A Meta-Analysis of Contemporary Lesion Modification Strategies During Percutaneous Coronary Intervention in 244,795 Patients From 22 Studies

Abstract: Objectives. Outcomes with use of lesion-modification strategies in the drug-eluting stent era have received limited study. Methods. We conducted a meta-analysis of 22 studies published between 2004-2016 reporting outcomes after use of rotational atherectomy, cutting-balloon, and scoring-balloon angioplasty. Results. In observational trials, acute luminal gain was higher after lesion modification as compared with control (standardized mean difference, 0.23 mm; 95% confidence interval [CI], 0.01-0.44; P=.04), with no difference in acute gain in randomized studies. Compared with control, lesion modification was associated with lower restenosis in randomized trials (odds ratio [OR], 0.64; 95% CI, 0.45-0.90; P=.01). Ninety-day incidence of major adverse cardiovascular event (MACE) was higher after lesion modification in observational studies (OR, 1.39; 95% CI, 1.05-1.83; P=.02), but similar in randomized trials. Ninety-day incidence of target-lesion or target-vessel revascularization (TLR-TVR) and myocardial infarction (MI) was similar. Ninety-day incidence of death was higher after lesion modification in observational studies (OR, 1.42; 95% CI, 1.04-1.95; P=.03), but similar in randomized trials. At 1 year, the MACE rate was similar for lesion modification compared with control in observational studies, but lower after lesion modification in randomized trials (OR, 0.65; 95% CI, 0.48-0.88; P<.01). TLR-TVR was higher with lesion modification in observational studies, but lower in randomized trials (OR, 0.64; 95% CI, 0.46-0.88; P<.01). Conclusions. While observational studies suggest a higher early MACE rate and more restenosis, randomized trials show similar short-term and improved long-term outcomes with pre-stenting lesion modification compared with control.

J INVASIVE CARDIOL 2017;29(12):E167-E176. Epub 2017 July 15.

Key words: atherectomy, plaque modification, drug-eluting stents, meta-analysis

Pre-stenting lesion modification in percutaneous coronary intervention (PCI) can be achieved with various devices, such as rotational atherectomy (Rotablator; Boston Scientific), orbital atherectomy (Diamondback 360; Cardiovascular Systems, Inc), and cutting balloon (Flextome; Boston Scientific) or scoring balloon (Angiosculpt; Angioscore). These devices can facilitate complex percutaneous coronary interventions, such as interventions of heavily calcified lesions, ostial/bifurcation lesions, and chronic total occlusions. The use of these strategies in selected lesions is considered beneficial, based on observational data.^1-3 Early studies comparing atherectomy with balloon angioplasty alone,^4-6 or comparing cutting balloon with plain old balloon angioplasty alone,^7-9 with stenting as a bail-out strategy, showed unfavorable long-term results.¹⁰ Several negative trials of routine atherectomy prior to stenting led to disillusionment with the use of rotational¹¹ and directional¹² atherectomy for non-selected lesions. Since the introduction of drug-eluting stents, PCI outcomes have been steadily improving, allowing operators to successfully treat increasingly complex lesions. The aim of this meta-analysis was to examine the impact of pre-stenting lesion modification with atherectomy or cutting-balloon/scoring-balloon angioplasty as compared with stenting alone in the contemporary PCI era. 

Methods

Study selection, data collection and processing, and reporting of the results were performed according to accepted principles of meta-analysis.¹³

We performed a comprehensive search of the PubMed/Medline database (on February 28, 2017) to identify publications on lesion modification strategies used during PCIs. The following search terms were used: percutaneous coronary intervention; lesion modification strategies; atherectomy; atheroablation; rotational atherectomy; orbital atherectomy; scoring balloon; and cutting balloon. Bibliographies of the retrieved studies were searched by hand for other relevant studies. Human studies in English published from 2004-2017 were included. Studies with fewer than 10 subjects were excluded, as were those that did not report on the outcomes of interest, such as review articles, editorials, and consensus documents. We also excluded studies of directional atherectomy, laser atherectomy, lesion modification for the treatment of in-stent restenosis, studies that did not involve stenting in at least one of the groups, and studies that did not use a comparison or control group.

