Percutaneous Transluminal Coronary Angioplasty Group Research Articles

Percutaneous transluminal coronary angioplasty performed 24-48 hours after the onset of acute myocardial infarction improves chronic-phase left ventricular regional wall motion.

The authors investigated the capacity of percutaneous transluminal coronary angioplasty (PTCA) performed 24-48 hours after the onset of acute myocardial infarction (AMI) to improve regional left ventricular wall motion. Twenty-four patients were divided into two groups: a PTCA group who received successful PTCA (14 cases) and a non-PTCA group (10 cases) who did not receive PTCA. Left ventricular end-diastolic volume (LVEDV) increased significantly (p<0.01) from 57+/-14 mL/m2 during the acute phase to 83+/-16 mL/m2 during the chronic phase in the non-PTCA group, whereas no significant change in LVEDV was seen in the PTCA group (69+/-26 vs. 76+/-16 mL/m2). In addition, in patients with 99% stenosis/thrombolysis in myocardial infarction (TIMI) grade 3 flow, increases in regional left ventricular wall motion (delta(sd)/chord) at the infarcted site between the acute and chronic phases were significantly greater in the PTCA group than in the non-PTCA group (2.49+/-1.05 vs. 0.67+/-0.65, p<0.01). PTCA performed 24-48 hours after the onset of AMI improved wall motion at the infarcted site.

Balloon optimization versus stent study (BOSS): provisional stenting and early recoil after balloon angioplasty

“Optimal” percutaneous transluminal coronary angioplasty (PTCA) may have a late restenosis rate similar to stenting. We sought to assess short- and long-term results of a provisional stenting/optimal PTCA approach compared with elective stenting in a prospective, randomized study. A total of 97 patients with discrete, de novo lesions in native coronary arteries ≥3 mm in diameter were randomized 2:1 in PTCA with prolonged perfusion balloon inflation (n = 66) versus elective stenting (n = 31). Recoil after PTCA was assessed by routine delayed angiograms (5 and 20 minutes). Cross over to stent was allowed for an inadequate result; there was no on-line quantitative angiography. An independent core angiographic laboratory assessed all results and evaluated the adequacy of the subjective interpretation. Within the PTCA arm, there were 24 (36%) crossovers to stenting (5 of 24 [21%] due to recoil), whereas 2 stents could not be delivered to the lesion and crossed over to PTCA. As assessed by quantitative angiography, baseline reference vessel diameters were similar between the PTCA and stent groups. The immediate lumen diameter achieved with PTCA was smaller than that achieved with stenting (2.18 ± 0.49 vs 2.44 ± 0.38 mm, respectively, p = 0.01). There were no differences in angiographic results between elective and crossover stenting and there were no in-hospital complications in any patient. Target lesion revascularization at 8 months was 19% (n = 6) in the elective stent arm versus 21% (n = 14) in the PTCA arm, p = NS; respective rates in PTCA alone and crossed over-to-stent subsets were 23% (n = 10) versus 17% (n = 4), p = NS. Angiographic restenosis was 47% after elective stenting versus 38% after PTCA (intention to treat), p = NS. By received treatment, it was 41% (11 of 27) in the group treated with the PTCA versus 33% (5 of 15) in the crossover-to-stent arm (p = NS). Thus, provisional stenting can be safely performed in the treatment of discrete, native de novo lesions. Early recoil after PTCA cannot be reliably assessed without quantitative angiography.

Seven-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI) by treatment and diabetic status

