Effectiveness of excimer laser coronary angioplasty in treatment of patients with in-stent restenosis

In-stent restenosis (ISR), when treated with balloon angioplasty (PTCA) alone, has an angiographic recurrence rate of 30-85%. Ablating the hypertrophic neointimal tissue prior to PTCA is an attractive alternative, however late outcomes of such treatment have not been fully determined. This multicenter case control study assessed angiographic and clinical outcomes of 137 consecutive procedures in 125 patients treated for ISR with either PTCA alone (n = 58) or excimer laser assisted coronary angioplasty (ELCA, n = 67). Demographics were similar. Lesions selected for ELCA compared with those selected for \PTCA were longer (17.1+/-9.9 mm vs. 13.6+/-9.1 mm; p=0,034), more complex (ACC/AHA type C: 36,5% vs. 14,3%; p=0,006), and with reduced antegrade flow (TIMI flow < 3: 18,9% vs. 4,8%; p = 0,025). ELCA- and PTCA treated patients had similar rates of procedural success (98,5 and 98,3%, respectively, p=1,0), major clinical complications (3,0% and 8,6%; respectively, NS), major cardiac events at 1 year (37,3 and 46,6%. respectively, NS), and target lesion revascularization (32,8 and. 34,5%; respectively, NS). These data suggest that ELCA in patients with complex in-stent restenosis is as safe and effective as PTCA. Despite higher lesion complexity in ELCA-treated patients, no increase in event rates was observed.     

Clinical and angiographic outcome in the laser angioplasty for restenotic stents (LARS) multicenter registry.

In-stent restenosis (ISR), when treated with balloon angioplasty (PTCA) alone, has an angiographic recurrence rate of 30%-85%. Ablating the hypertrophic neointimal tissue prior to PTCA is an attractive alternative, yet the late outcomes of such treatment have not been fully determined. This multicenter case control study assessed the angiographic and clinical outcomes of 157 consecutive procedures in 146 patients with ISR at nine institutions treated with either PTCA alone (n = 64) or excimer laser assisted coronary angioplasty (ELCA, n = 93)) for ISR. Demographics were similar except more unstable angina at presentation in ELCA-treated patients (74.5% vs. 63.5%; P = 0.141). Lesions selected for ELCA were longer (16.8 +/- 11.2 mm vs. 11.2 +/- 8.6 mm; P < 0.001), more complex (ACC/AHA type C: 35.1% vs. 13.6%; P < 0.001), and with compromised antegrade flow (TIMI flow < 3: 18.9% vs. 4.5%; P = 0.008) compared to PTCA-treated patients. ELCA-treated patients had similar rate of procedural success [93 (98.9% vs. 62 (98.4%); P = 1.0] and major clinical complications [1 (1.1%) vs. 1 (1.6%); P = 1.0]. At 30 days, repeat target site coronary intervention was lower in ELCA-treated patients (1.1% vs. 6.4% in PTCA-treated patients; P = 0.158), but not significantly so. At 1 year, ELCA-treated patients had similar rate of major cardiac events (39.1% vs. 45.2%; P = 0.456) and target lesion revascularization (30.0% vs. 32.3%; P = 0.646). These data suggest that ELCA in patients with complex in-stent restenosis is as safe and effective as balloon angioplasty alone. Despite higher lesion complexity in ELCA-treated patients, no increase in event rates was observed. Future studies should evaluate the relative benefit of ELCA over PTCA alone for the prevention of symptom recurrence specifically in patients with complex in-stent restenosis.     

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.     

