Comparison of Restenosis Rate in Various Devices for Coronary Intervention: Analysis Using Vessel Diameter and Lesion Length

The purpose of this study was to retrospectively compare the restenosis rates related to vessel diameter and lesion length among plain old balloon angioplasty (POBA), cutting balloon (CB) angioplasty, Palmaz-Schatz (PS) stems, Gianturco-Roubin (GR) stents, and directional coronary atherectomy (DCA). In 909 consecutive successfully treated cases, target lesion dimensions were divided into diameters of ± 2.5 mm and lengths of ± 20 mm to compare the restenosis rates obtained by the individual devices. Quantitative angiographic analysis was performed before the procedure, after the procedure, and at FU angiography at a mean FU time of 6 ± 3 months. Restenosis was defined as %DS > 50 at FU angiography. Patients with acute myocardial infarction, chronic total occlusions, left main lesions, ostial as well as venous graft lesions, severe calcifications, severe coronary thrombosis, and bleeding complications were excluded. The overall restenosis rate was 32%, with the CB it was 29%, with the PS stent it was 27%, and with DCA it was 39%. Each of these restenosis rates was significantly lower than that with POBA. The overall restenosis rate with short lesions at small vessels was 35%, while CB angioplasty yielded 29%, being significantly lower compared to that obtained by POBA. The overall restenosis rate with long lesions at small vessels was 53%. With those lesions there was no significant difference among the devices. The overall restenosis rate with short lesions at large vessels was 27%, with CB angioplasty it was 24%, with the PS stent it was 22%, and with DCA it was 25%. These restenosis rates were significantly lower compared to POBA. With long lesions at large vessels, the overall restenosis rate was 44%. In this subgroup, there was again no significant difference among the devices. Our study suggests that restenosis rates with short lesions are lower after CB angioplasty, stenting, and DCA, when compared to POBA. However, in the presence of long lesions, no difference was found among the devices.     

普通球囊与切割球囊成形术对冠状动脉支架内再狭窄的近远期疗效

目的　对切割球囊成形术 (CBA)与普通球囊成形术 (POBA)支架内再狭窄病变的近远期血管造影结果比较 ,评价 CBA对支架内再狭窄病变的有效性。方法　 37例 ,共 39处病变 ,2 3处进入 CBA组 ,16处进入 POBA组。分别比较术后即刻及远期定量冠状动脉造影最小血管径 (ML D)、狭窄度 (DS)、再狭窄率、即刻管腔获得 (AL G)、即刻血管弹性回缩 (AR)及弹性回缩率 (ARR)。结果　术后即刻 ML D、DS、AL G两组差异无显著性。 CBA组最大扩张压、AR及 ARR均较 POBA组低 (P<0 .0 5或 P<0 .0 0 1)。随访造影结果 ,CBA组 ML D明显大于 POBA组 (P<0 .0 5 ) ;DS及再狭窄率均小于 POBA组 (P<0 .0 1)。结论　 CBA组的低压扩张治疗支架内再狭窄病变是有效的 ,对血管损伤小于 POBA,且获得较 POBA低的再狭窄率 ,值得进一步探讨     

Efficacy of cutting balloon angioplasty for lesions at the ostium of the coronary arteries

We evaluated 37 patients (39 lesions, 11 women/26 men, median age of 66 years old) with coronary ostial lesions who underwent cutting balloon angioplasty (CB). Seventy-four patients (78 lesions, 18 women/56 men, median age of 65 years old) who had undergone plain old balloon angioplasty (POBA) for coronary ostial lesions were also enrolled as the control group. At clinical diagnosis, unstable angina was seen in 8.1% of the CB group and in 9.5% of the POBA group. Post myocardial infarction silent ischemia was seen in 28.3% of the POBA group and 32.4% of the CB group. The success rate was 94.8% in the CB group and 84.6% in the POBA group. The frequency of intimal dissection was not significantly different between the two groups. However, all cases of intimal dissection in the CB group were mild (either type A or B), whereas the POBA group included many cases of severe intimal dissection (types B through F). No cardiac event was observed in the CB group. However, in the POBA group, cardiac death occurred in 1.4% and emergency bypass surgery occurred in 0.7% of the patients. Calculating the restenosis rate based on the cumulative percent diameter stenosis curve resulted in 43% for the CB group and 53% of the POBA group. We concluded that the cutting balloon was useful for ostial lesions as compared to plain old balloon angioplasty.     