OBJECTIVESTo compare seven-year survival in the Bypass Angioplasty Revascularization Investigation (BARI) patients randomly assigned to percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass grafting (CABG).BACKGROUNDThe primary results of BARI reported no significant difference in five-year survival between CABG and PTCA groups. However, among patients with treated diabetes mellitus, a subgroup not specified a priori, a striking difference was seen in favor of CABG.METHODSSymptomatic patients with multivessel disease (n = 1,829) were randomly assigned to initial treatment strategy of CABG or PTCA and followed for an average of 7.8 years. The intention-to-treat principle was used to extend the initial five-year BARI treatment comparisons.RESULTSKaplan-Meier estimates of seven-year survival for the total population were 84.4% for CABG and 80.9% for PTCA (p = 0.043). This difference could be explained by the 353 patients with treated diabetes mellitus for whom estimates of seven year survival were 76.4% CABG and 55.7% PTCA (p = 0.0011). Among the remaining 1,476 patients without treated diabetes, survival was virtually identical by assigned treatment (86.4% CABG, 86.8% PTCA, p = 0.72). The PTCA group had substantially higher subsequent revascularization rates than the CABG group (59.7% vs. 13.1%, p < 0.001); however, the changes between the five- and seven-year rates were similar for the two groups.CONCLUSIONSAt seven years, there was a statistically significant survival advantage for patients randomized to CABG compared with PTCA. Among patients with treated diabetes mellitus, the benefit of CABG over PTCA seen at five years was more pronounced at seven years; among nondiabetic patients, there was essentially no treatment difference.

Quality of life after coronary angioplasty or continued medical treatment for angina: three-year follow-up in the RITA-2 trial

OBJECTIVESWe sought to evaluate the impact of percutaneous transluminal coronary angioplasty (PTCA) and medical treatment on self-perceived quality of life among patients with angina.BACKGROUNDThe second Randomized Intervention Treatment of Angina trial (RITA-2) implemented initial policies of PTCA or continued medical treatment in patients with angina, allowing assessment of long-term health consequences.METHODSA total of 1,018 patients were randomly assigned (504 to PTCA and 514 to medical treatment). The short form 36 (SF-36) self-administered quality-of-life questionnaire was completed at randomization and three months, one year and three years later. To date, 98% of patients reached one year and 67% reached three years.RESULTSThe PTCA group had significantly greater improvements in physical functioning, vitality and general health at both three months and one year, but not at three years. These quality-of-life scores were strongly related to breathlessness, angina grade and treadmill exercise time both at baseline and at one year. The treatment differences in quality of life are explained by the PTCA group’s improvements in breathlessness, angina and exercise time. The attenuation of treatment difference at three years is partly attributed to 27% of medically treated patients receiving nonrandomized interventions in the interim. For both groups, there were also improvements in ratings of physical role functioning, emotional role functioning, social functioning, pain and mental health, but for these the superiority of PTCA over medical treatment was less pronounced. After one year, 33% and 22% of the PTCA and medical groups, respectively, rated their health much better.CONCLUSIONSCoronary angioplasty substantially improves patient-perceived quality of life, especially physical functioning and vitality, as compared with continued medical treatment. These differences are attributed to alleviation of cardiac symptoms (specifically, breathlessness and angina), but must be balanced against the small procedure-related risks of PTCA.

Clinical Outcome after Successful Coronary Angioplasty: Impact of Intracoronary Stent Implantation

The clinical outcome after successful conventional coronary balloon angioplasty is compared with that of stent implantation after 30 days and 12 months. The study took place at the Divisions of Cardiology and Thoracic Radiology, Norrland University Hospital, Umeå, a referral centre for northern Sweden. The first 100 consecutive patients with stable or unstable angina undergoing successful percutaneous transluminal coronary angioplasty (PTCA) in 1994 and the first 100 consecutive patients undergoing successful coronary stent implantation in 1995 were included. The cardiac endpoints studied were death, myocardial infarction, need for repeat PTCA or coronary artery bypass grafting (CABG). Significantly more adverse cardiac events were observed in the PTCA group compared with the stent group. Event-free 12 months' follow-up (no deaths, myocardial infarction or re-intervention) was 64% in the PTCA group and 86% in the stent group (p < 0.005). The main explanation for the observed difference was a reduction in the need for a repeat PTCA (7 vs 18, p < 0.05) or CABG (4 vs 12, p < 0.05) in the stent group. Patients with stable or unstable angina who can be treated with a stent have a better clinical outcome than those treated with coronary balloon angioplasty only.

Prospective randomised comparison between thrombolysis, rescue PTCA, and primary PTCA in patients with extensive myocardial infarction admitted to a hospital without PTCA facilities: a safety and feasibility study

OBJECTIVETo assess the safety and feasibility of acute transport followed by rescue percutaneous transluminal coronary angioplasty (PTCA) or primary PTCA in patients with acute myocardial infarction initially admitted to a...