Success and Procedural Outcome of Excimer Laser Coronary Angioplasty Compared to Conventional Balloon Angioplasty

BACKGROUND: Coronary excimer laser angioplasty was suggested to be superior for treatment of lesions with complex lesion morphology. METHODS: In this study, 134 consecutive patients undergoing excimer laser angioplasty (ELCA) were compared to 203 patients treated with conventional balloon angioplasty (PTCA) in the same study period. Baseline characteristics did not differ between both groups except the distribution of target vessel (LAD: ELCA 72% vs. PTCA 50%). RESULTS: In the ELCA group, 64 of 139 lesions required adjunctive balloon angioplasty. Overall procedural success was achieved in 80% of patients treated with PTCA and in 78% of patients treated with ELCA (NS), as defined by a reduction of at least 20% of the luminal narrowing and 2 50% residual stenosis, and no in-hospital complication. Complications included acute vessel closure (ELCA: 23.7%, PTCA 6.9%; NS), myocardial infarction (ELCA: 3.6%, PTCA 1.7%; NS), emergency bypass surgery (ELCA: 0%, PTCA 0.5%; NS), and death (ELCA: 2.2%, PTCA: 0.5%; NS). No significant difference was found between the acute success rates and major complications in either A, B1, B2 and C lesions (modified ACC/AHA Task Force classification) treated with ELCA as compared to PTCA. A trend toward increased success rates were documented for ELCA of total and functional occlusion (ELCA: 86% vs. PTCA: 57%; NS) and bifurcational or ostial lesions (ELCA: 95% vs. PTCA 78%). CONCLUSIONS: Further randomized trials are needed to compare the acute success of excimer laser treatment with balloon angioplasty for these selected lesion types.     

Cutting balloon angioplasty for the treatment of in-stent restenosis in diabetics: A matched comparison of 6 months' outcome with conventional balloon angioplasty

Ranging from 24% to 55%, angiographic in-stent restenosis (ISR) rates in diabetics are higher than the 17% to 28% rates observed in nondiabetics. There are controversies regarding optimal treatment for ISR. Recently, cutting balloon angioplasty (CBA) emerged as a tool in management. The authors assessed the hypothesis that CBA has advantages over conventional percutaneous transluminal balloon angioplasty (PTCA) in treatment of ISR in diabetics. CBA or PTCA was applied to 165 diabetics (267 ISR lesions) in their institution. With a computer algorithm, an attempt was made to match each lesion in the CBA group with a corresponding lesion in the PTCA group. The lesion pairs should match with respect to the patients' age and gender, type of target vessel and stent, reference vessel diameter, and baseline minimal lumen diameter (MLD). Following the matching process, 55 ISR lesion pairs were identified. Baseline patient characteristics were similar among the groups (p = NS). There was no difference in the in-hospital major adverse cardiac events (MACE) between the groups, whereas MACE at follow up was significantly lower in the CBA group compared to the PTCA group (CBA, 20.0% vs PTCA, 43.6%, p<0.05). The recurrent ISR rate was significantly lower in the CBA group compared to the PTCA group (CBA, 27.3% vs PTCA, 49.1%; p < 0.05). Also, a diffuse pattern of recurrence was more common in lesions treated with PTCA, whereas a focal pattern of recurrence was more common in the CBA group. The minimal luminal diameter at follow-up, the acute gain, and net gain were significantly higher in the group of lesions treated with CBA than in the PTCA group. In addition, a significantly higher late loss and loss index at follow-up were observed in the PTCA group compared to the CBA group. CBA has advantages over PTCA in treatment of diabetic patients with ISR, with better immediate and follow-up angiographic outcomes, and better follow-up clinical outcome.     

Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT)

OBJECTIVES: The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR). BACKGROUND: Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR. METHODS: The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative). RESULTS: In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar. CONCLUSIONS: Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.     

Comparison of effectiveness and safety of drug-eluting stents versus vascular brachytherapy for saphenous vein graft in-stent restenosis

