suffered stent thrombosis. Titan^? stent implantation in diabetic patients achieves an excellent immediate clinical and angiographic outcome, with a low incidence of MACE at mid-term follow-up.     

Gender-related risk factors and outcomes for non-Q wave myocardial infarction patients receiving in-hospital PTCA

BACKGROUND: We analyzed the risk factors and outcomes associated with non-Q wave myocardial infarction (MI) in females and males. We studied 376 consecutive patients N 275 males (73%) and 101 females (27%) N who presented with non-Q wave MI and had percutaneous transluminal coronary angioplasty (PTCA) prior to discharge during the period between January 1992 and February 1996. RESULTS: Females were significantly older (68 +/- 10 years vs. 61 +/- 11 years; p < 0.001) and had more hypertension (67% vs. 51%; p < 0.01). Males had a slightly lower ejection fraction (47 +/- 11%) compared to females (50 +/- 10%; p < 0.001). Angioplasty was equally successful for women and men (96% vs. 97%; p = NS) with a statistically significant smaller number of lesions dilated per patient in females (1.38 vs. 1.51; p < 0.04). There were no significant differences in unstable angina, prior coronary artery bypass graft (CABG) surgery, saphenous vein graft PTCA, single vessel versus multiple vessel disease or history of prior MI. In-hospital complications (i.e., the need for CABG or repeat PTCA, recurrent MI, and stroke) were not statistically significant for either females or males. There was a trend for a higher in-hospital death rate in females after a non-Q wave MI, but it was not statistically significant (4% vs. 1%; p = 0.058). However, at one-year follow-up females had a significantly worse survival rate than men (89% vs. 95%; p < 0.04), although event-free survival rate was similar (61% female, 66% male; p = NS). CABG was performed less commonly in women by the end of one year (p < 0.02) than in men, while the performance of PTCA was similar. CONCLUSIONS: Although women with non-Q wave MI presented with more risk factors than men, in-hospital revascularization was equally successful with few complications and morbid events and similar event-free outcome at one year. However, one year mortality was worse for women, suggesting a need for more aggressive follow-up evaluation and treatment. For both women and men, this aggressive percutaneous revascularization strategy resulted in much better outcome than previously reported for medical treatment of non-Q wave MI.     

Excimer Laser Angioplasty with Adjunctive Balloon Dilatation Versus Balloon Dilatation Alone for the Treatment of In-Stent Restenosis: Results of a Randomized Single-Center Study

Background: Laser ablation of neointimal tissue prior to balloon dilatation has been shown to be a potential treatment modality for restenosis within previously implanted stents. It remains controversial whether this treatment provides superior acute and long-term results compared to conventional balloon dilatation. Methods and Results: Between November 1995 and November 1996, 96 patients with significant (≥ 50%) in-stent restenosis were randomized to receive excimer laser angioplasty with adjunctive balloon dilatation (ELCA + PTC A, n = 47) or PTCA alone (n = 49). Both groups did not differ with regard to gender, clinical history, location of the lesion, reference diameter, or lesion length. Angiographic success was achieved in 46 patients with ELCA + PTCA (98%) and in 48 patients with PTCA alone (98%). In-hospital complications included acute closure in one patient of each group, one CABG, one repeat PTCA, and one non-Q wave MI with ELCA + PTCA, versus two bleeding and one death with PTCA. Clinical follow-up was obtained in all patients, while angiographic follow-up was available in 35 of 47 (ELCA+PTCA) versus 35 of 49 (PTCA) patients with a mean follow-up time of 163 ± 81 days. With ELCA+PTCA, MLD increased from 0.82 ± 0.38 to 1.99 ± 0.33 mm versus 0.81 ± 0.39 mm to 2.07 ± 0.60 mm with PTCA (P = NS). At follow-up, MLD was 1.32 ± 0.60 mm with ELCA + PTCA versus 1.45 ± 0.75 mm with PTCA (P = NS). Late adverse events included nine repeat PTCA with ELCA +PTCA (19%) versus 12 with PTCA (24%), three CABG with ELCA +PTCA (6%) versus two with PTCA (4%), and one death (2%) with PTCA (P = NS). Angiographic restenosis rate was 52% with ELCA + PTCA versus 47% with PTCA alone (P = NS). Conclusion: Our data suggest that excimer laser angioplasty with adjunctive balloon dilatation for the treatment of in-stent restenosis provides similar acute results as plain balloon dilatation and may offer no advantage over PTCA alone with regard to intermediate-term outcomes.     