Effects of adjunctive balloon angioplasty after intravascular ultrasound-guided optimal directional coronary atherectomy: The result of adjunctive balloon angioplasty after coronary atherectomy study (ABACAS)

OBJECTIVESThis study was conducted to evaluate: 1) the effect of adjunctive percutaneous transluminal coronary angioplasty (PTCA) after directional coronary atherectomy (DCA) compared with stand-alone DCA, and 2) the outcome of intravascular ultrasound (IVUS)-guided aggressive DCA.BACKGROUNDIt has been shown that optimal angiographic results after coronary interventions are associated with a lower incidence of restenosis. Adjunctive PTCA after DCA improves the acute angiographic outcome; however, long-term benefits of adjunctive PTCA have not been established.METHODSOut of 225 patients who underwent IVUS-guided DCA, angiographically optimal debulking was achieved in 214 patients, then they were randomized to either no further treatment or to added PTCA.RESULTSPostprocedural quantitative angiographic analysis demonstrated an improved minimum luminal diameter (2.88 ± 0.48 vs. 2.6 ± 0.51 mm; p = 0.006) and a less residual stenosis (10.8% vs.15%; p = 0.009) in the adjunctive PTCA group. Quantitative ultrasound analysis showed a larger minimum luminal diameter (3.26 ± 0.48 vs. 3.04 ± 0.5 mm; p < 0.001) and lower residual plaque mass in the adjunctive PTCA group (42.6% vs. 45.6%; p < 0.001). Despite the improved acute findings in the adjunctive PTCA group, six-month angiographic and clinical results were not different. The restenosis rate (adjunctive PTCA 23.6%, DCA alone 19.6%; p = ns) and target lesion revascularization rate (20.6% vs. 15.2%; p = ns) did not differ between the groups.CONCLUSIONSWith IVUS guidance, aggressive DCA can safely achieve optimal angiographic results with low residual plaque mass, and this was associated with a low restenosis rate. Although adjunctive PTCA after optimal DCA improved the acute quantitative coronary angiography and quantitative coronary ultrasonography outcomes, its benefit was not maintained at six months.

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

OBJECTIVESThe 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.BACKGROUNDBeside the common use of stents in clinical practice, the number of stent indications proven by randomized trials is still limited.METHODSEighty-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.RESULTSThe 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.CONCLUSIONSStent 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.

Catheter-based reperfusion of unprotected left main stenosis during an acute myocardial infarction (the ULTIMA experience)

The ULTIMA registry was a prospective, multicenter, international registry of 277 patients who underwent percutaneous coronary interventions of unprotected left main trunk stenosis. The 40 patients who underwent an emergency percutaneous left main intervention for acute myocardial infarction are the focus of this study. We compared the results of primary angioplasty with primary stenting, characterizing both the short-term (in-hospital) and long-term (12-month) outcomes. Of the 40 patients, 23 underwent primary angioplasty, whereas 17 underwent primary stenting. The angiographic success rate was an 88% for the cohort. The in-hospital death or coronary artery bypass grafting rate was 65% for the entire group, 74% for the percutaneous transluminal coronary angioplasty group (PTCA), and 53% for the stent group (p = 0.2). The in-hospital death rate was 55% for the entire cohort, 70% for the PTCA group, and 35% for the stent group (p = 0.1). The 12-month rate of death or bypass surgery was 83% and 58% for the PTCA and stent groups, respectively (p = 0.047). The 12-month survival rate was 35% and 53% for the PTCA and stent groups, respectively (p = 0.18). Bypass surgery was required in 6 patients in the PTCA group and 2 patients in the stent group (p = 0.07). Patients undergoing percutaneous interventions for unprotected left main myocardial stenosis during an acute myocardial infarction are critically ill; an initial percutaneous revascularization approach appears feasible and may be the preferred revascularization strategy. Primary stenting was associated with improved clinical outcomes.