We investigated the safety and efficacy of drug-eluting stents (DESs) for the treatment of patients who presented with in-stent restenosis (ISR) of saphenous vein grafts (SVGs) and compared the in-hospital and 6-month clinical outcomes of DESs with those of intravascular brachytherapy and balloon angioplasty alone. Records of 187 patients who presented with ISR of SVGs were analyzed. Of these, 34 consecutive patients were treated with DES implantation, 93 were treated with intravascular brachytherapy (n = 60 with gamma-radiation, n = 33 with beta-radiation), and 60 patients underwent conventional treatment with balloon angioplasty alone. Clinical and angiographic characteristics at baseline were comparable between groups. The DES group had less non-Q-wave myocardial infarction than did the intravascular brachytherapy and balloon angioplasty groups (0%, 20%, and 26%, p = 0.003 and <0.001, respectively). At 6 months, death occurred in 0% of the DES group, 2% of the intravascular brachytherapy group, and 5% of the balloon angioplasty group (p = 0.36 and <0.18, respectively). Target lesion revascularization/major adverse cardiac events were similar in the intravascular brachytherapy and DES groups (12% and 3%, p = 0.13) and significantly decreased compared with patients who were treated with balloon angioplasty alone (55%, p <0.001 for the 2 comparisons). The results of this retrospective analysis suggest that DES implantation is at least as effective and safe as intravascular brachytherapy for the treatment of SVG ISR and that these treatment modalities are superior to balloon angioplasty alone.     

Device selection in the treatment of in-stent restenosis with and without radiation (from the Gamma Radiation Trials).

In-stent restenosis (ISR) is a major limitation of coronary stenting and is associated with high recurrence rates after intervention with all available devices. Intracoronary gamma (gamma) radiation was proved to reduce the recurrence rate after conventional therapy. The purpose of this study was to compare the different devices utilized for the treatment of ISR with and without gamma radiation. To search for the optimal device for the treatment of ISR, 685 patients from the radiation trials for ISR who were randomized to either iridium-192 gamma radiation (559 patients) or placebo (126 patients) following intervention were evaluated. Devices used included balloon percutaneous transluminal coronary angioplasty, excimer laser coronary angioplasty (ELCA), rotational atherectomy, and additional stent implantation. Baseline clinical and angiographic characteristics were similar between the gamma radiation and placebo groups. One- and 6-month clinical and angiographic outcomes were compared. The use of stenting compared with other devices was associated with increased late loss. Device selection used as adjunctive therapy did not influence the 30-day outcome. Patients treated with gamma radiation and placebo therapy had similar rates of composite major adverse coronary events (MACE) (death, Q-wave myocardial infarction, target vessel revascularization) (3% vs 2%, p = NS). At 6 months, MACE rates in irradiated patients were similar among POBA (29%), ELCA (28%), rotational atherectomy (18%), and additional stent implantation (30%, p = NS), and were significantly lower compared with placebo for the entire cohort and for each device subgroup. The overall recurrence rate of ISR was lower in patients treated with gamma radiation using iridium-192 compared with placebo. Device selection did not influence late clinical outcomes in irradiated and nonirradiated groups.     

Angiographic analysis of the angioplasty versus rotational atherectomy for the treatment of diffuse in-stent restenosis trial (ARTIST)

Patients with diffuse in-stent restenoses (ISRs) are at high risk for recurrent restenosis after percutaneous transluminal balloon angioplasty (PTCA). Percutaneous transluminal rotational ablation (PTCR) has proved effective in removing neointimal burden in ISRs. This study compares the acute and long-term results of PTCA and PTCR for the treatment of diffuse ISR in a randomized, multicenter investigation. The primary end point was the comparison of the minimum luminal diameter (MLD) between both groups at 6-month follow-up. Patients with symptomatic, diffuse, or high-grade ISRs were included; 146 patients were randomized to PTCA and 152 patients to PTCR. Diameter stenosis was reduced from 80 +/- 12% to 29 +/- 10% and from 80 +/- 11% to 28 +/- 12%, respectively, and MLD increased from 0.55 +/- 0.3 to 1.9 +/- 0.3 mm in the PTCA group and from 0.54 +/- 0.3 mm to 1.9 +/- 0.4 mm in the PTCR group. Spasm in the treated vessel and an intermittent slow flow phenomenon occurred more often after rotational ablation (17.7% vs 8.6%, p = 0.001; 5.3% vs 0%, p = 0.007). Minimum stenosis diameter at 6-month follow-up was smaller in the PTCR group than in the PTCA group (1.0 +/- 0.6 vs 1.2 +/- 0.6 mm, p = 0.008) and the restenosis rate was higher (64.9% vs 51.2%, p = 0.027). Procedural factors did not influence long-term outcome. In the PTCR group, the restenosis rate increased with decreasing vessel size, whereas this was not seen in the PTCA group. The lesion length and the baseline diameter stenosis were found to be predictive of restenosis with both treatment strategies; however, a residual diameter stenosis of <30% predicted absence of a restenosis only in the PTCR group. Thus, PTCA and PTCR of diffuse ISRs yield comparable acute angiographic results. The recurrence of a restenosis is higher after PTCR than after PTCA.     

Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER)

Background

Various autopsy and intravascular ultrasound (IVUS) studies have shown neointimal proliferation as the main mechanism of in-stent restenosis (ISR) responsible for >95% of luminal narrowing while stent struts are not compressed. ISR of diffuse type has a high incidence of recurrence (up to 70%) after balloon angioplasty (PTCA). Tissue ablation with percutaneous rotational coronary atherectomy (PRCA) may be more efficacious compared to tissue compression or extrusion after PTCA for the interventional treatment of diffuse ISR.

Methods

The Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-Stent Restenosis (ROSTER) trial is a single-center, randomized trial comparing PRCA to PTCA (both with IVUS guidance) in the treatment of diffuse ISR in 200 patients. In the PRCA group (n = 100), rotablation was performed using a burr-to-artery ratio >0.7 followed by adjunctive balloon dilatation at low pressure (4-6 atm). In the PTCA group (n = 100), high-pressure (>12 atm) balloon dilatation was performed using an optimal size balloon. The study's primary end point was target lesion revascularization (TLR) at 9 months and secondary end points included clinical events at 1 year and angiographic restenosis in a substudy of the last 75 patients enrolled.

Results

Baseline clinical and angiographic variables were comparable between the 2 groups with similar procedural and angiographic success, but a higher rate of repeat stenting occurred in the PTCA group (31% vs 10%; P <.001). Although the angiographic acute luminal gain was similar between the 2 groups, IVUS analysis revealed lower residual intimal hyperplasia area after PRCA versus PTCA (2.1 ± 0.9 mm² vs. 3.3 ± 1.8 mm²; P = .005). At a mean follow-up of 12 ± 2 months, there were 2 deaths, 3 myocardial infarctions, and 3 coronary artery bypass graft procedures in each group. TLR incidence was 32% in the PRCA group and 45% in the PTCA group (P = .042), with a similar trend noted in the angiographic substudy.

Conclusion

The ROSTER trial for diffuse ISR revealed both PRCA and PTCA to be safe and effective, but PRCA resulted in less residual intimal hyperplasia, lower repeat stent use, and decreased TLR.     

Intravascular ultrasound imaging after excimer laser angioplasty

To help elucidate the mechanism of excimer laser coronary angioplasty (ELCA), intra-vascular ultrasound (IVUS) imaging was performed in 19 of 29 patients who were treated with ELCA. The results were compared with a non-randomized control group of 18 patients who had IVUS studies both before and after PTCA alone. After ELCA alone, lumen diameter (1.9 × 1.7 mm) and lumen cross-sectional area (CSA) (2.9 mm²) by IVUS were not significantly different from baseline values in the patients before PTCA alone (2.1 × 1.8 mm, 3.2 mm²). After balloon dilatation in the laser treated group, lumen diameter (2.5 × 2.1 mm) and lumen CSA (4.9 mm²) were significantly greater than those post ELCA alone. However, there was no difference in lumen CSA or atheroma CSA in the group treated with excimer laser plus balloon dilatation vs. these measurements in the group treated with PTCA alone. ELCA does not ablate a large amount of atheroma (9% reduction) but creates a pathway to permit easier passage of a PTCA balloon. These quantitative and morphologic results may help explain why the restenosis rate with ELCA is similar to PTCA alone. © 1994 Wiley-Liss,Inc..     

Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial

The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation theoretically reduces the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in 1,238 patients. Six hundred seventeen patients were randomized to CB treatment, and 621 to PTCA. The mean reference vessel diameter was 2.86 +/- 0.49 mm, mean lesion length 8.9 +/- 4.3 mm, and prevalence of diabetes mellitus in patients was 13%. The primary end point, the 6-month binary angiographic restenosis rate, was 31.4% for CB and 30.4% for PTCA (p = 0.75). Acute procedural success, defined as the attainment of <50% diameter stenosis without in-hospital major adverse cardiac events, was 92.9% for CB and 94.7% for PTCA (p = 0.24). Freedom from target vessel revascularization was slightly higher in the CB arm (88.5% vs 84.6%, log-rank p = 0.04). Five coronary perforations occurred in the CB arm only (0.8% vs 0%, p = 0.03). At 270 days, rates of myocardial infarction, death, and total major adverse cardiac events for CB and PTCA were 4.7% versus 2.4% (p = 0.03), 1.3% versus 0.3% (p = 0.06), and 13.6% versus 15.1% (p = 0.34), respectively. In summary, the proposed mechanism of controlled dilatation did not reduce the rate of angiographic restenosis for the CB compared with conventional balloon angioplasty. CB angioplasty should be reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result compared with balloon angioplasty alone.     

Therapeutic implications of in-stent restenosis located at the stent edge. Insights from the restenosis intra-stent balloon angioplasty versus elective stenting (RIBS) randomized trial.

AIMS: In patients with in-stent restenosis (ISR) several anatomic subgroups have been identified. ISR affecting the stent edge (EDG) is a poorly characterised subgroup with undefined therapeutic implications. We sought to determine the implications of ISR affecting the stent EDG. METHODS AND RESULTS: 450 patients included in the "Restenosis Intra-stent: Balloon angioplasty vs elective Stenting" (RIBS) randomized study, were analysed. EDG ISR was predefined in the protocol and the pattern of ISR analysed in a centralized core-lab. Fifty-two patients (12%) had EDG ISR (29 stent group, 23 balloon arm). Patients with EDG ISR had less severe [minimal lumen diameter (MLD) (0.78+/-0.3 vs 0.66+/-0.3 mm, p=0.05)] and shorter lesions (lesion length 10.2+/-6 vs 13.2+/-7 mm, p=0.003). Patients with EDG ISR more frequently required crossover (12% vs 3%, p=0.006) but eventually the immediate angiographic result and the long-term clinical and angiographic outcome was similar to that found in patients without EDG ISR. Patients with EDG ISR treated in the balloon and stent arms had similar baseline characteristics. However, after intervention, the immediate angiographic result was better in the stent arm (MLD 2.79+/-0.4 vs 2.35+/-0.3 mm, p=0.001). This difference persisted at late follow-up: MLD (1.93+/-0.7 vs 1.39+/-0.7 mm, p=0.01), recurrent restenosis (20% vs 50%, p=0.03). In addition, the 1-year event-free survival was significantly better (83% vs 52%, log rank p=0.01; Cox HR 0.28, 95%CI 0.09-0.79) in the stent arm. Moreover, stent implantation was an independent predictor of freedom from target vessel revascularization (HR 0.15, 95%CI 0.03-0.67, p=0.003). CONCLUSIONS: EDG ISR constitutes a specific subgroup with relevant therapeutic implications. In patients with EDG ISR, repeat stent implantation provides better clinical and angiographic outcome than conventional balloon angioplasty.     

Excimer laser coronary angioplasty: Results in restenosis versus de novo coronary lesions

There is limited information regarding the use of excimer laser coronary angioplasty (ELCA) in patients with restenotic lesions. The purpose of this investigation was to compare the results of ELCA in patients with restenosis following prior PTCA with results obtained in de novo (no restenosis) patients. A retrospective review was obtained of all patients undergoing attempted ELCA at each of the 12 participating clinical investigative centers. There were 620 patients in the prior restenosis group and 949 in the de novo group. Both laser success (88% vs 78%) and procedural success (92% vs 88%) were higher in restenosis lesions compared with de novo lesions (P <0.001). Six-month follow-up was available in 40% of patients. Restenosis occurred in 49% of the prior restenosis group vs 44% of the de novo group (P nonsignificant) but death was more common in the de novo group (2.2 vs 0.4%, P = 0.01). ELCA can be performed with a high success rate in patients with restenosis following prior balloon angioplasty but recurrent restenosis following laser procedure remains a significant problem.     