Promising efficacy of primary gradual and prolonged balloon angioplasty in small coronary arteries: a randomized comparison with cutting balloon angioplasty and conventional balloon angioplasty

Background

Small vessel size represents a critical risk factor for an adverse outcome after both conventional balloon angioplasty (POBA) and stenting. Gradual and prolonged balloon angioplasty (GPBA) has been shown to cause less arterial trauma, which results in higher procedural success rates and fewer in-hospital complications than POBA. The aim of this study was to assess the clinical and angiographic benefits of primary GPBA with a perfusion balloon in small coronary arteries, as compared with cutting balloon angioplasty (CBA) and POBA.

Methods

A total of 263 patients with symptoms and reference diameters <3.0 mm were randomly assigned to undergo GPBA (n = 85), CBA (n = 88), or POBA (n = 90). The cumulative inflation time must be >10 minutes in GPBA. Crossover to stent was allowed for inadequate results. Follow-up angiography was performed after 6 months. The primary end point was angiographic restenosis at follow-up.

Results

Compared with POBA, GPBA resulted in a lower final residual diameter stenosis (27.3% vs 34.2%, P = .01) and decreased the need for stent placement (8.0% vs 22.2%, P = .031). At follow-up, the restenosis rates were lower with GPBA (31.3%, P = .034) and CBA (32.9%, P = .059) than POBA (50.6%). Target lesion revascularization was less frequently needed with GPBA (20.5%, P = .043) and CBA (20.0%, P = .033) than POBA (37.6%). Additionally, the event-free survival rate was higher with GPBA (77.1%, P = .033) and CBA (76.4%, P = .047) than POBA (58.8%).

Conclusions

In small coronary arteries, both GPBA and CBA resulted in favorable angiographic and clinical outcomes. With a lower restenosis rate and target lesion revascularization rate, GPBA may be a superior strategy for small vessels compared with POBA.     

Effectiveness of cutting balloon angioplasty for small vessels less than 3.0 mm in diameter

The aim of this study was to evaluate the effectiveness of cutting balloon angioplasty (CBA) in small vessels < 3.0 mm in diameter. Included were 166 patients (175 lesions) treated with CBA (CBA group), and 215 patients (240 lesions) were treated with plain old balloon angioplasty (POBA group). No differences were observed in patient backgrounds or lesion characteristics between the two groups. Procedural success rates were similar: 98.3% (CBA) versus 95.8% (POBA). Coronary dissection rates were also similar: 7.4% in the CBA versus 5.8% in the POBA group. Severe dissections (types E and F) occurred in 2.5% of cases in the POBA group, whereas there was none observed in the CBA group. In-hospital complications occurred in 3.3% in the POBA group, and in only 0.6% in the CBA group. The restenosis rate was 37.5% (CBA group) versus 48.1% (POBA group); and in vessels < 2.75 mm, restenosis was significantly lower in the CBA group than in the POBA group (36.9% vs 62.7%, P < 0.05). CBA may be a useful therapeutic strategy for small vessels, given the absence of severe coronary dissection and the significantly lower rate of restenosis compared to POBA.     

Local delivery of argatroban for the prevention of restenosis after coronary balloon angioplasty: a prospective randomized pilot study.

BACKGROUND: Effective pharmacological prevention of restenosis using the systemic administration of various drugs that were effective for the prevention of restenosis in experimental studies has not been reported. The purpose of this study was to evaluate whether the local delivery of a potent thrombin inhibitor, argatroban, using a local drug delivery device would prevent restenosis after plain old balloon angioplasty (POBA). METHODS AND RESULTS: Seventy patients with chronic coronary artery disease requiring POBA were randomly assigned to wither the control group (n=35) or the argatroban group (n=35). In the argatroban group, argatroban was administered intravenously for 30 min before the POBA and intracoronarily into the dilated site using a Dispatch catheter immediately after the POBA, followed by a postoperative intravenous infusion for 4 h. The angiographical lesion restenosis and clinical restenosis rates at follow-up were significantly lower in the argatroban group (27% and 14%) than in the control group (56% and 37%; p=0.02 and p=0.03, respectively). There was no major complication during the procedure. CONCLUSION: The local delivery of argatroban is safe and effective in preventing restenosis after balloon angioplasty.     