We analyzed the following outcomes: acute gain; binary restenosis, defined as stenosis >50% in the target-vessel segment during angiographic follow-up; incidence of major adverse cardiovascular event (MACE), defined as target-lesion revascularization (TLR) or target-vessel revascularization (TVR), death, or myocardial infarction (MI) within 90 days of the index procedure; and incidence of MACE, TLR-TVR, death, or MI within 6 months to 1 year of the index procedure. 

The original definitions of MACE, TLR, TVR, and MI from each study were used for this analysis. Numbers of events were obtained directly or calculated from rates given in tables and text. All events were calculated from the total population of patients available at each time point during follow-up. When event counts were not provided, counts were calculated using event rates on an intent-to-treat basis, assuming that no patients were lost to follow-up. Angiographic restenosis events and rates were calculated from the population of patients undergoing follow-up angiography. When a study reported both TLR and TVR rates, TVR data was used. For studies reporting event rates at multiple follow-up intervals, the longest available follow-up data were used. Data were abstracted by two physicians (BD and AK), and discrepancies were resolved by a third physician (JK). 

Data tables were constructed from primary sources with cumulative rates of each outcome. Pooled odds ratios (ORs) or standardized mean differences with 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel random-effects method. The random-effects model ORs are used throughout the manuscript. To assess heterogeneity across trials, we used the Cochrane Q statistic (P≤.10 was considered significant) and I² statistic (25%, 50%, and 75% correlate with low, moderate, and high heterogeneity, respectively) for each outcome. A two-sided P<.05 was considered statistically significant. Statistical analyses were performed using Review Manager, v. 5.3 (The Cochrane Collaboration).

Results

A total of 17 observational and 5 randomized studies^14-35 met the inclusion criteria and were included in the final pooled analysis (Figure 1). The studies included in the present analysis and their characteristics are summarized in Table 1. The number of studies that reported each of the outcomes of interest is shown in Table 2. No studies assessing the use of orbital atherectomy met the inclusion criteria. 

The 22 published studies reported outcomes of 244,795 patients who underwent lesion modification. Of these, 4548 patients underwent lesion modification before stenting and were compared with 240,247 patients who did not undergo lesion modification. 

In observational trials, use of lesion modification techniques before stenting was associated with greater acute luminal gain (standardized mean difference, 0.23 mm; 95% CI, 0.01-0.44; P=.04); in randomized trials, lesion modification was associated with no difference in acute gain (standardized mean difference, 0.14 mm; 95% CI, -0.10-0.38; P=.26) (Figure 2). After a mean follow-up of 7.2 months, use of lesion modification strategies was associated with no difference in binary restenosis in observational trials (OR, 0.57; 95% CI, 0.17-1.94; P=.37), but lower restenosis in randomized trials (OR, 0.64; 95% CI, 0.45-0.90; P=.01) (Figure 3). Significant heterogeneity was observed for both observational trials reporting acute gain (I² = 58%) and for randomized trials reporting this outcome (I² = 67%). In addition, there was significant heterogeneity among observational trials reporting binary restenosis rates (I² = 86%). 

The use of lesion modification techniques was associated with higher incidence of MACE at 90 days in observational studies (OR, 1.39; 95% CI, 1.05-1.83; P=.02), but no difference in randomized studies (OR, 1.60; 95% CI, 0.84-3.03; P=.15) (Figure 4). Heterogeneity was low for MACE (I² = 7% and 0% for observational and randomized trials, respectively). Use of lesion modification techniques resulted in similar rates of TLR or TVR at 90 days, in both observational and randomized trials (OR, 1.24; 95% CI, 0.69-2.23; P=.48; and OR, 1.17; 95% CI, 0.22-6.27; P=.86) (Figure 5). The incidence of death within 90 days was higher after lesion modification in observational studies (OR, 1.42; 95% CI, 1.04-1.95; P=.03), but similar in randomized studies (OR, 3.83; 95% CI, 0.42-34.95; P=.23) (Figure 6), although the event rate was very low, limiting conclusions for this outcome. The incidence of MI within 90 days was similar between lesion modification and control in both observational and randomized studies (OR, 1.57; 95% CI, 0.99-2.48; P=.06; and OR, 1.22; 95% CI, 0.33-4.49; P=.77, respectively) (Figure 7). 