Effect of age in the bypass angioplasty revascularization investigation (BARI) randomized trial

Background. The influence of age on the relative success of either percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) in patients requiring myocardial revascularization continues to be controversial. Methods. In the Bypass Angioplasty Revascularization Investigation (BARI) trial, 1,829 patients with symptomatic multivessel coronary artery disease requiring revascularization were randomly assigned to undergo either CABG or PTCA. Results. Seven hundred nine patients (39%) were 65 to 80 years old at baseline; the other 1,120 were younger than 65 years. The in-hospital 30-day mortality rate for PTCA and CABG in the younger patients was 0.7% and 1.1%, respectively, and that for patients 65 years or older was 1.7% and 1.7%, respectively. In older compared with younger patients, stroke was more common after CABG (1.7% versus 0.2%, p = 0.015) and heart failure or pulmonary edema was more common after PTCA (4.0 versus 1.3%, p = 0.011). In both age groups, CABG resulted in greater relief of angina and fewer repeat procedures. The 5-year survival rate in patients younger than 65 years was 91.5% for CABG and 89.5% for PTCA. In patients 65 years or older, the 5-year survival rate was 85.7% for CABG and 81.4% for PTCA. Cardiac mortality at 5 years was greater in patients assigned to the PTCA group than in those assigned to the CABG group. However, no significant treatment differences were noted in cardiac mortality when only nondiabetic patients were examined. Conclusions. Within the context of the Bypass Angioplasty Revascularization Investigation trial, older patients with multivessel coronary disease do well with either PTCA or CABG. Compared with younger patients, older patients had less recurrent angina and were less likely to undergo repeat procedures, particularly among those assigned to undergo CABG. Cardiac mortality was greater in patients 65 years or older assigned to undergo PTCA; however, this difference was not noted when treated diabetic patients were excluded from analysis.

Long-Term Outcome of Percutaneous Transluminal Coronary Angioplasty and Coronary Artery Bypass Grafting in Patients With End-Stage Renal Disease

This study was conducted to investigate therapeutic methods for end-stage renal disease (ESRD) by retrospectively analyzing in-hospital outcome and long-term outcome in patients who underwent either percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG). Ninety-two patients underwent PTCA and 47 underwent CABG, and the initial success rates were 87% and 85%, respectively. As major in-hospital complications, in the PTCA group 1 died (1%), 2 required emergency CABG (2%), and 2 had Q-wave myocardial infarction (2%); in the CABG group, 7 died (15%) and 3 had Q-wave myocardial infarction (6%). As for the long-term outcome, although there were no differences in the incidence of death or the incidence of cardiac death between the 2 groups, the cumulative proportion of patients free of death, myocardial infarction, CABG and repeat PTCA was lower in the PTCA group, which was mainly due to a higher incidence of repeat PTCA in that group. The incidence of cardiac death was low for both groups among the patients attaining complete revascularization. Twenty-three percent of the patients required cross-over implementation of PTCA and CABG. In conclusion, it is necessary to aim for complete revascularization using both treatments for a better prognosis in patients with ESRD.

Two- to three-year follow-up of patients with single-vessel coronary artery disease randomized to PTCA or medical therapy (results of a VA cooperative study)

Despite increasing use of percutaneous transluminal coronary angioplasty (PTCA) to treat stenotic coronary artery disease, there are relatively few prospective studies evaluating its long-term effectiveness. We prospectively randomized 212 stable patients with provocable myocardial ischemia and single-vessel subocclusive coronary disease to receive primary therapy with either PTCA or medical therapy. This report presents the clinical follow-up of these patients at a mean, after randomization, of 2.4 years for interview and 3.0 years for exercise testing. Of the 212 patients originally randomized, 175 received an extended follow-up interview, and 132 underwent exercise testing; 62% of patients in the PTCA group were angina free compared with 47% of patients in the medical group (p <0.05). Furthermore, exercise duration as measured by treadmill testing was prolonged by 1.33 minutes over baseline in the PTCA group, whereas it decreased by 0.28 minutes in the medical group (p <0.04). Although the angina-free time on the treadmill was not different (p = 0.50), fewer patients in the medical group developed angina on the treadmill at 3 years than those in the PTCA group (p = 0.04). By 36 months, excluding the initial randomized PTCA, use of PTCA and use of coronary artery bypass surgery were not different in the 2 treatment groups. These data indicate that some of the early benefits derived from PTCA in patients with single-vessel coronary artery disease are sustained, making it an attractive therapeutic option for these patients.