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.     

Angiographic and clinical outcomes at 8 months of cutting balloon angioplasty and beta-brachytherapy for native vessel in-stent restenosis (BETACUT): results from a stopped randomized controlled trial.

The objective of this study was to assess angiographic and clinical outcomes of cutting balloon (CB) angioplasty and concomitant Sr/Y-90 beta-brachytherapy as a treatment modality for patients with native vessel in-stent restenosis (ISR). Procedural advantages over the standard balloon (SB) have been claimed for the CB. Intracoronary brachytherapy preceded by SB angioplasty is regarded as the treatment of choice in patients with ISR. In an interim analysis of a prospective randomized trial designed for 652 patients, 100 consecutive patients with ISR were assigned to treatment with SB angioplasty (n = 51) or CB angioplasty (n = 49), followed in either case by Sr/Y-90 beta-brachytherapy. Quantitative coronary angiography at baseline, postintervention, and at 8 months was performed by an independent central laboratory. More than 90% of target lesions in the overall patient population were diffuse, with 14% of stents totally occluded. Procedural parameters and immediate angiographic outcomes were essentially the same in either study arm. At 8 months, no statistically significant differences were observed in recurrent angiographic restenosis (SB = 26.1%; CB = 29.5%; P = 0.82), target lesion revascularizations (SB = 13.7%; CB = 8.2%; P = 0.53), and major adverse cardiac events (SB = 15.7%; CB = 8.2%; P = 0.36). In this interim analysis, there was no indication of a beneficial effect of CB use over SB use in terms of angiographic or clinical outcomes at 8-month follow-up. CB angioplasty appears to be as safe and efficacious as SB angioplasty in beta-radiation treatment of patients with predominantly diffuse native vessel ISR. It was decided to discontinue the trial.     

Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty

ObjectivesThe aim of this study was to investigate the efficacy and safety of the Litos drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for reduction of late lumen loss (LLL) in patients with critical limb ischemia undergoing below-the-knee (BTK) intervention.BackgroundRestenosis after balloon angioplasty of BTK arteries approximates 70%. Previous studies of DCBs in BTK arteries produced conflicting results.MethodsACOART-BTK (Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos® in Below-the-Knee Arteries to Treat Critical Limb Ischemia) is a randomized controlled single-center study. Inclusion criteria were critical limb ischemia (Rutherford class ≥4) and significant stenosis or occlusion >40 mm of at least 1 BTK vessel with distal runoff successfully treated with angioplasty. Six-month angiographic LLL was the primary endpoint. Occlusive restenosis at 6 months and clinically driven target lesion revascularization at 12 months were secondary endpoints.ResultsFrom January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study. Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30). Almost 70% of lesions were occluded at baseline in both groups. On 6-month angiography, mean LLL was 0.51 ± 0.60 mm in the DCB group and 1.31 ± 0.72 mm in the POBA group (p < 0.001); rates of occlusive restenosis were 8.6% and 48.4%, respectively (p < 0.001). Twelve-month clinically driven target lesion revascularization occurred in 6 of 62 DCB-treated lesions (10%) versus 27 of 66 POBA-treated lesions (41%) (p < 0.001). Complete healing at 12 months was observed in 42 of 47 DCB-treated limbs (89.4) versus 35 of 47 POBA-treated limbs (74.5%) (p = 0.05); no major amputations occurred.ConclusionsLitos DCBs strikingly reduced LLL, vessel reocclusion, and clinically driven target lesion revascularization compared with POBA in BTK angioplasty.     

Primary stent implantation is superior to balloon angioplasty in acute myocardial infarction: final results of the primary angioplasty versus stent implantation in acute myocardial infarction (PASTA) trial. PASTA Trial Investigators.