Figures 2-7

At 1-year follow-up, use of lesion modification was associated with similar MACE in observational studies (OR, 1.20; 95% CI, 0.82-1.76; P=.36), and lower MACE (OR, 0.65; 95% CI, 0.48-0.88; P<.01) in randomized studies (Figure 8). The 1-year incidence of TLR-TVR was higher with lesion modification in observational studies (OR, 1.47; 95% CI, 1.06-2.04; P=.02), but lower in randomized studies (OR, 0.64; 95% CI, 0.46-0.88; P<.01) (Figure 9). There was no difference in 1-year incidence of death between the two groups in observational or randomized studies (OR, 1.12; 95% CI, 0.58-2.19; P=.73; OR, 0.80; 95% CI, 0.33-1.98; P=.63, respectively) (Figure 10). There was also no difference in the incidence of MI (observational OR, 1.07; 95% CI, 0.59-1.94; P=.82; randomized OR, 1.50; 95% CI, 0.62-3.62; P=.36) (Figure 11). 

Figures 8-11

Funnel plot analysis for publication bias demonstrated a reasonable degree of symmetry for observational studies, particularly for 1-year outcomes (Supplemental Figures 1-3). 

Supplemental Figures 1-3

Discussion

Our meta-analysis demonstrates a discrepancy between observational and randomized studies on outcomes after pre-stenting lesion modification: as compared with control, lesion modification was associated with similar acute angiographic outcomes and lower rates of subsequent TLR in randomized studies, whereas outcomes were similar or worse with pre-stenting lesion modification in observational studies. 

Lesion modification prior to stenting allows optimal stent delivery and expansion, which in combination with drug-eluting stents is anticipated to translate into lower long-term MACE and TLR-TVR rates as compared with stenting without lesion pre-treatment. The combination of drug-eluting stents and atherectomy has been proposed to have a synergistic effect in improving the long-term vessel patency of calcified lesions.³³ Atherectomy devices use slightly different mechanisms to improve vascular compliance, by ablating plaque with either orthogonal friction (rotational atherectomy) or centrifugal force (orbital atherectomy). Specialized cutting and scoring balloons use blades or nitinol wires, respectively, mounted on a semicompliant balloon, to form grooves in the plaque during balloon expansion. While there are differences between these devices, they can be used for similar lesion types and attempt to achieve the same goal; thus, they were grouped together in this pooled analysis. 

While plaque modification is essential for successful PCI in some cases, it may carry increased risk of complications. Rotational atherectomy can result in vessel perforation, especially in tortuous vessels.^36,37 It can also result in dissection,³⁸ burr entrapment,^39,40 heart block,⁴¹ and slow-flow due to platelet aggregation, especially during high-speed atherectomy³⁷ or distal embolization of plaque microparticles, with an increased incidence of periprocedural MI.⁴² Similarly, orbital atherectomy⁴³ and cutting/scoring balloons⁴⁴ have been associated with increased risk for dissection and perforation. These risks can be minimized by using low-speed atherectomy when possible, using a lower burr/vessel ratio, prophylactic use of intracoronary vasodilators such as verapamil, adenosine, or nicorandil, and limiting use of atherectomy techniques to experienced operators. Our meta-analysis shows similar 30-day incidence of MACE after lesion modification as compared with no modification, with improved long-term outcomes in randomized studies. 

The discrepancy between observational and randomized data in the present analysis likely reflects important differences in baseline characteristics between control and intervention arms in the observational studies. Randomized comparisons attempt to eliminate these differences in lesion and patient characteristics, and thus more reliably represent the true effect of lesion modification techniques. This is especially important for the use of lesion modification to facilitate stenting, which is indicated for complex lesions. Of note, a large number of the observational studies that were potentially eligible for this analysis did not have a comparison or control group (n = 79 studies), and were thus excluded. All orbital atherectomy studies were excluded for this reason. 