Comparative trial of stent-like balloon angioplasty versus coronary stenting for acute myocardial infarction.

Primary PTCA has been shown to be superior to any thrombolytic regimen and offers higher reperfusion rates and better coronary flow grades. Its limitations include recurrent ischemia (10%-15%), infarct-related artery reocclusion (5%-10%), angiographic restenosis (35%-50%), and need to perform repeat PTCA or CABG at 6-month follow-up (20%). Thus, the current role of coronary stenting for acute myocardial infarction (AMI) is very promising. From December 1995 through January 1997, 335 patients underwent primary angioplasty during the first 12 hr from symptom onset at our institution. We performed a retrospective study comparing the in-hospital and 6-month follow-up outcome of 61 patients who underwent coronary stenting (stent group) against 61 patients with optimal (residual lesion stenosis < 30%) balloon-only primary angioplasty (stent-like group). Patients were routinely treated with aspirin, and ticlopidine was given only to the stent group. In-hospital major adverse cardiac events (MACE) rate was 11.5% without statistical differences between the groups. Cardiac death rate was similar in both groups (4.9 vs. 6.6%; P = 1.0) and only two (3.3%) patients from the stent group and none from the PTCA group had nonfatal myocardial reinfarction. At 6-month follow-up, the rate of recurrent angina was higher in the stent-like group (30.9 vs. 7.1%; P < 0.001). Multivariate analysis showed that only stenting of the infarct-related artery was a borderline independent predictor for MACE (OR = 0; 95% CI = 0-1; P = 0.057). Primary stenting for AMI reduces the rate of recurrent angina or symptoms and MACE at 6-month follow-up.     

Immediate and six months clinical and angiographic results of intracoronary Ephesos stent implantation: the "Ephesos-1" study

BACKGROUND: This study was conducted to evaluate the clinical and angiographic results of the Ephesos stent implantation in patients with symptomatic coronary artery disease. The Ephesos stent is a new balloon-expandable, stainless steel, tubular stent with multicellular design. METHODS: One hundred ten patients with native coronary artery disease were included in the study. The Ephesos stents were implanted in 163 de novo lesions detected in these patients. Immediate and long-term clinical and angiographic follow-up results were evaluated. RESULTS: Most of the patients had unstable angina 63.6%, and 36.7% of the lesions were type B and C. Mean lesion length was 12.7 +/- 4.7. In 62% of the patients the reference lumen diameter was < 3 mm. One Q-wave and one non-Q-wave myocardial infarction (MI) occurred due to acute thrombotic occlusion during hospital stay. The 6-month event-free survival rate was 77.3%. No patients died in the six-month follow-up period, but 2 patients had non-Q wave MI and 1 patient experienced Q-wave MI within this period. Control angiographic data was collected from 110 patients (100% of patients and a total of 163 lesions). Angiographic restenosis rate was 18.1%. Twenty-two patients with restenosis had repeated target lesion balloon dilatation. CONCLUSION: The results of the present study showed that the Ephesos stent is a safe and effective choice with a low incidence of major adverse cardiac events and restenosis rate within six months of follow-up.     

Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions

OBJECTIVES: The aim of this study was to evaluate the immediate and long-term outcome of intracoronary stent implantation for the treatment of coronary artery bifurcation lesions. BACKGROUND: Balloon angioplasty of true coronary bifurcation lesions is associated with a lower success and higher complication rate than most other lesion types. METHODS: We treated 131 patients with bifurcation lesions with > or =1 stent. Patients were divided into two groups; Group (Gp) 1 included 77 patients treated with a stent in one branch and percutaneous transluminal coronary angioplasty (PTCA) (with or without atherectomy) in the side branch, and Gp 2 included 54 patients who underwent stent deployment in both branches. The Gp 2 patients were subsequently divided into two subgroups depending on the technique of stent deployment. The Gp 2a included 19 patients who underwent Y-stenting, and Gp 2b included 33 patients who underwent T-stenting. RESULTS: There were no significant differences between the groups in terms of age, gender, frequency of prior myocardial infarction (MI) or coronary artery bypass grafting (CABG), or vessels treated. Procedural success rates were excellent (89.5 to 97.4%). After one-year follow-up, no significant differences were seen in the frequency of major adverse events (death, MI, or repeat revascularization) between Gp 1 and Gp 2. Adverse cardiac events were higher with Y-stenting compared with T-stenting (86.3% vs. 30.4%, p = 0.004). CONCLUSIONS: Stenting of bifurcation lesions can be achieved with a high success rate. However, stenting of both branches offers no advantage over stenting one branch and performing balloon angioplasty of the other branch.     