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): Immediate and long-term follow-up results

Objective. This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography.Background. Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate.Methods. To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n = 57) or to optimal PTCA (n = 59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting).Results. Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63 ± 0.59 vs. 0.26 ± 0.44, respectively; p = 0.01). Hence, net gain with both techniques was similar (1.32 ± 0.3 vs. 1.24 ± 0.29 mm for the stent and the PTCA groups, respectively; p = NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p = NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p = NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p = NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02).Conclusions. The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.

Long-term results of RITA-1 trial: clinical and cost comparisons of coronary angioplasty and coronary-artery bypass grafting

Percutaneous transluminal coronary angioplasty (PTCA) and coronary-artery bypass grafting (CABG) are both effective intervention strategies for patients with coronary heart disease. We report comparative long-term clinical and health-service cost findings for these interventions in the first Randomised Intervention Treatment of Angina (RITA-1) trial. 1011 patients with coronary heart disease (45% single-vessel, 55% multivessel) were randomly assigned initial treatment strategies of PTCA or CABG. Information on clinical events, subsequent intervention, symptomatic status, exercise testing, and use of health-care resources is available for a median 6.5 years of follow-up. Analyses were by intention to treat. The predefined primary endpoint of death or nonfatal myocardial infarction occurred in 87 (17%) PTCA-group patients and 80 (16%) CABG-group patients (p=0.64). Similarly, there was no significant treatment difference in deaths alone (39 PTCA, 45 CABG), of which 46% were cardiac related. In both groups, the risk of cardiac death or myocardial infarction was more than five times higher in the first year than in subsequent years of follow-up. 26% of patients assigned PTCA subsequently also had CABG, and a further 19% required additional nonrandomised PTCA. Most of these reinterventions occurred within a year of randomisation, and from 3 years onwards the reintervention rate averaged 4% per year. In the CABG group the reintervention rate averaged 2% per year. The prevalence of angina was consistently higher in the PTCA group, with an absolute average 10% excess compared with the CABG group (p<0.001). Total health-service costs over 5 years showed no significant difference between initial strategies of PTCA and CABG (mean difference pounds sterling 426 [95% Cl -pounds sterling 383 to pounds sterling 1235]; p=0.30). The clinical and cost comparisons showed similar patterns for patients with single-vessel and multivessel disease. Initial strategies of PTCA and CABG led to similar long-term results in terms of survival and avoidance of myocardial infarction and to similar long-term health-care costs. Choice of approach, therefore, rests on weighing the more invasive nature of CABG against the greater risk of recurrent angina and reintervention over many years after PTCA.

Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the Stenting in Chronic Coronary Occlusion (SICCO) study

Objectives. This study assessed the long-term clinical outcome of stenting chronic occlusions.Background. In the Stenting in Chronic Coronary Occlusion (SICCO) study, patients were randomized to additional stent implantation (n = 58) or not (n = 59) after successful recanalization and dilation of a chronic coronary occlusion. Palmaz-Schatz stents were used with full anticoagulation. The previously published 6-month angiographic follow-up results showed reduction of the restenosis rate from 74% to 32%.Methods. The primary end point was the occurrence of major adverse cardiac events (cardiac death, lesion-related acute myocardial infarction, repeat lesion-related revascularization or angiographic documentation of reocclusion).Results. Late clinical follow-up was obtained in all patients at 33 ± 6 months. Major adverse cardiac events occurred in 14 patients (24.1%) in the stent group compared with 35 patients (59.3%) in the percutaneous transluminal coronary angioplasty (PTCA) group (odds ratio 0.22, 95% confidence interval 0.10 to 0.49, p = 0.0002). Target vessel revascularization (including failed PTCA attempts) was performed in 24% of the stent group and in 53% of the PTCA group (p = 0.002). There were no events in the stent group after 8 months, whereas events continued to occur in the PTCA group. By multivariate analysis, allocation to the PTCA group, left anterior descending coronary artery lesion and lesion length were significantly related to the development of major adverse cardiac events.Conclusions. These data demonstrate the long-term safety and clinical benefit of stenting recanalized chronic occlusions. There is a continued risk of late clinical events related to nonstented lesions. Implantation of an intracoronary stent should therefore be considered after successful opening of a chronic coronary occlusion.