Salvage of branch vessels during bifurcation lesion angioplasty: acute and long-term follow-up

To evaluate angiographic success, frequency of branch vessel loss and salvage, and long-term outcome, we studied the early and late outcomes of 56 consecutive patients who underwent PTCA of bifurcation lesions, which involved the left anterior descending or left circumflex coronary artery, with stenoses greater than 70% in both the parent and an involved branch vessel. In 35 patients (63%), the PTCA strategy was attempted dilation of both the main vessel and the involved branch vessels using predominantly a double-wire, sequential balloon technique; in 21 (27%) the PTCA attempt was confined to the main vessel alone. Transient angiographic occlusion of the branch vessel occurred in 32% of patients in whom dilation of both vessels was attempted, and in 38% in whom the main vessel alone was dilated (p = NS); 91% of the occluded branch vessels were the salvaged when sequential angioplasty of both vessels had been initially planned, compared to only 38% when the initial strategy had been dilation of the main vessel alone (p less than .05). Predischarge exercise testing showed residual ischemia in 6% of patients who had both vessels successfully dilated, versus 37% in those in whom dilatation was confined to the main vessels (p less than .01). Clinical restenosis, defined as late (greater than 6 weeks) recurrence of angina or a positive exercise test, occurred in 42% of patients who had both vessels successfully dilated. Thus although bifurcation lesion angioplasty frequently results in transient branch vessel loss, these branches can usually be salvaged using a double-wire technique but tend to have a higher late restenosis than conventional single vessel PTCA.     

Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty

OBJECTIVES: The purpose of the study was to determine whether cutting balloon angioplasty (CBA) has advantages over other modalities in treatment of in-stent restenosis (ISR). BACKGROUND: Controversies exist regarding optimal treatment for ISR. Recently, CBA emerged as a tool in management of ISR. METHODS: A total of 648 lesions treated for ISR were divided into four groups according to the treatment strategy: CBA, rotational atherectomy (ROTA), additional stenting (STENT), and percutaneous transluminal coronary angioplasty (PTCA). Following the matching process, 258 lesions were entered into the analysis. RESULTS: Baseline clinical and angiographic characteristics were similar among the groups (p = NS). Acute lumen gain was significantly higher in the STENT group (2.12 +/- 0.7 mm), whereas in the CBA group the gain was similar to one achieved following ROTA and following PTCA (1.70 +/- 0.6 vs. 1.79 +/- 0.5 mm and 1.56 +/- 0.7 mm, respectively; p = NS). The lumen loss at follow-up was lower for the CBA versus ROTA and versus STENT (0.63 +/- 0.6 vs. 1.30 +/- 0.8 mm and 1.36 +/- 0.8 mm, respectively; p < 0.0001), yielding a lower recurrent restenosis rate (20% vs. 35.9% and 41.4%, respectively; p < 0.05). By multivariate analysis, CBA (odds ratio [OR] = 0.17; confidence interval [CI], 0.06 to 0.51; p = 0.001) and diffuse restenosis type at baseline (OR = 2.07; CI, 1.15 to 3.71; p = 0.02) were identified as predictors of target lesion revascularization. CONCLUSIONS: We conclude that CBA is a safe and efficient technique for treatment of ISR, with immediate results similar to atheroablation and better clinical and angiographic outcomes at follow-up. This approach might be implemented as a viable option in management of focal ISR and to prepare diffuse ISR for brachytherapy treatment.     