Coronary stenting in patients with depressed left ventricular function: acute and long-term results in a selected population.

Percutaneous coronary angioplasty (PTCA) in patients with depressed left ventricular ejection fraction (LVEF) is associated with increased acute and late mortality; in contrast to plain PTCA, results of stenting in these patients have not been characterized. To assess the current outcome of stenting in patients with LV dysfunction, results from 80 patients procedures were analyzed. Intervention for acute myocardial infarction (MI) was excluded; 21% of patients had unstable angina and 30% had a recent MI. Mean LVEF was 40 +/- 9% (range, 25-45%). Multivessel revascularization was done in 25 patients (31%), with a total of 114 lesions treated. Prophylactic intra-aortic balloon pump was used in only two patients. Angiographic and clinical success was achieved in 79/80 patients (99%). There were no in-hospital deaths, one patient (1%) had a non-Q-wave MI, and no patients required emergency bypass surgery (CABG). All patients completed at least 6 months follow-up (mean, 30 +/- 14 months): 64 patients (80%) remained asymptomatic, 4 (5%) had acute MI, and 5 (6%) died. In-stent restenosis occurred in five patients (6%); of these, three required repeat PTCA, three patients (4%) underwent subsequent elective CABG. Including patients with repeat intervention, 67 patients (84%) are clinically improved; actuarial event-free survival was 87% at 56-month follow-up. Thus, stenting in patients with impaired LVEF is associated with excellent outcome and lower mortality than previously reported for balloon angioplasty alone. Whether coronary stenting may be a therapeutic strategy equivalent to surgery in selected patients needs to be investigated in prospective randomized trials.     

A randomized trial of elective stenting after balloon recanalization of chronic total occlusions.

OBJECTIVES: The aim of this study was to assess the role of Wiktor stent implantation after recanalization of chronic total coronary occlusions with regard to the clinical and angiographic outcome after six months. BACKGROUND: Beside the common use of stents in clinical practice, the number of stent indications proven by randomized trials is still limited. METHODS: Eighty-five patients with a thrombolysis in myocardial infarction grade 0 chronic coronary occlusion were examined. After standard balloon angioplasty, the patients were randomly assigned to stent implantation, or percutaneous transluminal coronary angioplasty (PTCA) alone (no further intervention). Quantitative coronary angiography was performed at baseline and after six months. RESULTS: The minimal lumen diameter did not differ immediately after recanalization (stent group 1.61 +/- 0.30 mm vs. PTCA group 1.65 +/- 0.36 mm), and increased after stent implantation to 2.51 +/- 0.41 mm. After six months, the stent group still had a significantly greater lumen (1.57 +/- 0.59 vs. 1.06 +/- 0.90 mm; p < 0.01) and a significantly lower restenosis and reocclusion rate (32% and 3%) compared with the PTCA group (64% and 24%); restenosis analysis according to treatment was 72% (PTCA) versus 29% (stent, p < 0.01). Late loss was equal in both groups. At follow-up, the stent patients had a better angina class (p < 0.01), and fewer cardiac events (p < 0.03). A meta-analysis including this trial and three other controlled trials with the Palmaz-Schatz stent showed concordant results. CONCLUSIONS: Stent implantation after reopening of a chronic total occlusion provides a better angiographic result, corresponding to a better clinical outcome with fewer recurrence of symptoms and reinterventions after six months.     