Mechanical debulking versus balloon angioplasty for the treatment of diffuse in-stent restenosis

Previous studies have shown a high rate of repeat intervention after treating diffuse in-stent restenosis with percutaneous transluminal coronary angioplasty (PTCA) alone. It is not clear whether debulking with atherectomy is more effective in this condition. Between January 1994 and February 1997, we treated 60 consecutive patients with diffuse in-stent restenosis of a native coronary artery using conventional PTCA (n = 30) or debulking (with rotational or directional atherectomy) plus adjunctive PTCA (n = 30). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained in all patients at 1 month, 6 months, and 1 year after revascularization. The mean lesion lengths were 13.5 ± 8.3 and 18.4 ± 13.2 mm in the debulking and PTCA groups, respectively (p = 0.09). Acute procedural success was 100% in both cohorts, with no major complications in either group. Treatment with atherectomy plus adjunctive PTCA resulted in lower postprocedure stenoses (18 ± 10 vs 26 ± 13%, p = 0.01) than treatment with balloon angioplasty alone. At 1-year follow-up, repeat target vessel revascularization was required in 28% of patients in the debulking group compared with 46% in the PTCA group (p = 0.18). Independent predictors of the need for repeat target vessel revascularization were longer lesion lengths, diabetes mellitus, and smaller postprocedure lumen diameter. Thus, the strategy of atherectomy and adjunctive PTCA for diffuse in-stent restenosis is safe, improves acute angiographic results compared with PTCA alone, and may decrease the need for target vessel revascularization.

Impact of postangioplasty restenosis on comparisons of outcome between angioplasty and bypass grafting

Restenosis is a major limitation of percutaneous transluminal coronary angioplasty (PTCA). In this study, we assessed the impact of restenosis on PTCA with reference to coronary angioplasty bypass grafting (CABG). In the Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI) PTCA population, those who had restenosis were defined as those needing a second revascularization at a site revascularized at the initial procedure. The 1-year clinical outcome of the nonrestenotic group (n = 437) was compared with those who underwent CABG (n = 453). There was no difference in deaths. In the nonrestenotic PTCA group, the incidence of more infarctions was insignificant (relative risk [RR] 1.9, 95% confidence intervals [CI] 0.96 to 3.75, p = 0.064), there was a much greater need for repeat revascularization (RR 8.6, CI 5.14 to 14.41, p <0.0005), and patients had a poorer angina status (RR 1.46, CI 1.01 to 2.13, p = 0.046). Using 2 measures of coronary disease, the degree of pre- and postrevascularization disease was compared between groups. There were no differences in prerevascularization disease. However, using either measure, residual postrevascularization disease was more frequent in the nonrestenotic PTCA group. Restenosis only partially accounts for the greater morbidity seen after PTCA, compared witrh CABG, in multivessel disease. The greater likelihood of residual disease post-PTCA may contribute to this greater morbidity.

One-Year Follow-Up of The Stent Restenosis (STRESS I) Study

We present the completed 1-year follow-up results of the original Stent Restenosis Study (STRESS I), in which 407 patients with symptomatic ischemic heart disease and new lesions of the native coronary circulation were randomly assigned to treatment with either the Palmaz-Schatz coronary stent or conventional percutaneous transluminal coronary angioplasty (PTCA). The present study compares the safety of elective stenting to balloon angioplasty (PTCA) in terms of freedom from clinical events up to 1 year after treatment. Patients were enrolled and treated from January 1991 through February 1993, and follow-up data were collected and verified until July 1995. Ninety-seven percent of all patients had complete follow-up (deceased or alive with known clinical status) beyond 8 months, and 94% beyond 11 months. Anginal status between 9 to 15 months postprocedure was available for 78% of patients. At 1 year, 154 patients (75%) assigned to stent implantation and 141 (70%) to PTCA were free of all clinical events (death, myocardial infarction, or any revascularization procedure), and 162 stent patients (79%) and 149 PTCA patients (74%) were free from death, myocardial infarction, or target lesion revascularization. Symptom-driven target lesion revascularization occurred in 12% of the stent group versus 17% of the PTCA group. None of these differences in clinical events was statistically significant. Only 2 patients in the stent group and 7 in the PTCA group had a first event after 239 days, and freedom from angina at 1 year was reported in equal frequency in both groups (84%). There appear to be no late adverse effects of stent implantation. However, these results are limited by low statistical power, narrow patient selection, and the anticoagulation regimen used in the early experience with this device.