Several studies have shown that stent implantations in acute myocardial infarction (AMI) result in better short- and long-term outcomes than primary balloon angioplasty. These results, however, have not been ascertained in randomized trials. We randomized 136 patients out of 208 patients with AMI within 12 hr from onset into two groups: 69 patients with primary balloon angioplasty (POBA group) and 67 patients with primary stent implantation (STENT group). We compared the incidences of major cardiac events (repeat MI, target lesion revascularization, and cardiac death) and angiographic parameters during hospitalization and follow-up periods up to 12 months in these two groups. There was no significant difference in the reperfusion success rates. The incidences of major cardiac events were lower in the STENT group than in the POBA group during hospitalization, the first 6 months and 12 months (6% vs. 19%, P = 0.023; 21% vs. 46%, P < 0.0001; 22% vs. 49%, P = 0.0011). Minimum lumen diameters were significantly bigger in the STENT group than the POBA group at predischarge angiogram and 6-month follow-up (2.85 +/- 0.62 vs. 2.08 +/- 0.82 mm, P < 0.0001; 2.24 +/- 0.64 vs. 1.72 +/- 0.76, P = 0.002). Restenosis rates at 6-month follow-up were significantly lower in the STENT group than in the POBA group (17% vs. 37.5%, P = 0.02). In selected patients with AMI, primary stent implantation results in a lower incidence of major cardiac events during the first 12 months, postprocedure, and less frequent 6-month restenosis than primary balloon angioplasty.     

Intracoronary beta-irradiation with liquid rhenium-188: results of the Taiwan radiation in prevention of post-pure balloon angioplasty restenosis study

STUDY OBJECTIVE: To assess the feasibility and short-term outcome of intracoronary irradiation after pure balloon angioplasty (POBA) of de novo and post-POBA restenotic lesions with a liquid beta-emitter (188)Re-filled balloon. DESIGN AND SETTING: Nonrandomized prospective study with contemporaneous control group in a single medical center. PATIENTS AND METHODS: In the Taiwan Radiation in Prevention of Post-Pure Balloon Angioplasty Restenosis study, 40 patients underwent 14-Gy irradiation and 15 patients underwent 20-Gy irradiation at a tissue depth of 0.5 mm after POBA. Thirty control patients received a 5-min inflation with a perfusion balloon catheter after POBA. RESULTS: No procedural or in-hospital complications, or 30-day major adverse cardiac events were noted. Six-month angiographic restenosis rates were 49% in the 14-Gy group, 20% in the 20-Gy group, and 57% in the control group (p = 0.05, 20-Gy group vs control group). In the lesions with an arc of calcification of < 180 degrees, restenosis occurred in 15 of the 34 lesions (44%) in the 14-Gy group and in none of the 11 lesions (0%) in the 20-Gy group (p = 0.007). In a vessel with a reference diameter < 3.0 mm, restenosis occurred in 1 of the 8 lesions (13%) in the 20-Gy group, and in 8 of the 11 lesions (73%) in the control group (p = 0.02). In the post-POBA restenotic lesions, restenosis occurred in none of the six lesions (0%) in the 20-Gy group, and in five of the six lesions (83%) in the control group (p = 0.008). CONCLUSIONS: Post-POBA, catheter-based brachytherapy in nonstented native coronary artery with a (188)Re-filled balloon can effectively reduce target lesion restenosis with 20-Gy irradiation at a tissue depth of 0.5 mm and seems to be more effective in the treatment of lesions with an arc of calcification < 180 degrees, in a vessel with a reference diameter of < 3.0 mm, and in post-POBA restenotic lesions.     

准分子激光治疗股腘动脉支架内再狭窄的临床研究

目的探讨准分子激光联合药物涂层球囊(DCB)治疗股腘动脉支架内再狭窄(ISR)的可行性及安全性。方法回顾性分析股腘动脉ISR患者的临床资料,其中36例准分子激光斑块消蚀术(ELA)+普通球囊血管成形术(POBA)+DCB治疗者为观察组;57例POBA+DCB治疗者为对照组。观察两组手术成功率、并发症发生率、术后即刻最小管腔直径(MLD)、术后3天踝肱指数(ABI)等。术后随访:1、3、6、12月彩超和ABI,12月靶病变血流重建(TLR)、ISR、截肢率、MLD、晚期管腔丢失(LLL)等指标。结果术前两组患者性别、年龄、TASCⅡ分级以及合并症等基线资料比较,差异无统计学意义。术后1、3、6、12月ABI,12月TLR、ISR、截肢率、MLD、LLL等指标,观察组优于对照组(P均0.05)。结论 ELA+POBA+DCB治疗股腘动脉ISR安全有效,近中期效果优于POBA+DCB。     