Six-month outcome after excimer laser coronary angioplasty for diffuse in-stent restenosis in native coronary arteries

This study evaluated the intermediate-term follow-up after excimer laser coronary angioplasty (ELCA) and adjunctive percutaneous transluminal coronary angioplasty (PTCA) in patients with diffuse in-stent restenosis (lesion length >10 mm). Clinical and angiographic follow-up were performed at 6 months. Quantitative coronary angiography performed at 3 stages-during stent implantation, before and after ELCA + PTCA, and at follow-up-included measurements of the minimum lumen diameter (MLD) and percent diameter stenosis (DS). Sixteen consecutive patients were included. The (median + range) stent length was 36 mm (range 15 to 105), with a restenotic lesion length of 32 mm (range 10 to 90). After ELCA + PTCA, the MLD increased from 0.60 +/- 0.41 to 2.28 +/- 0.50 mm, whereas the DS decreased from 76 +/- 16% to 22 +/- 8%. Despite adjunctive high-pressure PTCA, the MLD after ELCA + PTCA remained smaller than the MLD after initial stent implantation, (2.28 +/- 0. 50 mm vs 2.67 +/- 0.32 mm, p = 0.014). Adverse events included ELCA-related acute coronary occlusion in 4 patients and a per-procedural intracerebral hematoma in 1. At 6 months, there was recurrence of angina in all patients. Angiographic follow-up was completed in 13 patients (87%), showing a reocclusion in 6 (46%), a >50% DS in 6 (MLD 1.03 +/- 0.87 mm, DS 68 +/- 24%), and a distal de novo lesion in 1. Despite satisfactory acute angiographic results, the recurrence of significant restenosis in all patients suggests that ELCA + PTCA is not a suitable stand-alone therapy for diffuse in-stent restenosis of long stented segments.     

The benefit of a coronary stent in the reduction of major cardiac complications in acute coronary syndromes]

To assess the incidence of in-hospital major adverse cardiac events (MACE), we analyzed 694 procedures in 613 consecutive patients during one year period. Patient population included 550 (79.2%) patients with unstable angina, 43 (6.2%) with stable angina and 101 (14.5%) with acute myocardial infarction. Elective percutaneous transluminal coronary angioplasty (PTCA) was performed in 593 (85.4%) patients, rescue PTCA in 7 (1%), and primary PTCA in 94 (13.5%). Angiographic lesion morphology was as follows: type A 30%; type B 58%; type C 12%. We compared patient population who received stent with PTCA-balloon only. Technical success was 95% and clinical success was achieved in 80% of the cases. Overall mortality was 1% in the stent group and 3% in the conventional PTCA. The incidence of MACE was 4% and 15.1% in the stent and angioplasty balloon groups respectively. We found a dramatic impact on reduction of the incidence of acute complications in the groups with stenting for unstable angina (p = 0.0001) and acute myocardial infarction (p = 0.0001). The major clinical advantage of stenting over balloon angioplasty was a lower need for repeated procedures.     

Comparison of stenting with balloon angioplasty for lesions of small coronary vessels in patients with diabetes mellitus.

PURPOSE: We sought to assess whether stenting is a better treatment strategy than percutaneous transluminal coronary angioplasty (PTCA) for lesions in small coronary vessels of diabetic patients. METHODS: We studied the 100 diabetic patients who were enrolled in the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries trial; 51 patients were randomly assigned to receive a stent and 49 to PTCA alone. Small vessels were considered those with a reference diameter of 2.0 to 2.8 mm. The primary endpoint of the study was the incidence of restenosis, defined as 50% or greater diameter stenosis at follow-up angiography (performed in 83 of the 100 patients). The secondary endpoint was clinical restenosis, defined as the need for target vessel revascularization within 1 year. RESULTS: Angiographic restenosis occurred in 18 (44%) of the patients who received a stent and in 19 (45%) of the PTCA patients (P = 0.90). Target vessel revascularization was needed in 13 (25%) of the stent patients and 10 (20%) of the PTCA patients (P = 0.55). During the 1-year follow-up, 5 (10%) of the stent patients died or incurred myocardial infarction, compared with 3 (6%) of the PTCA patients (P = 0.50). CONCLUSIONS: Patients with diabetes who undergo percutaneous coronary interventions for lesions in small vessels have an especially high risk of restenosis that does not appear to be attenuated by stenting.     