Delayed percutaneous transluminal coronary angioplasty after acute myocardial infarction

The value of delayed percutaneous transluminal coronary angioplasty (>12 h from admission or after thrombolytic therapy) following acute myocardial infarction is controversial. We compared the short- and long-term prognosis of 1940 consecutive patients after acute myocardial infarction, of whom 188 underwent delayed percutaneous transluminal coronary angioplasty. Delayed percutaneous transluminal coronary angioplasty was more frequently done in patients treated with thrombolysis (12%) than among patients excluded from thrombolytic therapy (8%; P=0.005). Patients in the delayed percutaneous transluminal coronary angioplasty group were younger, included more men and smokers and had less in-hospital complications in comparison to patients who did not undergo delayed percutaneous transluminal coronary angioplasty. The crude 30-day and 1-year mortality rates were 3 and 6% among patients who underwent percutaneous transluminal coronary angioplasty vs. 14 and 21% ( P<0.01 for each) among those without percutaneous transluminal coronary angioplasty, respectively. After multivariate analysis adjusted for confounding factors, delayed percutaneous transluminal coronary angioplasty was associated with 65 (RR=0.35; 90% CI 0.14–0.88) and 50% (RR=0.50; 90% CI 0.27–0.92) mortality risk reduction after 30 days and 1 year, respectively. In conclusion, delayed percutaneous transluminal coronary angioplasty applied to selected post-myocardial infarction patients upon clinical indication is safe and beneficial for the treatment of acute myocardial infarction in the community.

Myocardial revascularisation in elderly patients with refractory or unstable angina and advanced coronary disease.

Elderly patients with ischaemic heart disease are often treated more conservatively and for longer than younger patients, but this strategy may result in subsequent invasive intervention of more advanced and higher risk coronary disease. We performed a retrospective analysis of 109 patients aged > or = 70 years (mean age 74 years, 66% men), who presented with angina refractory to maximal medical treatment or unstable angina over a 2-year period (1988-1990), to compare the relative risks and benefits of myocardial revascularisation [coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA)] in this higher-risk age group. Sixty patients underwent CABG and 49 patients PTCA. There were eight periprocedural deaths in total (six in the CABG group, and two in the PTCA group, P = 0.29). Six patients in the CABG group suffered a cerebrovascular accident (two fatal). Acute Q-wave myocardial infarction occurred in one patient in the CABG group and in two patients in the PTCA group. The length of hospital stay was longer for the CABG group (CABG group 11.4 +/- 5.4 days, range 7-30 days, PTCA group 7.4 +/- 7.6 days, range 1-39 days, P = 0.01). Outcome was assessed using the major cardiac event rate (MACE; i.e. the rate of death, myocardial infarction, repeat CABG or PTCA). The cumulative event-free survival in the CABG group in 1, 2 and 3 years was 87, 85 and 85%, respectively. In contrast, in the PTCA group it was 55, 48 and 48% (P = 0.0001). Age, sex, number of diseased vessels, degree of revascularisation and left ventricular function were not predictive of the recurrence of angina in both groups. Actuarial survival (total mortality, including perioperative mortality) was lower at 1 year in the CABG group due to the higher perioperative mortality, but similar in both groups after the second year (P = 0.62). Elderly patients with refractory or unstable angina who are revascularised surgically have a better long-term outcome (less frequent event rate of the composite end-point--myocardial infarction, revascularisation procedures and death) compared with those who are revascularised with PTCA. This benefit is been realised after the second year. Total mortality is similar in both groups after the second year. Therefore elderly patients who are fit for surgery should not be denied the benefits of CABG. PTCA may be regarded as a complementary and satisfactory treatment, especially for those whose life expectancy is limited to less than 2 years. The use of stents may improve outcome in the PTCA group and this needs to be evaluated.