Hemostatic and fibrinolytic activation is less following cutting balloon angioplasty of the coronary arteries

Recent studies have shown that percutaneous coronary intervention (PCI) activates systemic hemostatic activity, reflecting platelet activation and thrombin formation in the coronary arteries. The present study compared systemic levels of hemostatic markers induced by plain old balloon angioplasty (POBA), coronary stenting (STENT), and cutting balloon (CB) angioplasty. Sixty-one patients with stable angina pectoris, who underwent elective PCI or diagnostic coronary angiography (CAG) alone, were investigated. Patients who underwent PCI were divided into the POBA group (n = 11), the STENT group (n = 27), and the CB group (n = 11). Patients who underwent CAG alone were assigned to the CAG group (n = 12). Blood samples were collected before, 24 hours after, and 3 days after PCI or CAG. Plasma concentrations of prothrombin fragment 1+2 (F1+2), fibrinopeptide A (FPA), thrombin-antithrombin III complex (TAT), and plasminogen activator inhibitor-1 (PAI-1) were measured. In the CB group, the F1+2 (1.23 +/- 0.4 nmol/L) level 3 days after PCI was significantly smaller than that of the POBA group (2.37 +/- 0.5 nmol/L) (P < 0.05). The FPA (1.81 +/- 0.9 ng/mL), TAT (3.36 +/- 1.2 ng/mL) and PAI-1 (23.0 +/- 4.1 ng/mL) levels in the CB group 3 days after PCI were significantly smaller than those of the POBA group (P < 0.05, respectively) and STENT group (P < 0.05, respectively), but similar to the CAG group. Systemic hemostasis is activated to a greater extent after POBA and stenting than it is after CB angioplasty of the coronary arteries. This may contribute to the favorable long-term outcome of CB angioplasty.     

Comparison of dilatation mechanism and long-term vessel remodeling between directional coronary atherectomy and balloon angioplasty assessed by volumetric intravascular ultrasound

Although acute and late outcomes of coronary interventions have been determined by coronary angiography, this method cannot determine changes in vessel and plaque volume. Volumetric intravascular analysis has the potential to evaluate the morphology and redistribution of plaque after coronary intervention as well as longitudinal vessel remodeling. We used 3-dimensional intravascular ultrasound (3-D IVUS) to delineate the mechanism of coronary dilatation and long-term (> 1 year) remodeling in 25 patients. Ten patients underwent directional coronary atherectomy (DCA), and 15 underwent balloon angioplasty (POBA). No patients exhibited restenosis at 6-month angiographic follow-up. Validated Netra 3-D IVUS was performed pre- and post-intervention, at 6-months and at > 1-year. There were some differences in mechanism of dilatation and time course of change in vessel size between DCA and POBA patients. The principal mechanism was vessel stretching and longitudinal plaque redistribution in the POBA group and plaque debulking in the DCA group. In the POBA group, vessel volume increased just after the procedure; this increase was maintained at 6 months and at > 1-year. However, in the DCA group, vessel volume increased initially 6 months after the procedure. 3-D IVUS revealed a difference in mechanism of dilatation between POBA and DCA; this difference might affect late-term vessel remodeling even in patients without restenosis.     

Comparison of Angiographic and Clinical Outcome After Cutting Balloon and Conventional Balloon Angioplasty in Vessels Smaller than 3 mm in Diameter: A Randomized Trial