FX minirail balloon angioplasty for the treatment of patients with in-stent restenosis: a matched comparison of 6 months’ outcome with conventional balloon angioplasty

The optimal treatment for in-stent restenosis (ISR) is a subject of controversy. Recently, FX minirail balloon angioplasty (BA) has emerged as a management tool for ISR. We assessed the hypothesis that the FX minirail BA has advantages over conventional percutaneous transluminal balloon angioplasty (PTCA) in the treatment of ISR. FX minirail BA or PTCA were applied to 116 patients with ISR (145 lesions) at our institution. Using a computer algorithm, an attempt was made to match each lesion in the FX minirail BA group with a corresponding lesion in the PTCA group. The lesion pairs should match with respect to the patients age and sex, type of target vessel and stent, reference vessel diameter, and baseline minimal lumen diameter (MLD). Following the matching process, 46 ISR lesion pairs were identified. Baseline patient characteristics were similar among the groups (P = not significant). There was no difference in the in-hospital major adverse cardiac events (MACE) between the groups, whereas MACE at follow-up were significantly lower in the FX minirail BA group than in the PTCA group (19.6% vs 41.3%, P < 0.05). The recurrent ISR rate was significantly lower in the FX minirail BA group than in the PTCA group (19.6% vs 39.1%, P < 0.05). Also, a diffuse pattern of recurrence was more common in lesions treated with PTCA, whereas the focal pattern of recurrence was more common in the FX minirail BA group (22.2% vs 50%, P < 0.05). The MLD at follow-up, the acute gain, and net gain were significantly higher in the group of lesions treated with the FX minirail BA than in the PTCA group. In addition, a significantly higher late loss and loss index at follow-up were observed in the PTCA group compared in the FX minirail BA group. The FX minirail BA has advantages over PTCA in the treatment of patients with ISR, with better immediate and follow-up angiographic outcomes, and a better clinical outcome on follow-up.     

小冠状动脉狭窄性病变的介入治疗

目的 :探讨小冠状动脉 （直径 <3 mm）狭窄性病变实施普通球囊、切割球囊或小支架介入治疗的疗效和并发症。方法 :小冠脉狭窄性病变介入治疗 （PCI）患者 13 6（男 87,女 49）例 ,年龄 3 2～ 85（54± 17）岁。根据手术方法分为普通球囊组、切割球囊组和小支架组。残余狭窄率 <3 0 %且无动脉夹层、撕裂等并发症者为手术成功 ,术后 6个月复查冠脉造影。结果 :普通球囊组 3 2例 ,手术成功 2 6例 （81% ） ,出现动脉夹层或扩张不满意改支架术 6例 （2 4% ）。切割球囊组 48例 ,手术成功 43例 （90 % ） ,出现动脉夹层或扩张不满意改支架术 3例 ,出现造影剂血管外漏 2例。支架组 56例 ,手术成功 53例 （95% ） ,出现造影剂血管外漏 2例 ,出现心包填塞抢救成功 1例。3组均未出现血管急性闭塞。术后 6个月 ,切割球囊组、小支架组、普通球囊组冠脉造影狭窄率分别为 2 3 % （11例 ）、16% （9例 ）、3 8% （12例 ）。结论 :小冠脉狭窄性病变实施介入治疗能取得显著效果 ,小支架术优于普通球囊扩张术 ,切割球囊扩张与普通球囊扩张具有近似疗效     

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.     

Excimer laser coronary angioplasty.

Recent experience with excimer laser coronary angioplasty (ELCA) has shown the safety and efficacy of the technique in the treatment of coronary stenosis, with results similar to percutaneous transluminal coronary angioplasty (PTCA). Several advantages of the excimer laser for intravascular use have been identified by the ELCA Registry, a group of 15 institutions nationally that have pooled data on their cooperative experience with ELCA. Advantages include the ability of the laser to ablate atheroma with microscopic precision without thermal injury and the ability of vessel surfaces to heal without scarring. The initial results of the multicenter investigation of ELCA in 958 patients indicate that ELCA may be indicated particularly for long, diffuse lesions. With the advent of larger diameter catheters, ELCA is a viable alternative to PTCA. Restenosis was seen as a significant problem, and it remained problematic at 6-month follow-up. In comparison with conventional balloon angioplasty, ELCA may eliminate that component of restenosis due to inadequate dilation or elastic recoil, but it does not appear to affect restenosis caused by smooth muscle proliferation. Catheter design and energy delivery continue to evolve and may affect future results of laser coronary angioplasty.