There is a relative paucity of randomized comparisons of lesion modification strategies, either comparing lesion modification to no lesion modification, or comparing various lesion modification strategies to one another. Several factors likely contribute to the lack of randomized studies in this area. First, lesions that require debulking or lesion modification to facilitate stenting are thought to be relatively uncommon. Moreover, designing an adequate control treatment for lesions that are resistant to other treatment strategies (such as heavily calcified lesions, balloon uncrossable/undilatable chronic total occlusions) is challenging. Additionally, variable patient and lesion selection, a variable degree of debulking achieved, and variable operator expertise in using these techniques can obscure the effect of a given technique. Operator experience and skill are variables that are often unstudied, but may have a significant impact on procedural and long-term outcomes. A recent retrospective study of rotational atherectomy performed in a large Japanese cohort (n = 13,335) demonstrated an inversely proportional relationship between volume of rotational atherectomy cases and procedural complications.⁴⁵ Large-scale randomized trials with stringent inclusion criteria, performed at high-volume sites using detailed protocols, including intravascular imaging, will help to address these issues.

New studies are currently being performed on pre-stenting modification of calcified lesions. The PREPARE-CALC (Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial; NCT02502851) is randomizing 200 patients to rotational atherectomy or cutting/scoring balloon prior to placement of a sirolimus-eluting stent. The ECSPAND (Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions) trial (NCT02819531) is randomizing 30 patients to rotational atherectomy, orbital atherectomy, and scoring balloon in a randomized fashion with a primary endpoint of final in-stent minimum lumen area/reference lumen area, as determined by intravascular ultrasonography. The recently initiated multicenter, randomized ECLIPSE trial will compare orbital atherectomy to conventional balloon angioplasty prior to implantation of drug-eluting stents in 2000 patients with calcified coronary lesions.⁴⁶ 

Our meta-analysis is limited by the use of study-level data. Lesion modification was used for a variety of lesion types, in several cases at the operator’s discretion. Outcomes with lesion modification may differ according to lesion type, which likely contributed to the heterogeneity seen in angiographic outcomes. The number of studies assessing the use of scoring balloon was limited, and the present analysis does not include orbital atherectomy due to the lack of controlled studies with this technique to date. Cardiac biomarkers were not systematically measured in most of the studies included. Procedural complications that may potentially be of interest, such as perforation, burr entrapment, and tamponade, were not reported in the majority of the included studies, and thus could not be analyzed. Studies of atherectomy not otherwise specified were excluded from this analysis; however, one randomized study³⁴ that included patients who underwent plaque debulking with either rotational atherectomy (n = 90) or directional atherectomy (n = 48) was included. 

Conclusion

Our meta-analysis of contemporary observational and randomized studies of pre-stenting lesion modification shows a discrepancy between observational and randomized studies, with observational studies showing worse and randomized studies showing better acute and long-term outcomes with lesion modification. Additional randomized trials are needed to optimally evaluate the true impact of pre-stenting lesion modification techniques and their associated risks and benefits. 

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From the ¹VA North Texas Healthcare System and UT Southwestern Medical Center, Dallas, Texas; and ²Minneapolis Heart Institute, Minneapolis, Minnesota.

Disclosures: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Rangan reports research grants from InfraRedX and Spectranetics. Dr Burke reports consulting and speaking honoraria from Abbott Vascular and Boston Scientific. Dr Banerjee reports research grants from Gilead and the Medicines Company; consultant/speaker honoraria from Covidien, Merck, and Medtronic; ownership in MDCare Global (spouse); intellectual property in HygeiaTel; educational grant from Boston Scientific (spouse). Dr Brilakis reports consulting/speaker honoraria from Abbott Vascular, Asahi Intecc, Boston Scientific, Elsevier, Somahlution, St. Jude Medical, and Terumo; research support from Boston Scientific and InfraRedx; spouse is employee of Medtronic.The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted March 2, 2017 and accepted March 24, 2017.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Minneapolis Heart Institute, 920 E. 28th Street #300, Minneapolis, MN 55407. Email: esbrilakis@gmail.com