OBJECTIVES: The purpose of the study was to evaluate and compare the immediate and six month follow-up angiographic and clinical outcome of cutting balloon angioplasty and conventional balloon angioplasty in small vessels (less than 3 mm in diameter). METHODS AND RESULTS: Between August 1995 and August 1996 a total of 71 eligible symptomatic patients with angiographically proven significant lesions in their coronary arteries smaller than 3 mm and requiring revascularization, were randomized to receive treatment by either cutting balloon angioplasty (CB) or conventional balloon angioplasty (BA). òStand-aloneó CB was performed on 51 lesions in 36 patients and BA on 47 lesions in 35 patients. Basic angiographic and clinical characteristics were similar in both groups. The overall procedural success rates for CB and BA groups were 92% and 97%, respectively. The immediate post-procedural minimal luminal diameter, residual stenosis and acute gain were similar in the CB and BA cohorts (1.93 +/- 0.36 mm, 24 +/- 12%, 1.18 +/- 0.45 mm vs. 2.01 +/- 0.34 mm, 22 +/- 9%, 1.26 +/- 0.35 mm, respectively). Total dissection rate and C-F dissections were fewer in the CB group (37%, 6% vs. 51%, 19%, respectively, p < 0.05). Six month follow-up angiographic restenosis rate was lower in the CB group (27% vs. 47%, p < 0.05). We also detected a significant difference of total number of all events at nine month clinical follow up (28% vs. 51%, p < 0.05). CONCLUSION: CB angioplasty can be performed with a comparable success rate to conventional BA in small vessels. Fewer bail-out procedures are needed as CB causes fewer and less severe dissections. There is also a significant reduction in six month restenosis rate. We suggest that CB might be a better option for revascularizing vessels smaller than 3 mm in diameter which are inherently more prone to immediate complications and late restenosis with BA.     

High speed rotational coronary atherectomy for patients with diffuse coronary artery disease

High speed rotational coronary atherectomy was undertaken using the Rotablator in 42 patients who were suboptimal candidates for balloon angioplasty. Most patients (71%) had diffuse coronary artery disease, defined as a stenosis greater than 1 cm in length. Previous restenosis after balloon angioplasty was present in 21% and 10% had an ostial lesion. Adjunctive balloon angioplasty was not used to reduce residual stenosis after atherectomy. The procedure was successful in 76% of patients. Procedural success was achieved in 92% of patients with a lesion less than or equal to 1 cm in length, but in only 70% of patients with a lesion greater than 1 cm in length (p less than 0.01). One patient sustained abrupt closure of the target vessel, resulting in emergency bypass surgery and death. Small non-Q wave myocardial infarction occurred in eight patients (19%) and was associated with a longer lesion. The mean peak creatine kinase value in patients with non-Q wave myocardial infarction was 683 U/liter. Transient regional wall motion abnormalities were noted on the postatherectomy left ventricular angiogram in four of the eight patients with non-Q wave myocardial infarction. Follow-up angiography (at a mean interval of 6.2 +/- 2.6 months) was performed in 91% of patients and revealed restenosis (greater than 50% narrowing) in 59% The resistance rate was 22% for short lesions (less than or equal to 1 cm) and 75% for long lesions (greater than 1 cm) (p less than 0.05). In this study, the results of high speed rotational coronary atherectomy were strongly influenced by lesion length.(ABSTRACT TRUNCATED AT 250 WORDS)     

Immediate and chronic results of cutting balloon angioplasty: A matched comparison with conventional angioplasty

Background: At the initial stages of percutaneous transluminal coronary angioplasty (PTCA), several studies reported on the feasibility of coronary artery incision and dilatation leading to the extension of the PTCA technique. Hypothesis: This study was designed to determine the immediate and chronic results of cutting balloon (CB) angioplasty. Methods: This procedure was performed on 127 lesions in 110 patients (male 83%, age 61.8 ± 9.3 years). Results: The overall procedural success rates for the CB were 93.7% (119 lesions) and 92.7% (102 patients), while solitary CB without pre- and/or postdilatation was 76.4% (91 lesions). There was one major in-hospital complication (Q-wave myocardial infarction, 0.9%), but there were no deaths or emergency coronary artery bypass graftings. Significant angiographic dissections (≥ grade C) occurred in four patients, and coronary perforation occurred in one. The successfully treated CB group (95 lesions) was matched with the successful conventional angioplasty group (PTCA group) for chronic result assessment in regard to reference vessel size and lesion characteristics. In the CB group, postprocedural minimal luminal diameters were significantly larger and the percentage of stenosis at the stenotic site was significantly lower compared with the PTCA group. Restenosis occurred in 22 lesions (23.1%). This showed a significantly lower restenosis rate compared with the PTCA group (42.1%). In addition, the restenosis rate of the CB without inclusion of the pre- and/or postdilatation-treated lesions was 19.7%. Conclusions: (1) Cutting balloon angioplasty procedures can be performed with high success rates with few major in-hospital events. (2) The restenosis rate in the CB group was significantly lower compared with the PTCA group.     