Multiple stent implantation in single coronary arteries: Acute results and six-month angiographic follow-up

A total of 147 stents were implanted (in overlapping manner in 76% of vessels) in a single coronary artery in 59 patients (60 vessels, 97 lesions, 2.45 stents/vessel) over a period of 18 mo using high pressure stent deployment without ultrasound guidance. The indications for stenting were suboptimal percutaneous transluminal coronary angioplasty (PTCA) result (45%), primary prevention of restenosis (44%), acute closure (10%), and restenosis after plain balloon angioplasty (1%). One patient required emergency coronary artery bypass grafting (CABG) (extensive dissection), and one required early intervention with plain balloon angioplasty and intracoronary urokinase for stent thrombosis. There were no deaths. Thirteen patients had recurrence of angina within 6 mo and angiograms were performed in all. These showed intrastent restenosis in nine (all had successful repeat plain balloon angioplasty), development of new disease in other vessels along with restenosis close to the stent in the target vessel in one (underwent elective CABG) and normal angiograms with widely patent stents in three. Forty-five patients (77%) remained free of recurrent angina and 25 of these had follow-up angiograms (56%) at a mean of 172 days, two showing restenosis. Thus, the restenosis rate per patient in the symptomatic group (angiographic follow-up in 100%) was 77% and in the asymptomatic group (angiographic follow-up in 56%) was 8%. The restenosis rate in the subgroup with bailout stenting (n = 6) was 20% (angiographic follow-up in 83%). The overall restenosis rate per patient was 32% (overall angiographic follow-up in 66%). During the 6-mo follow-up period, one patient underwent elective CABG (1.7%), one sustained a non-Q myocardial infarction (1.7%), nine had repeat PTCA to the target vessel (15.5%), and there were no deaths. The event-free survival rate was 77%. Multiple stent implantation aided by high pressure stent deployment without ultrasound guidance and with adjunctive optimal antiplatelet therapy without oral anticoagulation seems to be a useful and effective revascularisation strategy to deal with long lesions and acute dissections with a high procedural success rate. The restenosis rate is acceptable and is not appreciably high as reported in previous studies from the “warfarin era.” Cathet. Cardiovasc. Diagn. 42:158–165, 1997. © 1997 Wiley-Liss, Inc.     

Argentine Randomized Study: Coronary Angioplasty with Stenting versus Coronary Bypass Surgery in patients with Multiple-Vessel Disease (ERACI II): 30-day and one-year follow-up results. ERACI II Investigators

OBJECTIVE: The purpose of this study was to compare percutaneous transluminal coronary revascularization (PTCR) employing stent implantation to conventional coronary artery bypass graft surgery (CABG) in symptomatic patients with multivessel coronary artery disease. BACKGROUND: Previous randomized studies comparing balloon angioplasty versus CABG have demonstrated equivalent safety results. However, CABG was associated with significantly fewer repeat revascularization procedures. METHODS: A total of 2,759 patients with coronary artery disease were screened at seven clinical sites, and 450 patients were randomly assigned to undergo either PTCR (225 patients) or CABG (225 patients). Only patients with multivessel disease and indication for revascularization were enrolled. RESULTS: Both groups had similar clinical demographics: unstable angina in 92%; 38% were older than 65 years, and 23% had a history of peripheral vascular disease. During the first 30 days, PTCR patients had lower major adverse events (death, myocardial infarction, repeat revascularization procedures and stroke) compared with CABG patients (3.6% vs. 12.3%, p = 0.002). Death occurred in 0.9% of PTCR patients versus 5.7% in CABG patients, p < 0.013, and Q myocardial infarction (MI) occurred in 0.9% PTCR versus 5.7% of CABG patients, p < 0.013. At follow-up (mean 18.5 +/- 6.4 months), survival was 96.9% in PTCR versus 92.5% in CABG, p < 0.017. Freedom from MI was also better in PTCR compared to CABG patients (97.7% vs. 93.4%, p < 0.017). Requirements for new revascularization procedures were higher in PTCR than in CABG patients (16.8% vs. 4.8%, p < 0.002). CONCLUSIONS: In this selected high-risk group of patients with multivessel disease, PTCR with stent implantation showed better survival and freedom from MI than did conventional surgery. Repeat revascularization procedures were higher in the PTCR group.