Re-angioplasty of in-stent restenosis versus balloon restenoses--a matched pair comparison

BACKGROUND: Despite different biological mechanisms involved in the restenotic process of in-stent restenosis and restenosis after balloon angioplasty alone, the occurrence of a second restenosis has been reported in the same range. There are no data available comparing the outcome after re-angioplasty of such lesions. We analyzed in a matched pair comparison the clinical outcome and angiographic long-term result of patients with balloon angioplasty of a first in-stent restenosis versus patients with balloon re-angioplasty of a first balloon restenosis. METHODS: Both groups consisted of 74 lesions matched by treated vessel, lesion location differentiated in proximal and non-proximal, and angiographic appearance of coronary artery disease differentiated in singular stenosis, diffuse or mixed pattern. Clinical follow-up was 100%. Angiographic follow-up was 78.4% after median 174 days. RESULTS: Angiographic restenosis rate in matched pairs of patients (n=46/74) was significantly higher in the balloon restenosis group (41.3%, n=19/46) compared to the in-stent restenosis group (21.7%, n=10/46, p<0.042). There was no death or myocardial infarction. After clinical follow-up, target lesion revascularization rate was significantly lower in the in-stent restenosis group compared to the balloon restenosis group (12.1%, n=9/74 versus 27.0%, n=20/74; difference between groups 14.9%, 95% confidence interval 2.0-27.3%, p<0.023). Multivariate logistic regression analysis revealed as predictors for a second restenosis unstable angina pectoris, non-proximal lesion, restenosis after balloon angioplasty and the occurrence of the first restenosis within 90 days after initial intervention. CONCLUSION: Clinical and angiographic outcome after balloon angioplasty of a first in-stent restenosis was significantly better compared with balloon re-angioplasty of a first balloon restenosis.     

切割球囊临床应用的有效性和安全性评价

目的 探讨切割球囊临床应用的安全性和有效性。方法 对131例患者142处狭窄病变进行切割球囊或切割球囊＋支架治疗。结果 142处狭窄病变行切割球囊治疗中4次失败，成功率为97.2%。切割球囊治疗支架内再狭窄、开口部病变、分叉病变和小血管弥漫性病变以及其他类型病变各为69处、16处、19处、7处和27处，7例切割球囊扩张后发生内膜撕裂，均为A型夹层，发生率为5.3%，术中无死亡和急性心肌梗死及其他严重血管并发症发生。失败原因与病变严重钙化以及切割球囊不能达到或通过狭窄部位有关。结论 切割球囊临床应用是安全面有效的。     

Rotational Atherectomy Combined with Drug Coated-Balloons for in-Stent Restenosis

BackgroundRefractory coronary in-stent restenosis remains a clinically relevant problem in interventional cardiology despite the use of drug coated balloon angioplasty and further drug eluting stent deployment. In this study, we investigated whether the novel approach of lesion debulking with rotational atherectomy prior to drug coated balloon angioplasty for challenging coronary in-stent restenosis is safe and effective.MethodsProcedural and registry data was retrospectively analysed for 26 patients who underwent rotational atherectomy immediately followed by drug coated balloon angioplasty to 43 coronary in-stent restenosis lesions with mean follow up of 19 months.ResultsLesion success was achieved in all cases with no major procedural complications. There were no instances of death or myocardial infarction in the follow up period. Target lesion revascularisation occurred in six patients and target vessel revascularisation occurred in eight patients. All target lesion revascularisation occurred in lesions that had already failed drug coated balloon angioplasty without debulking previously while four such lesions were free of lesion failure in the follow up period.ConclusionsLesion debulking with rotational atherectomy followed by drug coated balloon angioplasty is a feasible treatment option for selected cases of in-stent restenosis. Further study is needed to fully assess its efficacy in comparison to conventional treatment.